DETAILED ACTION
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 .
Status of Application, Amendments, and/or Claims
2. The Response filed on 03 June 2026 has been entered in full. Claims 1-8, 11 and 18-20 have been amended. Therefore, claims 1-20 are pending and the subject of this Office Action.
Withdrawn Objections and/or Rejections
3. The objection to the Specification as set forth at pp. 2-4 of the previous Office action (mailed 03 March 2026) is withdrawn in view of Applicant’s amendment (filed 03 June 2026).
4. The rejection of claims 3 and 6 under 35 U.S.C. 112(d) as set forth at pp. 4-5 of the previous Office action (mailed 03 March 2026) is withdrawn in view of Applicant’s amendment of claim 1 (filed 03 June 2026).
5. The rejection of claim 11 under 35 U.S.C. 112(b) as set forth at pp. 5-7 of the previous Office action (mailed 03 March 2026) is withdrawn in view of Applicant’s amendment of said claim (filed 03 June 2026).
6. The rejection of claims 31-49 under 35 U.S.C. 112(a) (Written Description) as set forth at pp. 3-9 of the previous Office action (mailed 02 October 2025) is withdrawn in view of Applicants amendment of claim 31 (filed 02 March 2026).
Claim Rejections - 35 USC § 112
7. 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.
8. 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.
9. Claim 1 is rejected as being indefinite for reciting “measuring DAPSA… after administration.” Since it is not clear if the measurement occurs after 1 interval, 2 intervals, 3..., the metes and bounds of the claim cannot be determined.
10. Claim 1 is rejected as being indefinite for reciting “if a subject achieves DAPSA low disease activity (LDA) and/or IGA ≤ 1” and “if a subject does not achieve 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 these limitations are intended to encompass since it appears that all subjects have achieved DAPSA low disease activity.
10. Claim 2 is rejected as being indefinite for reciting “an initial administration.” Since the indefinite article “an” makes it unclear if which administration is intended, the metes and bounds of the claim cannot be determined.
11. Claim 3 recites the limitation "dose is reduced from 200mg" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 3 ultimately depends, recites a dose of 100 mg or 200 mg.
12. Claim 4 recites the limitation "adjusted from every 4 weeks to every 8 weeks" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 4 ultimately depends, recites a dosing interval of every 4 weeks or every 8 weeks.
13. Claim 5 recites the limitation "dose is adjusted from 100 mg" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 5 ultimately depends, recites a dose of 100 mg or 200 mg.
14. Claim 6 recites the limitation "dose is increased from 100 mg" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 6 ultimately depends, recites a dose of 100 mg or 200 mg.
15. 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, recites a dosing interval of every 4 weeks or every 8 weeks.
13. Claim 8 recites the limitations "adjusted from 100 mg… or from 50mg ”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 8 ultimately depends, recites a dose of 100 mg or 200 mg.
14. Claim 19 is rejected as being indefinite for reciting “if a subject achieves 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 this limitation is intended to encompass since it appears that the subjects have achieved DAPSA low disease activity.
15. Claim 20 is rejected as being indefinite for reciting “if a subject achieves 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 this limitation is intended to encompass since it appears that the subjects have achieved DAPSA low disease activity.
16. Claim 19 is rejected as being indefinite for reciting “an initial administration.” Since the indefinite article “an” makes it unclear if which administration is intended, the metes and bounds of the claim cannot be determined.
17. Claims 9-18 are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 112
18. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
19. Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
20. Amended claim 20 recites if a subject achieves DAPSA LDA and IGA ≤ 1, decreasing the dosing interval and increasing the dosage. After extensive review, the Examiner is unable to find, in the Specification as originally filed, support for this newly added limitation. This newly added limitation is not expressly asserted, nor does it flow naturally from the Specification as originally filed. The Specification at pp. 49-50 discloses decreasing the interval and/or increasing the dosage if the subject does not achieve DAPSA LDA and IGA ≤ 1 (See also claim 1; Arguments at pg. 10). However, decreasing the interval and/or increasing the dosage if the subject achieves DAPSA LDA and IGA ≤ 1 is not expressly asserted, nor does it flow naturally from the Specification as originally filed. See
Maintained and/or New Objections and/or Rejections
Claim Rejections - 35 USC § 103
21. 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.
22. 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.
23. 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.
24. Claim(s) 1-20 remain 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). The basis for this rejection is set forth at pp. 8-11 of the previous Office action (mailed 03 March 2026).
25. 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.
26. 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.
27. 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.
28. 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.
Response to Arguments
29. Applicant’s arguments as they pertain to the rejections have been fully considered but are not persuasive for the following reasons.
30. Applicant argues at pp. 9-10 of the response (filed 03 March 2026) that the amended claims recite measuring DAPSA low disease activity and IGA ≤ 1 after treatment with the antibody, which measurement allows for prediction of whether the subject will maintain response to the antibody and whether the dosing interval and/or dosage can be adjusted. As an example Applicant asserts that if a subject is measured to show DAPSA low disease activity and IGA ≤ 1 at an earlier time point (e.g., 16 weeks or 24 weeks after an initial treatment), the dose of antibody can be decreases and the dosing interval can be increased. Likewise, if a subject does not show DAPSA low disease activity and IGA ≤ 1 at 16 weeks or 24 weeks, the dose of antibody can be increased and the dosing interval can be decreased. Applicant argues that the combination of cited references does not provide a reasonable expectation of success to one of ordinary skill in the art to arrive at the methods recited in the claims.
31. Applicant's arguments have been fully considered but are not found persuasive for the following reasons. 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 16 or 24 (3ʳᵈ - 4th page, under "Outcome Measures", for example). Randazzo et al. also discloses dosages of 50 mg, 100 mg and 200 mg (See claims 8 and 9). While Clinical Trial does not teach assessing DAPSA or Investigator’s Global Assessment (IGA), or adjusting the dose or dosing interval based on said assessments,
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. Therefore, 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) at week 16 or week 24 as taught by Clinical Trian, 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.
32. It is not inventive to claim a particular dosage and/or administration schedule when the “discovery” of optimum dosage values or workable ranges via routine experimentation within the context of a known process represents an activity well-known to those of ordinarily skill in the art. Note in this regard that it is a well settled principal that “[d]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). See also Merck & Co. vv. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). See MPEP § 2144.05 part II. Furthermore, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSA International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQe2d 1385 (2007)).
Double Patenting
33. 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).
34. 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).
35. 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.
36. Claims 1-10 and 12-20 remain 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). The basis for this and subsequent rejections is set forth at pp. 11-15 of the previous Office action (mailed 03 March 2026.
37. 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).
38. Claims 1-10 and 12-20 remain 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).
39. Claims 1-10 and 12-20 remain 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).
40. Claims 1-10 and 12-20 remain 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).
41. Claims 1-10 and 12-20 remain 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).
42. Claims 1-10 and 12-20 remain 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).
43. 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.
44. Claims 1-10 and 12-20 remain 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).
45. Claims 1-10 and 12-20 remain 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).
Response to Arguments
46. Applicant’s arguments as they pertain to the rejections have been fully considered but are not persuasive for the following reasons.
47. Applicant argues at pg. 11 of the response (filed 03 March 2026) that in light of the amended claims and the remarks asserted above in response to the rejection under 35 U.S.C. § 103, the combination of cited references combined with each patent listed supra do not render obvious the subject matter of the present claims.
48. Applicant's arguments have been fully considered but are not found persuasive for the reasons set forth in response to Applicant’s arguments to the rejection under 35 U.S.C. § 103. As previously stated, it is not inventive to claim a particular dosage and/or administration schedule when the “discovery” of optimum dosage values or workable ranges via routine experimentation within the context of a known process represents an activity well-known to those of ordinarily skill in the art. Note in this regard that it is a well settled principal that “[d]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). See also Merck & Co. vv. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). See MPEP § 2144.05 part II. Furthermore, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSA International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQe2d 1385 (2007)).
Conclusion
49. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Summary
50. No claim is allowed.
Advisory Information
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/J.L/Examiner, Art Unit 1647 August 11, 2026
/Christine J Saoud/ Primary Examiner, Art Unit 1645
