8Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in reply to Applicant’s Arguments/Remarks filed 31 July 2026 for application 18/685,551 filed 22 February 2024. Claims 1, 5-7, 10, 20-22 and 24 are amended. Claims 2-3, 11-12, 14-19 and 27-39 are canceled. Currently, claims 1, 4-10, 13 and 20-26 are pending.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous office action is set out below.
35 U.S.C. 102, 103 and Double Patenting
The amendments of claims 5, 7 and 24 are sufficient to overcome the prior 35 U.S.C. 112(a) rejections.
REJECTIONS – MAINTAINED & NEW
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Maintained) Claims 1, 4-5, 13, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Angst et al. (1) (Novel amino pyrimidine derivatives, WO 2015/079417 A1, 2015; entered in the IDS on 03 May 2024) in view of Angst et al. (2) (Discovery of LOU064 (Remibrutinib), a potent and highly selective covalent inhibitor of Bruton's Tyrosine Kinase, J. Med. Chem. 2020, 63, 5102-5118; entered in the IDS on 03 May 2024), Montalban et al. (Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis, NJEM 2019, 380, 25, 2406-2417; entered in the IDS on 03 May 2024), Caldwell et al. (Discovery of Evobrutinib: an oral, potent, and highly selective covalent Bruton's Tyrosine Kinase (BTK) inhibitor for the treatment of immunological diseases, J. Med. Chem. 2019, 62, 7643-7655) and Beelen et al. (G1T38 superior dosage regimes, US 2020/0405721 A1, 2020).
Angst (1) discloses LOU064, as known as Remibrutinib, example 6 (pg. 38), proposing therapeutic utility in several diseases and disorders based upon the disclosed BTK inhibition assays, including multiple sclerosis (pg. 95, Utilities). Angst (2) expounds upon LOU064 as belonging to a family of covalent BTK inhibitors including Ibrutinib, Acalabrutinib, Tirabrutinib, Evobrutinib, and Branebrutinib, that covalently bonds to the Cys481 residue of BTK enzymes, displaying preclinical tolerability and safety profiles, and encouraged progression into clinical studies regarding autoimmune diseases (pg. 5108, Fig. 6, conclusion).
Angst (1) and (2) do not, however, demonstrate therapeutic efficacy of the family of BTK inhibitors in the treatment of multiple sclerosis using a therapeutically effective dose.
Montalban addresses this by teaching the evaluation of oral BTK inhibitor Evobrutinib in a double-blind, randomized, phase 2 trial where 267 patients with relapsing multiple sclerosis were treated in five cohorts including placebo, 25 mg QD, 75 mg QD, 75 mg BID of Evobrutinib, or dimethyl fumarate as a reference. Montalban concludes from this study that patients with dosed 75 mg QD developed significantly fewer enhancing lesions characteristic of multiple sclerosis than the other cohorts. Montalban teaches the administration of Evobrutinib in the treatment of patients with multiple sclerosis at 75 mg BID (abstract -methods). Alternatively, given that the person of ordinary skill in the art would recognize the dosage of a pharmaceutical active ingredient as being a results effective parameter, this ordinary artisan would have been motivated to optimize the dosage of LOU064 for a particular patient or patient population to further goal of achieving the desired clinical outcome of treating multiple sclerosis, including ameliorating the symptoms thereof. Dosage of a pharmaceutical is considered an effective parameter that a person of ordinary skill in the art would have been motivated to optimize to obtain the desired clinical outcome or improved clinical outcome. Moreover, it is well-known that dosages may vary between patients due to parameters such as patient mass, gender, co-morbidities, age, etc. 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, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); 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, 4 USPQ 237 (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, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Caldwell elaborates the similarity between Evobrutinib and Remibrutinib, teaching that, like Remibrutinib, Evobrutinib is a covalent inhibitor of the BTK family of enzymes and utilizes the same amide α-ß Michael acceptor inhibitory mechanism targeting Cys481 (pg. 7646, Fig. 5).
Additionally, Beelen teaches that pharmaceutical compositions can be formulated for oral administration and that they can contain any amount of active compound to achieve the desired results, for example between 0.1 and 99 wt.%. This is a reasonable teaching as a person of ordinary skill in the art would necessarily be motivated to optimize the dosing regimen to obtain the desired clinical outcome or improved clinical outcome. Moreover, it is well-known that dosages may vary between patients due to parameters such as patient mass, gender, co-morbidities, age, etc.
Therefore, in the instant case, there is a reasonable expectation of success that a therapeutically efficacious amount of Remibrutinib, dosed in an appropriate manner, would result in a reduction in the signs and symptoms of patients with multiple sclerosis including, but not limited to, the formation of lesions in the protective layer around nerves in the brain and spinal cord, the frequency of patient relapses and slowing the disability progression (Montalban, pg. 2407) as Evobrutinib operates on the same inhibitory mechanism as Remibrutinib.
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of LOU064 (Remibrutinib) to treat patients with multiple sclerosis as it operates on the same mechanism as Evobrutinib, another compound within the same family of BTK inhibitors, which had already demonstrated efficacy in patients with multiple sclerosis in a phase 2 clinical trial. The dosage of 100 mg twice daily is construed as the optimization of parameters, something a person of ordinary skill in the art would necessarily be motivated to determine to obtain the desired clinical outcome or improved clinical outcome.
(Maintained) With regards to the limitation of claim 4, wherein the treatment is a long-term treatment, is met as the duration of treatment is a parameter that a person of ordinary skill in the art would modify absent evidence to the contrary in an attempt to optimize treatment and achieve improved or desired clinical outcomes.
(Maintained) Regarding the limitations of claim 5, where multiple sclerosis is selected from relapsing multiple sclerosis, in particular clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), in particular active SPMS, are met as Montalban teaches the criteria of patient eligibility if they had relapsing- remitting multiple sclerosis or secondary progressive multiple sclerosis with superimposed relapses (patients - pg. 2408).
(Maintained) Concerning the limitation of claim 13, where the treatment is a monotherapy, is met as Montalban teaches the use of Evobrutinib as a monotherapy for patients with multiple sclerosis.
(Maintained) With regards to the limitation of claim 20, where LOU064 (Remibrutinib) is administered after a relapse, is met as Montalban teaches the treatment of patients with relapsing-remitting multiple sclerosis with Evobrutinib.
(Maintained) Regarding the limitation of claim 23, where the patient is an adult, is met as Montalban teaches recruiting patients with relapsing-remitting multiple sclerosis between the age of 18 and 65 years old.
(Maintained) Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Angst (1), Angst (2), Montalban, Caldwell, and Beelen as applied to claims 1, 4-5, 13, 20 and 23 above, and further in view of Harding et al. (Modifying therapies in patients with multiple sclerosis, JAMA Neurology 2019, 76, 5, 536-541).
Angst discloses LOU064 (Remibrutinib) as a covalent BTK inhibitor, similar to Evobrutinib in its mechanism-of-action which was disclosed by Caldwell. Montalban teaches clinical phase trial with Evobrutinib in the treatment of multiple sclerosis while Beelen teaches dosing of pharmaceuticals in pursuit of therapeutic outcomes.
They do not, however, teach where patients are switched from a drug of an earlier disease-modifying therapy to LOU064 (Remibrutinib).
Harding rectifies this by examining the outcomes between two cohorts of MS patients, those who receive high-efficacy treatment at an early onset of the disease and those who undergo an escalatory approach. Harding discovers that those who received the high-efficacy treatment initially had a smaller increase in Expanded Disability Status Scale score at five years compared to those who first received moderate-efficacy disease-modifying therapy (key points).
While this study does not encompass use of LOU064 (Remibrutinib), it is demonstrative of standard-of-care practice for patients with moderate multiple sclerosis, to approach treatment generally from an escalatory viewpoint where patients often do not observe significant measurable improvements in long-term disability outcomes (introduction).
As such, it would be prima facie obvious, to a person of ordinary skill in the art, to consider that the patient population would necessarily include sizeable numbers who have already received other forms of disease-modifying therapies as the general long-term outcome of multiple sclerosis is poor.
(Maintained) Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Angst (1), Angst (2), Montalban, Caldwell, and Beelen as applied to claims 1, 4-5, 13, 20 and 23 above, and further in view of Scolding et al. (Association of British neurologists: revised (2015) guidelines for prescribing disease-modifying treatments in multiple sclerosis, Pract. Neurol. 2015, 15, 273-279).
Angst discloses LOU064 (Remibrutinib) as a covalent BTK inhibitor, similar to Evobrutinib in its mechanism-of-action which was disclosed by Caldwell. Montalban teaches clinical phase trial with Evobrutinib in the treatment of multiple sclerosis while Beelen teaches dosing of pharmaceuticals in pursuit of therapeutic outcomes.
They do not, however, teach the administration of LOU064 (Remibrutinib) after the detection of at least one Gd+ lesion or after the detection of new or enlarging T2 lesions.
Scolding addresses this obstacle by teaching general management advice to clinicians with a section on more active relapsing-remitting multiple sclerosis, defined as one relapse in the previous year on interferon-ß and either a ≥1 gadolinium-enhancing MRI lesion, as compared to claim 21, or at least nine T2-hyperintensive lesions on cranial MRI, as compared to claim 22. They recommend that patients with more active disease use one of category 2 drugs, Natalizumab or Alemtuzumab, drugs considered high efficacy. LOU064 (Remibrutinib), within the brutinib family of BTK inhibitors would also fall under the category of high efficacy disease-modifying treatment drugs.
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of LOU064 (Remibrutinib) after evaluation of a patient by MRI, identifying either one or more gadolinium-enhancing lesion or T2-hyperintensive lesions as they are indicative of relapsing inflammatory disease activity.
Allowable Subject Matter
Claims 7-10 and 24-26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons For Allowance
The following is a statement of reasons for the indication of allowable subject matter: the following is a statement of reason for the indication of allowable subject matter: claims 7-10 and 24-26 were not taught in the prior art in a 100% embodiment. The closest match is Montalban et al. (Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis, NJEM 2019, 380, 25, 2406-2417; entered in the IDS on 03 May 2024) that teaches using Evobrutinib for multiple sclerosis therapy in a phase 2 clinical study. While the limitations of claims 1, 4-6, 13 and 20-23 are taught, the limitations of other claims are not without encompassing any, some, or all aspects.
Therefore, the prior art neither anticipates nor reasonably makes obvious the claimed invention and therefore, the claimed invention is deemed novel and unobvious over the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for Allowance."
Response to Arguments
The office kindly thanks the Applicant for their consideration and arguments to the previous office action. Responses are detailed below.
Applicant’s arguments, see pg. 5 - Remarks, filed 31 July 2026, with respect to claims 5, 7 and 24 have been fully considered and are persuasive. The rejections of claims 5, 7 and 24 has been withdrawn.
Applicant's arguments filed 31 July 2026 have been fully considered but they are not persuasive.
On pgs. 5-12 – Remarks, filed 31 July 2026, the Applicant argues:
… Angst 1 does not disclose or suggest that remibrutinib is effective for the treatment of relapsing multiple sclerosis. Indeed, Angst 1 does not even mention relapsing multiple sclerosis. Angst 1 simply provides a laundry list of considerably diverse diseases as potential targets… without any indication as to which specific compound … is effective…
The Applicant’s argument that, as the prior art does not specifically point out, the use of Remibrutinib is unconvincing as the rejection is based on a combination of prior art where this teaching leads into the others. In response to applicants’ arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
… Angst 2 discloses a phase 1 study which used a dose range of 0.5 mg to 600 mg and lasted only 12 days … does not provide any pertinent information about the long-term safety and tolerability of Remibrutinib that would be required for treating a chronic condition such as relapsing multiple sclerosis… fails to teach or suggest anything about multiple sclerosis at all, much less treating relapsing multiple sclerosis specifically…
While the Applicant is correct in that Angst (2) does not mention multiple sclerosis or relapsing multiple sclerosis, long-term safety or tolerability, the purpose of the prior art is to help transition the rejection from Angst (1) which discloses Remibrutinib into commonality observed in the mechanism-of-action of other drugs within the Brutinib family where some of the determined drug-like properties can be conferred from the members previously studied. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
… the cited art fails to establish the interchangeability of Evobrutinib and Remibrutinib in the treatment of multiple sclerosis (MS), let alone relapsing multiple sclerosis (RMS), on the basis of their classification as BTK inhibitors… showed some efficacy in MS clinical trials does not indicate that Remibrutinib would be clinically effective in treating MS… it is well known in the pharmaceutical arts that small structural differences between drug molecules … can lead to substantial differences in pharmacologic properties … Caldwell does not teach anything about Remibrutinib at all … shows that even minor structural differences in compounds similar to Evobrutinib resulted in significant differences … Caldwell describes that both A5 and A7 maintain critical vectors and angles required to effective engage the back pocket and Cys481 … A5 and A7 varied significantly in activity… Caldwell actually serves to further highlight the fact that BTK inhibitor activity is molecule-specific and that the activity of one BTK inhibitor cannot be projected onto another… nothing in Montalban or Caldwell provides any motivation … to replace Evobrutinib with Remibrutinib, much less any indication that such a change would have been reasonably expected… the office action alleges that Montalban teaches a 75 mg twice daily dose of Evobrutinib and that the claimed dosage of Remibrutinib is merely a routine optimization … there was no significant difference between with placebo and the 75 mg twice daily group… further discloses that the highest rate of serious adverse events occurred in the Evobrutinib 75 mg twice-daily group and that trial discontinuation owing to an adverse event associated with a trial agent was most frequent in the Evobrutinib 75 mg once-daily and twice-daily groups… treatment with Evobrutinib at any dose had no effect on the annualized relapse rate or disability progression and was associated with elevations in liver aminotransferase levels… ultimately, in fact, further clinical trials of Evobrutinib for relapsing multiple sclerosis were not successful due to persistent safety issues… a person of skill in the art would not be motivated to use an alternative BTK inhibitor for the treatment of relapsing multiple sclerosis or have any reasonable expectation that such a treatment could be therapeutically effective and safe… Remibrutinib surprisingly did not induce any dose-limiting liver enzyme elevation and off-target effects as seen with Evobrutinib…
In response to applicant's argument that the person of ordinary skill in the art would not have conceived of developing and applying Remibrutinib from the structural activities and clinical outcomes observed by Evobrutinib, is unconvincing for several reasons including the fact that Evobrutinib, as an investigative drug, progressed to phase two clinical studies with demonstrative efficacy, validating the biological target for a disease that has few short term and almost no long term means to treat the symptoms and underlying etiologies. With regards to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The Examiner agrees with the Applicant in the Furberg 2020 statement as a general truism. However, the point of the rejection is to establish the commonality in the mechanism-of-action between Evobrutinib and Remibrutinib by covalently inhibiting Cys481 of the protein of interest as a means to treat the disease of interest, multiple sclerosis or relapsing multiple sclerosis. From this viewpoint, structure-activity-relationship, biological activity and pharmacokinetics can also be seen as a process of optimization as the parameters involved, structure vs. in vitro, in vivo activity, etc. vs. permeability, stability, bioavailability, etc. are iteratively modified. The process itself is not a patentable subject as it represents the core of the drug development process, well known to the person of ordinary skill in the art. Indeed, while Evobrutinib’s clinical results did not provide idealized outcomes, the Examiner argues that it would have provided more impetus for the creative individual to explore other compounds for better parameters, whether that is greater efficacy, reduced toxicity or some other variable, rather than less motivation. The instant specification eloquently emphasizes the urgency of developing a more efficacious treatment for multiple sclerosis, specifying that there is no cure and the limited treatment options that carry the risk of adverse events and time-limited potency. Surely, if the person of ordinary skill in the art were so discouraged by the Evobrutinib results, the Examiner reasons that the instant application likely would not exist. Of course, the opposite is true, where the Applicant themselves identify advantageous results including Remibrutinib surprisingly did not induce any dose-limiting liver enzyme elevation and off-target effects as seen with Evobrutinib. Additionally, the Applicant cites Ex parte Atkinson and Benedict with concern to the obviousness of a known result-effective variable being reasonable when an improvement is expected to arise in that range. The Examiner however disagrees that this is not connected with the cited references as there is no evidence provided that 100 mg twice daily is idealized for every possible case for treating relapsing multiple sclerosis. As previously stated, it is well-known to the person of ordinary skill in the art that administration and dosing regimens vary from patient-to-patient with many parameters that influence the efficacious dose. In this sense, the expected reasonable range is likely broad and not a singular value. However, the USPTO does not have the laboratory facilities to prove this otherwise. The burden is therefore properly shifted to the Applicant to provide evidence of singularly advantageous properties of the claimed dosing regimen over all others for all possible patients.
… there is nothing in Beelen, Harding or Scolding that cures the deficiency of Angst 1 and 2 and Montalban… provides any teaching with respect to Remibrutinib at all, much less any teaching or suggestion that relapsing multiple sclerosis could be treated with Remibrutinib… do not provide any motivation to modify Angst 1, Angst 2, Montalban and/or Caldwell…
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Beelen supports the idea that the purpose of drug dosing is to find efficacy in treatment and is not merely a static number. Harding teaches the outcomes of two different strategies for treating multiple sclerosis. Lastly, Scolding teaches general management of multiple sclerosis including possible treatments and additionally mentions Remibrutinib. Here the prior art builds upon the rejection and is not intended to stand alone. One cannot show non-obviousness by attacking references individually where the rejections are based on a combination of references.
Summary
Claims 1, 4-6, 13 and 20-23 are rejected under 35 U.S.C. 103. Claims 7-10 and 24-26 are objected to as being allowable but dependent on a rejected base claim.
Conclusion
Claims 1, 4-6, 13 and 20-23 are rejected. Claims 7-10 and 24-26 are objected to.
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 Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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