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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed January 12, 2026 is acknowledged. Claims 1-59, 61-66, 70-72, 76-79, 82-88 and 90 are cancelled. Claims 60, 69, 75 and 89 are amended. Claims 60, 67-69, 73-75, 80-81 and 89 are pending in this application and under examination in this office action.
3. Applicant’s arguments filed on January 12, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Priority
4. The priority for the subject matter related to treating NMOSD patients with an elevated GFAP using a B cell depleting therapy including an anti-CD19 antibody and VIB551 (inebilizumab) in the instant application is June 30, 2020.
Claim Rejections/Objections Withdrawn
5. The rejection of claims 60-72, 74-80 and 82-90 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 61-66, 70-72, 76-79, 82-88 and 90.
The rejection of claims 60-71 and 74 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 61-66 and 70-71.
The rejection of 61-66, 70-72, 76-79, 82-88 and 90 under 35 U.S.C. 103 as being unpatentable over Cree et al. (Lancet, 2019; 394:1352-63, as in IDS) in view of Watanabe et al. (Neurology,2019; 93:e12999-e1311) and Akas et al. (Neurology, 2020 April; 94 15_supplement (4105)) is moot because the claims are canceled.
The provisional rejection of claims 61-66, 70-72, 76-79, 82-88 and 90 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 34-36 and 106-132 of copending Application No. 17/606306 or claims 1-75 of copending Application No. 18/303303 or claims 1-7, 10-31 and 34-41 of copending Application No. 18997757 in view of Cree et al. (2019), Watanabe et al. (2019) and Akas et al. (2020 April) is moot because the claims are canceled.
Claim Rejections/Objections Maintained
In view of the amendment filed on January 12, 2026 the following rejections are maintained.
Claim Objections
6. Applicant is advised that should claim 75 be found allowable, claim 89 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 73 and 81 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. The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 5-6 of the response, Applicant argues that the rejection has been overcome in view of amendment to the claims by reciting “wherein the elevated GFAP concentration is ≥170pg/ml” and cancelation of claims 62-66 and 82-85.
Applicant' s arguments have been fully considered but they are not found persuasive. Contrary to Applicant' s arguments, the examiner asserts that based on MPEP§2171-MPEP§2173, claims 73 and 81 are indefinite because:
i. Claim 73 recites “the method of claim 72…”. However, claim 72 is canceled. It is unclear upon which claim the claim 73 depends.
ii. Claim 81 recites the limitation "the elevated concentration" “the biomarker” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Accordingly, the rejection of claims 73 and 81 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is maintained.
Claim Rejections - 35 USC § 103
8. 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 60, 67-69, 73-75, 80-81 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Cree et al. (Lancet, 2019; 394:1352-63, as in IDS) in view of Hartung et al. (ACTRIMS Forum 2020, Feb 28; p205:Serum Glial Fibrillary Acidic Protein is elected in a subset of Neuromyelitis Optica Patients and Associated with Increased Risk of Attacks) and Watanabe et al. (Neurology, 2019; 93:e12999-e1311. Doi:10.1212/WNL.0000000000008160). The reference of Akas et al. (Neurology, 2020 April; 94 15_supplement (4105)) is withdrawn in response to Applicant’s amendment to the claims. The reference of Hartung is necessitated by Applicant’s amendment to the claims. The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 60, 67-69, 73-75, 80-81 and 89 as amended are drawn to a method of treating neuromyelitis optica spectrum disorder (NMOSD) in a subject in need thereof, the method comprising administering to the subject in need thereof a therapeutically effective amount of a B cell depleting therapy that is an anti-CD19 antibody which comprises Inebilizumab, wherein a sample of the subject has an elevated serum glial fibrillary acidic protein (sGFAP), and wherein the elevated sGFAP is ≥170pg/ml.
Cree et al. teach a method of treating NMOSD or reducing NMOSD-related damage in a subject in need thereof using Inebilizumab (i.e. a B cell depleting therapy, an anti-CD19 antibody) (p. 1353-1354), the method comprising intravenously administering to the subject in need thereof a composition comprising Inebilizumab as recited in independent claims 60, 75 and 89 at a dose of 300mg as recited in claim 73 and repeated every six month as recited in claim 74 (abstract; p. 1352; p.1354; p. 1357-1361). Cree teaches that the subject is administered a second therapeutic agent including a steroid, plasmapheresis/immunoadsosption or a complement inhibitor or Eculizumab, Satralizumab, Ublituximab, Ravulizumab, Rituximab, Azathioprine, Mycophenolate Mofetil, or a combination thereof as recited in claims 68-69 (see p. 1352, 2nd col, 2nd paragraph to p. 1354).
But Cree does not explicitly teach that the subject with NMOSD in need of treatment has an elevated sGFAP concentration of ≥170pg/ml recited in independent claims 60, 75 and 89.
Hartung et al. teach that sGFAP is a useful biomarker of evaluating attack risk and disease activity and severity of NMOSD. Hartung teaches that NMOSD-study participants had an increased sGFAP level compared to healthy controls (HC) wherein the elevated sGFAP is defined as ≥3 standard deviations above the HC mean (≥171 pg/mL), which is ≥170pg/ml as recited in independent claims 60, 75 and 89 (see p.1, the section of Results).
Watanabe et al. teach the levels of GFAP in serum (sGFAP) of patients with NMOSD is higher than healthy controls (see p. e1299, Abstract; p. e1301-e1303, Tables 1-2; p. e1305-e1307, table 4; p. e1309-e1310), wherein the median sGFAP levels in patients with NMOSD were 207.7 pg/ml and the median sGFAP levels in patients with relapse were 540.9 pg/ml, which are ≥170pg/ml (see p. e1302, 1st col. section: GFAP levels). Watanabe teaches that the levels of sGFAP are positively associated with EDSS score (p.e1302, 2nd col., section: association of sGFAP with clinical parameters and p.e1305, 1st col., section: association of sNfL levels with clinical parameters).
The claimed method requires sGFAP ≥170 pg/mL, which overlaps with the range of Hartung and Watanabe because Hartung teaches elevated levels of sGFAP ≥171 pg/mL for patients with NMOSD and Watanabe teaches elevated levels of sGFAP at 207.7 pg/ml or 540.9 pg/ml for patients with NMOSD. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
A person of ordinary skill in the art would have recognized that selecting and applying the known increased levels of sGFAP ≥171 pg/ml or 170 pg/ml in the sample or serum sample of patients with NMOSD as biomarkers of selecting patients with NMOSD and selecting patients with elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml disclosed by Hartung and Watanabe to the Cree’s method would have yielded the predictable result of treating NMOSD and resulted in an improved method because NMOSD patients have elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml as compared to healthy controls, and the elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml are highly associated and correlate with the severity of NMOSD.
Using the known increased levels of sGFAP≥171 pg/ml or 170 pg/ml as biomarkers and selecting patients with the elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml in the Cree’s method would identify patients with NMOSD for treatment of NMOSD, and would expand application of the Cree’s method, and would increase patient’s satisfaction with treatment using Inebilizumab.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known increased levels of sGFAP≥170pg/ml in the sample or serum sample of patients with NMOSD as biomarkers and selecting patients with elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml disclosed by Hartung and Watanabe to the Cree’s method, and yield the predictable result of treating NMOSD.
Further, routine optimization of Hartung’s elevated levels of sGFAP ≥171 pg/mL would have led to the claimed range of sGFAP ≥170 pg/mL because Hartung teaches elevated levels of sGFAP ≥171 pg/mL for patients with NMOSD and Watanabe teaches elevated levels of sGFAP at 207.7 pg/ml or 540.9 pg/ml for patients with NMOSD. The person of ordinary skill in the art would have found it obvious to optimize within the range taught by Hartung and Watanabe because Hartung and Watanabe teach that this entire range of elevated sGFAP ≥170 pg/mL, and also teaches how to optimize the levels of elevated sGFAP compared to that of healthy controls. Note that
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”; “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert.denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP § 2144.05.
Response to Arguments
On p. 6-7 of the response, Applicant argues that none of the cited references teach treating subjects with sGFAP levels that are at least 170pg/ml.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Cree teaches a method of treating NMOSD or reducing NMOSD-related damage in a subject in need thereof using Inebilizumab, the method comprising intravenously administering to the subject in need thereof a composition comprising Inebilizumab (as in claims 60,75 and 89) at a dose of 300mg (as in claim 73) and repeated every six months (as in claim 74) (abstract; p. 1352; p.1354; p. 1357-1361). Cree also teaches the subject is administered a second therapeutic agent including a steroid, plasmapheresis/immunoadsosption or a complement inhibitor or Eculizumab, Satralizumab, Ublituximab, Ravulizumab, Rituximab, Azathioprine, Mycophenolate Mofetil, a low dose corticosteroid or a combination thereof as in claims 68-69 (see p. 1352, 2nd col, 2nd paragraph to p. 1354).
While Cree does not explicitly teach that the subject with NMOSD in need of treatment has an elevated sGFAP concentration of ≥170pg/ml recited in claims 60, 75 and 89, Hartung and Watanabe teach this limitation and provide motivation and an expectation of success because Hartung teaches that patients with NMOSD had an increased sGFAP level compared to that of healthy controls wherein the elevated sGFAP is defined as ≥3 standard deviations above the HC mean (≥171 pg/mL), which is ≥170pg/ml recited in independent claims 60, 75 and 89 and Watanabe that teach the level of sGFAP in patients with NMOSD is higher than that of healthy controls (see p. e1299, Abstract; p. e1301-e1303, Tables 1-2; p. e1305-e1307, table 4; p. e1309-e1310), wherein the median sGFAP levels in patients with NMOSD were 207.7 pg/ml and the median sGFAP levels in patients with relapse were 540.9 pg/ml, which are ≥170pg/ml (see p. e1302, 1st col. section: GFAP levels).
A person of ordinary skill in the art would have recognized that selecting and applying the known elevated level of sGFAP ≥171 pg/ml or 170 pg/ml in the sample of patients with NMOSD as biomarkers for selecting patients with NMOSD and selecting patients with an elevated level of sGFAP ≥171 pg/ml or 170 pg/ml disclosed by Hartung and Watanabe to the Cree’s method would have yielded the predictable result of treating NMOSD and resulted in an improved method because NMOSD patients have an elevated level of sGFAP ≥171 pg/ml or 170 pg/ml as compared to healthy controls, and the elevated level of sGFAP ≥171 pg/ml or 170 pg/ml are highly associated and correlate with the severity of NMOSD.
Using the known increased level of sGFAP≥171 pg/ml or 170 pg/ml as biomarkers and selecting patients with the elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml in the Cree’s method would identify patients with NMOSD for treatment of NMOSD, and would expand application of the Cree’s method, and would increase patient’s satisfaction with treatment using Inebilizumab.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known increased levels of sGFAP≥170pg/ml in the sample or serum sample of patients with NMOSD as biomarkers and selecting patients with elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml disclosed by Hartung and Watanabe to the Cree’s method, and yield the predictable result of treating NMOSD.
Accordingly, the rejection of claims 60, 67-69, 73-75, 80-81 and 89 under 35 U.S.C. 103 as being unpatentable over Cree in view of Hartung and Watanabe is maintained.
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 60, 67-69, 73-75, 80-81 and 89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 17, 35, 106, 109-110, 113-114, 117, 119-121, 124-129 and 133 of copending Application No. 17/606306 (the ‘306 Application) or claims 1-75 of copending Application No. 18/303303 (the ‘303 Application) or claims 1-7, 10-31 and 34-41 of copending Application No. 18997757 (the ‘757 Application) in view of Cree et al. (2019), Hartung et al. (2020) and Watanabe et al. (2019). The reference of Akas et al. (Neurology, 2020 April; 94 15_supplement (4105)) is withdrawn in response to Applicant’s amendment to the claims. The reference of Hartung is necessitated by Applicant’s amendment to the claims. The rejection is maintained for the reasons of record and the reasons set forth below.
On 7 of the response, Applicant argues that for the reasons set forth above, none of the cited references teach treating subjects with sGFAP levels that are at least 170pg/ml.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §804, MPEP §2141, MPEP §2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, while the claims of the ‘306 Application, the ‘303 Application and the ‘757 Application do not recite that the subject with NMOSD in need of treatment has an elevated concentration of sGFAP including at least 170pg/ml recited in independent claims 60, 75 and 89, or administering a second therapeutic recited in claims 68-69, Cree, Hartung, and Watanabe teach these limitations and provide motivation and an expectation of success for the reasons set forth above under the 103 rejection. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known increased levels of sGFAP≥170pg/ml in the sample or serum sample of patients with NMOSD as biomarkers and selecting patients with elevated levels of sGFAP ≥171 pg/ml or 170 pg/ml disclosed by Cree, Hartung and Watanabe and the known second therapeutic recited in claims 68-72 disclosed by Cree to the method recited in the claims of the 306 Application, the 303 Application and the ‘757 Application, and yield the predictable result of treating NMOSD, and yield the predictable result of treating NMOSD.
Accordingly, the provisional rejection of claims 60, 67-69, 73-75, 80-81 and 89 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 17, 35, 106, 109-110, 113-114, 117, 119-121, 124-129 and 133 of Application No. 17/606306, or claims 1-75 of Application No. 18/303303 or claims 1-7, 10-31 and 34-41 of copending Application No. 18997757 in view of Cree, Hartung and Watanabe is maintained.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on January 12, 2026.
Claim Rejections - 35 USC § 112
10. 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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claim 73 is 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 73 depends from claim 72 and recites “the method of claim 72…”. However, claim 72 is canceled. Thus, claim 73 does not further limit the subject matter of the claim upon which it depends. 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.
Conclusion
11. NO CLAIM IS ALLOWED.
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NCT02200770 (posted 2014-07-24) teaches a method of treating NMOSD or reducing NMOSD-related damage in a subject in need thereof using Inebilizumab (MEDI-551), the method comprising intravenously administering to the subject in need thereof a composition comprising MEDI-551 (i.e. Inebilizumab) at a dose of 300mg and repeated every six month (p. 1; p. 12-14; p. 20-23).
Cree et al. (Multiple Sclerosis J. 2016; 22:862-872) teach a method of treating NMOSD or reducing NMOSD-related damage in a subject in need thereof using Inebilizumab, the method comprising intravenously administering to the subject in need thereof a composition comprising MEDI-551 (i.e. Inebilizumab) at a dose of 300mg and repeated every six month (abstract; p. 862; p. 863; p. 866-871).
Kim et al. (Neurol. Neuroimmunol. Neuroinflamm. 2020; 7:e708. doi:10.1212/NSL000000000000708) teach that the levels of NfL, GFAP and tau in the sera of patients with NMOSD are higher and correlated with the EDSS score (p. 1, abstract; p. 2-6, table 1).
Edwards et al. (ACTRIMS 2018, Poster No. P006) teach that the levels of GFAP, NfL, tau, UCH-L1 are higher in patients with secondary progressive multiple sclerosis (p.1 abstract).
13. 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
April 28, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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