Notice of Pre-AIA or AIA Status
1. 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 Application, Amendments, and/or Claims
2. Claims 1-20 are pending and the subject of this Office Action.
Specification
Nucleotide and/or Amino Acid Sequence Disclosures
3. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete for the following reason(s): the size of the XML file is required to be in bytes. Please see image below for correct file size.
PNG
media_image1.png
105
956
media_image1.png
Greyscale
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claims 3, 6 and 12-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites “wherein the subject achieves DAPSA LDA and IGA ≤ 1”, however claim 1, from which claim 3 depends, recites “measuring DAPSA LDA and IGA ≤ 1”, thus claim 3 is not further limiting. Claim 6 recites “wherein the subject does not achieve DAPSA LDA and IGA 1 and/or the subject has DAPSA high disease activity with a score >28”, however claim 1, from which claim 3 depends, recites “measuring DAPSA LDA and IGA ≤ 1”, thus claim 6 fails to include all the limitations of the claim upon which it depends. Claims 12-18 recite a number of scores for tests, but do not set forth any additional elements or method steps, therefor the claims are not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
6. 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.
7. Claims 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Claim 1 is rejected as being indefinite for reciting “determining if the subject achieved DAPSA low disease activity (LDA) and/or IGA ≤ 1”. Since the previous step recites “measuring DAPSA low disease activity (LDA) and IGA ≤ 1”, it is not clear what the “determining” step is intended to encompass.
9. Claim 1 recites the limitation "the evaluation" in line 8 of the claim. There is insufficient antecedent basis for this limitation in the claim. The previous steps do not recite an “evaluation”, and it is not clear if it refers to the “measuring” or the “determining” steps. Furthermore, the claim is indefinite because it recites “maintaining or adjusting treatment parameters… based on the evaluation”, but it is not clear how they (e.g., dose or dosing interval) are adjusted based on the evaluation.
10. Claim 4 recites the limitation "every 4 weeks". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 4 ultimately depends, does not recite a dosing interval of every 4 weeks.
11. Claim 5 recites the limitation "100mg". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 5 ultimately depends, does not recite a dose of 100mg.
12. Claim 7 recites the limitation "every 8 weeks". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 7 ultimately depends, does not recite a dosing interval of every 8 weeks.
13. Claim 8 recites the limitations "100mg" and “50mg”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 8 ultimately depends, does not recite doses of 100mg or 50mg.
14. Claim 11 recites the limitation "the pharmaceutical composition" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 11 depends, does not recite a pharmaceutical composition.
15. Claim 19 is rejected as being indefinite for reciting “determining if the subject achieved DAPSA low disease activity (LDA) and/or IGA ≤ 1”. Since the previous step recites “measuring DAPSA low disease activity (LDA) and IGA ≤ 1”, it is not clear what the “determining” step is intended to encompass.
16. Claim 19 recites the limitation "initial administration". There is insufficient antecedent basis for this limitation in the claim. The previous steps do not recite an “initial administration”, thus it is not clear if it refers to the time after the single administration of the antibody, or if a dosing interval in the “administering” step is implied.
17. Claim 20 is rejected as being indefinite for reciting “determining if the subject achieved DAPSA low disease activity (LDA) and/or IGA ≤ 1”. Since the previous step recites “measuring DAPSA low disease activity (LDA) and IGA ≤ 1”, it is not clear what the “determining” step is intended to encompass.
18. Claim 20 recites the limitation "initial administration". There is insufficient antecedent basis for this limitation in the claim. The previous steps do not recite an “initial administration”, thus it is not clear if it refers to the time after the single administration of the antibody, or if a dosing interval in the “administering” step is implied.
19. Claims 2-3, 6, 9-10 and 12-18 are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
20. 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.
21. 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.
22. 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.
23. Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT02319759 (v1, 12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018).
24. Clinical Trial NCT02319759 discloses an efficacy and safety study of guselkumab in the treatment of participants with active psoriatic arthritis (PsA), wherein the participants received guselkumab 100 mg subcutaneous injection at weeks 0, 4, 12, 20, 28, 36, and 44 (2ⁿᵈ page, under "Study Description"; and under "Arms and Interventions", 1st group ("Experimental: Guselkumab"), for example). Additionally, Clinical Trial NCT02319759 teaches that the efficacy will be assessed primarily by measuring percentage of participants who achieve an American College of Rheumatology (ACR) 20 Response and/or other scores including, among others, ARC50, HAQ-DI Score, LEI, Dactylitis Scores, and PASI 75 at Week 24 or 16 (3ʳᵈ - 4th page, under "Outcome Measures", for example). Further, as evidenced by Reichert, guselkumab comprises the VH of SEQ ID NO:42 and the VL of SEQ ID NO:43 (page 15, Table 5), which are 100% identical to the present VH of SEQ ID NO:7 and VL of SEQ ID NO:8, respectively; and comprise the present CDRs of SEQ ID NO:1-3 and 4-6. It is noted with respect to the limitations of "wherein the subject achieves DAPSA LDA and IGA ≤1" (claim 3), "wherein the subject does not achieve DAPSA LDA and IGA ≤1" (claim 6), “wherein the subject achieves at least 20% improvement in the [ACR20]” (claims 12-13), and “wherein the subject achieves and maintains following a treatment period of about 100 weeks an improvement in a disease activity” (claims 14-18), these recitations represent the treatment efficacy and can be determined by reviewing the measured results (mental process); are not considered active method steps in the claims ("wherein "); and they do not in any way alter the method of treatment, and therefore do not carry patentable weight here.
25. Clinical Trial does not teach assessing DAPSA or Investigator’s Global Assessment (IGA), or adjusting the dose or dosing interval based on said assessments, nor does it disclose the specific composition of guselkumab, as recited in claim 11.
26. However, before the effective fling date of the claimed invention, both DAPSA and IGA were being used to assess psoriasis severity and were being used to monitor the success of treatment, as disclosed by Langley and Schoels.
27. Moreover, Randazzo discloses a pharmaceutical composition comprising the anti-IL-23 specific antibody guselkumab at 100 mg/mL; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water; and a method of treating psoriasis in a patient comprising subcutaneously administering the pharmaceutical composition of guselkumab (page 2, [0010] - [0014], for example). Additionally, Randazzo teaches that guselkumab has the VH amino acid sequence of SEQ ID NO: 106 and the VL amino acid sequence of SEQ ID NO: 116 and having the heavy chain CDR amino acid sequences of SEQ ID NO: 5, SEQ ID NO: 20, and SEQ ID NO: 44; and the light chain CDR amino acid sequences of SEQ ID NO: 50, SEQ ID NO: 56, and SEQ ID NO: 73 (page 4, [0030], for example), all of which sequences are 100% identical to the SEQ ID NOs recited in the present claims. 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 psoriatic arthritis with Randazzo's pharmaceutical composition of guselkumab following the teachings of Clinical Trial NCT02319759 and Randazzo, and to monitor the effectiveness and adjust the treatment (i.e. treat-to-target) utilizing DAPSA and/or IGA as disclosed by Langley and Schoels. The person of ordinary skill in the art would have been motivated to do so for the treatment of PsA, and reasonably would have expected success since measuring the effectiveness of PsA treatment with DAPSA and/or IGA were known, and Randazzo teaches that the pharmaceutical composition of guselkumab can be used for such treatment.. 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
28. 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.
29. Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8-10, 12 and 13 of U.S. Patent No. 7,935,344, in view of Clinical Trial NCT02319759 (12/18/2014) and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018). Claims 1, 3, 8-10, 12 and 13 of '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), a composition thereof (claims 10, 12 and 13, for example), wherein the CDRL1-3 of SEQ ID NO:50, 56 and 73, and CDRH1-3 of SEQ ID NO:5, 20 and 44 are 100% identical to the present SEQ ID NO:1-3 and 4-6, respectively, of the instant claims. In addition, '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 NCT02319759 are reviewed above. It would have been obvious to the person of ordinary skill in the art to treat psoriatic arthritis with guselkumab with the regimen as recited in the present claims, and to monitor the effectiveness and adjust the treatment utilizing DAPSA and/or IGA as disclosed by Langley and Schoels, 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).
30. Claims 1-10 and 12-20 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 NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018), for the reasons set forth supra (over US 7,935,344).
31. Claims 1-10 and 12-20 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 NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018), for the reasons set forth supra (over US 7,935,344).
32. Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 7-9 of U.S. Patent No. 10,030,070, in view of Clinical Trial NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018), for the reasons set forth supra (over US 7,935,344).
33. Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,129,293, in view of Clinical Trial NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018), for the reasons set forth supra (over US 7,935,344).
34. Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,221,760, in view of Clinical Trial NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018).
35. Claims 1-8 of the '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 (claims 1 and 7, for example), or a composition comprising an antibody comprising the VL of SEQ ID NO:116, and the VH of SEQ ID NO:106 (claims 4 and 8, 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, 4 and 7, for example). The CDRL1-3 of SEQ ID NO:50, 56 and 73, and CDRH1-3 of SEQ ID NO:5, 20 and 44 of the patent are 100% identical to the present SEQ ID NOs:1-3 and 4-6, 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:7 and 8, respectively. The teachings of Clinical Trial NCT02319759 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, and to monitor the effectiveness and adjust the treatment utilizing DAPSA and/or IGA as disclosed by Langley and Schoels, for the reasons discussed in detail above (under "Prior Art Rejections"). Therefore, the conflicting claims are not patentably distinct from each other.
36. Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,548,941, in view of Clinical Trial NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018), for the reasons set forth supra (over US 8,221,760).
37. Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 12,404,324, in view of Clinical Trial NCT02319759 (12/18/2014), and further in view of Langley et al. (J. Dermatolog. Treat. 26(1):23-31; published 2015); Schoels et al. (Ann. Rheum. Dis. 75:811-818; published 2016); and Randazzo et al. (US 2018/0094052, published 05 April 2018), for the reasons set forth supra (over US 8,221,760).
Summary
38. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax 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.
/JON M LOCKARD/
Examiner, Art Unit 1647
February 21, 2026