DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment filed on 09 February 2023 is acknowledged and entered. Following the amendment, the original claims 7, 9, 11, 19, 21 and 23 are canceled, claims 6, 10, 18, 22 and 25 are amended.
Currently, claims 1-6, 8, 10, 12-18, 20, 22 and 24-26 are pending and under consideration.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 12/23/2025, 2/20/2025, 5/13/2024, 4/9/2024, 6/14/2023 and 6/7/23 are acknowledged and has been considered. A signed copy is attached hereto.
Priority acknowledgement
This application claims benefit of U.S. application 16/892,533 filed 06/04/2020, which claims benefit of U.S. provisional applications 62/856,997 filed on 06/04/2019; and 62/993,259 filed on 03/23/2020, which is acknowledged.
Claims
Claims 1-3 and 14-16 are objected to for the following informalities, appropriate corrections are required:
Claim 1 recites “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 of SEQ ID NO: 2, and a CDRH3 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 of SEQ ID NO: 5, and a CDRL3 of SEQ ID NO: 6”; the following is suggested: “wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NO: 1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NO: 4-6, respectively” (see specification, p217, for example).. Same is suggested for claim 14.
Claim 2 recites “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; the following is suggested: “wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8”. Same is suggested for claim 15.
Claim 3 recites “wherein the antibody comprises the heavy chain amino acid sequence of SEQ ID NO: 9, and the light chain amino acid sequence of SEQ ID NO: 10”; the following is suggested: “wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10”. Same is suggested for claim 16.
Rejections under 35 U.S.C. §112:
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION. - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8, 10, 12-18, 20, 22 and 24-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for the recitation “wherein the subject achieves at least a 20% improvement in the American College of Rheumatology core set disease index (ACR20) after the treatment” because such represents the treatment result or efficacy after the treatment, thus, it is unclear how anyone would be able to predict or demand such a treatment result/efficacy, or how a patient for the treatment can be selected prior to the treatment in order for the patient to achieve such a result after the treatment? What about if a patient is a non-responder after the treatment? Treatment result or efficacy cannot be predicted or demanded as it is out of anyone’s control once the therapeutic agents are administered. The metes and bounds of the claim, therefore, cannot be determined. Deleting “wherein …” clause is suggested. Claims 6, 8, 10, 12, 14, 18, 20, 22 and 24 are similarly indefinite.
Claim 6 is indefinite for the recitation “wherein the ACR20 is achieved following a treatment period of about 24 weeks or about 52 weeks” because of the following: a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation of “about 52 weeks”, and the claim also recites “about 24 weeks”, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 18 is similarly indefinite.
Claim 10 is indefinite for the recitation “at least about 24 weeks” as neither the claim nor the specification defines the term. Therefore, it is unclear as to what time period is covered by the term “at least about”; for example, is 23 weeks “at least about 24 weeks”? “At least” implies a minimum; while “about” suggests a range around the number, rendering the combination of “at least” and “about” ("at least about") logically contradictory. The metes and bounds of the claim, therefore, cannot be determined. Deleting “at least” or “about” is suggested. Claims 11, 12 and 22-24 are similarly indefinite.
Claim 20 is further indefinite because it is incomplete as it is dependent from a canceled claim, claim 19. Claims 22 and 24 are similarly indefinite.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
Rejections Over Prior Art:
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.
Note, as claims 20, 22 and 24 are indefinite for the reasons above, their relevance over the prior art could not be properly evaluated at this point. Therefore, claims 20, 22 and 24 are excluded from the following prior art rejections.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8, 10, 12-18 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT03158285 (5/18/2017; provided by applicant), and as evidenced by Bedi et al. (WO2018218215A1, 11/29/2018; provided by applicant).
Clinical Trial NCT03158285 discloses a study evaluating the efficacy and safety of guselkumab administered subcutaneously in participants with active psoriatic arthritis (PsA) who are biologically naive and have had inadequate response to standard therapies, which study will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA; wherein efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule (pages 1-2, for example). Additionally, NCT03158285 teaches that the study regimens include that participants received subcutaneous (SC) guselkumab 100 mg once every 4 weeks (q4w) from Week 0 through Week 100 (Group 1); or received SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Group 2) (page 3); and that outcome measures were performed at week 24 or week 52, which measures include, among others, ACR 20, HAQ-DI, ACR 50, IGA and DAS28 (pages 4-5 and 7; and pages 25, item 74, for example); wherein regarding IGA at week 24, percentage of participants who achieved psoriasis response with IGA score of 0 (Cleared) or 1 (minimal) and >=2 grade reduction from baseline at week 24 among participants with >=3% BSA psoriatic involvement and IGA score of >=2 (mild) at baseline (page 5, item 3). As evidenced by Bedi, the heavy chain (HC) of guselkumab comprises amino acids 1-447 of SEQ ID NO:130 (which is a fusion protein comprising the HC of guselkumab, a peptide linker (GGGGS)3, and TIM3 ECD (Fig. 97A), and the light chain (LC) of guselkumab comprises the amino acid sequence of SEQ ID NO:131; wherein amino acids 1-447 of SEQ ID NO:130 and SEQ ID NO:131 are 100% identical to the present HC of SEQ ID NO:9 and LC of SEQ ID NO:10, respectively (see attached sequence search result below). The present HC of SEQ ID NO:9 and LC of SEQ ID NO:10 comprise the VH of SEQ ID NO: 7, and the VL of SEQ ID NO: 8. Therefore, Clinical Trial NCT03158285 anticipates claims 1-6, 8, 10, 12, 13 and 25. Note, with respect to the efficacy limitations recited in claims 1, 6, 8, 10, 12, they would be inherent properties of the prior art method because the treatment results are out of anyone’s control. Further, NCT03158285 teaches that inclusion criteria of the study also include, among others, having active plaque psoriasis, with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis (pages 65-66, “Inclusion Criteria”). Therefore, Clinical Trial NCT03158285 also anticipates claims 14-18. Note, with respect to the efficacy limitations recited in claims 14 and 18, they would be inherent properties of the prior art method because the treatment results are out of anyone’s control.
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 of this title, 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.
Claims 1-6, 8, 10, 12-18, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03158285 (5/18/2017), and as evidenced by Bedi et al. (WO 2018/218215A1, 11/29/2018), as applied to claims 1-6, 8, 10, 12-18 and 25 above, and further in view of Wang et al. (US 2015/0064193, 3/5/2015; provided by applicant).
The teachings of Clinical Trial NCT03158285 are reviewed above. NCT03158285 does not teach to treat PsA with guselkumab and a standard therapy for the PsA (claim 26).
Wang teaches that PsA is a frequent and chronic disease that encompasses a spectrum of overlapping clinical entities, including psoriasis and joint pain; and about 10-40% of patients with psoriasis suffer from PsA; that the majority of patients will have psoriasis before the associated arthritis occurs and will be under treatment for their skin disease, and NSAIDs are used for musculoskeletal pain symptoms; and that traditional disease modifying anti-rheumatic drugs (DMARDs) include methotrexate (MTX), sulfasalazine, cyclopsorine, and leflunomide and are inadequate for a number of patients because these drugs only partially control established disease (page 1, [0004] and [0005]). Additionally, Wang teaches methods of treating a patient having PsA with an IL-17 antibody such as secukinumab (abstract, for example); and that secukinumab may be administered either alone or in combination with other agents and therapies for treating PsA patients, e.g., in combination with at least one additional PsA agent, such as, among others, a disease-modifying anti-rheumatic drug (DMARD) (e.g., MTX), a pain-control drug (e.g., tramadol or paracetamol), a steroid (e.g., prednisone), and a non-steroidal anti-inflammatory drug (NSAID) (page 19, [0144]).
With respect to claim 26, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat PsA patients, especially those who had inadequate response to traditional disease DMARDs or PsA agents, with guselkumab and a PsA agent (“a standard therapy”) such as a traditional DMARD, following the teachings of NCT03158285 and Wang. Note, according to the specification, “the standard therapy is at least one selected form the group consisting of non-biological disease-modifying antirheumatic drugs (DMARDs), oral corticosteroid, apremilast, nonsteroidal anti-inflammatory drugs (NSAIDs)” (page 52, lines 9-11). The person of ordinary skill in the art would have been motivated to do so for more effective treatment of PsA because Wang teaches that traditional DMARDs are inadequate for a number of patients as these drugs only partially control established disease, and because guselkumab has a different mode of action from that of traditional PsA agents or DMARDs; and reasonably would have expected success because both traditional PsA agents and guselkumab are known for treating PsA, and they have different modes of action.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting Rejections:
Note, as claims 20, 22 and 24 are indefinite for the reasons above, their relevance over the claims in a patent or a patent application could not be properly evaluated at this point. Therefore, claims 20, 22 and 24 are excluded from the following double patenting rejections.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4-6, 8, 10, 12-15, 17, 18 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 10, 12 and 13 of U.S. Patent No. 7,935,344, and in view of Clinical Trial NCT03158285 (5/18/2017; provided by applicant).
Claims 1, 2, 5, 10, 12 and 13 of the ‘344 patent are directed to an isolated IL-23p19 antibody comprising CDRL1-3 of SEQ ID NO:50, 56 and 73, respectively; and CDRH1-3 of SEQ ID NO:5, 20 and 44, respectively (claim 1, for example); or comprising the VH and VL of SEQ ID NO:105 and 116, respectively (claim 5); a composition thereof (claims 10, 12 and 13, for example), wherein the CDRH1-3 of SEQ ID NO:5, 20 and 44 and the CDRL1-3 of SEQ ID NO:50, 56 and 73 of the patent are 100% identical to the present SEQ ID NO:1-6, respectively; and the VH and VL of SEQ ID NO:105 and 116 are 100% identical to the present VH and VL of SEQ ID NO:7 and 8, respectively. In addition, the ‘344 patent teaches the use of the composition of the anti-IL-23p19 antibody for treating diseases including psoriatic arthritis (column 44, lines 29-31, for example). The teachings of Clinical Trial NCT03158285 are reviewed above. It would have been obvious to the person of ordinary skill in the art to treat PsA with guselkumab by subcutaneous administration with the regimen as recited in the present claims for the reasons discussed in detail above (under “Prior Art Rejections”). Therefore, the conflicting claims are not patentably distinct from each other for the reasons discussed above. See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010).
Claims 1, 2, 4-6, 8, 10, 12-15, 17, 18 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5-7, 9 and 10 of U.S. Patent No. 7,993,645, in view of Clinical Trial NCT03158285 (5/18/2017; provided by applicant), for the similar reasons above (over US 7,935,344).
Claims 1, 2, 4-6, 8, 10, 12-15, 17, 18 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,783,607, in view of Clinical Trial NCT03158285 (5/18/2017; provided by applicant), for the similar reasons above (over US 7,935,344).
Claims 1, 2, 4-6, 8, 10, 12-15, 17, 18 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5 and 7-9 of U.S. Patent No. 10,030,070, in view of Clinical Trial NCT03158285 (5/18/2017; provided by applicant), for the similar reasons above (over US 7,935,344).
Claims 1, 2, 4-6, 8, 10, 12-15, 17, 18 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4 and 6 of U.S. Patent No. 8,221,760, in view of Clinical Trial NCT03158285 (5/18/2017; provided by applicant).
Claims 1-8 of ‘760 patent are directed to a method for treating an IL-23 related condition by administering a composition comprising an antibody comprising CDRL1-3 of SEQ ID NO:50, 56 and 73, respectively; and CDRH1-3 of SEQ ID NO:5, 20 and 44, respectively (claim 1, for example), or a composition comprising an antibody comprising the VL of SEQ ID NO:116, and the VH of SEQ ID NO:106 (claim 4, for example), wherein the composition can be administered subcutaneously (claims 3 and 6, for example); and wherein the IL-23 related condition includes psoriatic arthritis (claims 1 and 4, for example). The CDRH1-3 of SEQ ID NO:5, 20 and 44 and CDRL1-3 of SEQ ID NO:50, 56 and 73 of the patent are 100% identical to the present SEQ ID NO:1-6, respectively; and the VL of SEQ ID NO:116, and the VH of SEQ ID NO:106 of the patent are 100% identical to the present SEQ ID NO:8 and 7, respectively. The teachings of Clinical Trial NCT03158285 are reviewed above. It would have been obvious to the person of ordinary skill in the art to treat psoriatic arthritis with guselkumab by subcutaneous administration with the regimen as recited in the present claims for the reasons discussed in detail above (under “Prior Art Rejections”). Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1, 2, 4, 6, 8, 10, 12-15, 17, 18, 25 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-21 and 23-41 of U.S. Patent No. 12,404,324. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1, 3-21 and 23-41 of the ‘324 patent are directed to a method for treating psoriatic arthritis by subcutaneous administration a composition comprising an antibody to IL-23 in an initial dose of 100 mg at week 0, a dose of 100 mg at week 4 and a dose of 100 mg every 8 weeks thereafter (q8w), wherein the patient showed an inadequate response to or intolerance to standard non-biologic therapies for psoriatic arthritis; wherein the antibody comprises CDRL1-3 of SEQ ID NO:50, 56 and 73, respectively; and CDRH1-3 of SEQ ID NO:5, 20 and 44, respectively (claim 1, for example); or comprises the VH and VL of SEQ ID NO:105 and 116, respectively; or is guselkumab (claims 21 and 41, for example); wherein improvement in disease activity is measured by various scoring systems by week 24 of treatment with the antibody (claims 1, 3-17, 21 and 23-37, for example); and wherein the treatment can further comprises administering one or more additional drugs used to treat psoriasis arthritis such as NSAIDs (claims 19, 20, 39 and 40, for example). The CDRs of SEQ ID NO:50, 56, 73, 5, 20 and 44 of the ‘324 patent are 100% identical to the present SEQ ID NO:1-6, respectively; and the VH and VL of SEQ ID NO:105 and 116 of the ‘324 patent are 100% identical to the present SEQ ID NO:7 and 8; the various scoring systems recited in the claims of the ‘324 patent are the same as those recited in the present claims 1, 6, 8, 10, 12, 14 and 18; and the regimen recited in independent claims 1 and 21 of the ‘324 patent is the same as that in the present independent claim 14, and more than that in the present independent claim 1. Therefore, the claims of the ‘324 patent render the present claims 1, 2, 4, 6, 8, 10, 12-15, 17, 18, 25 and 26 obvious; and the conflicting claims are not patentably distinct from each other.
Claims 1, 2, 4-6, 8, 10, 12-15, 17, 18, 25 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-10 and 12-17 of copending Application No. 19/259,990 in view of Clinical Trial NCT03158285 (5/18/2017), for the similar reasons above (over US 12,404,324; both belong to the same family).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 8, 10, 12, 13, 25 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-14, 16-25 and 27-29 of copending Application No. 17/691,182.
Claims 1-3, 5-14, 16-25 and 27-29 of the ‘182 application are directed to a method of treating psoriatic arthritis by subcutaneous administering 100 mg of an anti-IL-23 antibody once every 4 weeks (q4w) or once every 8 weeks (q8w) (claims 1 and 12, for example); or a pharmaceutical composition of the anti-IL-23 antibody useful for treating moderately to severely active psoriatic arthritis (claim 25); wherein the patient achieves at least a 20% improvement in ACR20 after the treatment (claims 1 and 12, for example), or the patient has at least one psoriatic plaque of > 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis before the treatment (claim 12, for example); the patient further achieves and maintains following a treatment period of about 100 weeks the improvement in, among others, ACR50, HAQ-DI, CRP, and IGA following a treatment period, such as about 24 weeks or 100 weeks (claims 5-10 and 17-21, for example); and the patient has had inadequate response to a standard therapy for the PsA (claims 11 and 22), and is also administered with the standard therapy during the treatment (claim 23); and wherein the antibody comprises the CDRH1-3 of SEQ ID NO: 1-3, and CDRL1-3 of SEQ ID NO: 4-6, respectively; or the VH and VL of SEQ ID NO: 7 and 8, respectively; or the H and L chains of SEQ ID NO: 9 and 10, respectively (claims 1-3 and 12-14, for example). The CDRs of SEQ ID NO:1-6 of the ‘182 application are 100% identical to the present SEQ ID NO:1-6, respectively; the VH and VL of SEQ ID NO:7 and 8 of the ‘182 application are 100% identical to the present SEQ ID NO:7 and 8; and the H and L chains of SEQ ID NO: 9 and 10 of the ‘182 application are 100% identical to the present SEQ ID NO:9 and 10. Therefore, the claims of the ‘182 application render the present claims 1-5, 8, 10, 12, 13, 25 and 26 obvious; and the conflicting claims are not patentably distinct from each other.
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DONG JIANG/
Primary Examiner, Art Unit 1674
2/4/26
Sequence Alignment
RESULT 9
BFW15577
ID BFW15577 standard; protein; 643 AA.
XX
DT 24-JAN-2019 (first entry)
XX
DE Anti-IL23 antibody heavy chain-TIM-3 ECD fusion protein, SEQ ID 130.
XX
KW Guselkumab; HAVCR2 protein; IL23 protein;
KW T-cell immunoglobulin and mucin-domain containing-3; TIM-3; antibiotic;
KW antibody; antibody therapy; antiinflammatory; antimicrobial-gen.; cancer;
KW chemotherapy; cytostatic; fusion protein; heavy chain; immune disorder;
KW immune modulation; immunomodulator; immunotherapy; infectious disease;
KW inflammatory disease; prophylactic to disease; protein therapy;
KW recombinant protein; therapeutic.
XX
OS Homo sapiens.
OS Synthetic.
XX
CC PN WO2018218215-A1.
XX
CC PD 29-NOV-2018.
XX
CC PF 25-MAY-2018; 2018WO-US034755.
XX
PR 26-MAY-2017; 2017US-0511911P.
PR 29-NOV-2017; 2017US-0592341P.
XX
CC PA (UYJO ) UNIV JOHNS HOPKINS.
XX
CC PI Bedi A, Ravi R;
XX
DR WPI; 2018-94915U/01.
XX
CC PT New molecule comprises a targeting moiety and immunomodulatory moieties,
CC PT useful for treating cancer or an infectious disease.
XX
CC PS Claim 24; SEQ ID NO 130; 195pp; English.
SQ Sequence 643 AA;
Query Match 100.0%; Score 2400; DB 27; Length 643;
Best Local Similarity 100.0%;
Matches 447; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVQSGAEVKKPGESLKISCKGSGYSFSNYWIGWVRQMPGKGLEWMGIIDPSNSYTRY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVQSGAEVKKPGESLKISCKGSGYSFSNYWIGWVRQMPGKGLEWMGIIDPSNSYTRY 60
Qy 61 SPSFQGQVTISADKSISTAYLQWSSLKASDTAMYYCARWYYKPFDVWGQGTLVTVSSAST 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SPSFQGQVTISADKSISTAYLQWSSLKASDTAMYYCARWYYKPFDVWGQGTLVTVSSAST 120
Qy 121 KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY 180
Qy 181 SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV 240
Qy 241 FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY 300
Qy 301 RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTK 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTK 360
Qy 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG 420
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Db 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG 420
Qy 421 NVFSCSVMHEALHNHYTQKSLSLSPGK 447
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Db 421 NVFSCSVMHEALHNHYTQKSLSLSPGK 447