DETAILED ACTION 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. Claims Status The amendment filed 07/01/2024 has been entered. Claims 26-45 are pending and under examination. Priority The instant application is a 371 of PCT/EP2022/059900, filed 04/13/2022, which claims priority to Provisional application 63174765, filed 04/14/2021. The effective filing date is 04/14/2021, which is the filing date of the provisional application. Information Disclosure Statement The information disclosure statement (IDS) submitted on FILLIN "Enter date IDS was filed" \* MERGEFORMAT 06/12/2024, 07/03/2024, 05/13/2025 , 02/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Drawings Figure 5 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). According to the Figure 5 description on page 20 of the instant specification, this figure is from prior art and should be designated as such in the Drawings. Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112 (b) 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. Claim s 26-45 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. Claim 26 recites a method of treating a patient, wherein said patient is of Asian race. The specification teaches an open-ended definition for Asian race – what it “may” comprise of – based in part on self-identification , countries a person is reportedly from , and inherited physical and genetic traits (page 14-15) but even these definitions do not provide a clear boundary for what does or does not constitute “Asian” or “race” or “Asian race . ” For example, it is further unclear if a patient needs to meet any one of these metrics and not other specific metrics . As the specification further delineates between “Westerners” and “Asian race”, i t is further unclear if meeting metrics of both “Asian race” and “Westerner” , as stated in the specification, would exclude them from the definition of “Asian race.” Furthermore, one would not know the full scope of “Asian race” from common language as common language also does not provide a definitive definition of “race” ( e.g. see Takezawa , Yasuko I., Wade, Peter, Smedley, Audrey. "race". Encyclopedia Britannica, 16 Jan. 2026, https://www.britannica.com/topic/race-human. Accessed 2 March 2026 ). Claims 2 7 -45 depend on claim 26 . Claims 27-43 inherit the indefiniteness of their parent claim and fail to resolve the indefiniteness of their parent claims. Regarding claim 28, although each of the claimed genotypes by themselves may be definitive genotypes and subject populations , in light of the claim’s dependency on claim 26, these genotypes do not resolve the initial indefiniteness of claim 26. In other words, this claim does not simply define the subjects solely by their genotype , but requires this genotype in the larger “Asian race” qualification . Although, s ome genotypes can be more associated with specific populations as a whole, they are not definitive of any population . For example, without definiteness on “Asian race,” the CYP 2C9*2 allelic frequency could not be used to further limit the boundaries of the claimed patient population. E ven recently, the art, as exemplified by Zhou et al, teaches about the prior art that CYP2C9 allele frequencies were commonly extrapolated from subpopulations within the same geographic group and the generalizability of these results were questionable (Zhou, Y., et al. Global distribution of functionally important CYP2C9 alleles and their inferred metabolic consequences. Hum Genomics 17, 15 (2023); published 2023) . In addition, evaluation of CYP2C9 allele frequencies with higher resolution was required to account for the complex patterns of ethnogeographic variability that were not reflected when only aggregated populations are considered (Introduction, paragraph 3). Considering these limitations, Zhou et al conducted a meta-analysis of prior CYP2C9 allele frequencies studies in 70 countries . They found, in Africa, CYP2C9*2 was generally absent in Sub-Saharan Africa (see Results) . In the Americas, low CYP2C9*2 frequencies were observed in Ecuador (0.5%), Mexico (3.7%) and Peru (3.8%) (see Results) . It is unclear if the subject population now expand to include these populations or must still be constrained by the limitation of “Asian race”. As such, the limitation regarding the CYP 2C9*2 allele frequency of less than 10% is not exclusive to the instant specification’s definition and cannot be used to provide definiteness to the claimed patient population in claim 26. As another example, without definiteness on “Asian race,” the VKORC1 low warfarin dose haplotype could not be used to further limit the boundaries of the claimed patient population. Gaikwad et al teaches , from their meta-analysis of studies encompassing 14 Asian countries, teaches high variation in the presence of the low warfarin dose haplotype (i.e. VKORC1 homozygous) across populations of people in Asian countries (see Table 2 and section Distribution of VKORC1 Genotype in Asian Population) (Gaikwad, T., et al, VKORC1 and CYP2C9 genotype distribution in Asian countries, Thrombosis, published 2014) . It is unclear whether people from these Asian countries meeting the specification’s definition of “Asian race” but do not meet the claimed genotype would be excluded, or if this genotype is a way to define “Asian race” to only those with this haplotype. Claim 29 is further indefinite because it recites “ Brugada syndrome” in parenthesis after a “family history of sudden death”. It is unclear whether this element is limited to Brugada syndrome or if it includes sudden death of any cause. As such, it is unclear whether the limitation in the parenthesis are part of the claimed invention. Claim 44 recites specifically the patient is of Chinese, Japanese, or Korean race. It is unclear from the disclosure and common language what constitute the entire scope and bound s of “ Chinese, Japanese, or Korean ” and specifically what makes someone of “Chinese, Japanese, or Korean race ” . Claim 45 recites specifically the patient has ancestors in any of the original peoples of the Far East. There is no definition in the disclosure or in common language that would resolve the boundaries of this limitations , including what is considered the “ original peoples ” , what is considered the Far East throughout time , and the boundaries of ancestry . The additional limitations in claim 44-45 used to describe a human patient has unclear boundaries considering, for example, the entire history of human migration, world geography , and geopolitics. As such, claims 44-45 inherit the indefiniteness of their parent claim, provide no clarification on “ Asian race ” , and add further indefiniteness. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 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. Claim s 26, 30-3 4 , 36-37 , 44 are rejected under 35 U.S.C. 102 (a)(1) as being FILLIN "Insert either—clearly anticipated—or—anticipated—with an explanation at the end of the paragraph." \d "[ 3 ]" anticipated by Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020). Regarding claim 26 , Kira Ichi et al teaches a method of treating multiple sclerosis in a patient, comprising administering a therapeutically effective amount of ofatumumab to said patient , wherein said patient is of Asian race ( page 3-4 ). Claims 30-34, 36-37, 44 depend on claim 26. The teachings of the references for claims 26 are incorporated in entirety for claims 30-34, 36-37, 44 and further discussed, as is relevant, for each claim below. Regarding claim 30 , Kira Ichi et al teaches wherein the risk of adverse effects occurring in the patient of Asian race is consistent with the overall safety profile of ofatumumab, as compared to the Phase 3 ASCLEPIOS I/II trials (page 10, Conclusions). Regarding claim 31 -34 , Kira Ichi et al teaches wherein risk of adverse effects in the patient of Asian race is reduced compared to treatment with teriflunomide, wherein the adverse effects include malignancies and infections (page 3), and specifically, opportunistic infections (page 9). Regarding claim 36-37 , Kira Ichi et al teaches ofatumumab is administered at a dose of 20 mg every 4 weeks subcutaneously from Week 4 onwards (page 4). Regarding claim 44 , Kira Ichi et al teaches wherein the patient are Japanese ( e.g. page 3) Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . 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. Claim 35 and 38-43 is rejected under 35 U.S.C. 103 as being unpatentable over Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of WO ‘841 (WO 2018/033841 Al; published 02/22/2018) . Claim s 35 and 38-43 depend on claim 26. The teachings of the references for claims 26 are incorporated in entirety for claim s 35 and 38-43 and further discussed, as is relevant, for each claim below. Regarding claim 35 , Kira Ichi et al and WO ‘841 do not explicitly teach a treatment term for more than two-years. However, WO ‘841 teaches that MS is a chronic disease with anticipated long-term treatment, and thus dosage should be calibrated to balance efficacy and safety (page 21) . The y teach studies that span months (e.g. 48 weeks) and multiple doses (e.g. page 6) and do not limit the term length and teach that ofatumumab was safe and well tolerated in patients with multiple sclerosis (page 8) . It would be obvious to one skilled in the art, before the effective filing date of the instant application, that long term-treatment is expected for treating Multiple Sclerosis, which is a chronic condition, by administration of ofatumumab to human patients as taught by WO ‘841, especially in light of the teaching that the dosage can be adjusted accordingly to balance efficacy and safety over time and the good long-term safety profile of ofatumumab taught in Kira Ichi et al. One skilled in the art, before the effective filing date of the instant application, would be motivated to continue administering the drug for as long as it is showing patient benefit and until the disease is determined to be treated. One skilled in the art, before the effective filing date of the instant application, would understand the treatment term limitation is an obvious timeframe already encompassed by the method taught by WO ‘841. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectations of success in light of the findings that ofatumumab is safe and well-tolerated, even with repeated doses over multiple months, in patients with multiple sclerosis (e.g. Page 6-8 ). KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill, before the effective filing date of the instant application, to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is an obvious modification or combination of the reference. In this case, the prior art does not distinctly teach the treatment term, but in light of the teachings that multiple sclerosis is a chronic condition that requires long-term care, that ofatumumab is safe and well-tolerated, even with repeated doses over multiple months, in patients with multiple sclerosis, and the obvious motivation to continue treatment to treat or help treat patients, the treatment term limitation is an obvious timeframe already encompassed by the method taught by WO ‘841. Claims 38-39 further depend on claim 35. The teachings of the references regarding parent claims are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim. Regarding claims 38-39 , Kira Ichi et al further teaches ofatumumab is administered with a loading dose, and the loading dose comprises of 20 mg ofatumumab at weeks 0, 1, and 2 (page 4). Regarding claims 40-41, WO ‘841 further teaches the multiple sclerosis is relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), or progressive multiple sclerosis (PPMS) (Claims 16-18). Regarding claims 42-43, Kira Ichi et al and WO ‘841 do not explicitly teach the method with or without premedication. However WO ‘841 further teaches that premedication, such as corticosteroids, have been used to help mitigate infusion reactions from high intravenous doses of Ofatumumab (Page 5, paragraph 4). In contrast lower subcutaneous doses of Ofatumumab have been tolerated without additional corticosteroid premedication. It would be obvious to one skilled in the art, before the effective filing date of the instant application, that premedication can be administered or not depending on the dose, and relatedly, the administration route. As the claims encompass all methods of administration, including both intravenous and subcutaneous, and all reasonable doses, it would be obvious to one skilled in the art, before the effective filing date of the instant application, that the premedication administration depends on if infusion reactions due to high doses are expected. Further, it would be obvious to one skilled in the art, before the effective filing date of the instant application, that if premedication is needed, it could be a steroid, as taught by WO ‘841. One skilled in the art, before the effective filing date of the instant application, would be motivated to administer the premedication, such as the steroid taught in the art, if a high risk of infusion reaction is expected and/or high doses of ofatumumab will be administered. On the other hand, one skilled in the art, before the effective filing date of the instant application, would be motivated to consider not administering the premedication if there is a low risk of infusion reaction and/or only a low dose of ofatumumab will be administered, to avoid potentially unnecessary drugs. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectations of success because the point of the premedication is only to prevent adverse reactions caused by ofatumumab administration, and not to treat the diseases, so is needed and not needed depending on the risk of reactions to ofatumumab. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill, before the effective filing date of the instant application, to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is an obvious modification or combination of the reference. In this case, the prior art does not distinctly teach the premedication usage or avoidance, but in light of when premedication is and is not typically used before ofatumumab administration, the obvious motivation to prevent preventable reactions to ofatumumab but avoid unnecessary medication, the premedication limitation is an obvious limitation already encompassed by the method taught by WO ‘841. Claim 27 rejected under 35 U.S.C. 103 as being unpatentable over Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of Zoehner et al (Reduced serum immunoglobulin G concentrations in multiple sclerosis: prevalence and association with disease modifying therapy and disease course, Ther Adv Neurol Disord , Vol. 12: 1–8; published 2019); and further in view of Agarwal et al (Assessment and clinical interpretation of reduced IgG values, Ann Allergy Asthma Immunol , 2007 September ; 99(3): 281–283; published 2007). Claim 2 7 depends on claim 26. The teachings of the references for claims 26 are incorporated in entirety for claim 27 and further discussed, as is relevant, for each claim below. Regarding claim 27 , Kira Ichi does not explicitly teach the serum IgG levels in patients are maintained during treatment in the range of 900 mg/dl to 1400 mg/dl. However, Zoehner et al teaches that serum IgG levels in MS patients are reduced from normal, with about 700 mg/dl being the lower limit of normal serum IgG concentration, and less than 400 mg/dl as especially concerning , and that increasing the serum IgG concentration should be considered (Abstract). Zoehner et al further teaches that monitoring the serum IgG levels is especially useful with anti-B-cell therapies (Abstract), which is a therapy class ofatumumab belongs to as an anti-CD20 antibody. Agarwal et al teaches the normal IgG concentration of a healthy adult is, on average, 994 mg/dl, and the range of serum IgG across healthy adults, is about 639-1349 mg/dl (Table 1). It would be obvious to one skilled in the art, before the effective filing date of the instant application, to maintain the serum IgG levels in MS patients at the average adult normal concentration or higher, but within the upper range of normal concentration, in light of the finding that MS patients typically have pathologically reduced serum IgG levels and that monitoring IgG levels is especially useful with anti-B-cell therapies, such as ofatumumab, as these drugs likely also have a role in depleting IgG levels. One skilled in the art, before the effective filing date of the instant application, would be motivated to maintain normal serum IgG in patients to maintain the health of their immune system, as reduced serum IgG is a pathology of MS. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectations of success since restoring and maintaining serum IgG levels would help maintain the patient’s immune system and since the method of treatment taught by Kira Ichi et al would inherently encompass this claim limitation. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill, before the effective filing date of the instant application, to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is an obvious modification or combination of the reference. In this case, the prior art does not distinctly teach the range of serum IgG levels, but in light of teachings in the art regarding the pathological reduction of serum IgG levels from normal in patients with MS and the obvious motivation to maintain normal immune conditions, it would be obvious to try to maintain the serum IgG levels at a physiologically normal range. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of Gaikwad et al (Gaikwad, T., et al, VKORC1 and CYP2C9 genotype distribution in Asian countries, Thrombosis, published 2014). Kira Ichi et al is silent on whether the particular subjects have the disclosed genotype; however, it does not explicitly exclude these limitations. Gaikwad et al teaches that about 90% of subjects from East Asian countries were found to have the VKORC1 haplotypes associated with low dose warfarin. As such, the Japanese subjects in Kira Ichi et al are statistically likely to possess these VKORC1 haplotypes. Therefore, the limitation would implicitly have been included in Kira Ichi et al. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007) discloses that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, before the effective filing date of the claimed invention, and that this variation is obvious. The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous method. In this case, the prior art teaches treating multiple sclerosis in a Japanese population, in an attempt to represent the Asian population, with ofatumumab. The instant claims is directed to a particular Asian population that further exhibit genotypes that are prevalent in Asian populations, particularly East Asian, and particularly Japanese populations. There were design incentives or market forces which would have prompted adaptation of the known method/product. In this case, in light of the prior art teaching other anti-CD20 treatment options for multiple sclerosis has potentially adverse side effects, particularly for some population of Asian subjects, which inherently skews towards subjects that have the claimed mutations by nature of its prevalence in Asian subjects, there are design incentives to focus ofatumumab in multiple sclerosis patients with these genotypes. One of ordinary skill in the art, before the effective filing date of the claimed invention, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable. In light of the safety findings in an Asian population taught by Kira Ichi et al , it would be obvious and motivated to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply this treatment more specifically to Asian subjects with known prevalent genotypes associated with Asian populations. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have reasonable expectations of success in light of the safe results in a population known to have statistically high prevalence of the claimed genotypes. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30- 34, 36-37, 44 above, and further in view of Marrie et al ( Marrie , R., et al, A systematic review of the incidence and prevalence of comorbidity in multiple sclerosis: Overview; Multiple Sclerosis Journal, 2015;21(3):263-281; published 2015). Kira Ichi et al is silent on whether the particular subjects have the disclosed medical history; however, it does not explicitly exclude these limitations. As SLE and other disorders in claim 29 are known co-morbidities with multiple sclerosis ( Marrie et al, e.g. Table 1-2) and the Kira Ichi et al does not explicitly exclude these populations from their methods and studies, the cited prior art likely includes subjects that have these claimed limitations. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007) discloses that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, before the effective filing date of the claimed invention, and that this variation is obvious. The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous method. In this case, the prior art teaches treating multiple sclerosis in a Japanese population, in an attempt to represent the Asian population, with ofatumumab. The instant claims is directed to a particular Asian population that further exhibit disorders that are known to be generally comorbid with multiple sclerosis. There were design incentives or market forces which would have prompted adaptation of the known method/product. In this case, in light of the prior art teaching other anti-CD20 treatment options for multiple sclerosis has potentially adverse side effects, particularly for some population of Asian subjects, there are design incentives to focus ofatumumab in multiple sclerosis patients with existing comorbidities, especially in Asian populations, as they may be more vulnerable populations to start with. One of ordinary skill in the art, before the effective filing date of the claimed invention, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable. In light of the safety findings taught by Kira Ichi, it would be obvious and motivated to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply this treatment more specifically to Asian subjects with comorbidities. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have reasonable expectations of success in light of the better safety profiles compared to other known anti-CD20 treatment options for multiple sclerosis. Claim 45 is not included in the 102/103 art rejection due to the indefiniteness of the claim. Kira Ichi does not explicitly teach whether or not the Japanese subjects had ancestors in any of the original peoples of the Far East, and due to the indefiniteness of this limitation, it is unclear how this could be resolved either way. However, even if definiteness is resolved, the Japanese subjects in Kira Ichi et al may have a high chance of meeting this claim limitation. Double Patenting Nonstatutory double patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Application No. 17753635 Claims 26, 30-34, 36-37, 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11, 13, 16, 18-21, 27, 31-37, 40-41, 54-57 of copending Application No. 17753635 (filed 06/26/2025) in view of Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The claim set of App ‘635 is directed towards a method of treating or preventing relapsing multiple sclerosis comprising of administering to a patient in need thereof ofatumumab and a vaccine (see claim 1 and dependent claims ) . Regarding instant claim 26 , t he claim set of App ‘635 does not explicitly claim treating of Asian patients in particular . However, Kira Ichi et al teaches a method of treating multiple sclerosis in a patient, comprising administering a therapeutically effective amount of ofatumumab to said patient, wherein said patient is of Asian race (page 3-4). The instant claim set does not explicitly refer to the administration of a vaccine but claims a method comprising administration of ofatumumab and therefore does not preclude the additional step of vaccine administration. It would have been obvious to a person having ordinary skill in the art to modify the method claimed in App ‘635 claim 1 and dependent claims to specifically administer to Japanese patients as taught by Kira-Ichi et al, considering it uses the same drug and disease model, thereby arriving at the invention of the claims listed above. Instant c laims 30-34, 36-37, 44 depend on instant claim 26. The teachings of the references for claims 26 are incorporated in entirety for claims 30-34, 36-37, 44 and further discussed, as is relevant, for each claim below. Regarding instant claim 30 -34 , App ‘635 does not explicitly teach the adverse effects risk in patient of Asian race. However, regarding instant claim 30 , App ‘635 claims 2, 4, and 6 teaches the patient treated has an infection but is still administered ofatumumab for multiple sclerosis. Kira Ichi et al further teaches wherein the risk of adverse effects occurring in the patient of Asian race is consistent with the overall safety profile of ofatumumab, as compared to the Phase 3 ASCLEPIOS I/II trials (page 10, Conclusions). Regarding instant claim 31-34 , App ‘635 does not explicitly teach the adverse effects risk in patient of Asian race. Kira Ichi et al further teaches wherein risk of adverse effects in the patient of Asian race is reduced compared to treatment with teriflunomide, wherein the adverse effects include malignancies and infections (page 3), and specifically, opportunistic infections (page 9). Regarding claim 36 , App ‘635 claim 57 teaches 20 mg ofatumumab is administered monthly. Kira Ichi et al also further teaches ofatumumab is administered at a dose of 20 mg every 4 weeks (page 4) . Regarding claim 37 , App ‘635 claim 27 and Kira Ichi et al (page 4) further teaches ofatumumab is administered subcutaneously . Regarding claim 44 , Kira Ichi et al further teaches wherein the patient are Japanese (e.g. page 3). Claims 35 and 38-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11, 13, 16, 18-21, 27, 31-37, 40-41, 54-57 of copending Application No. 17753635 (filed 06/26/2025) over Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of WO ‘841 (WO 2018/033841 Al; published 02/22/2018). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 35 and 38-43 depend on claim 26. The teachings of the references for claims 26 are incorporated in entirety for claims 35 and 38-43 and further discussed, as is relevant, for each claim below. Regarding claim 35 , App ‘635 claims, Kira Ichi et al, and WO ‘841 do not explicitly teach a treatment term for more than two-years. However, WO ‘841 teaches that MS is a chronic disease with anticipated long-term treatment, and thus dosage should be calibrated to balance efficacy and safety (page 21). They teach studies that span months (e.g. 48 weeks) and multiple doses (e.g. page 6) and do not limit the term length and teach that ofatumumab was safe and well tolerated in patients with multiple sclerosis (page 8). It would be obvious to one skilled in the art, before the effective filing date of the instant application, that long term-treatment is expected for treating Multiple Sclerosis, which is a chronic condition, by administration of ofatumumab to human patients as taught by WO ‘841, especially in light of the teaching that the dosage can be adjusted accordingly to balance efficacy and safety over time. One skilled in the art, before the effective filing date of the instant application, would be motivated to continue administering the drug for as long as it is showing patient benefit and until the disease is determined to be treated. One skilled in the art, before the effective filing date of the instant application, would understand the treatment term limitation is an obvious timeframe already encompassed by the methods taught by App ‘635 claims, in view of Kira Ichi et al, and further in view of WO ‘841. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectations of success in light of the findings that ofatumumab is safe and well-tolerated, even with repeated doses over multiple months, in patients with multiple sclerosis (e.g. WO ‘841, page 6-8). Claims 38-39 further depend on claim 35. The teachings of the references regarding parent claims are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim. Regarding claims 38-39 , App ‘635 claim 31 and Kira Ichi et al (page 4) further teaches ofatumumab is administered with a loading dose, and the loading dose comprises of 20 mg ofatumumab at weeks 0, 1, and 2 . Regarding claims 40, App ‘635 claim 33 teaches the relapsing multiple sclerosis is selected from RRMS or SPMS. Regarding claims 42-43, App ‘635 claims 34-36 teach the method with or without premedication , wherein the premedication comprises acetaminophen, antihistamines, and/or steroids . Furthermore, WO ‘841 further teaches that premedication, such as corticosteroids, have been used to help mitigate infusion reactions from high intravenous doses of Ofatumumab (Page 5, paragraph 4). In contrast , lower subcutaneous doses of Ofatumumab have been tolerated without additional corticosteroid premedication. Regarding claims 41, App ‘635 and Kira Ichi et al do not explicitly teach wherein the multiple sclerosis is PPMS or PRMS. However, WO ‘841 further teaches the multiple sclerosis is relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), or progressive multiple sclerosis (PPMS) (WO ‘841 claims 16-18). It would be obvious to one skilled in the art, before the effective filing date of the instant application, that the relapsing multiple sclerosis taught in App ‘635 could be PRMS, based on the teachings that ofatumumab can also treat this form of RMS. One skilled in the art, before the effective filing date of the instant application, would be motivated to treat the progressive form of relapsing multiple sclerosis with ofatumumab since this drug was already claimed to treat RMS generally and secondary progressive multiple sclerosis, and would have reasonable expectations of success because of shared pathophysiology between the progressive multiple sclerosis forms. Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11, 13, 16, 18-21, 27, 31-37, 40-41, 54-57 of copending Application No. 17753635 (filed 06/26/2025) in view of Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of Zoehner et al (Reduced serum immunoglobulin G concentrations in multiple sclerosis: prevalence and association with disease modifying therapy and disease course, Ther Adv Neurol Disord , Vol. 12: 1–8; published 2019); and further in view of Agarwal et al (Assessment and clinical interpretation of reduced IgG values, Ann Allergy Asthma Immunol , 2007 September ; 99(3): 281–283; published 2007). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented Claim 27 depends on claim 26. The teachings of the references for claims 26 are incorporated in entirety for claim 27 and further discussed, as is relevant, for each claim below. Regarding claim 27 , App ‘635 in view of Kira Ichi et al does not explicitly teach the serum IgG levels in patients are maintained during treatment in the range of 900 mg/dl to 1400 mg/dl. However, Zoehner et al teaches that serum IgG levels in MS patients are reduced from normal, with about 700 mg/dl being the lower limit of normal serum IgG concentration, and less than 400 mg/dl as especially concerning, and that increasing the serum IgG concentration should be considered (Abstract). Zoehner et al further teaches that monitoring the serum IgG levels is especially useful with anti-B-cell therapies (Abstract), which is a therapy class ofatumumab belongs to as an anti-CD20 antibody. Agarwal et al teaches the normal IgG concentration of a healthy adult is, on average, 994 mg/dl, and the range of serum IgG across healthy adults, is about 639-1349 mg/dl (Table 1). It would be obvious to one skilled in the art, before the effective filing date of the instant application, to maintain the serum IgG levels in MS patients at the average adult normal concentration or higher, but within the upper range of normal concentration, in light of the finding that MS patients typically have pathologically reduced serum IgG levels and that monitoring IgG levels is especially useful with anti-B-cell therapies, such as ofatumumab, as these drugs likely also have a role in depleting IgG levels. One skilled in the art, before the effective filing date of the instant application, would be motivated to maintain normal serum IgG in patients to maintain the health of their immune system, as reduced serum IgG is a pathology of MS. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectations of success since restoring and maintaining serum IgG levels would help maintain the patient’s immune system and since the method of treatment taught by App ‘635 in view of Kira Ichi et al would inherently encompass this claim limitation. Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11, 13, 16, 18-21, 27, 31-37, 40-41, 54-57 of copending Application No. 17753635 (filed 06/26/2025) in view of Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of Gaikwad et al (Gaikwad, T., et al, VKORC1 and CYP2C9 genotype distribution in Asian countries, Thrombosis, published 2014). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. App ‘635 claims in view of Kira Ichi et al are silent on whether the particular subjects have the disclosed genotype; however, it does not explicitly exclude these limitations. However, Gaikwad et al teaches that about 90% of subjects from East Asian countries were found to have the VKORC1 haplotypes associated with low dose warfarin. As such, the Japanese subjects in Kira Ichi et al are statistically likely to possess these VKORC1 haplotypes. Therefore, the limitation would implicitly have been included in Kira Ichi et al. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007) discloses that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, before the effective filing date of the claimed invention, and that this variation is obvious. The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous method. In this case, the prior art teaches treating multiple sclerosis in a Japanese population, in an attempt to represent the Asian population, with ofatumumab. The instant claims is directed to a particular Asian population that further exhibit genotypes that are prevalent in Asian populations, particularly East Asian, and particularly Japanese populations. There were design incentives or market forces which would have prompted adaptation of the known method/product. In this case, in light of the prior art teaching other anti-CD20 treatment options for multiple sclerosis has potentially adverse side effects, particularly for some population of Asian subjects, which inherently skews towards subjects that have the claimed mutations by nature of its prevalence in Asian subjects, there are design incentives to focus ofatumumab in multiple sclerosis patients with these genotypes. One of ordinary skill in the art, before the effective filing date of the claimed invention, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable. In light of the safety findings in an Asian population taught by Kira Ichi, it would be obvious and motivated to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply this treatment more specifically to Asian subjects with known prevalent genotypes associated with Asian populations. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have reasonable expectations of success in light of the safe results in a population known to have statistically high prevalence of the claimed genotypes. Claim 29 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11, 13, 16, 18-21, 27, 31-37, 40-41, 54-57 of copending Application No. 17753635 (filed 06/26/2025) in view of Kira Ichi et al (IDS 06/12/2024 reference 23, Poster P0209; published 01/01/2020), as applied to claims 26, 30-34, 36-37, 44 above, and further in view of Marrie et al ( Marrie , R., et al, A systematic review of the incidence and prevalence of comorbidity in multiple sclerosis: Overview; Multiple Sclerosis Journal, 2015;21(3):263-281 ; published 2015). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. App ‘635 claims in view of Kira Ichi et al are silent on whether the particular subjects have the disclosed medical history; however, it does not explicitly exclude these limitations. As SLE and other disorders in instant claim 29 are known co-morbidities with multiple sclerosis ( Marrie et al, e.g. Table 1-2) and App ‘635 claims in view of Kira Ichi et al does not explicitly exclude these populations from their methods and studies, the cited prior art likely includes subjects that have these claimed limitations. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007) discloses that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, before the effective filing date of the claimed invention, and that this variation is obvious. The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous method. In this case, the prior art teaches treating multiple sclerosis in a Japanese population, in an attempt to represent the Asian population, with ofatumumab. The instant claims is directed to a particular Asian population that further exhibit disorders that are known to be generally comorbid with multiple sclerosis. There were design incentives or market forces which would have prompted adaptation of the known method/product. In this case, in light of the prior art teaching other anti-CD20 treatment options for multiple sclerosis has potentially adverse side eff