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 .
Election/Restriction
Applicant’s election without traverse of Group I (claims 1, 3 – 4, 6, 8 – 9, 11 – 12, 14 – 15, 17 – 18, 21, 23 – 24, 26 – 27, 29 – 30, 32 – 33, 37 – 38, and 45 – 46) drawn to a crystalline form of Compound 1:
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, or a solvate thereof in the reply filed on August 10th, 2026 is acknowledged.
Claims 39 – 44, and 47 – 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method of treating a disease or condition in a subject), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 10th, 2026.
Hence claims 1, 3 – 4, 6, 8 – 9, 11 – 12, 14 – 15, 17 – 18, 21, 23 – 24, 26 – 27, 29 – 30, 32 – 33, 37 – 38, and 45 – 46 are being examined on the merits herein.
Claim Objections
Claims 3 – 4, 6, 8 – 9, 11 – 12, 14 – 15, 17 – 18, 23 – 24, 26 – 27, 29 – 30, 32 – 33, and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claims 1, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) in view of Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Regarding claims 1, and 38, Erion’056 teach phosphinic acid-containing compounds that are thyroid receptor ligands, pharmaceutically acceptable salts, and to prodrugs of these compounds as well as their preparation and uses for preventing and/or treating metabolic diseases such as obesity, NASH, hypercholesterolemia and hyperlipidemia as well as associated conditions such as atherosclerosis, coronary heart disease, impaired glucose tolerance and diabetes. See page 1 paragraph 0002. Additionally, Erion’056 teach pharmaceutically acceptable salts and cocrystals, prodrugs, and pharmaceutically acceptable salts and co-crystals of these prodrugs of phosphinic acid-containing compounds. See page 8 paragraph 0037. See claim 1 limitation for a crystalline form. Specifically, Erion’056 teach that phosphinic acid-containing compounds includes compound example 38 of structure
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. See page 393 paragraph 0837. See claim 1 limitation. Additionally, Erion’056 teach that the compounds of the disclosure, which includes compound example 38, may be either crystalline, amorphous or a mixture thereof with compositions comprising a crystalline form containing only one crystalline form of said compound or more than one crystalline form. See page 69 paragraph 0250. See claim 1 limitation for the crystalline form.
Moreover, Erion’056 teach one embodiment of the invention encompasses a unit dosage form which comprises a compound of the present invention or a pharmaceutically acceptable salt, or a polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof, and one or more pharmaceutically acceptable excipients or diluents, wherein the pharmaceutical composition or dosage form is formulated for controlled-release. See page 203 paragraph 0432. See claim 38 limitation for a pharmaceutical composition comprising the crystallin form of claim 1 and one or more pharmaceutically acceptable excipients. Furthermore, Erion’056 teach that the compounds of the disclosure, which include compound example 38, includes salts derived from a finite list of organic bases which includes 2-dimethylaminoethanol. See page 69 paragraph 0251.
While the prior art of Erior’056 does not explicitly teach an example of the crystalline form of compound 1 of structure
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; the prior art of Erion’056 does teach that the crystalline form of compound example 38 is included within the scope of the disclosure. Given that the skill level of one of ordinary skill in the pharmaceutical arts with relatively high being that of a PharmD or PhD it would be within purview of such artisan to take the teachings of Erion’056 to crystalize the compounds of the disclosure, which include compound example 38.
Nevertheless, Domingo et. al. teach that the challenge to optimize the properties of old drugs has led to an expanding world of crystal forms. See page 831 column 2 paragraph 1. Moreover, Domingo et. al. teach that a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS), to identify the most reliable supramolecular synthons, noncovalent bonding patterns or motifs that encode the molecular recognition information during the crystallization process. See page 831 column 2 paragraph 4. Thus, Domingo et. al. suggest that the use of systematic analysis is routine when determine crystal forms. Furthermore, Domingo et. al. teach that this is fundamental for the selection of co-formers for co-crystals, or counter-ions for salts and API-ILs, not disregarding that this choice should be restricted to compounds included in the Everything Added to Food in the US or Generally Regarded as Safe (GRAS) lists. See page 831 column 2 paragraph 4.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the teachings of Erion’056 to modify compound example 38 to make the crystalline form of the molecule in view of Domingo et. al. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Claims 21, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902 in view of Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Regarding claims 21, and 46, Erion’056 teach phosphinic acid-containing compounds that are thyroid receptor ligands, pharmaceutically acceptable salts, and to prodrugs of these compounds as well as their preparation and uses for preventing and/or treating metabolic diseases such as obesity, NASH, hypercholesterolemia and hyperlipidemia as well as associated conditions such as atherosclerosis, coronary heart disease, impaired glucose tolerance and diabetes. See page 1 paragraph 0002. Additionally, Erion’056 teach pharmaceutically acceptable salts and cocrystals, prodrugs, and pharmaceutically acceptable salts and co-crystals of these prodrugs of phosphinic acid-containing compounds. See page 8 paragraph 0037. See claim 21 limitation for a crystalline form. Specifically, Erion’056 teach that phosphinic acid-containing compounds includes compound example 38 of structure
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. See page 393 paragraph 0837. See claim 21 limitation. Additionally, Erion’056 teach that the compounds of the disclosure, which includes compound example 38, may be either crystalline, amorphous or a mixture thereof with compositions comprising a crystalline form containing only one crystalline form of said compound or more than one crystalline form. See page 69 paragraph 0250. See claim 21 limitation for the crystalline form.
Moreover, Erion’056 teach one embodiment of the invention encompasses a unit dosage form which comprises a compound of the present invention or a pharmaceutically acceptable salt, or a polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof, and one or more pharmaceutically acceptable excipients or diluents, wherein the pharmaceutical composition or dosage form is formulated for controlled-release. See page 203 paragraph 0432. See claim 46 limitation for a pharmaceutical composition comprising the crystallin form of claim 21 and one or more pharmaceutically acceptable excipients. Furthermore, Erion’056 teach that the compounds of the disclosure, which include compound example 38, includes salts derived from a finite list of organic bases which includes 2-dimethylaminoethanol. See page 69 paragraph 0251. As evidenced by NCBI the structure of 2-dimethylaminoethanol is
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. See NCBI page 2. See claim 21 limitation for a crystalline form of compound 1-A:
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.
While the prior art of Erior’056 does not explicitly teach an example of the crystalline form of compound 1-A of structure
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; the prior art of Erion’056 does teach that the crystalline form of compound example 38 is included within the scope of the disclosure. Moreover, the prior art of Erion’056 teach that the compounds of the disclosure, which include compound example 38, includes salts derived from a finite list of organic bases which includes 2-dimethylaminoethanol. Given that the skill level of one of ordinary skill in the pharmaceutical arts with relatively high being that of a PharmD or PhD it would be within purview of such artisan to take the teachings of Erion’056 to crystalize the 2-dimethylaminoethanol salt of compound example 38 of the .
Nevertheless, Domingo et. al. teach that the challenge to optimize the properties of old drugs has led to an expanding world of crystal forms. See page 831 column 2 paragraph 1. Moreover, Domingo et. al. teach that a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS), to identify the most reliable supramolecular synthons, noncovalent bonding patterns or motifs that encode the molecular recognition information during the crystallization process. See page 831 column 2 paragraph 4. Thus, Domingo et. al. suggest that the use of systematic analysis is routine when determine crystal forms. Furthermore, Domingo et. al. teach that this is fundamental for the selection of co-formers for co-crystals, or counter-ions for salts and API-ILs, not disregarding that this choice should be restricted to compounds included in the Everything Added to Food in the US or Generally Regarded as Safe (GRAS) lists. See page 831 column 2 paragraph 4.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the teachings of Erion’056 to modify compound example 38 to make the crystalline form of the of the 2-dimethylaminoethanol salt of compound example 38 and in view of Domingo et. al. to crystalize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902.
Regarding claim 45, Erion’056 teach phosphinic acid-containing compounds that are thyroid receptor ligands, pharmaceutically acceptable salts, and to prodrugs of these compounds as well as their preparation and uses for preventing and/or treating metabolic diseases such as obesity, NASH, hypercholesterolemia and hyperlipidemia as well as associated conditions such as atherosclerosis, coronary heart disease, impaired glucose tolerance and diabetes. See page 1 paragraph 0002. Additionally, Erion’056 teach pharmaceutically acceptable salts and cocrystals, prodrugs, and pharmaceutically acceptable salts and co-crystals of these prodrugs of phosphinic acid-containing compounds. See page 8 paragraph 0037. Specifically, Erion’056 teach that phosphinic acid-containing compounds includes compound example 38 of structure
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. See page 393 paragraph 0837. See claim 45 limitation.
Furthermore, Erion’056 teach that the compounds of the disclosure, which include compound example 38, includes salts derived from a finite list of organic bases which includes 2-dimethylaminoethanol. See page 69 paragraph 0251. As evidenced by NCBI the structure of 2-dimethylaminoethanol is
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. See NCBI page 2. See claim 21 limitation for a crystalline form of compound 1-A:
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.
While the prior art of Erior’056 does not explicitly teach an example of a compound having the structure
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; the prior art of Erion’056 teach that the compounds of the disclosure, which include compound example 38, includes salts derived from a finite list of organic bases which includes 2-dimethylaminoethanol. Given that the skill level of one of ordinary skill in the pharmaceutical arts with relatively high being that of a PharmD or PhD it would be within purview of such artisan to take the teachings of Erion’056 to make the 2-dimethylaminoethanol salt of compound example 38 through routine optimization of the solid form.
Nevertheless, Domingo et. al. teach that the challenge to optimize the properties of old drugs has led to an expanding world of crystal forms. See page 831 column 2 paragraph 1. Moreover, Domingo et. al. teach that a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS), to identify the most reliable supramolecular synthons, noncovalent bonding patterns or motifs that encode the molecular recognition information during the crystallization process. See page 831 column 2 paragraph 4. Thus, Domingo et. al. suggest that the use of systematic analysis is routine when determine crystal forms. Furthermore, Domingo et. al. teach that this is fundamental for the selection of co-formers for co-crystals, or counter-ions for salts and API-ILs, not disregarding that this choice should be restricted to compounds included in the Everything Added to Food in the US or Generally Regarded as Safe (GRAS) lists. See page 831 column 2 paragraph 4.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the teachings of Erion’056 to modify compound example 38 to make the 2-dimethylaminoethanol salt and in view of Domingo et. al. to crystallize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
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.
Claims 1, 21, 38, 45 – 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 of U.S. Patent No. US 11707472 B2 to Lian et. al. (Lian’472) in view of International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902 and Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Lian’472 recite a method of therapeutically treating fibrosis, said method resulting in the reduction in the amount of extracellular matrix proteins present in one or more tissues in a subject in need thereof, comprising administering to said subject in need thereof at least one compound having a structure selected from the group consisting of:
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. See reference claim 1. See examined claims 1, 21, and 45. Furthermore, Lian’472 recite a method where said subject has one or more conditions selected from species of fibrotic diseases. See reference claims 2 – 7. Additionally, Lian’472 recite a method of reduction in the amount of extracellular matrix proteins present in one or more tissues in a subject, comprising administering one or more compounds having a structure selected from the group consisting of:
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. See reference claim 8. See examined claims 1, 21, and 45. Furthermore, Lian’472 recite a method where said subject has one or more conditions selected from species of fibrotic diseases. See reference claims 9 – 11 and 14 – 21. Moreover, Lian’472 recite the method comprising administering a composition comprising said compound and one or more pharmaceutically acceptable excipients. See reference claim 12. See examined claims 38 and 46. Additionally, Lian’472 recite the method of (reference) claim 12 where said composition is formulated for oral, intravenous, intraarterial, intestinal, rectal, vaginal, nasal, pulmonary, topical, intradermal, trans dermal, transbuccal, translingual, sublingual, or ophthalmic administration, or any combination thereof. See examined claim 13.
However, Lian’472 fail to recite the crystalline form of compound 1:
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. See examined claim 1 limitation. Moreover, Lian’472 fail to recite the crystalline form of Compound 1-A:
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. See examined claim 21 limitation. Furthermore, Lian’472 fail to recite the compound having the structure
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. See examined claim 45 limitation.
Nevertheless, the prior art teachings of Erion’056 and Domingo et. al. as they relate to thew prior art rejections of examined claims 1, 21, and 45 – 46 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Lian’472 that is to treat fibrosis in view of Erion’056 that is to use the modified compound example 38 that is in the crystalline form of the 2-dimethylaminoethanol salt in further view of Domingo et. al. to crystallize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Claims 1, 21, and 45 – 46 are provisionally rejected on the group or nonstatutory double patenting as being unpatentable over claims 40 – 42, 47, 49 – 51, and 53 – 63 of copending Application No. 16/333513 to Lian et. al. (Lian’513) in view of International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902, and Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Lian’513 recite a method of treating non-alcoholic fatty liver disease, the method comprising administering a dose of a compound every other day to the subject, wherein the dose is about 0.5 mg to about 30 mg, wherein said compound has the structure of Formula I:
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. See reference claim 40. Furthermore, Lian’513 recite dosages and dosage regimens or administration. See reference claims 41, 47, 49 – 51, and 53 – 63. Specifically, Lian’513 teach a method where the selected compound is
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. See reference claim 42. See examined claims 1, 21, and 45.
However, Lian’513 fail to recite the crystalline form of compound 1:
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. See examined claim 1 limitation. Moreover, Lian’513 fail to recite the crystalline form of Compound 1-A:
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. See examined claim 21 limitation. Furthermore, Lian’513 fail to recite the compound having the structure
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. See examined claim 45 limitation.
Nevertheless, the prior art teachings of Erion’056 and Domingo et. al. as they relate to thew prior art rejections of examined claims 1, 21, and 45 – 46 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Lian’513 that is to treat fibrosis in view of Erion’056 that is to use the modified compound example 38 that is in the crystalline form of the 2-dimethylaminoethanol salt in further view of Domingo et. al. to crystallize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Claims 1, 21, 38, 45 – 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 of U.S. Patent No. 11951114 B2 to Lian et.al. (Lian’114) in view of International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902 and Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Lian’114 recite a method for treating X-linked adrenoleukodystrophy, comprising administering to a subject a compound selected from:
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. See reference claims 1 – 3. See examined claims 1, 21, and 45. Furthermore, Lian’114 the method of (reference) claim 1, wherein the compound is administered daily, every other day, or intermittently for three months followed by a period of time of one month when the compound is not administered. See reference claim 6.
However, Lian’114 fail to recite the crystalline form of compound 1:
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. See examined claim 1 limitation. Moreover, Lian’114 fail to recite the crystalline form of Compound 1-A:
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. See examined claim 21 limitation. Furthermore, Lian’114 fail to recite the compound having the structure
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. See examined claim 45 limitation.
Nevertheless, the prior art teachings of Erion’056 and Domino et. al. as they relate to thew prior art rejections of examined claims 1, 21, and 45 – 46 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Lian’114 that is to treat X-linked adrenoleukodystrophy in view of Erion’056 that is to use the modified compound example 38 that is in the crystalline form of the 2-dimethylaminoethanol salt in further view of Domingo et. al. to crystallize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Claims 1, 21, and 45 – 46 are provisionally rejected on the group or nonstatutory double patenting as being unpatentable over claims 1 – 7, 9 – 15, and 17 – 22 of copending Application No. 18/874819 to Lian et. al. (Lian’819) in view of International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902 and Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Lian’819 recite a method of treating X-linked adrenoleukodystrophy in a subject in need thereof, the method comprising administering to the subject a therapeutically effective dosing regimen of compound (1):
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. See reference claim 1. See examined claims 1, 21, and 45 – 46. Furthermore, Lian’819 recite dosages and dosage regimens or administration. See reference claims 2 – 5. Additionally, Lian’819 teach a method where either the subject exhibits certain symptoms or the administration has a certain result. See references claim 6 – 7, 9 – 15, and 17 – 22. See examined claims 1, 21, and 45.
However, Lian’819 fail to recite the crystalline form of compound 1:
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. See examined claim 1 limitation. Moreover, Lian’819 fail to recite the crystalline form of Compound 1-A:
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. See examined claim 21 limitation. Furthermore, Lian’819 fail to recite the compound having the structure
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. See examined claim 45 limitation.
Nevertheless, the prior art teachings of Erion’056 and Domingo et. al. as they relate to thew prior art rejections of examined claims 1, 21, and 45 – 46 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Lian’819 that is to treat X-linked adrenoleukodystrophy in view of Erion’056 that is to use the modified compound example 38 that is in the crystalline form of the 2-dimethylaminoethanol salt in further view of Domingo et. al. to crystallize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Claims 1, 21, and 45 – 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7 of U.S. Patent No. US 12440502 B2 to Lian et. al. (Lian’502) in view of International Publication Number WO 2006/128056 A2 to Erion et. al. (Erion’056; cited on ISR form) as evidenced by National Center for Biotechnology Information (NCBI) (2026). PubChem Compound Summary for CID 7902, 2-(Dimethylamino)ethanol. Retrieved September 5, 2026. Archived by the Internet Archive https://web.archive.org/web/20211127195432/https://pubchem.ncbi.nlm.nih.gov/compound/7902, and Domingo et. al. ((2014), New forms of old drugs: improving without changing, Journal of Pharmacy and Pharmacology, 67, 830 – 846).
Lian’502 recite a method of treating X-linked adrenoleukodystrophy in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a thyroid hormone receptor beta agonist of Formula I:
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. See reference claim 1. Furthermore, Lian’502 recite structure limitations that anticipate the compound of the examined application. See reference claims 2 – 4. See examined claims 1, 21, and 45. Specifically, Lian’513 teach a method where the selected compound is
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. See reference claim 42. See examined claims 1, 21, and 45. Furthermore, Lian’502 recite dosages and dosage regimens or administration. See reference claims 5 – 7.
However, Lian’502 fail to recite the crystalline form of compound 1:
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. See examined claim 1 limitation. Moreover, Lian’502 fail to recite the crystalline form of Compound 1-A:
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. See examined claim 21 limitation. Furthermore, Lian’502 fail to recite the compound having the structure
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. See examined claim 45 limitation.
Nevertheless, the prior art teachings of Erion’056 and Domingo et. al. as they relate to thew prior art rejections of examined claims 1, 21, and 45 – 46 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Lian’502 that is to treat X-linked adrenoleukodystrophy in view of Erion’056 that is to use the modified compound example 38 that is in the crystalline form of the 2-dimethylaminoethanol salt in further view of Domingo et. al. to crystallize the product. One of ordinary skill in art would have been motivated to make this modification to address the challenge of optimize the properties of drugs. One of ordinary skill in the art would have had a reasonable expectation of success because a key concept in the design is a systematic analysis, recurring to the Cambridge Structural Database (CDS).
Conclusion
Claims 1, 21, 38, 45 – 46 are rejected. Claims 3 – 4, 6, 8 – 9, 11 – 12, 14 – 15, 17 – 18, 23 – 24, 26 – 27, 29 – 30, 32 – 33, and 37 are objected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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