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 .
Detailed Action
Claims 1, 3-5, 9-11, 45-51, and 73-78 are currently pending.
Specification
The disclosure is objected to because several functional groups are incorrectly spelled throughout. For example, “oxazoyl” on page Page 14, Line 5 should instead be spelled “oxazolyl”.
Appropriate correction for all such errors throughout the specification is required.
Claim Objections
Claims 1, 3, and 47-48 are objected to because of the following informalities:
Claim 1: “heterocycle” in the definition of RZ should instead be “heterocyclyl” to accord with the other listed “-yl” groups and reflect its radical nature.
Claim 1: the “C1-C6)alkyl” group in the definition of RN’ should be corrected to close the parenthetical.
Claim 1: G2 should be superscripted in the following:
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Claim 3 recites “wherein” twice in succession. One of the two must be deleted.
Claims 47-48 recites “in form of” instead of “in the form of”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, 3-5, 9-11, 47-51, and 73-76 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 regards as the invention.
Claim 1 recites no definition for the RC group listed in the definition of R1, R2, and R6. Therefore, the metes and bounds of RC and Claim 1 have not been established. The groups at the R1, R2, and R6 positions in compounds listed in Claims 45-46 are used to determine the scope of acceptable RC groups for the purpose of compact prosecution. Claims 3-5, 9-11, 47-51, 73-74, and 76 are rejected by virtue of dependency.
Claim 1 recites no definition for R in the definition of RZ’. Therefore the metes and bounds of R and Claim 1 are not established and the scope is unclear. Claims 3-5, 9-11, 47-51, 73-74, and 76 are rejected by virtue of dependency.
Claim 1 recites an unclear limitation in the definition of R1, R2, and R6. The proviso numbered (iii) reads as follows:
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, which does not have a clear meaning. Examiner interprets the above limitation to read as follows: “provided that when X=CR1, and G1=N, then G2 is not O”. Claims 3-5, 9-11, 47-51, 73-74, and 76 are rejected by virtue of dependency.
Claim 5 recites “wherein each carbon atom is substituted by R3”. However, R3 is not an acceptable substituent of the carbon to which the imidazole is attached to the formula I core:
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, as described in Claim 1. Carbon does not normally form five bonds but is tetravalent, forming only four bonds. Requiring additional substitution at this carbon with R3 would disrupt the naturally tendency of carbon. Therefore, the metes and bounds of the claim with respect to this carbon and its substitution are unclear. Claims 9-11 are rejected by virtue of dependency.
Claim 75 recites “the compound comprises” followed by two embodiments. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). The phrase "group consisting of" is a closed term, which is often used in claim drafting to signal a "Markush group" that is by its nature closed. See MPEP 2111.03 (I)-(II). Therefore, it is currently unclear whether the listing is intended to be open as written or requires correction to clearly read as a single closed Markush group. For the purpose of compact prosecution, Claim 75 is interpreted to be limited to the two compounds and salts thereof.
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.
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, 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.
Claims 1, 3-5, 9-11, 45-51, 73-75, and 77-78 are rejected under 35 U.S.C. 103 as being unpatentable over Khalifah (WO2021022215; 1/03/2025 IDS) in view of Sharma (Redox Biology, Volume 34, 2020, 101546. 1-6.).
Khalifah teaches AGE formation inhibitors of the following formula with the same core as that of examined claim formula I:
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(Page 17, Lines 11-15; Claim 1). Similar groups and narrowing limitations are taught (Claims 2-5 and 9-11). The same embodiments of examined Claims 45, 46, 75, and 77-78 are taught at least in Khalifah Claims 45-46. Salts and Zn salts are taught in the stoichiometry claimed (Claims 47-53). The compounds are used in methods of treating “AGE- and/or ALE- associated complications in a subject” (Claim 55). The methods comprise oral and intravenous administration of the claimed compounds (Pages 21-22). AGE-associated disorders comprise neurodegenerative disorders including Alzheimer’s (Page 1).
Khalifah, although implicating AGE in Alzheimer’s disease, fails to teach the treatment of the specific neurological disorders listed in Claim 1.
Sharma teaches plainly “Neurodegenerative diseases (NDD) such as Alzheimer's (AD) and Parkinson's disease (PD) are distinct clinical entities, however, the aggregation of key neuronal proteins, presumably leading to neuronal demise appears to represent a common mechanism…advanced glycation end products (AGEs) trigger the accumulation of such modified proteins, which eventually contributes to pathological aspect of NDDs. Increased levels of AGEs are found in amyloid plaques in AD brains and in both advanced and early PD (incidental Lewy body disease)” (Abstract). Therefore, one of ordinary skill in the art seeking to treat Parkinson’s or Lewy body disease, having identified AGE’s role in the “pathological aspect of NDDs”, would find it obvious to administer the AGE inhibitors or salts thereof of Khalifah to treat said diseases in which AGEs are known to be implicated. The same artisan, before the effective filing date of the present invention, would expect success in doing so because Khalifah explicitly and broadly teaches treating or inhibiting the development of AGE-associated disorders, a genus of conditions to which Parkinson’s belongs, with the claimed AGE inhibitors.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Khalifah in view of Sharma as applied to Claims 1, 3-5, 9-11, 45-51, 73-75, and 77-78 in further view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 1/03/2025 IDS).
The teachings of Khalifah and Sharma are set forth above and incorporated by reference herein.
Khalifah fails to teach di- or trihydrochloride salts of the AGE formation inhibitors.
Berge teaches “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1). Berge lists a limited number of FDA approved pharmaceutical salts including dihydrochloride in Table 1 (Page 2). Therefore, one of skill in the art before the effective filing date of the present invention would find it obvious to select such a salt form of the Khalifah compounds because Khalifah teaches the compounds may be formulated as salts and Berge teaches the particular salt, dihydrochloride, is well-known, FDA approved, and commercially available.
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.
PROVISIONAL:
Claims 1, 3-5, 9-11, 45-51, and 73-78 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 63-82 of copending Application No. 18903228 (hereinafter referred to as Praetego) in view of Khalifah (WO2021022215; 1/03/2025 IDS), Sharma (Redox Biology, Volume 34, 2020, 101546. 1-6.), and Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 1/03/2025 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of administering AGE inhibitors, wherein the inhibitors share the following core:
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, similar substituent groups, and the same embodiments (e.g.,
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and
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).
Praetego fails to teach treating neurological diseases of examined claim 1, oral or intravenous administration, and particular Zn and dihydrochloride salts with specific stoichiometry.
Khalifah teaches AGE formation inhibitors of the following formula with the same core as that of examined claim formula I and Praetego:
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(Page 17, Lines 11-15; Claim 1). Salts and Zn salts with the claimed counterions are taught in the stoichiometry claimed (Claims 47-53). The compounds are used in methods of treating “AGE- and/or ALE- associated complications in a subject” (Claim 55). The methods comprise oral and intravenous administration of the claimed compounds (Pages 21-22). AGE-associated disorders comprise neurodegenerative disorders including Alzheimer’s (Page 1).
Sharma teaches plainly “Neurodegenerative diseases (NDD) such as Alzheimer's (AD) and Parkinson's disease (PD) are distinct clinical entities, however, the aggregation of key neuronal proteins, presumably leading to neuronal demise appears to represent a common mechanism…advanced glycation end products (AGEs) trigger the accumulation of such modified proteins, which eventually contributes to pathological aspect of NDDs. Increased levels of AGEs are found in amyloid plaques in AD brains and in both advanced and early PD (incidental Lewy body disease)” (Abstract).
Berge teaches “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1). Berge lists a limited number of FDA approved pharmaceutical salts including dihydrochloride in Table 1 (Page 2).
Therefore, one of ordinary skill in the art seeking to treat Parkinson’s or Lewy body disease, having identified AGE’s role in the “pathological aspect of NDDs”, would find it obvious to administer the AGE inhibitors of Praetego or salts thereof of Khalifah and Berge to treat said diseases in which AGEs are known to be implicated. The same artisan would expect success in doing so with the compounds of Praetego in the salt forms of Khalifah and Berge because Khalifah explicitly and broadly teaches treating or inhibiting the development of AGE-associated disorders; Berge teaches the particular salt, dihydrochloride, is well-known, FDA approved, and commercially available; and Praetego teaches methods of inhibiting AGE formation with the claimed compounds.
Regarding particular subject conditions, Praetego describes a narrower subset (those afflicted with hyperglycemia for example) which is not precluded by the instant claims.
Since both applications teach methods of administering salts of the same compound to a subject, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Praetego.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-5, 9-11, 45-51, and 73-78 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 63-83 of copending Application No. 19016790 (hereinafter referred to as Praetego) in view of Khalifah (WO2021022215; 1/03/2025 IDS), Sharma (Redox Biology, Volume 34, 2020, 101546. 1-6.), and Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 1/03/2025 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of administering AGE inhibitors to treat a neurological disease, wherein the inhibitors share the following core:
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, similar substituent groups, and the same embodiments (e.g.,
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and
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).
Praetego fails to teach treating specific neurological diseases of examined claim 1, oral or intravenous administration, and Zn and dihydrochloride salts with specific stoichiometry.
Khalifah teaches AGE formation inhibitors of the following formula with the same core as that of examined claim formula I and Praetego:
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(Page 17, Lines 11-15; Claim 1). Salts and Zn salts with the claimed counterions are taught in the stoichiometry claimed (Claims 47-53). The compounds are used in methods of treating “AGE- and/or ALE- associated complications in a subject” (Claim 55). The methods comprise oral and intravenous administration of the claimed compounds (Pages 21-22). AGE-associated disorders comprise neurodegenerative disorders including Alzheimer’s (Page 1).
Sharma teaches plainly “Neurodegenerative diseases (NDD) such as Alzheimer's (AD) and Parkinson's disease (PD) are distinct clinical entities, however, the aggregation of key neuronal proteins, presumably leading to neuronal demise appears to represent a common mechanism…advanced glycation end products (AGEs) trigger the accumulation of such modified proteins, which eventually contributes to pathological aspect of NDDs. Increased levels of AGEs are found in amyloid plaques in AD brains and in both advanced and early PD (incidental Lewy body disease)” (Abstract).
Berge teaches “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1). Berge lists a limited number of FDA approved pharmaceutical salts including dihydrochloride in Table 1 (Page 2).
Therefore, one of ordinary skill in the art seeking to treat Parkinson’s or Lewy body disease, both neurological diseases, having identified AGE’s role in the “pathological aspect of NDDs”, would find it obvious to administer the AGE inhibitors of Praetego or salts thereof of Khalifah and Berge orally or intravenously to treat said diseases in which AGEs are known to be implicated. The same artisan would expect success in doing so with the compounds of Praetego in the salt forms of Khalifah and Berge because Khalifah explicitly and broadly teaches treating or inhibiting the development of AGE-associated disorders; Berge teaches the particular salt, dihydrochloride, is well-known, FDA approved, and commercially available; and Praetego teaches methods of inhibiting AGE formation with the claimed compounds.
Regarding particular subject conditions, Praetego describes a narrower subset (those with cancer, exposed to radiation, etc.) which is not precluded by the instant claims.
Since both applications teach methods of administering salts of the same compound to a subject to treat overlapping genera of neurological diseases, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Praetego.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
Claims 1, 3-5, 11, 45-51, 73-76, and 78 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 9428533 (hereinafter referred to as Praetego) in view of Khalifah (WO2021022215; 1/03/2025 IDS), Sharma (Redox Biology, Volume 34, 2020, 101546. 1-6.), and Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 1/03/2025 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to AGE inhibitors, wherein the inhibitors share the following core:
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and embodiment
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/
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.
Further, O is taught as an alternative embodiment to NRN1 when ring C of A comprises 2 heteroatoms and 6 total members (Claim 8). Therefore, the compound of instant Claim 78
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is obvious over the single embodiment of the Praetego claims because said compound is encompassed within the genus of the Praetego formula and Praetego provides particular specific guidance to form the morpholino analog.
Alternatively, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09. In view of the above, one might modify the Praetego compound to remove a methylene in the piperazinyl ring such that m of the instant formula is 1 and expect similar activities by virtue of the modification being encompassed by the Praetego formula.
Praetego fails to teach compounds of 4 or 7 ring members as described in instant Claims 9-10 or a homolog of the compound described in Claim 77, which would render said claims obvious.
No particular use for the compounds and compositions thereof is taught in the Praetego claims. However, regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Praetego teaches the compounds are used in “methods for treating…one or more AGE- and/or ALE-associated complications…comprising administering one or more compounds…of the invention to a subject in need thereof” (Col. 15).
Praetego fails to claim treating neurological diseases of examined Claim 1, oral or intravenous administration, and Zn and dihydrochloride salts with specific stoichiometry.
Khalifah teaches AGE formation inhibitors of the following formula with the same core as that of examined claim formula I and Praetego:
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(Page 17, Lines 11-15; Claim 1). The same compounds as claimed in or rendered obvious over Praetego and the instant claims are taught:
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(Claim 45). Salts and Zn salts with the claimed counterions are taught in the stoichiometry claimed (Claims 47-53). The compounds are also used in methods of treating “AGE- and/or ALE- associated complications in a subject” (Claim 55). The methods comprise oral and intravenous administration of the claimed compounds (Pages 21-22). AGE-associated disorders comprise neurodegenerative disorders including Alzheimer’s (Page 1).
Sharma teaches plainly “Neurodegenerative diseases (NDD) such as Alzheimer's (AD) and Parkinson's disease (PD) are distinct clinical entities, however, the aggregation of key neuronal proteins, presumably leading to neuronal demise appears to represent a common mechanism…advanced glycation end products (AGEs) trigger the accumulation of such modified proteins, which eventually contributes to pathological aspect of NDDs. Increased levels of AGEs are found in amyloid plaques in AD brains and in both advanced and early PD (incidental Lewy body disease)” (Abstract).
Berge teaches “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1). Berge lists a limited number of FDA approved pharmaceutical salts including dihydrochloride in Table 1 (Page 2).
Therefore, one of ordinary skill in the art seeking to treat Parkinson’s or Lewy body disease, both neurological diseases, having identified AGE’s role in the “pathological aspect of NDDs”, would find it obvious to administer the AGE inhibitors of Praetego, obvious variants thereof, or salts thereof of Khalifah and Berge orally or intravenously to treat said diseases in which AGEs are known to be implicated. The same artisan would expect success in doing so with the compounds of Praetego in the salt forms of Khalifah and Berge because Khalifah explicitly and broadly teaches treating or inhibiting the development of AGE-associated disorders; Berge teaches the particular salt, dihydrochloride, is well-known, FDA approved, and commercially available; Praetego teaches methods of inhibiting AGE formation with the claimed compounds; and Sharma teaches AGE are implicated in the claimed disease pathologies.
Since both claim sets teach overlapping genera of AGE inhibitors and the same embodiments for the use of treating AGE-associated diseases, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Praetego.
Claims 1, 3-5, 9-11, 45-51, and 73-78 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-16 and 19 of U.S. Patent No. 12139472 (hereinafter referred to as Praetego) in view of Khalifah (WO2021022215; 1/03/2025 IDS), Sharma (Redox Biology, Volume 34, 2020, 101546. 1-6.), and Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 1/03/2025 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to AGE formation inhibitors of the same core:
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, similar substituents, and the same embodiments (e.g.,
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) for use in methods of treating AGE-associated diseases. Regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Claims 16 and 19 describe the method of use for treating associated diseases.
Praetego fails to teach treating specific neurological diseases of examined claim 1, oral or intravenous administration, and Zn and dihydrochloride salts with specific stoichiometry.
Khalifah teaches AGE formation inhibitors of the following formula with the same core as that of examined claim formula I and Praetego:
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(Page 17, Lines 11-15; Claim 1). Salts and Zn salts with the claimed counterions are taught in the stoichiometry claimed (Claims 47-53). The compounds are used in methods of treating “AGE- and/or ALE- associated complications in a subject” (Claim 55). The methods comprise oral and intravenous administration of the claimed compounds (Pages 21-22). AGE-associated disorders comprise neurodegenerative disorders including Alzheimer’s (Page 1).
Sharma teaches plainly “Neurodegenerative diseases (NDD) such as Alzheimer's (AD) and Parkinson's disease (PD) are distinct clinical entities, however, the aggregation of key neuronal proteins, presumably leading to neuronal demise appears to represent a common mechanism…advanced glycation end products (AGEs) trigger the accumulation of such modified proteins, which eventually contributes to pathological aspect of NDDs. Increased levels of AGEs are found in amyloid plaques in AD brains and in both advanced and early PD (incidental Lewy body disease)” (Abstract).
Berge teaches “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1). Berge lists a limited number of FDA approved pharmaceutical salts including dihydrochloride in Table 1 (Page 2).
Therefore, one of ordinary skill in the art seeking to treat Parkinson’s or Lewy body disease, both neurological diseases, having identified AGE’s role in the “pathological aspect of NDDs”, would find it obvious to administer the AGE inhibitors of Praetego or salts thereof of Khalifah and Berge orally or intravenously to treat said diseases in which AGEs are known to be implicated. The same artisan would expect success in doing so with the compounds of Praetego in the salt forms of Khalifah and Berge because Khalifah explicitly and broadly teaches treating or inhibiting the development of AGE-associated disorders; Berge teaches the particular salt, dihydrochloride, is well-known, FDA approved, and commercially available; and Praetego teaches methods of inhibiting AGE formation with the claimed compounds.
Since both claim sets teach AGE inhibitors for the use of treating AGE-associated conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Praetego.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
Prosecution Insights