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 2, 5, 6, 10, 12, 14, 15, 18, 21, 24, and 28 have been canceled. Claims 1, 3, 4, 7, 8, 9, 11, 13, 16, 17, 19, 20, 22, 23, 25-27 have been amended. Claims 29-31 have been added. Claims 1, 3, 4, 7, 8, 9, 11, 13, 16, 17, 19, 20, 22, 23, 25-27 and 29-31 are pending and examined on the merits.
The claim set submitted on 9/18/2023 is not in compliance with 37 C.F.R 1.52(a) which states that (a) papers that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application, or a reexamination or supplemental examination proceeding must be (iv) Plainly and legibly written either by a typewriter or machine printer in permanent dark ink or its equivalent; and (v) Presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition.
In the instant case a grey or colored font was used that fails to reproduce as a dark or black text, and the resulting document is nearly illegible and thus is not presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition.
A complete response to this office action will require a listing of the claims in compliance with 37 C.F.R. 1.52.
Claim Objections
Claims 8, 9, 29 and 31 are objected to because of the following informalities:
(i)the typographical error of 2-pyridyldithio “varian” in claim 8 instead of variant, as stated in the spec;
(ii)Alemtuzumab is repeated twice in claims 29 and 31;
(iii)-(CH2)mXY(CH2)n- is repeated as –(CH2)mX-Y(CH2)n- in claim 9 which represents the same formula.
Appropriate correction is required.
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 1, 4, 7, 8, 8, 9, 17, 29 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is vague and indefinite in the recitation of “capable of site-specific conjugation (formula (1b) and (1a). It is unclear if T retains this capability in formulas 1b and 1a, which show that T is either directly attached to P, L1 and L2 or P and A1 and A2. It is unclear what applicants intent is in stating that the T in formulas (1a) and (1b) is capable of site specific conjugation.
Claim 4 is vague and indefinite in the recitation of “small” molecular drug therapy. The term “small” in claim 4 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear where applicant considers the molecular weight cut-off for a determination of what constitutes a “small” molecular drug therapy, versus that which is a molecular drug therapy that was not small. For instance, it is unclear if Copaxone, also known as Glatiramer acetate is a small molecular drug therapy since it comprises a polymer. One of skill in the art would not be able to determine the metes and bounds of claim 4.
The recitation of 2-pyridyldithio varian[t] in claim 8 and 2-pyridyldithio variant in claim 19 is vague and indefinite because its meaning is not recognized in the art.
Claim 8 is vague and indefinite for the recitation of an improper Markush format, which should be “selected from the group consisting of a, b, c and d”. Rather claim 8 recites “aromatic or vinyl sulfone”, “bromo or iodo acetate”, 2-amino-benzaldehyde or 2-amino-acetophenone” within the group. Thus, it is unclear what the group consists of.
Claim 9 is vague and indefinite in the recitation of “Y” being NR3, wherein R3 is H or C1-C10 alkyl. In the case of R3 being H, NR3 fails to fit into any of the formulas listed in the claim which require a bond between “Y” and another species.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 7 recites the broad recitation single domain antibody, and the claim also recites nanobody which is the narrower statement of the range/limitation;
claims 29 and 31 recites the broad recitation of anti-CD52 antibodies, and the claims also recites alemtuzumab which is the narrower statement of the range/limitation;
claims 29 and 31 recite the broad recitation of anti-CD19 agent, and the claims also recites Inebilizumab and Obexelimab which are the narrower statements of the range/limitation;
claims 29 and 31 recite anti-CD20 agent, and the claims also recites Rituximab, ocrelizumab and ofatumumab which are the narrower statements of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 7 contains the trademark/trade name “nanobody”. Claims 29 and 31 contain the trademark/trade names Tecfidera, Gilenya, Tysabri, Aubagio, Mavenclad and Copaxone. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antibody(nanobody, Tysabri), a modified deoxyadenosine (Mavenclad), a polypeptide (Copaxone), and small organic molecule drugs (Tecfidera and Aubagio) and, accordingly, the identification/description is indefinite.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Further, it is unclear if the parenthetical information is actually a claim limitation.
Claim 29 is vague and indefinite in the recitation of anti-CD52 antibodies (plural). It is unclear if the autoimmune disease must be resistant to more than one anti-CD52 antibody.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 29 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 29 states that the autoimmune disease of claim 4 is resistant or refractory to therapy with Tysabri, Copaxone, IFN-β1a, 1b, alemtuzumab, natalizumab, inebilizumab, obexelimab, rituximab, ocrelizumab, ofatumumab. Claim 4 requires that the autoimmune disease is resistant or refractory to conventional small molecular drug therapy. None of Tysabri alemtuzumab, natalizumab, inebilizumab, obexelimab, rituximab, ocrelizumab, and ofatumumab are ”small “molecular drugs because they are antibodies. Copaxone, also known as Glatiramer acetate, is a polymer, which is not a “small” molecular drug. IFN-β1a, and β1b are proteins and not ”small “molecular drugs. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3, 4, 7, 8, 9, 11, 13, 16, 17, 19, 20, 23, 25-27, 29 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Section 2163 of the M.P.E.P. states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
(A)Claims 1, 3, 4, 7, 8, 9, 11, 13, 16, 17, 19, 20, 23, 25-27, 29 and 31 are reliant on the description of a genus of molecules dependent on the description of “T” as having one, two or more functional groups that after derivization and/or extension with a bifunctional spacer are capable of site-specific conjugation with A1, A2 or derivatives thereof; and L1 and L2 are bifunctional linkers. This fails to provide any description for the actual molecule of T, L1 and L2. Claim 8 is reliant on a description of the genus of linkage molecules between T and A1, T and .A2, T and L1, T and L2, L1 and A1, L2 and A2 are “derived from functional groups selected from the group consisting of alkyl halide, acid halide, aldehyde, ketone, ester, anhydride, carboxylic acid, amide, amine, hydrazide, alkylhydrazines, hydroxy, epoxide, thiol, maleimide, 2-pyridyldithio varian, aromatic or vinyl sulfone, acrylate, bromo or iodo acetamide, azide, alkene, alkyne, dibenzocyclooctyl (DBCO), 2-amino-benzaldehyde or 2-amino-acetophenone group, hydrazide, oxime, potassium acyltrifluoroborate, O-carbamoylhydroxylamine, trans-cyclooctene, tetrazine and triarylphosphine”. Stating what the linker has been “derived from fails to provide any structural data that describes the linker after the reaction with the functional groups, and does not provide any information as to the nature of the other reactants used in the derivization. One of skill in the art would not be able to determine if a linker was part of the genus of claim 8 as one could do with a well-described genus.
Claim 17 is reliant on a genus of “T” derived from a natural or unnatural amino acid selected from the group consisting of cysteine, lysine, asparagine, aspartic, glutamic acid, glutamine, histidine, serine, threonine, tryptophan, tyrosine or genetically-encoded alkene lysine (such as N6-(hex-5-enoyl)-L-lysine), 2-Amino-8-oxononanoic acid, m- or p-acetyl-phenylalanine, amino acid bearing a β-diketone side chain (such as 2-amino-3-(4-(3-oxobutanoyl)phenyl)propanoic acid), (S)-2-amino-6-(((1R,2R)-2-azidocyclopentyloxy)carbonylamino) hexanoic acid, azidohomoalanine, pyrrolysine analogue N6-((prop-2-yn-1-yloxy)carbonyl)-L-lysine, (S)-2-Amino-6-pent-4-ynamidohexanoic acid, (S)-2-Amino-6-((prop-2-ynyloxy)carbonylamino)hexanoic acid, (S)-2-Amino-6-((2-azidoethoxy)carbonylamino)hexanoic acid, p-azidophenylalanine, para-azidophenylalanine, Nε-Acryloyl-1-lysine, Nε-5-norbornene-2-yloxycarbonyl-1-lysine, N-ε-(Cyclooct-2-yn-1-yloxy)carbonyl)-L-lysine, N-ε-(2-(Cyclooct-2-yn-1-yloxy)ethyl) carbonyl-L-lysine, and genetically encoded tetrazine amino acid (such as 4-(6-methyl-s-tetrazin-3-yl)aminophenylalanine). Claim 20 states that “T” is derived from cysteine. Stating what T has been “derived from fails to provide any structural data that describes T after the reaction with the natural or unnatural amino acids, and does not provide any information as to the nature of the other reactants used in the derivazation, or the resulting structures form by the derivation. One of skill in the art would not be able to envisage a “T” that was part of the genus of claim 17 without knowledge of the other compounds involved in the derivization, or the resulting structures form by the derivation.
Applicant has reduced to practice:
PNG
media_image1.png
193
549
media_image1.png
Greyscale
However, this structure fails to adequate describe the required genuses of “T”, the linkages between T and A1, T and A2, T and L1, T and L2, L1 and A1, L2 and A2, because saaid genuses are highly varaint and the above molecule does not adeuquately describe all the varaint species encompassed in the genuses.
(B) Claim 8 and 19 are reliant upon the description of the 2-pyridyldithio variant. This compound is not described in the specification nor known in the art. Accordingly,, the specification lacks an adequate written description of the compound.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 7, 8, 9, 11, 13, 16, 17, 22, 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al (WO2018/075308, reference of the IDS filed 1/17/2024).
Liu et al disclose the structure of formula (1b)(page 2):
PNG
media_image2.png
403
529
media_image2.png
Greyscale
Which meets the same limitation of instant claim 1.
Liu et al disclose compounds of formula (Ia)(page 8):
PNG
media_image3.png
184
519
media_image3.png
Greyscale
which meets the same limitation of instant claim 1.
Liu et al disclose that A1 and A2 can be two antibodies, one a CD3 binding antibody and the other a CD19 binding antibody, and that the two antibodies can be single chain antibodies (page 2, line 27 to page 3, line 2) which meets that limitation in claim 1 and claim 7. Liu et al disclose compound 12:
PNG
media_image4.png
188
425
media_image4.png
Greyscale
(Figure 2A) which meets the limitations of claim 9 for L1 comprising a spacer that is –(CH2)2mX- wherein m is 4 or 2, respectively, and X is null, if the spacer of claim 9 is only a part of the linker, or the limitation of and the limitations of claim 22, wherein mPEG has M.W. of 30,000; a=1, b=10, X=O and R1 and R2 are C1-10 alkane.
Liu et al disclose that the PEG can be linked to the multifunctional moiety either through a permanent bond, or a cleavable bond (page 3, lines 10-11) which fulfills that limitation in claim 11; compound 12 indicates that PEG is capped with a methyl group, which fulfills the limitation of a C1-C10 alkyl capping group in claim 1, and a “B” which is methyl in claim 11. A methyl capping group is also disclosed on page 3, lines 7-8). Liu et al disclose that the PEG can be branched or linear (page 3, lines 6-7) and that that molecular weight of the PEG can be 3 thousand to 80 thousand (page 3, lines 8-9) which meets the limitations of claim 13. Liu et al disclose that the terminal hydroxyl group of a PEG moiety (P) may be activated and then coupled with lysine (T) to provide a desirable linkage point between P and T of Formula la or lb (page 13, lines 31-33) which meets the limitation of an amide in claim 16. Liu et al disclose that T is derived from a lysine (page 12, line 22) which meets that limitation in claim 17. Liu et al disclose that the multispecific molecules of the invention are administered in a usual dosage of 0.01-50mg/kg (page 34, lines 7-9) which meets the limitations of claim 23. Liu et al disclose that a preferred dosing schedule is six doses within four weeks (page 34, lines 13-16), which meets the embodiments of claim 25 for 1-8 times every 4-8 weeks. Liu et al disclose that pharmaceutical compositions of the invention can be administered in combination therapy (page 33, lines 3-5), which meets the limitations of claim 26 because simultaneous or sequential are the only two options for combining two medicaments and claim 26 encompasses both options.
Liu et al disclose that he multispecific binding molecules/multi-specific antibodies disclosed herein can be used in the preparation of medicaments for the treatment of an autoimmune disease (page 20, lines 23-26). Which meets the limitations of claim 1 for a method of treating an autoimmune disease. Liu et al disclose exemplary non-limiting examples of autoimmune diseases treatable by the multifunctional molecules are acute idiopathic thrombocytopenic purpura, chronic idiopathic thrombocytopenic purpura, dermatomyositis,, systemic lupus erythematosus, diabetes mellitus, , rheumatoid arthritis, multiple sclerosis, sarcoidosis, Goodpasture's syndrome, Sjogren's syndrome, Hashimoto's thyroiditis,, pemphigus vulgaris, rapidly progressive, and psoriasis. (page 21, lines 1-12) which meets the limitations of the same in claim 3.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 7, 8, 9, 11, 13, 16, 17, 22, 26 , 27, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (WO2018/075308) in view of Gross and Naismith (Journal of Internal Medicine, 2014, Vol. 275, pp. 350-363.).
Claim 27 requires that the autoimmune disease being treated in claim 1 is resistant or refractory autoimmune disease. Claim 4 requires that the autoimmune disease of claim 27 is resistant or refractory to conventional small molecular drug therapy. Claim 29 specifies that the autoimmune disease in claim 4 is resistant or refractory to a therapy with Tysabri, Copaxone, IFN-β1a, 1b, alemtuzumab, natalizumab, inebilizumab, obexelimab, rituximab, ocrelizumab, ofatumumab.
Liu et al teach the administration of the inventive compounds for the treatment of autoimmune disease, specifically multiple sclerosis (page 21, line 6). Liu et al teach a combination of the inventive compounds with a secondary agent (page 33, lines 3-5). Liu et al do not specifically teach the combination of the inventive compounds with Tysabri, Copaxone, IFN-β1a, 1b, alemtuzumab, natalizumab, inebilizumab, obexelimab, rituximab, ocrelizumab, or ofatumumab for the treatment of MS; the treatment of MS which is resistant or refractory; or the treatment of MS which is resistant or refractory to Tysabri, Copaxone, IFN-β1a, 1b, alemtuzumab, natalizumab, inebilizumab, obexelimab, rituximab, ocrelizumab, or ofatumumab.
Cross and Naismith teach first-line therapy of MS is beta-IFN or glatiramer acetate (abstract, first column,, lines 11-13), but that patients starting this therapy must be closely monitored for development of suboptimal response(abstract, second column, lines 8-13) in order to switch the patient to newer drugs which greater potential efficacy with potential greater risks (abstract, second column, lines 18-19). Cross and Naismith teach that mitoxantrone is a chemotherapeutic agent that inhibits T-cell activation and reduces proliferation of B- and T-cells (page 354, lines 1-3 under the heading “Mitoxantrone”) but the duration of treatment with mitoxantrone is limited by cardiotoxicity (page 355, first column, first full paragraph). Cross and Naismith teach that administration of beta interferon results in inhibition of antigen presentation leading to reduced activation of T lymphocytes, reduction of T cell activation and reduction of proteases required for T cell entry across the blood-brain barrier (page 351, first column, lines 9-12 of the bottom paragraph). Cross and Naismith teach that dimethyl fumarate, otherwise known as Tecfidera, has a mode of action that involves enhancing endogenous mechanisms to counteract oxidative stress via activation of the nuclear factor erythroid-2-related factor transcriptional pathway (page 357, bridging sentence between the first and second column). Cross and Naismith teach that glitamer acetate, otherwise known as Copaxone, has a mode of action resulting in a shift of Th1 cytokines to Th2 cytokine (page 351, second column, top paragraph). Cross and Naismith teach Alemtuzumab, Natalizumab, otherwise known as Tysabri,, ocrelizumab and oftumumab bind to CD52 (page 358, first column, lines 1-2 under “Alemtuzumab”), the alpha4 subunit of the VLA-4 receptor (page 351, second column, lines 103 under the heading “Natalizumab”), or CD20 (page 359, lines 1-3 under the heading “Ocrelizumab” and lines 1-3 under the heading of Ofatumumab).
It would have been prima facie obvious at the time prior to the effective filing date to combine any of beta-IFN, dimethylfumarate, glatiramer acetate, dimethyl fumarate, Alemtuzumab, Natalizumab, ocrelizumab or oftumumab with the inventive compounds of Liu et al. One of skill in the art would have been motivated to dos o because Liu et al teach the use of the inventive compounds in combination therapy. One of skill in the art would understand that all of beta-IFN, dimethylfumarate, glatiramer acetate, dimethyl fumarate, Alemtuzumab, Natalizumab, ocrelizumab or oftumumab are recognized therapies for MS.
It would have been prima facie obvious at the time prior to the effective filing date to treat MS having become resistant or refractory to any of beta-IFN, dimethylfumarate, glatiramer acetate, dimethyl fumarate, Alemtuzumab, Natalizumab, ocrelizumab or oftumumab with the inventive compound of Liu et al. One of skill in the art would have been motivated to dos o because the compounds of Liu et al are conjugated to anti-CD19 and anti-CD3 binding scFv and thus will bring activated T cells into proximity with cells positive for CD19. One of skill in the art would recognize that this is a totally different mode of action than any of beta-IFN, dimethylfumarate, glatiramer acetate, dimethyl fumarate, Alemtuzumab, Natalizumab, ocrelizumab or oftumumab and thus would have a reasonable expectation of success in the treatment of beta-IFN, dimethylfumarate, glatiramer acetate, dimethyl fumarate, Alemtuzumab, Natalizumab, ocrelizumab or oftumumab resistant or refractory MS.
Allowable Subject Matter
Claim 30 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
