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 .
Claim Status
Applicant’s amendments and remarks, filed 06/10/2026, are acknowledged.
Claims 3-4, 6, 9, 12, and 14 are canceled.
Claims 1-2, 5, 7-8, 10, and 13 are amended.
Claims 1-2, 5, 7-8, 10-11, and 13 are pending.
Examiner acknowledges that claims 5-8 and 13 were amended to no longer depend from multiple dependent claims or were canceled, thus making these claims proper. As such, claims 1-2, 5, 7-8, 10-11, and 13 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 06/10/2026.
Withdrawn Rejections
Applicant’s arguments, see pages 4 and 5, filed 06/10/2026, with respect to:
Claims 1 and 2 reciting a broad recitation followed by a narrow recitation;
Claims 1, 2, and 10 reciting the term “preferably”;
Claims 1 and 2 reciting the limitation “the anti-VLA-4 therapy”;
Claim 2 reciting “suspected of suffering from”;
Claim 10 being unclear whether the term “subcutaneously” is only in reference to the SID schedule or if the term is also encompassing the EID schedule;
Claim 10 reciting “at least 12 months”
rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 3, 4, and 14 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn in part.
Applicant’s arguments, see page 5, filed 06/10/2026, with respect to claims 1-4, 10-11, and 14 rejected under 35 USC 112(a) as allegedly lacking written description have been fully considered and are persuasive. The issue regarding the specification failing to disclose Applicant’s possession of reducing pathological inflammation in a patient with any disease or condition comprising administering any anti-VLA-4 antibody has been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 3, 4, and 14 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(a) is withdrawn.
Applicant’s arguments, see page 5, filed 06/10/2026, with respect to claims 1-3 rejected under 35 USC 112(a) as allegedly lacking enablement have been fully considered and are persuasive. The issue regarding the claims encompassing treating pathological inflammation in a multiple sclerosis patient comprising administering any anti-VLA-4 antibody has been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claim 3 is canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(a) is withdrawn.
Applicant’s remarks, see page 6, filed 06/10/2026, with respect to claims 1-3 rejected under 35 USC 102 as allegedly anticipated by Campbell et al (WO 2019/084335 A1) have been fully considered and are persuasive. Examiner acknowledges that claims 3, 4, and 14 are canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claims 1 and 2 were amended to recite “followed by a chronic phase comprising subcutaneous (SC) administration of natalizumab once every six weeks” which is not disclosed by Campbell et al. As such, the rejection of claims 1 and 2 under 35 USC 102 is withdrawn.
New Objections Necessitated by Amendment
Claim Objections
Claims 1, 2, and 11 are objected to because of the following informalities:
Claims 1 and 2: The claims were amended to end with a comma (,) followed by a period (.).
Claim 11: “the therapeutically effective amount administered” should read “the natalizumab therapy”.
Appropriate correction is required.
Maintained Objections and Rejections
Specification
The disclosure is objected to because of the following informalities:
Para. [0012] is missing a period (.) at the end of the paragraph.
[0079] – [0088] and Tables 2-3: decimals should be lowered (e.g., “4·0” should read “4.0”).
[0079]: “randomisation” should read “randomization”.
Table 2: “Normalised” should read “Normalized”.
[0086]: “enrolment” should read “enrollment”.
Appropriate correction is required.
The use of the term TYSABRI®, BIOGEN®, and STRATIFY JCV™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Response to Arguments
Applicant has not addressed the objections to the specification. As such, the objections are maintained.
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.
Claims 8 and 11 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.
The term “preferably” in claims 8 and 11 renders the claims indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claims 11 recites the limitation "the chronic phase" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant’s Arguments
Applicant states the remaining rejections with respect to claims 11 and 14 are mooted by the cancellation of these claims above (see page 5 of the Remarks filed 06/10/2026).
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive. First, it is noted that claim 11 was not canceled with the claim set filed 06/10/2026. Further, as stated above, claim 8 was amended to no longer depend from multiple dependent claims, thus making this claim proper and under consideration for patentability. As such, the 112(b) rejections are maintained.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 5, 7-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (WO 2019/084335 A1; publication date: 05/02/2019; previously submitted with the Office Action mailed 12/10/2025) and further in view of Plavina et al (The Journal of Clinical Pharmacology (2016)/Volume 56, Issue 10/pp. 1254-1262; Abstract only; previously submitted with the Office Action mailed 12/10/2025).
With respect to instant claims 1-2, 5, 8, and 10-11, Campbell et al is drawn to methods for reducing the risk of developing progressive multifocal encephalopathy in MS patients undergoing natalizumab therapy by switching to an extended interval dosing (EID) schedule (see Abstract; claims 37 and 38; Examples 5 and 8). With respect to the instant biphasic regimen, Campbell et al disclose of a method of administering to a patient in need thereof a natalizumab therapy wherein the method comprises administering natalizumab therapy on an SID schedule for 12 months and then administering the natalizumab therapy on an EID schedule (at least 5 weeks and no more than 7 weeks) (see claims 41-47), specifically every 6 weeks (see Example 8). The natalizumab therapy during the SID and EID schedule would be administered at the dosage of 300 mg IV (see claims 42 and 43). Campbell et al found that the EID schedule was associated with a reduction in the conditional risk of PML (see Tables 23 and 34; Examples 1-4 and 7).
Campbell et al disclose of a method of reducing risk of developing PML in a subject, comprising: a. identifying a low PML risk subject who has been receiving natalizumab therapy on a SID schedule of 4-week intervals; b. determining whether the subject has switched from a low PML risk subject to a high PML risk subject during the natalizumab therapy; and c. if the subject has switched to a high PML risk subject, identifying the high PML risk subject for natalizumab therapy on an EID schedule of greater than 4-week intervals (e.g., at least 5-week intervals) (see pg. 108, lines 18-25). Particularly, Campbell et al disclose of detecting soluble vascular cell adhesion molecule 1 (sVCAM1) in serum, plasma, whole blood RNA, and PBMC samples (see pg. 64).
Campbell et al fails to teach of administering natalizumab subcutaneously as recited in the instant claims. This is remedied by Plavina et al.
Plavina et al disclose of a randomized trial evaluating various administration routes of natalizumab in multiple sclerosis (see Title). The study compared the PK and PD of single SC or intramuscular (IM) 300-mg doses of natalizumab with IV 300-mg doses of natalizumab in patients with MS (see Abstract). Following SC or IM administration of natalizumab, peak serum concentrations were approximately 40% of those observed with IV administration and showed no major differences in elimination characteristics (see Abstract). The mean bioavailability relative to IV administration was 57.1% to 71.3% with SC administration and 48.7% with IM administration; mean trough serum concentrations were similar with SC or IV administration and lower with IM administration (see Abstract). Following single or multiple doses of natalizumab, PD response was comparable across administration routes and disease stages; no meaningful differences were observed across administration groups in the incidence or nature of overall adverse events, serious adverse events, administration site reactions, hypersensitivity reactions, or anti-natalizumab antibodies (see Abstract).
As such, it would have been obvious to combine the teachings of Campbell et al and Plavina et al to develop the claimed invention. One would be motivated to do so because Campbell et al found that incorporating an EID schedule has reduced PML in MS patients especially following an SID schedule. Further, one would consider subcutaneous administration of natalizumab compared to IV administration as taught by Campbell et al because Plavina et al disclose that there were no meaningful differences in overall adverse events, serious adverse events, administration site reactions, hypersensitivity reactions, or anti-natalizumab antibodies across the administration groups. As such, one would have a reasonable expectation that administering natalizumab subcutaneously would provide therapeutic benefit similarly, or even improved, compared to IV administration.
Further, Applicant’s attention is drawn to MPEP 2144.05(II)(A), Routine Optimization - 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
Although this passage does not specifically point to, for example, administration schedules and modes of drug administration, this passage points to numerous variables that affect the function of inventions, such as concentration of reagents and temperature ranges. Furthermore this passage indicates that the optimization of such variables is often obvious activity for one of ordinary skill in the art. It is submitted that the claimed modes of drug administration are akin to the variables discussed in the cited MPEP passage, because said modes of drug administration are optimizable variables that would affect at least the toxicity and/or efficacy, i.e., function, of the claimed invention. Given the “normal desire of scientists or artisans to improve upon what is already generally known,” it would have been prima facie obvious to one of ordinary skill in the art to optimize the claimed drug dosages, administration schedules, and treatment period, because such optimization would produce a more effective invention.
Also as set forth in MPEP 2144.05(II)(B), There is a Motivation to Optimize Result-Effective Variables:
In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because “obvious to try” is not a valid rationale for an obviousness finding. In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that “obvious to try” was a valid rationale for an obviousness finding, for example, when there is a “design need” or “market demand” and there are a “finite number” of solutions. 550 U.S. at 421 (“The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.”). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a personal of ordinary skill in the art to experiment to reach another workable product or process.
In the instant case, the claims are drawn to administration schedules and modes of drug administration which achieve a recognized result, such as drug toxicity and/or therapeutic benefit. Accordingly the recited administration schedules and modes of drug administration are result-effective variables that achieve a recognized result, such as drug toxicity and/or therapeutic benefit for a patient with MS, and it is submitted that since one of ordinary skill in the art would have thus been motivated to determine the optimum or workable ranges of said variables, the administration schedules and modes of drug administration recited were prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention.
Applicant’s Arguments
Applicant respectfully requests the withdrawal of the obviousness rejection (see pages 6 and 7 of the Remarks filed 06/10/2026).
The Examiner asserts that Plavina remedies the failure of Campbell et al to teach or suggest administering natalizumab subcutaneously (see Office Action at page 41). Respectfully, the highlighted reasoning and conclusion is clearly incorrect. In fact, exactly the opposite is true: subcutaneous administration resulted in a significantly lower (57%) mean bioavailability relative to IV administration (71%), not higher, which is necessarily in line with the lower peak serum concentration seen with subcutaneous vs. IV. As such it’s necessarily not the case that “one would have a reasonable expectation that administering natalizumab subcutaneously would provide therapeutic benefit similarly, or even improved, compared to IV administration.” Office Action at p. 41.
Moreover, the prior art also taught that extended interval dosing protocols independently impacted the pharmacokinetics and pharmacodynamics of natalizumab, and therefore the combination of extended interval dosing with subcutaneous administration created still more uncertainty in view of the art. In particular, natalizumab serum and trough concentrations were known to decrease with EID dosing protocols. See Ryerson et al., Neurol Neuroimmunol Neuroinflamm 2020 Feb 4;7(2):e672. As such it was further uncertain whether combining EID with subcutaneous administration would reduce natalizumab saturation of lymphocyte a4- integrin receptor sites to sub-therapeutic levels. Additionally, it was also well known in the art that drug holidays with natalizumab were poorly tolerated, and that radiological and clinical disease activity was not adequately controlled at longer dosing intervals. See, e.g., Killestein et al., Natalizumab drug holiday in multiple sclerosis: Poorly Tolerated, Annals of Neurology 68(3):392-395 (2010); Trojano et al., A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis, Mult Scler 27:2240-53 (2021). Accordingly, and since EID and SC dosing protocol modifications both independently impact the PK and PD of natalizumab, the findings with respect to one protocol modification alone did not resolve the uncertainty regarding a combination of the two.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
The rejection has been updated to reflect current claim amendments. Plavina does teach that the mean trough serum concentrations were similar with SC or IV administration and that PD response was comparable across administration routes and disease stages; no meaningful differences were observed across administration groups in the incidence or nature of overall adverse events, serious adverse events, administration site reactions, hypersensitivity reactions, or anti-natalizumab antibodies. Thus, while SC administration did not demonstrate higher mean bioavailability, one would still have a reasonable expectation that administering natalizumab subcutaneously would provide therapeutic benefit similarly compared to IV administration because the PD response was comparable across administration routes and disease stages.
While Applicant indicates that the prior art taught that extended interval dosing protocols independently impacted the pharmacokinetics and pharmacodynamics of natalizumab, it is noted that the pharmacokinetics and pharmacodynamics of natalizumab for different interval dosing protocols are not recited in the rejected claims. The present invention is drawn to the combination of standard interval dosing and extended interval dosing for reducing pathological inflammation and reducing the risk of PML in MS patients. Natalizumab serum and trough concentrations being known to decrease with EID dosing protocols does not render the claimed invention non-enabling (i.e., would not reduce pathological inflammation or reduce the risk of PML). Campbell et al disclose of a method of administering to a patient in need thereof a natalizumab therapy wherein the method comprises administering natalizumab therapy on an SID schedule for 12 months and then administering the natalizumab therapy on an EID schedule (at least 5 weeks and no more than 7 weeks) (see claims 41-47; Example 5). Further, the art regarding drug holidays that Applicant relies upon do not disclose of the same dosing schedule.
As such, the 103 rejection is maintained.
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.
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18/286,721
Claims 1, 5, 7-8, and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/286,721 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to claims 1, 5, 7-8, and 10-11, the ‘721 application is drawn to a method of treating Radiologically Isolated Syndrome in a patient in need thereof comprising administering a therapeutically effective amount of a disease-modifying antibody therapy to said patient, wherein said patient has at least one phase rim lesion (PRL) in at least one susceptibility-weighted magnetic resonance image (MRI), or the patient has at least one slowly expanding lesion (SEL) in at least one T1-weighted/T2-weighted MRI (see claim 1). The ‘721 application is drawn to a method of reducing and/or treating chronic active white matter lesions in an early-stage and/or asymptomatic MS patient comprising administering a therapeutically effective amount of a disease-modifying antibody therapy to said patient, wherein said patient has at least one PRL in at least one susceptibility-weighted MRI, or the patient has at least one SEL in at least one T1- weighted/T2-weighted MRI (see claim 2). The ‘721 application is drawn to the method according to claim 9, wherein natalizumab is administered in a biphasic dosing regimen, wherein the biphasic regimen comprises an induction phase comprising administration of natalizumab once a month for about 10 to about 14 months, followed by a chronic phase comprising administration of natalizumab once every 5, 6, 7 or 8 weeks (see claim 10). The ‘721 application is drawn to the method according to claim 10, wherein at least one phase or both phases of the biphasic protocol comprises subcutaneous (SC) administration (see claims 11 and 12). The ‘721 application is drawn to a method for reducing and/or treating chronic lesion activity in an asymptomatic and/or early-stage MS patient (e.g. having no relapse events) comprising a) identifying at least one phase rim lesion (PRL) in at least one susceptibility-weighted magnetic resonance image from a patient known or suspected of having chronic lesion activity, b) identifying at least one slowly- expanding lesion (SEL) in at least one T1-weighted/T2-weighted MRI from said patient; c) determining if the at least one PRL co-localizes with the at least one SEL in said patient, and/or vice-versa, and d) in the event of co-localization initiating treatment with a disease-modifying antibody therapy (see claim 13). The ‘721 application is drawn to the method of any preceding claim, wherein the disease-modifying antibody therapy is natalizumab (see claims 9 and 16-17). The ‘721 application is drawn to the method according to any one of claims 13 to 15, wherein the disease-modifying antibody therapy is an anti-VLA-4 antibody, e.g. natalizumab or BIIB 107 (see claim 17). The ‘721 application is drawn to the method according to claim 17, wherein the anti-VLA-4 antibody is natalizumab, and the method further comprises administering to said patient a therapeutically effective amount of natalizumab in a biphasic dosing regimen, wherein the biphasic regimen comprises an induction phase comprising administration of the anti-VLA-4 antibody once every 2 weeks, once every 4 weeks, once every 30 days, or once a month for at least 6 months, for at least 8 months, for at least 10 months, or for at least 12 months, followed by a chronic phase comprising administration of natalizumab once every 5 to 10 weeks (see claim 18). Lastly, the ‘271 application is drawn to the method according to claim 18, wherein the chronic phase comprises administration of natalizumab once every 5 weeks, once every 6 weeks, once every 7 weeks, or once every 8 weeks (see claim 19).
As such, the ‘271 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments
Applicant respectfully traverses in view of the foregoing amendments to claim 1, which incorporate features from claim 6 that were omitted from the scope of the pending double-patenting rejection (see page 7 of the Remarks filed 06/10/2026).
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive. Applicant is reminded that claim 6 was omitted from the double patenting rejection because it was an improper dependent claim. However, copending Application No. 18/286,721 disclose at least one phase or both phases of the biphasic protocol comprises subcutaneous (SC) administration (see claims 11 and 12).
Applicant is reminded that a rejection under double patenting precludes the identification of allowable subject matter. Applicant has not filed a terminal disclaimer, and the claims remain rejected for reasons set forth above.
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As such, the double patenting rejection is maintained.
Conclusion
Claims 1-2, 5, 7-8, and 10-11 are rejected.
Claim 13 is objected to as being dependent upon a rejected base claim.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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