CTNF 18/044,568 CTNF 80847 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Election/Restrictions 1. Applicant's election with traverse of species (recombinant vaccine; multiple sclerosis; anti-viral vaccine; recombinant (anti-)varicella zoster virus vaccine) in the reply filed on 12/2/2025 is acknowledged. The traversal is on the ground(s) that: the burden is on the Examiner to show serious search or examination burden; the Restriction does not identify such a burden; the Restriction does not provide the unity of invention analysis required; the showing has not been made. Upon further consideration, the Restriction Action is withdrawn. Claims 1, 101-150 are under consideration. Information Disclosure Statement 2. The information disclosure statements (IDS) were submitted on 3/8/2023; 8/6/2024; 4/4/2025; 5/7/2025; 7/28/2025; 12/1/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections 07-29-01 AIA 3. Claim s 124, 140 are objected to because of the following informalities: As to claim 124, the claim should recite “50 years”. Claim 140 recites “Administration”. For consistent language, the term should be in lower case . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 4. Claims 1, 101-109, 114-125, 131, 135 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. See claims 1, 101-109, 114-125, 131, 135 as submitted 3/13/2023. As to claim 1, the claim recites “optional” after (a). It is not clear what is included in optional and if optional only refers to (a) or possibly (a), (b), and/or (c). Further, the claim recites “wherein said method comprises one or more treatment periods in which cladribine is administered”. However, the claim recites wherein at steps (a) and (d) cladribine administration is optional. Thus, it is not clear if cladribine administration is optional or not. Further as to claim 118, the claim recites “preferably”. It is not clear if the ensuing language is a limitation or not. As to claims 131, 135, it is not clear what the metes and bounds of “very similar” or ‘essentially identical” are. 07-30-01 AIA 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. 07-31-03 AIA 5. Claim s 1, 101-117, 121-138, 148-150 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for treating multiple sclerosis and administering cladribine with vaccination for VZV , does not reasonably provide enablement for treating any autoimmune disease and administering cladribine with vaccination for any infection . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. See claims 1, 101-117, 121-138, 148-150 as submitted 3/13/2023. In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantityof experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) thebreadth of the claims. Id. While it is not essential that every factor be examined in detail, thosefactors deemed most relevant should be considered. In the present case, the factors deemedrelevant are those of: the breadth of the claims; the (un)predictability of the art; the amount of direction and the working examples provided, and the quantity of experimentation necessary. Breadth of the claims : Claims 1, 110, 111, 112, 113, 126 recite “autoimmune disorder,” “infection,” “vaccine”. Thus, the claims read on “any” autoimmune disorder, “any” infection, “any” vaccine against infection. State of the art : The prior art teaches wherein the term autoimmune disorder reads on a variety of conditions. For example, Duan et al. (“Regulation of Inflammation in Autoimmune Disease,” Hindawi, Journal of Immunology Research, Article ID 7403796, Volume 2019, 2 pages (2019))(See PTO-892: Notice of References Cited) teaches: wherein autoimmune diseases include conditions as varied as rheumatoid arthritis; inflammatory bowel disease, lupus, gout, diabetes (p. 1). Cladribine is known in the prior art for use against MS (See Dangond et al., below; specification p. 25). The amount of direction and the working examples provided : The present specification discloses: cladribine (Mavenclad) for treating blood cancers, leukemia (p. 2); MS (p. 25); vaccination, including against influenza, VZV, Covid19 (p. 34); including wherein Example 2 teaches RRMS; Example 3 teaches COVID-19; Example 4 teaches MS; Example 5 teaches patients with MS. However, in view of the breadth of the claims towards “any” autoimmune disease and use of cladribine, and vaccination against any infection, including use of varicella zoster vaccine, the present specification does not teach a representative set of examples or combinations of species of vaccines or examples within the breadth of the claims. As a result, the skilled artisan would be required to conduct undue amount of experimentation in order to use cladribine regiments with vaccination against any infection including VZV vaccine to treat any autoimmune disease. As discussed above undue experimentation would be required to practice the claimedinvention commensurate with the scope of the claims. Reasonable correlation must exist betweenthe scope of the claims and scope of enablement set forth. In view of the quantity ofexperimentation necessary, the limited working examples, the unpredictability of the art, the lackof sufficient guidance in specification, and the breadth of the claims, it would take undue trialsand errors to practice the claimed invention. Claim Rejections - 35 USC § 102/103 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-20-aia AIA 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. 07-27-aia AIA 6. Claim s 1, 117-119 are rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sotelo-Morales et al. (US20060121052)(cited in applicant's IDS submitted 3/8/2024) . See claims 1, 117-119 as submitted 3/13/2023. See the 35 U.S.C. 112(b) rejection above. For this rejection, claim 1 is interpreted as steps (a) and (d) are optional. Sotelo-Morales et al. teaches: wherein VZV plays a role in the pathogeny of MS (abstract)(as recited in claims 118, 119; as read upon in claim 1); the use of a vaccine against this virus with preventive and therapeutic ends for multiple sclerosis which eventually could also be applicable in the prevention of varicella and zoster (abstract); wherein herpes zoster appears as a consequence of reactivation of VVZ [0001]; varicella-zoster virus (VVZ) is a coated double stranded DNA virus that can produce at least two different diseases, one of them being varicella (clinical manifestation of primary infection) which is ubiquitous and highly contagious, and the other being herpes zoster, which appears as a consequence of the reactivation of VVZ which is latent in the nervous system and occurs usually in aged patients or immunocompromised subjects (as recited in claim 1(b)); vaccine (abstract); using recombinant vaccine for treating MS [0045] (as recited in claim 1(c)); using recombinant proteins from gE of VZV for treating disease related to VZV in mammals (claim 1 of Sotelo-Morales et al.)(as recited in claim 117). Thus Sotelo- Morales et al. anticipates or renders obvious the instant claims . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA 7. Claim 109 is rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales et al. (US20060121052)(cited above) as applied to claims 1, 117-119 above . See claim 109 as submitted 4/7/2025. See the teachings of Sotelo-Morales et al. above. As to claim 109, Sotelo- Morales et al. already teaches multiple doses [0011]. As to claim 109, such recitations are considered obvious to one of ordinary skill in the art in view of the teachings or suggestions of Sotelo-Morales et al. absent unexpected results (See also MPEP 2144.05: I. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention . 07-22-aia AIA 8. Claim 120 is rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales et al . as applied to claim s 1, 117-119 above and further in view of Steinman (“Immunology of relapse and remission in multiple sclerosis,” Annu Rev Immunol, 32: 257-281 (2014))(See PTO-892: Notice of References Cited) . See claim 120 as submitted 4/7/2025. See the teachings of Sotelo-Morales et al. above. Sotelo-Morales et al. does not teach: RRMS. Steinman teaches: wherein individuals with MS develop a clinical pattern called RRMS (relapsing remitting MS)(abstract). One of ordinary skill in the art would have been motivated to treat RRMS as taught by Steinman with the method as taught by over Sotelo-Morales et al. Sotelo-Morales et al. teaches treatment of MS, and Steinman teaches a type of MS (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for treating RRMS as taught by Steinman with the method as taught by over Sotelo-Morales et al. There would have been a reasonable expectation of success given the underlying materials and methods (treating MS) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention . 07-21-aia AIA 9. Claim s 1, 101-103, 109, 115-126, 129, 130, 131, 135, 138 are rejected under 35 U.S.C. 103 as being unpatentable over Dangond et al. (WO-2019101960-A1)(cited in applicant's IDS submitted 3/8/2024) in view of Sotelo- Morales et al. (US20060121052)(cited in applicant's IDS submitted 3/8/2024) . See claims 1, 101-103, 109, 115-126, 129, 130, 131, 135, 138 as submitted 4/7/2025. It is noted claims 1, 126 do not appear to recite or limit to a time frame where vaccination takes place in relation to any optional cladribine administration (See also p. 25 of the instant specification with respect to immunosuppression by cladribine and vaccine administration). Dangond et al. teaches: cladribine regimen for treating multiple sclerosis (autoimmune disorder)(title)(as recited in claims 118, 119); treatment of RRMS, SPMS (p. 4)(as recited in claim 120); oral administration to patient at a fixed dose per patient, wherein said fixed dose is selected from the range of 1.5 mg/kg to 4.0 mg/kg, comprising treatment period of 2 months (as recited in claims 1, 101, 102, 103, 115, 121, 126); bioavailability of 40% (p. 88)(as recited in claim 122); one or more additional treatment years (Section 22, p. 16); cladribine-free period lasting at least 10 months (p. 17); over two consecutive years (p. 10). Dangond et al. teaches wherein a typical treatment year includes time (10 months) wherein no cladribine is administered (p. 15); as well as use of fixed dose per treatment year (p. 9). Dangold also teaches: wherein patients have grade 3 or 4 lymphopenia (p. 58) (as recited in claim 125); patients have absolute lymphocyte count of 1.02-3.36x103/uL (Example 1); HDA (p. 12)(as recited in claim 123); 51 year old patient (p. 12)(as recited in claim 124); grade 3 lymphopenia (p. 58)(as recited in claim 125). Dangold et al. also teaches: use of a gap (p. 16); wherein gap lasts between 1 and 8 months (p. 16); as well as periods of 2 months of active treatment and 10 months without active treatment (Section 21 of Dangold et al.; p. 15). Dangold et al. also teaches wherein fixed dose is selected from 3.0 mg/kg to 4.0 mg/kg over two consecutive years, in each of the two years (Section 2). Dangond et al. does not teach: (a) identifying whether the patient is at risk of reactivation of latent varicella zoster virus (VZV), (b) vaccinating the patient (as recited in claim 1). Sotelo-Morales et al. teaches: wherein VZV plays a role in the pathogeny of MS (abstract); the use of a vaccine against this virus with preventive and therapeutic ends for multiple sclerosis which eventually could also be applicable in the prevention of varicella and zoster (abstract); wherein herpes zoster appears as a consequence of reactivation of VVZ [0001]; varicella-zoster virus (VVZ) is a coated double stranded DNA virus that can produce at least two different diseases, one of them being varicella (clinical manifestation of primary infection) which is ubiquitous and highly contagious, and the other being herpes zoster, which appears as a consequence of the reactivation of VVZ which is latent in the nervous system and occurs usually in aged patients or immunocompromised subjects (as recited in claim 1(b)); vaccine (abstract); using recombinant vaccine for treating MS [0045] (as recited in claim 117); using recombinant proteins from gE of VZV for treating disease related to VZV in mammals (claim 1 of Sotelo-Morales et al.)(as recited in claim 138); adjuvant [0040]; including multiple doses (2)[0011]. One of ordinary skill in the art would have been motivated to combine the method as taught by Sotelo-Morales et al. with the method as taught by Dangold et al. for the same patient. Dangold et al. teaches treatment of MS, and Sotelo-Morales et al. also teaches treatment of MS, as well as wherein VZV plays a role in the pathogeny of MS and wherein vaccine against this virus with preventive and therapeutic ends for multiple sclerosis which eventually could also be applicable in the prevention of varicella and zoster (interpreted as identifying a patient at risk of reactivation of latent varicella zoster virus (VZV))(See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: 1. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.. [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). As to "thereby treating said patient against said autoimmune disorder and limiting the risk of said patient of reactivation of varicella zoster virus (VZV)" (as recited in claim 1), such results are considered to flow from the method steps and compositions as recited in claim 1 (See also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin V. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps ); In Hoffer V. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton V. Nat 1 Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). As to the claimed ranges of cladribine, measurements, duration times, as recited in claims 1, 101, 102, 103, 121, 122, 126 and dosages of vaccine as recited in claim 109, 129, 130, 131, 135, 138, such recitations are considered obvious to one of ordinary skill in the art in view of the teachings or suggestions of Dangold et al. in view of Sotelo-Morales et al. absent unexpected results (See MPEP 2144.05: 1. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990);. see also MPEP 2144.05: Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05: I. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). One of ordinary skill in the art would have had a reasonable expectation of success for combining the method as taught by Sotelo-Morales et al. with the method as taught by Dangold et al. There would have been a reasonable expectation of success given the underlying materials and methods (treatment of MS as taught by Sotelo-Morales et al. and Dangold et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Double Patenting 08-33 AIA 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. 10. Claims 1, 101-106, 109-121, 126-142, 144-150 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12533408. See claims 1, 101-106, 109-121, 126-142, 144-150 as submitted 3/13/2023. Claims 1-8 of U.S. Patent No. 12533408 recite a method for treating multiple sclerosis (MS) in a patient in need thereof, the method comprising: (a) administering cladribine during a first treatment period orally to the patient at a fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is 1.75 mg/kg plus/minus 0.25 mg/kg, (b) identifying whether the patient is at risk of reactivation of latent varicella zoster virus (VZV), (c) vaccinating said patient at risk of reactivation of varicella zoster virus (VZV) with a vaccine against said varicella zoster virus (VZV) reactivation, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E, and (d) administering cladribine during a 2.sup.nd and optionally 3.sup.rd treatment period orally to the patient at a fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is 1.75 mg/kg plus/minus 0.25 mg/kg, with the proviso that said fixed dose per patient is about the same in all of the two or three treatment periods of (a) and (d) wherein cladribine is administered, and wherein (a), (b), (c) and (d) are performed in the order given above, thereby treating said patient against said MS and limiting the risk of said patient of reactivation of varicella zoster virus (VZV). Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 101-106, 109-121, 126-142, 144-150 and claims 1-8 of U.S. Patent No. 12533408 recite a method for treating an autoimmune disorder in a patient in need thereof, the method comprising: (a) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from a range of 1.0 mg/kg to 3.0 mg/kg, (b) identifying a patient at risk of acquiring an infection, (c) vaccinating the patient at risk of acquiring the infection with a vaccine against said infection, and (d) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from the range of 1.0 mg/kg to 3.0 mg/kg, wherein said method comprises one or more treatment periods in which cladribine is administered, and wherein said fixed dose per patient is about the same in all of the one or more treatment periods wherein cladribine is administered, thereby treating said patient against said autoimmune disorder and limiting a risk of said patient of acquiring said infection; multiple sclerosis; recombinant gE vaccine. It is noted that instant claims 1, 110, 111, 112, 113, 126, 139, 140, 141, 142, 144, 145, 146, 147 do not recite the order as recited in claims 1-8 of U.S. Patent No. 12533408. The patented subgenus claims anticipate the instant genus claims, and a patent to the instant genus claims would, necessarily, extend the rights of the already patented sub-genus claims should the instant genus claims issue as a patent. 11. Claims 1, 101-106, 109-122, 126-150 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12539329. See claims 1, 101-106, 109-122, 126-150 as submitted 3/13/2023. Claims 1-29 of U.S. Patent No. 12539329 recite a method for treating Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS) in a patient in need thereof, the method comprising: (a) identifying whether the patient is at risk of reactivation of latent varicella zoster virus (VZV), (b) vaccinating said patient at risk of reactivation varicella zoster virus (VZV) with a vaccine against said varicella zoster virus (VZV) reactivation within a timeframe of about 4 weeks prior to a first treatment period wherein cladribine is orally administered to said patient, and (c) administering cladribine during said first treatment period and one or more additional treatment periods orally to the patient at fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is selected from the range of 1.75 mg/kg plus/minus 0.25 mg/kg, i) wherein said first treatment period and said one or more additional treatment periods in which cladribine is administered each have a duration from 1 to 3 months, ii) wherein each of said treatment periods in which cladribine is orally administered are separated by a period in which no cladribine is administered to said patient, and iii) wherein each of the periods in which no cladribine is administered to said patient has a duration of at least 9 months, with the proviso that said fixed dose per patient is about the same in all of the first treatment period and said one or more additional treatment periods wherein cladribine is administered, and wherein (a), (b) and (c) are performed in the order given above, thereby treating said patient against said autoimmune disorder and limiting the risk of said patient of reactivation of varicella zoster virus (VZV). Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 101-106, 109-122, 126-150 and claims 1-29 of U.S. Patent No. 12539329 recite a method for treating an autoimmune disorder in a patient in need thereof, the method comprising: (a) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from a range of 1.0 mg/kg to 3.0 mg/kg, (b) identifying a patient at risk of acquiring an infection, (c) vaccinating the patient at risk of acquiring the infection with a vaccine against said infection, and (d) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from the range of 1.0 mg/kg to 3.0 mg/kg, wherein said method comprises one or more treatment periods in which cladribine is administered, and wherein said fixed dose per patient is about the same in all of the one or more treatment periods wherein cladribine is administered, thereby treating said patient against said autoimmune disorder and limiting a risk of said patient of acquiring said infection; multiple sclerosis; recombinant gE vaccine. It is noted that instant claims 1, 110, 111, 112, 113, 126, 139, 140, 141, 142, 144, 145, 146, 147 do not recite the order as recited in claims 1-29 of U.S. Patent No. 12539329. The patented subgenus claims anticipate the instant genus claims, and a patent to the instant genus claims would, necessarily, extend the rights of the already patented sub-genus claims should the instant genus claims issue as a patent. 12. Claims 1, 101-106, 108-121, 125-150 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/384362. See claims 1, 101-106, 108-121, 125-150 as submitted 3/13/2023. Claims 1-19 of copending Application No. 19/384362 recite a method for treating Multiple Sclerosis (MS) in a patient in need thereof that is at risk of reactivation of latent varicella zoster virus (VZV), the method comprising: (a) administering cladribine during a first and a second treatment period orally to said patient at a fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is 1.75 mg/kg plus/minus 0.25 mg/kg, i) wherein said first and said second treatment period in which cladribine is orally administered each have a duration from 1 to 3 months, ii) wherein said first and said second treatment period in which cladribine is orally administered are separated by a period in which no cladribine is administered to said patient, iii) wherein the period in which no cladribine is administered to said patient has a duration of at least 9 months, iv) wherein said second treatment period in which cladribine is orally administered is directly followed by a period of at least 9 months in which no cladribine is administered to said patient, with the proviso that said fixed dose per patient is about the same in the said first and said second treatment period wherein cladribine is orally administered; (b) vaccinating said patient at risk of reactivation of varicella zoster virus (VZV) with a vaccine against said varicella zoster virus (VZV) reactivation, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E, wherein said vaccinating comprises administering two shots of said vaccine to said patient, wherein said administration of said two shots is at least 3 weeks to about 8 months apart from each other, and wherein at least one of said shots is administered between the beginning of said first treatment period and the end of said second treatment period in which cladribine is orally administered. Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 101-106, 108-121, 125-150 and claims 1-19 of copending Application No. 19/384362 recite a method for treating an autoimmune disorder in a patient in need thereof, the method comprising: (a) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from a range of 1.0 mg/kg to 3.0 mg/kg, (b) identifying a patient at risk of acquiring an infection, (c) vaccinating the patient at risk of acquiring the infection with a vaccine against said infection, and (d) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from the range of 1.0 mg/kg to 3.0 mg/kg, wherein said method comprises one or more treatment periods in which cladribine is administered, and wherein said fixed dose per patient is about the same in all of the one or more treatment periods wherein cladribine is administered, thereby treating said patient against said autoimmune disorder and limiting a risk of said patient of acquiring said infection; multiple sclerosis; recombinant gE vaccine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 13. Claims 1, 101-106, 108-122, 124-150 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19/430755. See claims 1, 101-106, 108-122, 124-150 as submitted 3/13/2023. Claims 1-23 of copending Application No. 19/430755 recite a method for treating Multiple Sclerosis (MS) in a patient in need thereof, the method comprising: (a) administering cladribine during a first and a second treatment period orally to said patient at a fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is 1.75 mg/kg plus/minus 0.25 mg/kg, i) wherein said first and said second treatment period in which cladribine is orally administered each have duration from 1 to 3 months, ii) wherein said first and said second treatment period in which cladribine is orally administered are separated by a period in which no cladribine is administered to said patient, iii) wherein the period in which no cladribine is administered to said patient has a duration of at least 9 months, (b) administering a first shot and a second shot of a vaccine against varicella zoster virus (VZV) reactivation to said patient, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E, wherein said first shot and said second shot of said vaccine against varicella zoster virus (VZV) reactivation are separated by about 3 weeks to about 8 months, and wherein at least one of the two shot of said vaccine is administered between the beginning of said first treatment period and the end said second treatment period in which cladribine is orally administered. Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 101-106, 108-122, 124-150 and claims 1-23 of copending Application No. 19/430755 recite a method for treating an autoimmune disorder in a patient in need thereof, the method comprising: (a) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from a range of 1.0 mg/kg to 3.0 mg/kg, (b) identifying a patient at risk of acquiring an infection, (c) vaccinating the patient at risk of acquiring the infection with a vaccine against said infection, and (d) optionally administering cladribine during one or more treatment periods orally to a patient at fixed dose per patient, per body weight, and per treatment period, wherein said fixed dose is selected from the range of 1.0 mg/kg to 3.0 mg/kg, wherein said method comprises one or more treatment periods in which cladribine is administered, and wherein said fixed dose per patient is about the same in all of the one or more treatment periods wherein cladribine is administered, thereby treating said patient against said autoimmune disorder and limiting a risk of said patient of acquiring said infection; multiple sclerosis; recombinant gE vaccine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion 14. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672 Application/Control Number: 18/044,568 Page 2 Art Unit: 1672 Application/Control Number: 18/044,568 Page 3 Art Unit: 1672 Application/Control Number: 18/044,568 Page 4 Art Unit: 1672 Application/Control Number: 18/044,568 Page 5 Art Unit: 1672 Application/Control Number: 18/044,568 Page 6 Art Unit: 1672 Application/Control Number: 18/044,568 Page 7 Art Unit: 1672 Application/Control Number: 18/044,568 Page 8 Art Unit: 1672 Application/Control Number: 18/044,568 Page 9 Art Unit: 1672 Application/Control Number: 18/044,568 Page 10 Art Unit: 1672 Application/Control Number: 18/044,568 Page 11 Art Unit: 1672 Application/Control Number: 18/044,568 Page 12 Art Unit: 1672 Application/Control Number: 18/044,568 Page 13 Art Unit: 1672 Application/Control Number: 18/044,568 Page 14 Art Unit: 1672 Application/Control Number: 18/044,568 Page 15 Art Unit: 1672 Application/Control Number: 18/044,568 Page 16 Art Unit: 1672 Application/Control Number: 18/044,568 Page 17 Art Unit: 1672 Application/Control Number: 18/044,568 Page 18 Art Unit: 1672 Application/Control Number: 18/044,568 Page 19 Art Unit: 1672 Application/Control Number: 18/044,568 Page 20 Art Unit: 1672 Application/Control Number: 18/044,568 Page 21 Art Unit: 1672 Application/Control Number: 18/044,568 Page 22 Art Unit: 1672