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 .
Claims 116-135 are pending and have been considered on the merits.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 116-135 are rejected under 35 U.S.C. 103 as being unpatentable over Fiorino et al. (2010, Arthritis Rheum.; IDS ref.) in view of Maldonado et al. (US 2014/0328854; IDS ref.), Fraser et al. (US 2012/0276134; IDS ref.), 3SBio (2014, PR Newswire; IDS ref.) and Sundy et al. (2008, Arthritis & Rheumatism; IDS ref.).
Regarding claims 116 and 124, Fiorino et al. teach a method of treating hyperuricemia in gout patients by administering pegsiticase intravenously at a dose 0.05-0.4 mg/kg (see entire document).
Fiorino et al. do not teach a method of concomitantly administering a composition comprising synthetic nanocarriers comprising PLA and PLA-PEG and comprising rapamycin at a dose of 0.05-0.5 mg/kg with each administration.
Maldonado et al. teach a method of concomitantly administering an immunosuppressant dose such as rapamycin (para. 161) with a pharmacodynamically effective dose of a therapeutic macromolecule (paras. 2, 4, 6). Maldonado et al. teach that the therapeutic macromolecule includes pegsiticase (para. 16 and 183).
It would have been obvious to a person skilled in the art to use the method step of concomitantly administering rapamycin along with pegsiticase as taught by Maldonado et al. for the method of Fiorino et al. This is because Maldonado et al. teach that the concomitant administration of immunosuppressant along with therapeutic macromolecules reduces the undesired formation of anti-therapeutic macromolecule antibody and thus enhances pharmacodynamic effects (Abstract; para. 4). Since pegsiticase taught by Fiorino et al. as well as Maldonado et al. is PEG-conjugated agents like pegloticase, one skilled in the art would expect negative effects of anti-PEG antibodies induced by pegsiticase, and thus, would try to use rapamycin as taught by Maldonado et al. in the method of Fiorino et al. with a reasonable expectation of success.
Regarding the synthetic nanocarriers comprising PLA and PLA-PEG, while Maldonado et al. do not particularly teach the combination of PLA and PLA-PEG, however, Maldonado et al. teach that polymers of synthetic nanocarriers include PLA, PEG, PLGA, PLA-PEG, etc. (paras. 127, 133). Thus, it would have been obvious to one skilled in the art to use both PLA and PLA-PEG together for synthetic nanocarriers with a reasonable expectation of success because both PLA and PLA-PEG are taught by Maldonado et al. as suitable polymers for synthetic nanocarriers, and combining elements known for the same purpose is obvious. See MPEP§2144.06(I).
Regarding the limitation directed to the subject being identified as having had or as being expected to have gout flare (claim 116); having chronic refractory gout (claim 125-126 and 137), the patient with refractory gout taught by Fiorino et al. would meet the subject of the claimed invention.
Regarding the concentration of rapamycin in the synthetic nanocarriers being 0.05-0.5 mg/kg (claim 116), Fiorino et al. in view of Maldonado et al. do not teach the limitation.
Fraser et al. teach a composition comprising synthetic nanocarriers for immunosuppressants including mTOR inhibitors such as rapamycin (Examples 13 and 16; para. 96) and it can be administered along with pegloticase (para. 212). Fraser et al. teach that the doses of the immunosuppressants in the compositions can range from about 0.1 mg/kg to about 25 mg/kg (para. 70), and thus meets the claimed range of 0.05-0.5 mg/kg, or 0.1 or 0.15 mg/kg (RE: claims 116, 127-128).
It would have been obvious to a person skilled in the art to use the dosage of the immunosuppressants such as rapamycin with the synthetic nanocarriers taught by Fraser et al. for the method of Fiorino et al. in view of Maldonado et al. This is because Fraser et al. teach that the composition (i.e. rapamycin attached to synthetic nanocarriers) of Fraser et al. is more targeted immune effects allowing for the targeted delivery to immune cells of interest and thus helpful in reducing off-target effects and/or toxicity (para. 53), and thus, one skilled in the art would recognize the benefit of using the composition (i.e. synthetic nanocarrier coupled to immunosuppressants) is consistent with the teaching of Maldonado et al. that the rapamycin nanocarriers prevent undesired formation of the antibodies against pegsiticase, a PEGylated uricase.
Regarding the limitation directed to the administration of the composition being monthly or at least 3 months (claim 116), Fiorino et al. in view of Maldonado et al. do not teach the limitation. However, Fiorino et al. teach that the single dosage of pegsiticase was followed for 24 days, and the profoundly suppressing effect of uric acid levels by pegsiticase was up to 24 days, and suggested a chronic therapy in gout patients (see conclusion). Furthermore, it is known in the art that other PEGylated uricase, such as pegloticase, is administered every 4 weeks for up to 14 weeks (more than 3 months) for refractory gout (based on Study population) according to Sundy et al. (p.2883, 2nd col., last para.; Fig. 1). Thus, it would have been obvious to a person skilled in the art to administer the combination of pegsiticase and rapamycin nanocarriers taught by Fiorino et al. in view of Maldonado et al. monthly for at least 3 months.
Regarding the limitation that the composition comprising synthetic nanocarriers is administered prior to the composition comprising pegsiticase (claim 117) or the composition comprising synthetic nanocarriers and the composition comprising pegsiticase being administered within an hour of each other (claim 131), Maldonado et al. define the term “concomitantly” as two or more dosages being administered within 1 hour (para. 79). One skilled in the art would understand this “concomitant” administration as one composition administered within 1 hour of the other composition administered, and the order can be either urate oxidase followed by rapamycin or vice versa.
Therefore, it would have been obvious to a person skilled in the art that the concomitant administration of the two compositions of rapamycin and pegsiticase taught by Fiorino et al. in view of Maldonado et al. and Fraser et al. could be in any order including one prior/after the other and within an hour of each other.
Regarding the limitation directed to the rapamycin being encapsulated in the synthetic nanocarriers (claim 118), Maldonado et al. teach that the immunosuppressants are contained within the synthetic nanocarriers (encapsulated) (para. 122).
Regarding claims 119-120 and 132-134, Maldonado et al. teach the diameter of rapamycin nanocarriers being 199 nm or 183 nm determined by dynamic light scattering (para. 288 and 306), which is greater than 100 nm but less than 200 nm. Maldonado et al. teach the load of rapamycin of the synthetic nanocarriers being 9.9% (w/w), for example (para. 266). Thus, the nanocarriers taught by Maldonado et al. utilized for the method of Fiorino et al. would meet the claimed diameter of the synthetic nanocarriers and the load of the rapamycin.
Regarding the route of administration being intravenous infusion (claims 121 and 135), Fiorino et al. teach intravenous administration of pegsiticase (see above), and Maldonado et al. teach intravenous administration or injection in the tail vein (para. 8, 211 and 316; Example 8). Furthermore, Fraser et al. teach the administration of immunosuppressant conjugated synthetic nanocarriers is carried out by intravenously (para. 12). Thus, it would have been obvious to a person skilled in the art to administer pegsiticase and rapamycin nanocarriers intravenously because both are known to be administered intravenously.
Regarding the limitation directed to the subject being with an elevated serum uric acid level (claim 122), Fiorino et al. teach that the gout patients have been screened for plasma uric acid > 6 mg/dL for men and > 5 mg/dL for women, and the mean plasma uric acid was 7.8 mg/dL (see entire document).
Regarding claim 123, Fiorino et al. teach that the method is for managing hyperuricemia, i.e. higher uric acid level in the serum (plasma).
Regarding claims 125-126, Fiorino et al. do not particularly teach the chronic refractory gout.
3SBio teach that pegsiticase could be used for treating chronic refractory gout (p.2).
Thus, it would have been obvious to a person skilled in the art to use the method of Fiorino et al. in view of Maldonado et al. for treating chronic refractory gout using pegsiticase along with synthetic nanocarriers carrying rapamycin with a reasonable expectation of success.
Therefore, the inservention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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 116-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12553041 in view of Maldonado et al. (supra), Fiorino et al. (supra), Sundy et al. (supra), Fraser et al. (supra) and 3SBio (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘041 patent disclose a method of administering a subject having an anti-uricase antibody titer level below a threshold a composition comprising synthetic nanocarriers comprising an immunosuppressant, and a composition comprising pegsiticase. The subject of the claims of the ‘041 patent is considered to meet a subject as claimed in the instant application. The immunosuppressant of the ‘041 patent is not particularly defined, however, the scope of the immunosuppressant encompasses rapamycin according to the specification of the ‘041 patent. Furthermore, it is extremely well known in the art that rapamycin is an immunosuppressant utilized for treating gout according to Maldonado et al. Thus, it would have been obvious to use rapamycin as the immunosuppressant of the ‘041 patent. The claims of the ‘041 patent disclose the amount of immunosuppressant as claimed in the instant application, i.e. 0.05-0.5 mg/kg, and the amount of uricase, i.e. pegsiticase, at 0.1-1.2 mg/kg.
Regarding the “concomitantly administering” of the instant application, the administering step of the composition comprising an immunosuppressant and the composition comprising pegsiticase are “sequentially co-administering”. The instant specification defines the term “concomitantly” as “administering two or more materials/agents to a subject in a manner that is correlated in time”, and the examples of “concomitant administration” include two or more materials/agents administered within 1 week, within 1 day, or with 1 hour. Thus, the scope of the “concomitantly administering” of the instant application includes two materials/agents (i.e. rapamycin and pegsiticase) being sequentially administered as in the claims of the ‘041 patent.
The claims of the ‘041 patent do not particularly disclose the type of nanocarriers, however, Maldonado et al. teach that polymers of synthetic nanocarriers include PLA, PEG, PLGA, PLA-PEG, etc. (paras. 127, 133). Thus, it would have been obvious to one skilled in the art to use both PLA and PLA-PEG together for synthetic nanocarriers with a reasonable expectation of success because both PLA and PLA-PEG are taught by Maldonado et al. as suitable polymers for synthetic nanocarriers, and combining elements known for the same purpose is obvious. Furthermore, Maldonado et al. teach the diameter of rapamycin nanocarriers being 199 nm or 183 nm determined by dynamic light scattering (para. 288 and 306), which is greater than 100 nm but less than 200 nm. Maldonado et al. teach the load of rapamycin of the synthetic nanocarriers being 9.9% (w/w), for example (para. 266). Thus, the nanocarriers taught by Maldonado et al. utilized for the method of the ‘041 patent would meet the claimed diameter of the synthetic nanocarriers and the load of the rapamycin.
Regarding the limitation directed to the administration of the composition being monthly or at least 3 months (claim 116), the claims of the ‘041 patent do not teach the limitation. However, Fiorino et al. teach that the single dosage of pegsiticase was followed for 24 days, and the profoundly suppressing effect of uric acid levels by pegsiticase was up to 24 days, and suggested a chronic therapy in gout patients (see conclusion). Furthermore, it is known in the art that other PEGylated uricase, such as pegloticase, is administered every 4 weeks for up to 14 weeks (more than 3 months) for refractory gout (based on Study population) according to Sundy et al. (p.2883, 2nd col., last para.; Fig. 1). Thus, it would have been obvious to a person skilled in the art to administer the combination of pegsiticase and rapamycin nanocarriers disclosed in the claims of the ‘041 patent monthly for at least 3 months.
Regarding the route of administration being intravenous infusion (claims 121 and 135), the claims of the ‘041 patent do not particularly disclose the route of administration. However, Fiorino et al. teach intravenous administration of pegsiticase, and Maldonado et al. teach intravenous administration or injection in the tail vein (para. 8, 211 and 316; Example 8). Furthermore, Fraser et al. teach the administration of immunosuppressant conjugated synthetic nanocarriers is carried out by intravenously (para. 12). Thus, it would have been obvious to a person skilled in the art to administer pegsiticase and immunosuppressant nanocarriers of the ‘041 patent intravenously because both are known to be administered intravenously according to Fiorino et al., Maldonado et al. and Fraser et al.
Regarding the limitation directed to the subject being with an elevated serum uric acid level (claim 122), the claims of the ‘041 patent do not teach the limitation. However, Fiorino et al. teach that the gout patients have been screened for plasma uric acid > 6 mg/dL for men and > 5 mg/dL for women, and the mean plasma uric acid was 7.8 mg/dL (see entire document).
Regarding claim 123, the claims of the ‘041 patent do not teach the limitation. However, Fiorino et al. teach that the method is for managing hyperuricemia, i.e. higher uric acid level in the serum (plasma).
Regarding claims 125-126, the claims of the ‘041 patent do not particularly teach the chronic refractory gout. However, 3SBio teach that pegsiticase could be used for treating chronic refractory gout (p.2). Thus, it would have been obvious to a person skilled in the art to use the method of the ‘041 patent for treating chronic refractory gout.
Claims 116-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 20, 24, 28, 31, 35, 39, 53 of copending Application No. 17/092148 (reference application) in view of Maldonado et al. (supra), Fiorino et al. (supra), Fraser et al. (supra) as evidenced by Schlesinger et al. (2022, BioDrugs). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘148 application disclose the identical method of administering to a subject having symptomatic chronic gout inadequately controlled with a xanthine oxidase inhibitor and a serum uric acid level of > 7 mg/dL a compositions identical to the claims of the instant application. The difference between the claims of the ‘148 application and the instant application is the use of pegadricase (‘148 application) vs. pegsiticase (instant application). While the claims of the ‘148 application do not disclose pegsiticase, however, it is considered that pegadricase is inherently the same as pegsiticase as it is known in the art that pegsiticase is formerly known as pegsiticase according to Schlesinger et al. (p.96, 1st col.).
Another difference between the claims of the ‘148 application and the instant application is and the administering step of the composition comprising rapamycin and the composition comprising pegsiticase are “sequentially” (reference) and “concomitantly” (instant application). The instant specification defines the term “concomitantly” as “administering two or more materials/agents to a subject in a manner that is correlated in time”, and the examples of “concomitant administration” include two or more materials/agents administered within 1 week, within 1 day, or with 1 hour. Thus, the scope of the “concomitantly administering” of the instant application includes two materials/agents (i.e. rapamycin and pegsiticase) being sequentially administered as in the claims of the ‘148 application. The claims of the ‘148 application disclose that the administering is for at least 6 months.
The claims of the ‘148 application specifically disclose the concentration of rapamycin and pegsiticase within the ranges claimed in the instant application.
The claims of the ‘148 application teach the load of the rapamycin of the synthetic nanocarriers being 7-12% by weight, and the elevated uric acid level of > 7mg/dL, the subject having symptomatic chronic gout inadequately controlled (i.e. chronic refractory gout) which is identical to those claimed in the instant application.
The claims of the ‘148 application do not teach the route of administration, size of the nanoparticle, the subject having hyperuricemia. However, it is well known in the art that the subject having chronic refractory gout would have hyperuricemia.
Regarding the route of administration being intravenous infusion (claims 121 and 135), Fiorino et al. teach intravenous administration of pegsiticase (see above), and Maldonado et al. teach intravenous administration or injection in the tail vein (para. 8, 211 and 316; Example 8). Furthermore, Fraser et al. teach the administration of immunosuppressant conjugated synthetic nanocarriers is carried out by intravenously (para. 12). Thus, it would have been obvious to a person skilled in the art to administer pegsiticase and rapamycin nanocarriers intravenously because both are known to be administered intravenously.
Regarding the limitation directed to the subject being with an elevated serum uric acid level (claim 122), Fiorino et al. teach that the gout patients have been screened for plasma uric acid > 6 mg/dL for men and > 5 mg/dL for women, and the mean plasma uric acid was 7.8 mg/dL (see entire document).
Regarding claim 123, Fiorino et al. teach that the method is for managing hyperuricemia, i.e. higher uric acid level in the serum (plasma).
Regarding the size, Maldonado et al. teach the diameter of rapamycin nanocarriers being 199 nm or 183 nm determined by dynamic light scattering (para. 288 and 306), which is greater than 100 nm but less than 200 nm. Maldonado et al. teach the load of rapamycin of the synthetic nanocarriers being 9.9% (w/w), for example (para. 266).
Thus, the claims of the ‘148 application render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 116-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 116, 118-120, 122-129, 132-134 of copending Application No. 18/933195 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘195 application disclose the identical method of administering to a subject with an elevated serum uric acid level and/or undesired uric acid deposits or a subject identified as having had or as being expected to have gout flare a composition identical to the claims of the instant application for at least three months. The difference between the claims of the ‘195 application and the instant application is that the administering step of the composition comprising rapamycin and the composition comprising pegsiticase are “sequentially” (reference) and “concomitantly” (instant application). The instant specification defines the term “concomitantly” as “administering two or more materials/agents to a subject in a manner that is correlated in time”, and the examples of “concomitant administration” include two or more materials/agents administered within 1 week, within 1 day, or with 1 hour. Thus, the scope of the “concomitantly administering” of the instant application includes two materials/agents (i.e. rapamycin and pegsiticase) being sequentially administered as in the claims of the ‘195 application.
The claims of the ‘195 application specifically disclose the concentration of rapamycin and pegsiticase within the ranges claimed in the instant application. The claims of the ‘195 application teach the route of administration, size of the nanoparticle, the load of the rapamycin of the synthetic nanocarriers, the elevated uric acid level, the subject having hyperuricemia or gout, or acute gout, chronic refractory gout, etc. identical to those claimed in the instant application.
Thus, the claims of the ‘195 application render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 116-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7, 9, 14, 18, 22-23, 28, 32, 36, 38, 49, 83, 97, 113 of copending Application No. 19/448738 (reference application) in view of Fiorino et al. (supra), Maldonado et al. (supra), Fraser et al. (supra), Sundy et al. (supra) and 3SBio (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘738 application disclose the identical method of concomitantly administering to a subject having gout or conditions associated with gout, or preventing gout flares a composition identical to the claims of the instant application. The ‘738 application discloses “an immunosuppressant” being rapamycin, and the identical nanocarriers, the quantity of the immunosuppressant and uricase. As the claims of the ‘738 application disclose that the uricase is pegylated uricase, including pegsiticase.
Regarding the limitation directed to the administration of the composition being monthly or at least 3 months (claim 116), the claims of the ‘738 application do not disclose the limitation. However, Fiorino et al. teach that the single dosage of pegsiticase was followed for 24 days, and the profoundly suppressing effect of uric acid levels by pegsiticase was up to 24 days, and suggested a chronic therapy in gout patients (see conclusion). Furthermore, it is known in the art that other PEGylated uricase, such as pegloticase, is administered every 4 weeks for up to 14 weeks (more than 3 months) for refractory gout (based on Study population) according to Sundy et al. (p.2883, 2nd col., last para.; Fig. 1). Thus, it would have been obvious to a person skilled in the art to administer the combination of pegsiticase and rapamycin nanocarriers taught by Fiorino et al. in view of Maldonado et al. monthly for at least 3 months.
The claims of the ‘738 application do not particularly teach the route of administration, size of the nanoparticle, the load of the rapamycin of the synthetic nanocarriers, the elevated uric acid level, the subject having hyperuricemia, or acute gout, chronic refractory gout.
Regarding the route of administration being intravenous infusion (claims 121 and 135), Fiorino et al. teach intravenous administration of pegsiticase (see above), and Maldonado et al. teach intravenous administration or injection in the tail vein (para. 8, 211 and 316; Example 8). Furthermore, Fraser et al. teach the administration of immunosuppressant conjugated synthetic nanocarriers is carried out by intravenously (para. 12). Thus, it would have been obvious to a person skilled in the art to administer pegsiticase and rapamycin nanocarriers intravenously because both are known to be administered intravenously.
Regarding the size of the synthetic nanocarriers, Maldonado et al. teach the diameter of rapamycin nanocarriers being 199 nm or 183 nm determined by dynamic light scattering (para. 288 and 306), which is greater than 100 nm but less than 200 nm. Regarding the load of rapamycin, Maldonado et al. teach the load of rapamycin of the synthetic nanocarriers being 9.9% (w/w), for example (para. 266).
Regarding the limitation directed to the subject being with an elevated serum uric acid level (claim 122), the claims of the ‘738 application do not teach the limitation. However, Fiorino et al. teach that the gout patients have been screened for plasma uric acid > 6 mg/dL for men and > 5 mg/dL for women, and the mean plasma uric acid was 7.8 mg/dL (see entire document).
Regarding the hyperuricemia (claim 123), the claims of the ‘738 application do not teach the limitation. However, Fiorino et al. teach that the method is for managing hyperuricemia, i.e. higher uric acid level in the serum (plasma).
Regarding claims 125-126, the claims of the ‘738 application do not particularly teach the chronic refractory gout. However, 3SBio teach that pegsiticase could be used for treating chronic refractory gout (p.2). Thus, it would have been obvious to a person skilled in the art to use the method of the ‘738 application for treating chronic refractory gout.
Thus, the claims of the ‘738 application in view of the cited references render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
