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 63-82 are currently pending.
Specification
The disclosure is objected to because of the following informalities:
Several groups are incorrectly spelled throughout the specification. For example, “pyrroyl” on Page 6, Line 18 should instead be spelled “pyrrolyl” (pyrrole + yl).
Appropriate correction is required for all such misspellings throughout the specification.
Claim Objections
Claims 63, 66, 77, and 81 are objected to because of the following informalities:
Claim 63: in the definition of RZ, “heterocycle” should instead read “heterocyclyl” to comport with the other acceptable functional groups and reflect its radical nature.
Claim 63: in the definition of RN’, the term “C1-C6)alkyl” should be corrected to close the parenthetical.
Claim 63: G2 should be superscripted in the following:
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Claim 66: all groups erroneously ending in “oyl” instead of “olyl” must be corrected.
Claim 77: an additional blank table row is included between the second and third compounds.
Claim 81: “which” should be amended to read “wherein”
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.
Claims 63-76 and 80-82 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 63 recites “RC” in the definition of R1, R2, and R6; however, RC is undefined. No metes and bounds are established. Examiner looks to Claim 69 reciting a definition of analogous RZ6 for the parameters of RC for the purpose of compact prosecution. The bounds of Claim 69 are clear through exclusion of said undefined group. Claims 64-68, 70-76, and 80-82 are rejected by virtue of dependency.
Claim 63 defines RZ as potentially containing “R”; however, R is undefined. No metes and bounds for R are established. Claim 68 recites a definition of R as it pertains to R3, to which RZ belongs, which is used to interpret the variable recited in Claim 63 for the purpose of compact prosecution. Claims 64-67, 69-76, and 90-82 are rejected by virtue of dependency. Claim 69 recites a definition of R as it relates to R2 and R6 and RZ6 and RZ6’, but not RZ.
Claim 63 in the proviso of R1, R2, and R6 recites “and G1=N together,”. It is unclear what this particular phrase means. Currently (iii) is read 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 64-76 and 80-82 are rejected by virtue of dependency.
Claim 69 recites RZ6 which appears to be an analogous variable or subgroup of RC of Claim 63. It is unclear if the provisos regarding RC of Claim 63 are applicable to RZ6 in Claim 69 because the relation between the two groups is merely implied and assumed for the sake of compact prosecution.
Claim 75 recites “two RA1 together with N-atom”; however, no nitrogen or “N-atom” is present on the RA groups to which RA1 is attached. The RA group of Claim 75 is limited to non-nitrogen embodiments. Further, RA1 is only attached at an oxygen atom such that “two RA1” cannot exist within the confines of Claim 75 without charged and unstable configurations.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 70 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 70 recites a lengthy definition of RN’. However, the same variable is limited to either hydrogen or C1-C6alkyl in Claim 63 upon which Claim 70 ultimately depends. For example, haloalkyl or aryl is not hydrogen or alkyl. The scope of Claim 70 improperly broadens the scope of all the claims upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 63-70, 73-77, 79-80, and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Khalifah (US9428533, published 2016; 12/13/2024 IDS).
Khalifah teaches exemplary AGE inhibitors like
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for treating associated diseases (Abstract; Fig. 1; Col. 15-16; Claim 19). The subject to be treated is particularly identified as having hyperglycemia and/or hyperlipidemia and a human in preferred embodiments (Col. 2 and 22). BST-605 differs from the closest embodiment of the instant claims,
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, in that N-CH3 is instead O. Claim 8 specifically suggests that in a 6-membered A of ring C with two heteroatoms, the NRN1 may instead be an O, resulting in the compound above.
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 Khalifah compound to remove a methylene in the piperazinyl ring such that m of the instant formula is 1 and that the proviso of instant claim 1 (
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) is circumvented.
Therefore, one of skill in the art seeking to treat an AGE associated disease would find it obvious to perform the modifications of BST-605 which is the only identified compound in the Claims (Claim 19) because Khalifah provides narrow guidance for modifying such a compound with the alternative embodiment described above and routine homolog modification is expected to yield a compound of similar properties. The same artisan would expect an AGE formation inhibitor to result from the modification because Khalifah teaches a broad formula in Claim 1 encompassing the modified compounds for the same use as described above along with specific guidance for modification before the effective filing date of the instant claims.
Regarding the language of the instant claims: “inhibiting…(AGE) formation”, upon administration of an AGE formation inhibitor to a patient, one of skill in the art would expect such inhibition to result by virtue of the activity of the inhibitor compounds of Khalifah. Additionally, In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. The same positively recited process step of administration is recited in Khalifah (Col. 2). Thus, the expected intended result of AGE inhibition occurs in the Khalifah methods.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Khalifah as applied to Claims 63-70, 73-77, 79-80, and 82 in further view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 12/13/2024 IDS).
The teachings of Khalifah are set forth above and incorporated by reference herein.
Khalifah teaches generic pharmaceutically acceptable salts of the compounds of the invention (Col. 2; Claim 1). However, no specific salt is described.
Berge, however, teaches such salts to include cations like Zn, Na, K, Mg, Ca, and anions including HCl on Page 2, Table 1. One of skill in the art seeking to form a salt as suggested by Khalifah would find it obvious to form such a salt with those commercial salts described in Berge because 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). The same artisan in pursuit of optimal characteristics as described would also expect success in the formation of said salts before the effective filing date of the instant claims because Berge does not preclude particular pharmaceutical agents and teaches a large proportion of commercially available salts are formed with the respective anions or cations above; e.g., 62% Na, 43% HCl, 3% Zn etc.
Regarding unrejected Claims 71-72 and 78, Khalifah does not permit A groups of ring C wherein the ring comprises fewer than 5 or more than 6 members or embody particular compounds which are obvious variants of the compounds encompassed by the above claims.
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 63-82 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1, 3-5, 9-11, 45-51, and 73-78 of copending Application No. 18818005 (hereinafter referred to as Praetego) in view of Khalifah (US9428533, published 2016; 12/13/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of administering the same inhibitors of AGE/ALE including the following compounds:
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(PTG-670) and
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(PTG-630), and Zn salts thereof.
Praetego does not explicitly teach inhibiting AGE or ALE following administration. However, Praetego teaches the above embodiments as specifically AGE/ALE inhibitors; “PTG-630 and PTG-670 were developed as potent AGE inhibitors” (Specification: Page 33, Line 30). Therefore, one of skill in the art practicing the Praetego method would find it obvious that the administration of the compounds also inhibit AGE formation by virtue of their known activity as AGE inhibitors. Further, In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. The same positively recited process step of administration is recited in both claim sets. Thus, the expected intended result of AGE inhibition occurs in the Praetago methods.
Regarding Claim 80, Praetego does not teach the subjects as human. However, no such subjects for administration are precluded and Praetego lists several diseases in copending Claim 1 known to afflict human patients: Huntington’s, Parkinson’s, etc. Therefore, one of skill in the art would find it obvious to administer the same compounds of the instant invention according to the methods of Praetego in a human to treat diseases known to afflict humans, thereby inhibiting AGE/ALE formation. Khalifah teaches administering pyridine AGE inhibitors to humans (Col. 22).
Regarding Claim 82, Khalifah teaches methods of using AGE inhibitors of the same core to treat patients with hyperglycemia and/or hyperlipidemia (Abstract; Fig. 1; Col. 16). The diseases of Praetego Claim 1 and hyperglycemia and/or hyperlipidemia are not mutually exclusive. Therefore, one of skill in the art would expect success in treating a patient with such conditions of Khalifah and Praetego known to be treated with similar means, pyridine AGE inhibitors including those of Praetego.
Since both applications teach methods resulting in the inhibition of AGE formation comprising administration of the same compounds, 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 63-79 and 81 are anticipated.
This is a provisional nonstatutory double patenting rejection.
Claims 63-82 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 Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 12/13/2024 IDS) and Khalifah (US9428533, published 2016; 12/13/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of administering inhibitors of AGE formation including the particular compounds
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and
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, and pharmaceutical salts thereof.
Praetego does not explicitly teach inhibiting AGE or ALE following administration. However, Praetego teaches the compounds common to both inventions as AGE/ALE inhibitors; “compounds of the disclosure are useful in…their ability to inhibit AGE and/or ALE formation” (Specification: Page 17, Lines 11-15). Therefore, one of skill in the art practicing the Praetego method would find it obvious that the administration of the compounds also inhibit AGE formation by virtue of their known activity as AGE inhibitors. Further, In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. The same positively recited process step of administration is recited in both claim sets. Thus, the expected intended result of AGE inhibition occurs in the Praetago methods.
Regarding Claim 80, Praetego does not teach the subjects as human. However, no such subjects for administration are precluded and Praetego recites “a neurological disease or condition” in copending Claim 63 which are known to afflict human patients. Therefore, one of skill in the art would find it obvious to administer the same compounds of the instant invention according to the methods of Praetego in a human to treat diseases known to afflict humans, thereby inhibiting AGE/ALE formation. Khalifah teaches administering pyridine AGE inhibitors to humans and for the treatment of neurological diseases (Col. 16 and 22).
Regarding Claim 82, Khalifah teaches methods of using AGE inhibitors of the same core to treat patients with hyperglycemia and/or hyperlipidemia (Abstract; Fig. 1; Col. 16). The diseases of Praetego Claim 1 and hyperglycemia and/or hyperlipidemia are not mutually exclusive. Therefore, one of skill in the art would expect success in treating a patient with such conditions of Khalifah and Praetego known to be treated with similar means, pyridine AGE inhibitors including those of Praetego.
Regarding the particular salts listed in Claim 81, Praetego only recites generic “pharmaceutically acceptable salts”.
Berge, however, teaches such salts to include cations including Zn, Na, K, Mg, Ca, and anions including HCl on Page 2, Table 1. One of skill in the art seeking to form a salt as suggested by Praetego would find it obvious to form such a salt with those commercial salts described in Berge because 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). The same artisan in pursuit of optimal characteristics as described would also expect success in the formation of said salts because Berge does not preclude particular pharmaceutical agents and teaches up to 43% of commercially available salts are formed with the respective anions or cations above.
Since both applications teach administering the same AGE inhibitors as salts, 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 63-79 are anticipated.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
Claims 63-70, 73-77, and 79-82 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 Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977. 1-19; 12/13/2024 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 of the same core
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Praetego teaches
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, which is
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.
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 AGE inhibitors for treating associated diseases in a subject in need thereof (Abstract; Col. 15-16; Claim 19). The subject to be treated is particularly identified as having hyperglycemia and/or hyperlipidemia and a human in preferred embodiments (Col. 16 and 22).
The Praetego compound, however, is excepted from the instant claims via proviso. However, multiple modifications are obvious so as to overcome the proviso regarding Z and m of the claimed A group:
Claim 8 of Praetego specifically suggests that in a 6-membered A of ring C with two heteroatoms, the NRN1 may instead be an O, resulting in the compound of instant Claim 79
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.
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 m of the instant formula is 1 and that the proviso of instant claim 1 (
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) is overcome.
Therefore, one of skill in the art seeking to treat an AGE associated disease would find it obvious to perform the above modifications of the Praetego compound because Praetego provides narrow guidance for modifying such a compound with the alternative embodiment described above and routine homolog modification is expected to yield a compound of similar properties. The same artisan would expect an AGE formation inhibitor to result from the modification because Praetego teaches a broad formula in Claim 1 encompassing the modified compounds for the same use as described above.
Regarding the language of the instant claims: “inhibiting…(AGE) formation”, upon administration of an AGE formation inhibitor to a patient, one of skill in the art would expect such inhibition to result by virtue of the activity of the compounds of Khalifah. Additionally, In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. The same positively recited process step of administration is recited in Khalifah. Thus, the expected intended result of AGE inhibition occurs in the Praetego methods.
Praetego does teach salts of the compounds in Claim 1, but does not describe the particular species of examined Claim 81.
Berge, however, teaches such salts to include cations like Zn, Na, K, Mg, Ca, and anions including HCl on Page 2, Table 1. One of skill in the art seeking to form a salt as suggested by Praetego would find it obvious to form such a salt with those commercial salts described in Berge because 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). The same artisan in pursuit of optimal characteristics as described would also expect success in the formation of said salts because Berge does not preclude particular pharmaceutical agents and teaches a large amount of commercially available salts are formed with the respective anions or cations above (Table 1).
Since both claim sets teach AGE inhibitors for the same use, 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 63-82 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-21 of U.S. Patent No. 12139472 (hereinafter referred to as Praetego).
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 for use in administration to subjects afflicted with hyperlipidemia, wherein the inhibitors include compounds
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and
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, and Zn salts thereof.
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). The above compounds for example are taught to treat complications associated with hyperlipidemia and hyperglycemia, inhibit AGE/ALE formation, and inhibit complications associated therewith in humans (Col. 14 and 20).
Praetego does not explicitly teach “methods of inhibiting AGE or ALE” through administration. However, Praetego teaches the compounds common to both inventions as AGE/ALE inhibitors; “compounds of the disclosure are useful in…their ability to inhibit AGE and/or ALE formation” (Col. 14). Therefore, one of skill in the art practicing the Praetego method would expect that the administration of the compounds also inhibit AGE formation by virtue of their known activity as AGE inhibitors. Further, In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. The same positively recited process step of administration is recited in both claim sets. Thus, the expected intended result of AGE inhibition occurs in the Praetago methods.
Since both claim sets teach administering AGE inhibitors as salts with the same activity, 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
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