DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 are pending and currently under consideration.
Claim Objections
Claims 7-12 and 16-19 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 7-12 and 16-19 have not been further treated on the merits.
Claim Rejections - 35 USC § 112
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 13-15 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.
Claims 13-15 are rejected because it is unclear how, or if “e.g. having no relapse events” recited in the first set of parentheses of claim 13 limits the claims. Therefore, the metes-and-bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 4 is/are rejected under 35 U.S.C. 102Ia)(1) as being anticipated by Preziosa et al (Multiple Sclerosis Journal, 2021, 27(10): 1520-1532; published online 11/13/2020).
Preziosa et al teaches a method comprising administering a therapeutically effective amount of the disease-modifying antibody natalizumab to multiple sclerosis (MS) patients, wherein said patients have at least one slowly expanding lesion (SEL) in at least one T1-weighted/T2-weighted MRI (Figure 2, 3, and Table 1, in particular). Figure 1 shows treated patients include those where at least 1% of the patients’ total T2 hyperintense lesion volume and/or number is identified as SEL. Preziosa et al does not specifically describe patients as “early stage” and the specification does not provide a limiting definition of “early stage MS”; therefore, the examiner takes the position that patients of Preziosa et al include those that are early stage MS (such as those with less than 3 years since diagnosis; see Table 1). Preziosa et al does not specifically teach the method of Preziosa et al treats “Radiologically Isolated Syndrome” in the patients however; the claimed method (treating a patient “in need thereof”) appears to be the same as that of Preziosa et al because patients of Preziosa et al are “in need thereof”, have recited SEL in at least one T1-weighted/T2-weighted MRI, and are administered recited “disease-modifying antibody therapy”. Preziosa et al further teaches the multiple sclerosis therapeutic natalizumab (i) limits the burden of chronic active lesions showing smouldering inflammation, demyelination and axonal loss and (ii) promotes reparative mechanisms in stable/chronic inactive lesions (left column on page 1531, in particular).
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.
Claim(s) 1-6 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Preziosa et al (Multiple Sclerosis Journal, 2021, 27(10): 1520-1532) as applied to claims 1, 2, and 4 above, and further in view of Maggi et al (Ann Neurol, 2020, 88: 1034-1042) and Absinta et al (JAMA Neurology, 2019, 76(12): 1474-1483, 33 pages of web download).
Teachings of Preziosa et al are discussed above.
Preziosa et al does not specifically teach multiple sclerosis patients of Preziosa et al administered natalizumab have a phase rim lesion (PRL; same as “paramagnetic rim lesion”) or have at least 1% of the patients’ total T2 hyperintense lesion volume and/or number is identified as phase rim lesion, or that phase rim lesion (such as 5% of a phase rim lesion) of a patient co-localizes with slowly expanding lesion of the patient. However, these deficiencies are made up in the teachings of Maggi et al and Absinta et al.
Maggi et al teaches phase rim lesions (PRLs; same as “paramagnetic rim lesion”) are found in 52% of patients with multiple sclerosis (Abstract, in particular). Maggi et al further teaches phase rim lesions include those that are chronic lesions (left column on page 1037, in particular).
Absinta et al teaches patients with multiple sclerosis having chronic active/slowly expanding/smoldering lesions detectable by MRI by their characteristic paramagnetic rims (see Findings, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating any patient with multiple sclerosis with (i) chronic active lesions showing smouldering inflammation, demyelination and axonal loss or (ii) stable/chronic inactive lesions because Preziosa et al teaches natalizumab (i) limits the burden of chronic active lesions showing smouldering inflammation, demyelination and axonal loss and (ii) promotes reparative mechanisms in stable/chronic inactive lesions. Such multiple sclerosis patients include those with a phase rim lesion (PRL; same as “paramagnetic rim lesion”), patients equivalent to those that have at least 1% of the patients’ total T2 hyperintense lesion volume and/or number identified as phase rim lesion, and patients that have phase rim lesions (such as 5% of phase rim lesions) that co-localize with slowly expanding lesions of the patient because Maggi et al teaches phase rim lesions (PRLs; same as “paramagnetic rim lesion”) are found in 52% of patients with multiple sclerosis (Abstract, in particular). Maggi et al further teaches phase rim lesions include those that are chronic lesions (left column on page 1037, in particular) and Absinta et al teaches patients with multiple sclerosis having chronic active/slowly expanding/smoldering lesions detectable by MRI by their characteristic paramagnetic rims (see Findings, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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