DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 06/02/2025, 9/15/2025, and 12/15/2025 is acknowledged. Applicant also elected the species for the composition form to be a powder (dry, lyophilized powder), the organic base to be metformin, and the disease species to be diabetic nephropathy the examination. Upon review, the species for the composition form is expanded to include tablets, the organic base is expanded to include choline, the disease species is expanded to include diabetes and hyperuricemia and metabolic syndrome along with its symptoms including obesity and hyperglycemia (i.e. elevated fasting plasma glucose).
Priority
This application repeats a substantial portion of prior Application No. 14776905 filed 03/17/2014, and adds disclosure not presented in the prior application wherein the instant application is a continuation-in-part of the prior application.
The instant claims recites a method of treating a disease/condition associated with increased expression of xanthine oxidase enzyme or increased activity of xanthine oxidase enzyme or elevated uric acid levels or a combination thereof in a patient, comprising administering a therapeutically effective amount of a xanthine oxidase inhibitor and an organic base, and optionally a pharmaceutical carrier with a molar ratio of oxypurinol to organic base of about 1:1-about 1:10 with 50-1000mg of oxypurinol and the organic base is optionally lysine, arginine, choline or metformin or a combination thereof. The content for the organic base to possibly include metformin was not previously present in the prior application wherein the priority date of these claims is given the filing date of the instant application of 09/15/2015.
Status of Application
Applicant has elected Group II in response to restriction requirement and elected the species for the composition form to be a powder (dry, lyophilized powder), the organic base to be metformin, and the disease species to be diabetic nephropathy the examination. Upon review, the species for the composition form is expanded to include tablets, the organic base is expanded to include choline, the disease species is expanded to include diabetes and hyperuricemia and metabolic syndrome along with its symptoms including obesity and hyperglycemia (i.e. elevated fasting plasma glucose.
Due to restriction, based on election of Group II and species elections above, claims 1-8, 19-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-24 are pending.
Claims 9-18 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The independent claim and its dependent claims is directed to the method of treatment with a composition comprising a xanthine oxidase inhibitor and an organic base, and optionally a pharmaceutically acceptable carrier; wherein (i) the molar ratio of oxypurinol to organic base is about 1:1-to about 1:10; and (ii) the composition comprises 50mg -1000mg of oxypurinol, wherein the organic base is optionally, lysine, arginine, choline or metformin or a combination thereof. This is indefinite as the claims do not recite what the xanthine oxidase inhibitor is wherein it is unclear if the oxypurinol is the xanthine oxidase inhibitor or if there is a separate xanthine oxidase inhibitor in addition to the oxypurinol. It is also unclear as the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (i.e. the organic base is optionally, lysine, arginine, choline or metformin or a combination thereof”). It does not allow one of skill in the art to ascertain the metes and bounds of the invention. For purposes of examination it is treated to the species addressed above.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim is indefinite as it recites that the administered composition “is disposed in a bottle, container or sachet or gelatin capsule, of any combination both powdered preparation for mixing with water by the user in one two or more containers to make a liquid formulation”; wherein it is unclear what is meant by “gelatin capsule, of any combination both powdered preparation for mixing with water….” – what is “of any combination both powdered preparation for mixing with water”? What are the both powdered preparation for mixing? It does not allow one to ascertain the metes and bounds of the claimed invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9, 13-16, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plouvier et al. (WO 2006/083687).
The claims are so broad as to read upon the following prior art.
Rejection:
Plouvier et al. teaches treating conditions including diabetes and kidney disease and hyperuricemia, with the administration of a crystalline choline salt of oxypurinol (molar ratio of 1:1 oxypurinol to choline, claims 19-20). The composition forms administered for the method include a powder, tablet, sachet (claim 19 and 10). The composition can contain various excipients including citric acid (antioxidant).
All the critical elements are taught by the cited reference and thus the claims are anticipated.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Plouvier et al. (WO 2006/083687) as applied to claims 9, 13-16, 18 above.
Rejection:
The teachings of Plouvier et al. are addressed above
Plouvier et al. does not claim or exemplify the inclusion of citric acid but does teach its inclusion.
Wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exemplify the taught/claimed method of treatment with the oxypurinol choline salt with excipients in the composition such as citric acid with a reasonable expectation of success.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Plouvier et al. (WO 2006/083687) as applied to claims 9, 13-16, 18 above, in view of Winfield (Powders and granules).
The teachings of Plouvier et al. are addressed above.
Plouvier et al. does not recite the type/size of the powder or a container for the powder but does teach the composition form administered to include powders.
Winfield teaches that powders (dry) are known to have standard particle size descriptions where they would normally be “moderately fine” or a “fine" powder where they would pass through a nominal mess aperture of 355um and 180um respectively (both micronized size dry powder, Particle size). Winfield also teaches that the powder can be placed in containers like glass or plastic, and in sachet (Containers for internal powders).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have powders in its known size and place the powder in containers/sachets as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to have powders in its conventional size and place powders in its conventional packaging with a reasonable expectation of success.
Claims 9-10, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Melani et al. (WO 2011/141419) in view of Jenkins et al. (U.S. Pat. Pub. 2010/0160351).
Rejection:
Melani et al. teaches treating conditions including metabolic syndrome and diabetes (exemplified models, Page 8-10) and the hyperglycemia associated with the condition (including fasting plasma glucose) with the administration of a composition comprising a xanthine oxidase inhibitor and biguanide (abstract, Page 8, Page 2 line 26-Page 3 line 3, Page 4 line 2-9). Metabolic syndrome manifestations also include obesity (Page 7 line 4-5). The xanthine oxidase inhibitor can be febuxostat and the biguanide can be metformin (Page 2 line 26-35, Page 3 line 25-Page 4 line 9 and line 16-21).
The xanthine oxidase inhibitor can be from 10-200mg per dose and metformin is from 100-1500mg dose, and the dose is known to lowered or raised according to the response and assessment of the patient (Page 7 line 7-24). Composition forms include powders, granules, and tablets (Page 4 line 37- Page 5 line 13 line 30-32, Page 5 line 36-Page 6 line 14). The powder can also be used for reconstitution for injectable solutions/dispersions (Page 6 line 6-8). Excipients include sodium citrate (an antioxidant, Page 5 line 13-15) and bentonite (an antioxidant, Page 5 line 23, see full document specifically areas cited).
Melani et al. does not recite the inclusion of oxypurinol but does teach the inclusion of xanthine oxidase inhibitors like febuxostat.
Jenkins et al. teaches that known xanthine oxidase inhibitors include allopurinol, febuxostat, oxypurinol, tisopurine or an inositol (claim 6).
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to incorporate oxypurinol into the composition for administration as suggested by Jenkins et al. and produced the claimed invention; as simple substitution of one known xanthine oxidase inhibitor for another is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specifically claimed xanthine oxidase inhibitor. It would also be prima facie obvious to optimize within the taught ranges for the amount of xanthine oxidase inhibitors and metformin to arrive at the claimed ratio (xanthine oxidase inhibitor from 10-200mg (about 0.07-about 1.32 mole oxypurinol) and metformin is from 100-1500mg (about 0.77-about 11.61 mole metformin), molar ratio with oxypurinol to metformin is from 1:0.58-1:165.86) absent evidence of criticality for the claimed values.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Melani et al. (WO 2011/141419) in view of Jenkins et al. (U.S. Pat. Pub. 2010/0160351) as applied to claims 9-10, 13-18 above, further in view of Winfield (Powders and granules).
The teaching of Melani et al. in view of Jenkins et al. are addressed above.
Melani et al. in view of Jenkins et al. does not recite the type/size of the powder or a container for the powder but does teach the composition form administered to include powders.
Winfield teaches that powders (dry) are known to have standard particle size descriptions where they would normally be “moderately fine” or a “fine” powder where they would pass through a nominal mesh aperture of 355um and 180um respectively (both micronized size dry powder, Particle size). Winfield also teaches that the powder can be placed in containers like glass or plastic, and in sachet (Containers for internal powders).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have powders in its known size and place the powder in containers/sachets as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to have powders in its conventional size and place powders in its conventional packaging with a reasonable expectation of success.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 9, 11-12, 14-18 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 9, 11-12, 14-18 of copending Application No. 19102611 (reference application).
The copending claim recites the same method with the same composition form wherein the copending claim is obvious over the instant claims.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 10 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19102611 (reference application).
The copending claim recites the same method with the same composition form wherein the copending claim is obvious over the instant claims.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 9-10, 13-16, 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/722330 in view of Melani et al. (WO 2011/141419).
The copending claim is directed to a method of treating kidney disease progression comprising administering a xanthine oxidase inhibitor comprising oxypurinol and an organic base such as biguanide.
The copending claim does not recite the amount of oxypurinol or the ratio to the biguanide, or the composition form.
Melani et al. teaches that the combination of a xanthine oxidase inhibitor and biguanide for treating conditions is known (abstract, Page 8, Page 2 line 26-Page 3 line 3, Page 4 line 2-9). The biguanide can be metformin (Page 2 line 26-35, Page 3 line 25-Page 4 line 9 and line 16-21) and the xanthine oxidase inhibitor can be from 10-200mg per dose and metformin is from 100-1500mg dose, and the dose is known to lowered or raised according to the response and assessment of the patient (Page 7 line 7-24). Composition forms include powders, granules, and tablets (Page 4 line 37- Page 5 line 13 line 30-32, Page 5 line 36-Page 6 line 14). The powder can also be used for reconstitution for injectable solutions/dispersions (Page 6 line 6-8). Excipients include sodium citrate (an antioxidant, Page 5 line 13-15) and bentonite (an antioxidant, Page 5 line 23).
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to incorporate oxypurinol along with the biguanide metformin into the composition for administration at their known ranges as suggested by Melani et al. and produced the claimed invention; as the inclusion of the active at its known therapeutic range is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specifically claimed amount. It would also be prima facie obvious to optimize within the taught ranges for the amount of xanthine oxidase inhibitors and metformin to arrive at the claimed ratio (xanthine oxidase inhibitor from 10-200mg (about 0.07-about 1.32 mole oxypurinol) and metformin is from 100-1500mg (about 0.77-about 11.61 mole metformin), molar ratio with oxypurinol to metformin is from 1:0.58-1:165.86) absent evidence of criticality for the claimed values.
This is a provisional nonstatutory double patenting rejection.
Claims 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/722330 in view of Melani et al. (WO 2011/141419) as applied to claims 9-10, 13-16, 18 above, further in view of Winfield (Powders and granules).
The teachings of the copending claim in view of Melani et al. are addressed above.
The copending claim in view of Melani et al. does not recite the type/size of the powder or a container for the powder but does teach the composition form administered to include powders.
Winfield teaches that powders (dry) are known to have standard particle size descriptions where they would normally be “moderately fine” or a “fine" powder where they would pass through a nominal mess aperture of 355um and 180um respectively (both micronized size dry powder, Particle size). Winfield also teaches that the powder can be placed in containers like glass or plastic, and in sachet (Containers for internal powders).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have powders in its known size and place the powder in containers/sachets as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to have powders in its conventional size and place powders in its conventional packaging with a reasonable expectation of success.
Conclusion
Claims 9-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613