DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Rejections:
The rejection of claims 1 and 20-28 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is overcome by the Applicants’ amendments and is hereby withdrawn. Specifically, Applicants amended claim 1 to delete the limitation of “the end of pegloticase treatment”.
Status of the Claims
Claims 1 and 21-28 are pending.
Applicants’ arguments filed 09/10/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 09/10/2026, have each been entered into the record. Applicants have amended claims 1 and 28. Applicants have cancelled claim 20. Therefore, claims 1 and 21-28 are subject of the Office action below.
Maintained Rejections:
Claim Rejections - 35 USC § 102-Maintained
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.
The rejection of claims 1 and 21-22 under 35 U.S.C. 102(a)(1) as being anticipated by NCT03303989 of record (10/06/2017), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
By way of a background, Applicants’ invention (see, e.g., ¶ 0009 of the specification), is drawn to a method for treating gout with a combination therapy comprising pegloticase and mycophenolate mofetil (MMF), which is an immune suppressive agent. Pegloticase (Cell Cept or Krystexxa, KXX), is a monomethoxy polyethylene glycol (mPEG) linked uricase (mPEGylated uricase), which is known in the art for reducing serum uric acid levels in patients with gout (see ¶s 0004 and 0027 of the specification).
Independent claim 1 is directed to a method for treating gout comprising the steps of:
a) administering 500 mg twice/day of MMF orally;
b) co-administering 8 mg of pegloticase intravenously every 2 weeks and 1000 mg twice/day of MMF orally for 12 weeks.
Similar to the Applicants’ invention (see discussions above), NCT03303989 relates to a phase II clinical trial study of a combination therapy (comprising pegloticase and MMF), for treating patients with chronic refractory gout, in order to significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life. Please see “Study Description” section on page 2/11. Pegloticase is also known by other names (Cell Cept or Krystexxa). Please see pages 5/11-6/11.
Specifically, NCT03303989 (see “Intervention/treatment” section on page 5/11), discloses:
a) administering 500 mg twice/day of MMF orally;
b) co-administering 8 mg of pegloticase intravenously every 2 weeks and 1000 mg twice/day of MMF orally for 12 weeks (6 doses of pegloticase) and continue pegloticase therapy for additional 3 months (12 weeks, i.e., additional 6 doses of pegloticase therapy), for a total 12 doses of pegloticase therapy.
Treatment outcome is aimed at lowering serum uric acid (SUA, serum urate) to ≤ 6 mg/dL (see page 3/11).
The gout patients have serum uric acid level of > 6 mg/dL (20 patients 8.9 ± 1.8 mg/dL; 10 patients 9.8 ± 1.3 mg/dL; and 32 patients 9.2 ± 1.7 mg/dL). Please see page 11/19.
Therefore, claim 1 is anticipated by NCT03303989.
Regarding claims 21-22, NCT03303989 teaches patients’ serum uric acid level of >6 mg/dL, measured before infusion (see discussions above).
Response to the Applicant’s Arguments
Applicants argue (see page 5 of Remarks) alleging that NCT03303989 does not qualify as a prior art because the “printout date” of NCT03303989 is 11/17/2022, which is after the priority date of the instant application (01/30/2019).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because Applicants appear to have wrongly construed the date stamp that NCT03303989 was printed from ClinicalTrials.gov website, as meaning the same as the date NCT03303989 was first posted on the website. NCT03303989 was first posted on the ClinicalTrials.gov website (made available to the public) on 10/06/2017 (see page 1), which is before the priority date of the instant application (01/30/2019). Therefore, the use of NCT03303989 as a prior art is proper.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Claim Rejections - 35 USC § 103-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1 and 21-28 under 35 U.S.C. 103 as being unpatentable over: 1) NCT03303989 (10/06/2017); and 2) NCT03303989 (10/06/2017) in view of Freyne of record (Transplantation Proceedings, 2018), is maintained for the reasons of record set forth in the previous Office action.
Response to the Applicant’s Arguments
Applicants did not address the specific grounds of rejection set forth in the previous Office action settings. Applicants argue (see pages 5-6 of Remarks) alleging that claims 1 and 21-28 are non-obvious over the prior art because NCT03303989 does not qualify as a prior art.
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because Applicants’ arguments are reiterations of similar arguments which have been addressed (see discussions above). The Examiner, therefore, applies the same response hereto.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
