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 .
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 (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.
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.
The factual inquiries 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.
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over the Clinical Trial Listing NCT02277444 (Version Published: Nov 28, 2018) as evidenced by the instant Specification in view of Benedetti et al. (The New England Journal of Medicine. 367: 2385-2395; Published: December 20, 2012).
The Clinical Trial Listing for NCT02277444 teaches a method comprising treating juvenile idiopathic arthritis (JIA) in pediatric patients, the method comprising administering an intravenous (IV) dose of golimumab, an anti-TNF antibody, to the pediatric patient. As evidenced by the instant Specification, golimumab comprises a heavy chain (HC) comprising an amino acid sequence of SEQ ID NO:36 and a light chain (LC) comprising an amino acid sequence of SEQ ID NO:37; see page 1, lines 19-21 of the instant disclosure. The IV dose is 80mg/m2 of the anti-TNF antibody, at weeks 0, 4, and then every 8 weeks thereafter; see Arms and Interventions.
Regarding claims 2 and 3, the pediatric patients enrolled in NCT02277444 are 2 to <18 years old and have been diagnosed with juvenile idiopathic arthritis (JIA) is polyarticular juvenile idiopathic arthritis (pJIA).
Regarding claim 5, the method further comprises administering methotrexate (MTX) to the pediatric patients.
Regarding the treatment period in claim 1, treatment could be administered for up to 244 weeks with outcome measures assessed through week-52.
Regarding the results of said treatment as recited in claim 1, a method cannot be separated from its inherent outcome (see the entire document).
The Clinical Trial Listing for NCT02277444 does not teach a step of measuring whether the pediatric patient has achieved sustained improvement after 52 weeks nor of determining that the patient is a response by achieving the measure of sustained improvement.
Benedetti et al. teaches a clinical trial of tocilizumab in juvenile idiopathic arthritis. Benedetti et al. teaches assessing the proportion of patients who had a JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response; see page 2387 left column.
It would have been obvious to one of ordinary skill in the art to measure JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52, which is the same time frame for measuring pharmacokinetics in the Clinical Trial Listing for NCT02277444. One would have been motivated to modify the Clinical Trial Listing for NCT02277444 to add the JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response measures through week 52 into to compare efficacy with other biologics competing for market share in the in juvenile idiopathic arthritis space. One would have had a reasonable expectation of success measuring JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52 because Benedetti et al. teaches measuring the same efficacy metrics in the same time frame for another biologic therapy in juvenile idiopathic arthritis. Regarding the step of determining that a patient is a responder by achieving the measure of sustained improvement necessarily flows from the step of measuring. Indeed, one measuring whether a patient achieved a sustained improvement, in do so, is determining that a patient is a responder based on the patient having achieved one of the metrics recited. The instant Specification evidences that the outcome inherent to the step of administering the TNF-antibody comprising SEQ ID NOs: 36 and 37 intravenously to patients having juvenile idiopathic arthritis is 70% and 47% of patients achieving JIA ACR 70 or JIA ACR 90, respectively, with response rates maintained through week 52; see page 201.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art
before the effective filing date of the application, as evidenced by the references.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Leu et al. (Clinical Pharmacology in Drug Development. 8(S1): 1–101; Published: August 21, 2019) as evidenced by the instant Specification in view of Benedetti et al. (The New England Journal of Medicine. 367: 2385-2395; Published: December 20, 2012).
Leu et al. teaches treating juvenile idiopathic arthritis (JIA) in pediatric patients, the method comprising administering an intravenous (IV) dose of golimumab, an anti-TNF antibody, to the pediatric patient; see Statement of Purpose, Innovation or Hypothesis section on page 28. As evidenced by the instant Specification, golimumab comprises a heavy chain (HC) comprising an amino acid sequence of SEQ ID NO:36 and a light chain (LC) comprising an amino acid sequence of SEQ ID NO:37; see page 1, lines 19-21 of the instant disclosure. The IV dose is 80mg/m2 of the anti-TNF antibody, at weeks 0, 4, and then every 8 weeks thereafter; see Description of Methods and Materials section.
Regarding claims 2 and 3, the pediatric patients treated were 2 to <18 years old and had been diagnosed with juvenile idiopathic arthritis (JIA) or polyarticular juvenile idiopathic arthritis (pJIA); see Statement of Purpose, Innovation or Hypothesis section on page 28.
Regarding claim 5, the method further comprises administering methotrexate (MTX) to the pediatric patients; see Description of Methods and Materials sections on page 29.
Regarding the treatment period in claim 1, treatment could be administered for up to 244 weeks with outcome measures assessed through week-52. Leu et al. teaches that JIA ACR 30, 50, 70 and 90 response rates were measured; see Data and Results section on page 29.
Regarding the results of said treatment as recited in claim 1, a method cannot be separated from its inherent outcome (see entire Leu et al. Abstract).
Leu et al. does not teach a step of measuring whether the pediatric patient has achieved sustained improvement after 52 weeks nor of determining that the patient is a response by achieving the measure of sustained improvement.
Benedetti et al. teaches a clinical trial of tocilizumab in juvenile idiopathic arthritis. Benedetti et al. teaches assessing the proportion of patients who had a JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response; see page 2387 left column.
It would have been obvious to one of ordinary skill in the art to measure JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52, which is the same time frame for measuring pharmacokinetics in Leu et al. One would have been motivated to modify Leu et al. to add the JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response measures through week 52 into to compare efficacy with other biologics competing for market share in the in juvenile idiopathic arthritis space. One would have had a reasonable expectation of success measuring JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52 because Benedetti et al. teaches measuring the same efficacy metrics in the same time frame for another biologic therapy in juvenile idiopathic arthritis. Regarding the step of determining that a patient is a responder by achieving the measure of sustained improvement necessarily flows from the step of measuring. Indeed, one measuring whether a patient achieved a sustained improvement, in do so, is determining that a patient is a responder based on the patient having achieved one of the metrics recited. The instant Specification evidences that the outcome inherent to the step of administering the TNF-antibody comprising SEQ ID NOs: 36 and 37 intravenously to patients having juvenile idiopathic arthritis is 70% and 47% of patients achieving JIA ACR 70 or JIA ACR 90, respectively, with response rates maintained through week 52; see page 201.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art
before the effective filing date of the application, as evidenced by the references.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ruperto et al. (Clinical Pharmacology in Drug Development. 8(S1): 1–101; Published: August 21, 2019) as evidenced by the instant Specification in view of Benedetti et al. (The New England Journal of Medicine. 367: 2385-2395; Published: December 20, 2012).
Ruperto et al. teaches treating juvenile idiopathic arthritis (JIA) in pediatric patients, the method comprising administering an intravenous (IV) dose of golimumab, an anti-TNF antibody, to the pediatric patient; see Methods section. As evidenced by the instant Specification, golimumab comprises a heavy chain (HC) comprising an amino acid sequence of SEQ ID NO:36 and a light chain (LC) comprising an amino acid sequence of SEQ ID NO:37; see page 1, lines 19-21 of the instant disclosure. The IV dose is 80mg/m2 of the anti-TNF antibody, at weeks 0, 4, and then every 8 weeks thereafter; see Methods section.
Regarding claims 2 and 3, the pediatric patients treated were 2 to <18 years old and had been diagnosed with juvenile idiopathic arthritis (JIA) or polyarticular juvenile idiopathic arthritis (pJIA); see Methods section.
Regarding claim 5, the method further comprises administering methotrexate (MTX) to the pediatric patients; see Methods section.
Ruperto et al. teaches that JIA ACR 30, 50, 70 and 90 response rates were measured at week 28; see Results section.
Regarding the results of said treatment as recited in claim 1, a method cannot be separated from its inherent outcome (see entire Ruperto et al. Abstract).
Ruperto et al. does not teach a step of measuring whether the pediatric patient has achieved sustained improvement after 52 weeks nor of determining that the patient is a response by achieving the measure of sustained improvement.
Benedetti et al. teaches a clinical trial of tocilizumab in juvenile idiopathic arthritis. Benedetti et al. teaches assessing the proportion of patients who had a JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response; see page 2387 left column.
It would have been obvious to one of ordinary skill in the art to measure JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52. One would have been motivated to modify Ruperto et al. to add the JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response measures through week 52 into to compare efficacy with other biologics competing for market share in the in juvenile idiopathic arthritis space. Further, since Benedetti et al. teaches that juvenile idiopathic arthritis is a chronic disease (see Introduction), one would have been motivated to assess efficacy for a treatment duration of minimally through a year given that patients will require long-term therapy. One would have had a reasonable expectation of success measuring JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52 because Benedetti et al. teaches measuring the same efficacy metrics in the same time frame for another biologic therapy in juvenile idiopathic arthritis. Regarding the step of determining that a patient is a responder by achieving the measure of sustained improvement necessarily flows from the step of measuring. Indeed, one measuring whether a patient achieved a sustained improvement, in do so, is determining that a patient is a responder based on the patient having achieved one of the metrics recited. The instant Specification evidences that the outcome inherent to the step of administering the TNF-antibody comprising SEQ ID NOs: 36 and 37 intravenously to patients having juvenile idiopathic arthritis is 70% and 47% of patients achieving JIA ACR 70 or JIA ACR 90, respectively, with response rates maintained through week 52; see page 201.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art
before the effective filing date of the application, as evidenced by the references.
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 1-3 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 17/423,177 in view of Packham et al. (Rheumatology. 41(12): 1428-1435; Published: Dec 1, 2002) and the Clinical Trial Listing NCT02277444 (Version Published: Nov 28, 2018) as evidenced by the instant Specification.
Regarding instant claim 1, copending claims 1, 7, and 15 teach administering an intravenous dose of an anti-TNF antibody comprising the heavy chain and light chains comprising SEQ ID NOs: 36 and 37, respectively, to pediatric patients having JIA. Copending SEQ ID NOs: 36 and 37 are 100% identical to instant SEQ ID NOs: 36 and 37, respectively.
Regarding the outcomes of instant claim 1 (a) – (d), copending claims 1, 2, 7-10, and 15-17 teach the outcomes of achieving: (a) JIA ACR 30, 50, and/or 70, (b) JADAS 71 minimal or low disease activity, and (c) inactive disease.
Regarding instant claims 2 and 3, copending claims 3, 4, 11, 12, 18, and 19 teach treating the same patient population.
Regarding the dosing of the anti-TNF antibody and the use of methotrexate in instant claims 1 and 5, copending claims 5, 6, 13, 14, 20, and 21 teach the same dosing regimen and combination partner.
While the copending claims teach measuring efficacy through week 28, they do not teach a step of measuring whether the pediatric patient has achieved sustained improvement after 52 weeks nor of determining that the patient is a response by achieving the measure of sustained improvement.
Benedetti et al. teaches a clinical trial of tocilizumab in juvenile idiopathic arthritis. Benedetti et al. teaches assessing the proportion of patients who had a JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response; see page 2387 left column.
It would have been obvious to one of ordinary skill in the art to measure JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52. One would have been motivated to modify the method of the copending claims to add the JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response measures through week 52 into to compare efficacy with other biologics competing for market share in the in juvenile idiopathic arthritis space. Further, since Benedetti et al. teaches that juvenile idiopathic arthritis is a chronic disease (see Introduction), one would have been motivated to assess efficacy for a treatment duration of minimally through a year given that patients will require long-term therapy. One would have had a reasonable expectation of success measuring JIA ACR 30, JIA ACR 50, JIA ACR 70, or JIA ACR 90 response through week 52 because Benedetti et al. teaches measuring the same efficacy metrics in the same time frame for another biologic therapy in juvenile idiopathic arthritis. Regarding the step of determining that a patient is a responder by achieving the measure of sustained improvement necessarily flows from the step of measuring. Indeed, one measuring whether a patient achieved a sustained improvement, in do so, is determining that a patient is a responder based on the patient having achieved one of the metrics recited. The instant Specification evidences that the outcome inherent to the step of administering the TNF-antibody comprising SEQ ID NOs: 36 and 37 intravenously to patients having juvenile idiopathic arthritis is 70% and 47% of patients achieving JIA ACR 70 or JIA ACR 90, respectively, with response rates maintained through week 52; see page 201.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art
before the effective filing date of the application, as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s amendments filed November 19, 2025 are acknowledged. Any rejection not repeated above is resolved by amendment.
Applicant’s arguments filed November 19, 2025 have been fully considered but are not persuasive.
Regarding the rejections under 35 U.S.C. 103, specifically the prior art Benedetti et al., Applicant argues that because Benedetti et al. teaches an anti-IL6R antibody at a different dose regimen, the reference does not provide any predictability that the recited anti-TNF antibody 1. can be delivered by IV at dose of 80mg/m2 at weeks 0, 4, and then every 8 weeks thereafter and 2. that a pediatric patient who is administered this dose would achieve a sustained improvement at 52 weeks of treatment.
First, the dose and route of administration (RoA) of the anti-TNF antibody is taught by Leu et al., the Clinical Trial Listing NCT02277444, or Ruperto et al. – Benedetti et al. is not relied upon for the dose and RoA.
Second, Applicants’ interpretation of how the skilled artisan would have interpreted Benedetti et al. is directly contradicted by Tanaka et al. (Biologics: Target and Therapy. 8: 141-1553; Published: April 7, 2014) who demonstrates that the art understood that the effectiveness of tocilizumab and anti-TNF antibodies are comparable with respect to ACR 20 and ACR 50 in rheumatoid arthritis. The instant claims require sustained improvement in only one metric. The inflammatory cytokines involved in rheumatoid arthritis and juvenile idiopathic arthritis, also called juvenile rheumatoid arthritis, are similar as evidenced by Prahalad et al. (Arthritis Research. 4(suppl 3): 303-310; Published: July 24, 2002). Thus, one of ordinary skill in the art, knowing that the TNF – IL-6 inflammatory cascade is present in both RA and JIA and that ACR 20 and ACR 50 efficacy results of the anti-IL-6, tocilizumab, and anti-TNF antibodies in RA were comparable, would have interpreted the findings presented in Benedetti et al. to add to the reasonable expectation of success of the instant anti-TNF antibody in JIA in conjunction with the clinical Trial Listing NCT02277444, Leu et al., or Ruperto et al.
Regarding the Clinical Trial Listing NCT02277444, Applicant argues that there are no efficacy endpoints listed and, thus, there is no reasonable expectation of success and predictability. It is true that no efficacy endpoints are listed in the Outcome Measures; however, the Title and Detailed Description section teach that the trial is evaluating efficacy suggesting there are efficacy endpoints being measured although not disclosed in the listing. Further, Applicants’ interpretation of how the skilled artisan would have interpreted the Clinical Trial Listing NCT02277444 is directly contradicted by Simponi Aria label (Published: February 2018) which demonstrates that golimumab is already used to treat rheumatic articular diseases in adults. NCT02277444 is merely a single-arm trial to establish safety and efficacy in a pediatric population. Additionally, MPEP 2107.03 states “if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.”
Regarding Leu et al., Applicant argues that Leu et al. is silent to measuring JIA ACR 30, 50, 70, or 90 response, inactive disease or clinical remission after 52 weeks of treatment and because Benedetti et al. teaching an IL-6R antibody – not an anti-TNF – there is no reasonable expectation of success and predictability.
In the Data and Results section, Leu et al. teaches that “[c]onsistently high JIA ACR 30, 50, 70 and 90 response rates were observed across the trough serum golimumab concentration quartiles. Clinically-important improvement from baseline in joint symptoms, physical function and physician/parent/subject-reported assessments of disease were observed.” Although, Leu et al. does not state that the JIA ACR 30, 50, 70 and 90 response rates were evaluated after 52 weeks of treatment, the reference teaches that pharmacokinetic and safety data were assessed across the 52 week treatment period and the title states “Week 52 Results”. Thus, it would have been reasonable to conclude that the JIA ACR data was obtained over the same 52 week treatment period as the pharmacokinetic data. Additionally, Leu et al. teaches findings from the clinical trial NCT02277444, MPEP 2107.03 states “if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.”
Regarding Ruperto et al., Applicant argues that 28-week efficacy data does not provide reasonable expectation of success and points to Patel et al. which teaches that there is a high fail rate of candidate drugs moving from Phase 2 to Phase 3 trials.
As of the effective filing date, golimumab is not a “candidate drug”, but rather a commercial asset. Golimumab is sold under the brand Simponi Aria and prescribed for rheumatic articular diseases in adults; see Simponi Aria label (Published: February 2018). The Phase 3 trial taught by Ruperto et al. is a single-arm, open-label trial to move into a pediatric population. The argument of high failure rate of candidate drugs is not persuasive. Additionally, Ruperto et al. teaches interim findings from the clinical trial NCT02277444, MPEP 2107.03 states “if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.”
Regarding the nonstatutory double patenting rejection over the copending claims of 17/423,177, Applicant argues that the copending claims are distinct because the copending claims recite after 28 weeks and the instant claims recite after 52 weeks. After 28 weeks is open-ended and encompasses after 52 weeks. The argument is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Clinical Trial Listing NCT01230827 (Version Published: Mar 31, 2016) and Results (Version Published: Apr 4, 2016) teaches treating JIA patients with multiple joint involvement (reads on polyarticular) by administering SC golimumab and methotrexate for a 48-treatment period and assessing the outcomes of claim 1 (a) – (d). Wallace et al. (The Journal of Rheumatology. 41: 1163-1170; Published: May 1, 2014) teaches that in polyarticular JIA achieving at least JIA ACR 70 at 4 months was a positive predictor of clinically inactive disease after 4 months; see Table 3 and Figure 2. Gerloni et al. (Arthritis & Rheumatism. 52(2): 548-553; Published: Feb 3, 2005) teaches treating polyarticular JIA by administering intravenous infliximab (anti-TNFα) and methotrexate for 1 year and measuring JIA ACR 20, JIA ACR 50, and JIA ACR 70.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE ANN HOLTZMAN whose telephone number is (571)270-0252. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm MT.
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/KATHERINE ANN HOLTZMAN/Examiner, Art Unit 1646
/JULIET C SWITZER/Primary Examiner, Art Unit 1682