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
Status of the Claims
1. Claims 1-3 are the original claims filed 6/16/2023. Claims 1-3 are the pending claims.
Priority
2. USAN 18/210,885, filed 06/16/2023, is a Divisional of 17/175,129, filed 02/12/2021, now abandoned, 17/175,129 Claims Priority from Provisional Application 62/976,582, filed 02/14/2020.
Information Disclosure Statement
3. As of 4/15/2026, no IDS is on file for this application.
Objections
Specification
4. The disclosure is objected to because of the following informalities:
a) The use of the term Tween, Tris, ATCC, NCBI, FASTA, BLASTX, Neupogen, Leucine, Pulmozyme, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
5. Claim 1(h) is objected to because of the following informalities:
a) Amend Claim 1(h) to recite “[mayo] Mayo remission.”
Appropriate correction is required.
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.
6. Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over ClinicalTrials.gov NCT02407236 (pp:1-34; 2015-04-02; “NCT236”) in view of Johanns et al (USPN 10961307; filed 2019-09-24).
Claims 1-3 are drawn to treating moderate to severely active ulcerative colitis using Ustekinumab in a subject showing responsiveness to treatment at 92 weeks based on a clinical endpoint such as listed in the Markush group of claim 1.
AS regards claims 1-3, NCT236 teaches the study for maintenance therapy using ustekinumab for treatment of moderately to severely active ulcerative colitis in subjects demonstrating responsiveness at 44 weeks based on or more clinical scores per US definition as clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
NCT236 teaches “the maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.”
The clinical remission period of an additional 3 years (156 weeks) in the long-term extension study encompasses a 96-week timepoint. Given that evaluation of clinical scores is understood to be inherent to the trial procedure, the testing at any interval at least for the instant claims is routine and within the ordinary skill in the art. IN addition, Applicants have not shown the 92-week interval to be critical or surprising compared to any other interval (e.g. 44 weeks) within the 3-year extension taught by NCT236.
Johanns teaches and claims treating moderately to severely ulcerative colitis and substantiates: the sequence information for Ustekinumab as identical to SEQ ID NOS: 1-11 for the instant claims; and the clinical endpoints corresponding to instant claim 1-
Ref 1. A method of treating moderately to severely active ulcerative colitis (UC) in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising a clinically proven safe and clinically proven effective amount of an anti-IL-12/IL-23p40 antibody, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising: a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1; a CDRH2 amino acid sequence of SEQ ID NO:2; and a CDRH3 amino acid sequence of SEQ ID NO:3; and the light chain variable region comprising: a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4; a CDRL2 amino acid sequence of SEQ ID NO:5; and a CDRL3 amino acid sequence of SEQ ID NO:6, wherein after treating with the antibody, the subject is a responder to treatment by at least one measure of response to treatment selected from the group consisting of:
(i) clinical remission based on at least one of the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1 and the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1,
(ii) endoscopic healing with a Mayo endoscopy subscore of 0 or 1,
(iii) clinical response based on the Mayo endoscopy subscore,
(iv) improvements from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score,
(v) mucosal healing,
(vi) decrease from baseline in Mayo score, and
(vii) clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1.
Ref 2. The method of claim 1, wherein the antibody comprises the heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and the light chain variable region of the amino acid sequence of SEQ ID NO:8.
Ref 3. The method of claim 1, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11.
Johanns teaches and claims testing responsiveness or remission up to 44 weeks
Ref 10. The method of claim 9, wherein the subject is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16 of the treatment and the clinical remission continues at least 44 weeks after week 0.
Johanns teaches and claims testing responsiveness or remission at least up to 44 weeks
Ref 15. The method of claim 9, wherein the subject is identified as having a mucosal healing continuing at least 44 weeks after week 0.
The references in combination are overlapping in the intended use and the measurable clinical outcomes using the Ustekinumab for periods of testing ranging from 44 weeks to 3 years in the long term extension. The clinical remission period of an additional 3 years (156 weeks) in the long-term extension study encompasses a 96-week timepoint. Given that evaluation of clinical scores is understood to be inherent to the trial procedure, the testing at any interval at least for the instant claims is routine and within the ordinary skill in the art. IN addition, Applicants have not shown the 92-week interval to be critical or surprising compared to any other interval (e.g. 44 weeks) within the 3-year extension taught by NCT236.
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.
6. Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10765724. The reference patent is not afforded safe harbor protection under 35 USC 121 because it does not share continuity nor a restriction/speciation with the claims for the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the claim sets is drawn to a method of treating an IL-12/23-related disease in a patient using a the ustekinumab antibody.
Ref antibody claims:
1. A method of treating psoriasis in a patient using an increasing dosing or maintenance interval, comprising administering a pharmaceutical composition comprising an antibody to both IL-12 and IL-23 to the patient, wherein the antibody comprises a heavy chain variable amino acid sequence of SEQ ID NO: 7 and a light chain variable amino acid sequence of SEQ ID NO: 8, in an initial dose, a dose 4 weeks after the initial dose and a dose once every 12 weeks for 24 weeks after administration of the initial dose and increasing the dosing interval 28 weeks after administration of the initial dose to a dosing interval of every 24 weeks after identifying the patient as a responder to the antibody 28 weeks after administration of the initial dose, wherein the dose is 45 mg or 90 mg.
2. The method of claim 1, wherein the step of identifying the patient as a responder to the antibody comprises measuring and identifying the patient as having a PASI75 or PGA 0 or 1 score.
3. The method of claim 1, wherein the antibody to IL-12 and IL-23 administered to the patient is ustekinumab.
4. The method of claim 1, wherein the patient does not show an increased risk of immunogenicity.
5. The method of claim 1, wherein the patient has a PASI75, PASI90 or PGA 0 or 1 score 28 weeks after initial treatment.
6. The method of claim 1, wherein the patient has a PASI75, PASI90 or PGA 0 or 1 score 52 weeks after initial treatment.
7. The method of claim 1, wherein the patient has a PASI75, PASI90 or PGA 0 or 1 score 108, 112 and/or 116 weeks after initial treatment.
8. The method of claim 1, wherein the antibody comprises the heavy chain variable region amino acid sequence of SEQ ID NO: 7 and the light chain variable region amino acid sequence of SEQ ID NO: 8 and comprises about 0.53 mg L-histidine per ml of the pharmaceutical composition; about 1.37 mg L-histidine monohydrochloride monohydrate per ml of the pharmaceutical composition; about 0.04 mg polysorbate 80 per ml of the pharmaceutical composition; about 76 mg of sucrose per ml of the pharmaceutical composition; and water as a diluent at standard state.
9. A method of treating psoriasis in a patient using an a increasing dosing or maintenance interval, comprising administering a pharmaceutical composition comprising an antibody to both IL-12 and IL-23 to the patient in an initial dose, a dose 4 weeks after the initial dose and a dose once every 12 weeks for 24 weeks after administration of the initial dose and increasing the dosing interval 28 weeks after administration of the initial dose to a dosing interval of every 24 weeks after identifying the patient as a responder to the antibody 28 weeks after administration of the initial dose, wherein the dose is 45 mg or 90 mg, and wherein the antibody comprises the heavy chain CDR amino acid sequences of SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3; and the light chain CDR amino acid sequences of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6 and comprises about 0.53 mg L-histidine per ml of the pharmaceutical composition; about 1.37 mg L-histidine monohydrochloride monohydrate per ml of the pharmaceutical composition; about 0.04 mg polysorbate 80 per ml of the pharmaceutical composition; about 76 mg of sucrose per ml of the pharmaceutical composition; and water as a diluent at standard state.
Ref SEQ ID NO: 7 vs SEQ ID NO: 7
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257
640
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Ref SEQ ID NO: 8 vs SEQ ID NO: 8
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244
635
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Ref SEQ ID NO: 1-2-3 vs SEQ ID NO: 1-2-3
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263
640
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Ref SEQ ID NO: 4-5-6 vs SEQ ID NO: 4-5-6
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447
988
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Ref patent SEQ ID NO: 1-8 are 100% identical to SEQ ID NO: 1-8, respectively, of the instant claims.
7. Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11197913. The reference patent is not afforded safe harbor protection under 35 USC 121 because it does not share continuity nor a restriction/speciation with the claims for the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the claim sets is drawn to a method of treating an IL-12/23-related disease in a patient using a the ustekinumab antibody.
Ref patent claims
1. A method of treating psoriatic arthritis in a patient using an increasing dosing or maintenance interval, comprising administering a pharmaceutical composition comprising an antibody to both IL-12 and IL-23 to the patient, wherein the antibody comprises a heavy chain variable amino acid sequence of SEQ ID NO: 7 and a light chain variable amino acid sequence of SEQ ID NO: 8, in an initial dose, a dose 4 weeks after the initial dose and a dose once every 12 weeks for 24 weeks after administration of the initial dose and increasing the dosing interval 28 weeks after administration of the initial dose to a dosing interval of every 24 weeks after identifying the patient as a responder to the antibody 28 weeks after administration of the initial dose, wherein the dose is 45 mg or 90 mg.
2. The method of claim 1, wherein the antibody to IL-12 and IL-23 administered to the patient is ustekinumab.
3. The method of claim 1, wherein the patient does not show an increased risk of immunogenicity.
4. The method of claim 1, wherein the antibody comprises the heavy chain variable region amino acid sequence of SEQ ID NO: 7 and the light chain variable region amino acid sequence of SEQ ID NO: 8 and comprises about 0.53 mg L-histidine per ml of the pharmaceutical composition; about 1.37 mg L-histidine monohydrochloride monohydrate per ml of the pharmaceutical composition; about 0.04 mg polysorbate 80 per ml of the pharmaceutical composition; about 76 mg of sucrose per ml of the pharmaceutical composition; and water as a diluent at standard state.
5. The method of claim 4, wherein the antibody is ustekinumab.
6. A method of treating psoriatic arthritis in a patient using an increasing dosing or maintenance interval, comprising administering a pharmaceutical composition comprising an antibody to both IL-12 and IL-23 to the patient in an initial dose, a dose 4 weeks after the initial dose and a dose once every 12 weeks for 24 weeks after administration of the initial dose and increasing the dosing interval 28 weeks after administration of the initial dose to a dosing interval of every 24 weeks after identifying the patient as a responder to the antibody 28 weeks after administration of the initial dose, wherein the dose is 45 mg or 90 mg, and wherein the antibody comprises the heavy chain CDR amino acid sequences of SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3; and the light chain CDR amino acid sequences of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6 and comprises about 0.53 mg L-histidine per ml of the pharmaceutical composition; about 1.37 mg L-histidine monohydrochloride monohydrate per ml of the pharmaceutical composition; about 0.04 mg polysorbate 80 per ml of the pharmaceutical composition; about 76 mg of sucrose per ml of the pharmaceutical composition; and water as a diluent at standard state.
Ref patent SEQ ID NO: 1-8 are 100% identical to SEQ ID NO: 1-8, respectively, of the instant claims.
8. Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6 and 8-9 of copending Application No. 17/691277 (reference application US 20220291238). The reference is not afforded safe harbor protection under 35 USC 121 because it does not share continuity nor a restriction/speciation with the claims for the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ref and instant claims are drawn to treatment regimens for inflammatory bowel disease inclusive of UC using the VH/VL CDR1-3 of ustekinumab.
Ref patent SEQ ID NO: 1-11 are 100% identical to SEQ ID NO: 1-11, respectively, of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12595510. The reference patent is not afforded safe harbor protection under 35 USC 121 because it does not share continuity nor a restriction/speciation with the claims for the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the claim sets is drawn to a method of treating an IL-12/23-related disease in a patient using a the ustekinumab antibody.
Ref patent claims
1. A method of treating a subject diagnosed with an inflammatory bowel disease (IBD), comprising: (i) identifying a subject diagnosed with an IBD to be a responder to an IBD treatment comprising an anti-interleukin 23 (anti-IL23) antibody, the method comprising: a). contacting a sample from a subject with a set of probes capable of detecting a panel of biomarkers comprising 13 biomarkers selected from the group consisting of CKLF-like MARVEL transmembrane domain containing 2 (CMTM2), complement C5a receptor 1 (C5AR1), fibroblast growth factor 2 (FGF2), glycerol kinase (GK), hepatocyte growth factor (HGF), interleukin 1 receptor antagonist (IL1RN), leukocyte immunoglobulin like receptor A2 (LILRA2), nicotinamide phosphoribosyltransferase (NAMPT), pappalysin 1 (PAPPA), synuclein alpha (SNCA), superoxide dismutase 2, mitochondrial (SOD2), STEAP4 metalloreductase (STEAP4), and zinc finger BED-type containing 3 (ZBED3); b). determining a signature score of the panel of biomarkers, wherein the determining comprises determining the baseline gene expression levels of the panel of biomarkers; and c). identifying a subject to be a responder to the IBD treatment if the signature score of the panel of biomarkers is above a pre-specified threshold indicative of response; and (ii) administering to the subject who has been identified as a responder in c) a therapeutically effective amount of the IBD treatment.
2. The method of claim 1, wherein a. the sample is obtained before the subject is treated with the IBD treatment; or b. the probe is selected from the group consisting of an aptamer, an antibody, an affibody, a peptide, and a nucleic acid.
3. The method of claim 2, wherein the probe is a nucleic acid.
4. The method of claim 2, wherein the probe is selected from the group consisting of SEQ ID NOS. 1-14, SEQ ID NO. 17, SEQ ID NO. 20, SEQ ID NO. 23, SEQ ID NO. 26, SEQ ID NO. 29, SEQ ID NO. 32, SEQ ID NO. 35, SEQ ID NO. 38, SEQ ID NO. 41, SEQ ID NO. 44, SEQ ID NO. 47, and SEQ ID NO. 50.
5. The method of claim 1, wherein the gene expression levels of the panel of biomarkers are determined by quantitative polymerase chain reaction (qPCR).
6. The method of claim 5, wherein the qPCR primers are selected from the group consisting of SEQ ID NO. 15, SEQ ID NO. 16, SEQ ID NO. 18, SEQ ID NO. 19, SEQ ID NO. 21, SEQ ID NO. 22, SEQ ID NO. 24, SEQ ID NO. 25, SEQ ID NO. 27, SEQ ID NO. 28, SEQ ID NO. 30, SEQ ID NO. 31, SEQ ID NO. 33, SEQ ID NO. 34, SEQ ID NO. 36, SEQ ID NO. 37, SEQ ID NO. 39, SEQ ID NO. 40, SEQ ID NO. 42, SEQ ID NO. 43, SEQ ID NO. 45, SEQ ID NO. 46, SEQ ID NO. 48, SEQ ID NO. 49, SEQ ID NO. 51, and SEQ ID NO. 52.
7. The method of claim 1, wherein the pre-specified threshold level is a. selected from the group consisting of between-3.9000 and 1.1000; b. −3.8234; or c. 1.0000.
8. The method of claim 1, further comprising predicting the response by one or more other characteristics of the subject.
9. The method of claim 8, wherein the other characteristics are selected from the group consisting of protein levels, gut microbiome, histology and clinical characteristics of the subject.
10. The method of claim 1, further comprising measuring the response at or after week 6, 30 or 50 of the IBD treatment, or anytime in between.
11. The method of claim 1, wherein the sample is a tissue sample or a blood sample.
12. The method of claim 1, wherein the IBD is at least one of ulcerative colitis (UC) or Crohn's disease (CD).
13. The method of claim 1, wherein the subject had previously failed or were intolerant of at least one therapy selected from the group consisting of: vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence.
14. The method of claim 1, wherein the anti-IL23 antibody is ustekinumab.
10. Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10961307. The reference patent is not afforded safe harbor protection under 35 USC 121 because it does not share continuity nor a restriction/speciation with the claims for the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ref patent and instant claims are drawn to treatment regimens for moderately to severely active ulcerative colitis using the VH/VL CDR1-3, VH/VL domains and HC/CL of ustekinumab.
Ref SEQ ID NO: 1-11 are 100% identical to SEQ ID NO: 1-11, respectively, of the instant claims.
11. Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-12, and 14-19 of copending Application No. 18/383,310 (reference application US 20240182557). The reference is not afforded safe harbor protection under 35 USC 121 because it does not share continuity nor a restriction/speciation with the claims for the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ref and instant claims are drawn to treatment regimens for moderately to severely active ulcerative colitis using the VH/VL CDR1-3 and VH/VL domains of ustekinumab.
Ref SEQ ID NO: 1-11 are 100% identical to SEQ ID NO: 1-11, respectively, of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. No claims are allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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