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 .
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 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.
DETAILED ACTION
Claims 1 and 6-24 are pending in the instant application.
Priority
This application is a continuation of abandoned application 17671420 filed on 2/14/2022 which claims priority to the provisional application 63149359 filed on 2/14/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 1/11/2024, 12/20/2024, and 4/14/2025 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 41, paragraph 1 of the specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Correction is required. See MPEP § 608.01(b).
Objections to the Claims
Claim 11 uses unconventional language. Please replace “a mouse antibody characterized by a mature heavy chain variable region of SEQ ID NO: 7” with “a mouse antibody comprising a mature heavy chain variable region of SEQ ID NO: 7”.
Correction is required. See MPEP § 608.01(m).
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.
Claim 24 is 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 24
Claim 24 is drawn to the antibody of claim 23 comprising a mutation in the constant region wherein it is unclear if alanine:
a) is replacing an existing amino acid,
b) is being inserted between two existing amino acids,
c) is getting replaced by another amino acid, or
d) is originally present at the specified position(s).
Because of these multiple interpretations, this claim is rendered indefinite.
Claim Rejections – 35 USC § 102(a)(1)
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, 6-8, 11-13, 17, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et. al. (WO2020223279).
Claim 1, 8
Regarding claims 1 and 8, Hou teaches an anti-Tau antibody comprising the CDRs of instant SEQ ID NO: 8, 9, and the sequence LDF (SEQ ID NO: 13189), shown below.
instant_8_9 -------------------------GFNIKDYYLH--------------WIDPENGDTVY 21
Hou_13189 EVQLQQSGADLVRPGALVKLSCKASGFNIKDYYLHWVRQRPEQGLEWIGWIDPENGDTVY 60
********** ***********
instant_8_9 DPKFQG--------------------------------LDF------------------- 30
Hou_13189 DPKFQGKATITADTSSNTAYLQLGSLTSEDTAVYFCSTLDFWGQGTTLTVSSASTKGPSV 120
****** ***
Hou also teaches the CDRs of SEQ ID NO: 12, 13, and 14, shown below (SEQ ID NO: 13190).
instant_12_13_14 -----------------------KSSQSLLDSDGKTYLN---------------LVSKLD 18
Hou_13190 DVVMTQTPLTLSVTIGQPASISCKSSQSLLDSDGKTYLNWLLQRPGQSPKRLIYLVSKLD 60
**************** ******
instant_12_13_14 S--------------------------------WQGTHFPYT------------------ 32
Hou_13190 SGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPYTFGGGTKLEIKRTVAAPSV 120
* *********
Hou further teaches the antibody as a therapeutic for Tauopathies, via preventing the aggregation of amylogenic proteins (pg 137, para 0339). Hou teaches a method of treating tau-induced disease, such as Alzheimer’s, comprising administering an AAV particle that delivers the antibody payload (pg 762, para 1856), wherein the disease progression is slowed, stopped, or reversed (pg 762, para 1858), which meets the limitation of “reducing development of tau pathology.” Hou teaches administering the antibody via an adeno-associated virus (AAV), thus meeting the limitation “administering to a subject in need thereof an amount of an antibody” (claims 104, 105, 108, and 125).
Claim 6, 7
Regarding claims 6 and 7, Hou teaches the subject has Alzheimer’s disease including pathological features such as dementia and psychiatric disorders (pg 762, para 186).
Claim 11
Regarding claim 11, Hou teaches the mouse antibody variable heavy chain region of instant SEQ ID NO:7 (SEQ ID NO: 13165), shown below.
instant_7 EVQLQQSGADLVRPGALVKLSCKASGFNIKDYYLHWVRQRPEQGLEWIGWIDPENGDTVY 60
Hou_13165 EVQLQQSGADLVRPGALVKLSCKASGFNIKDYYLHWVRQRPEQGLEWIGWIDPENGDTVY 60
************************************************************
instant_7 DPKFQGKATITADTSSNTAYLQLGSLTSEDTAVYFCSTLDFWGQGTTLTVSS 112
Hou_13165 DPKFQGKATITADTSSNTAYLQLGSLTSEDTAVYFCSTLDFWGQGTTLTVSS 112
****************************************************
Hou also teaches the mouse antibody variable light chain region of instant SEQ ID NO: 11 (SEQ ID NO: 13166), shown below.
instant_11 DVVMTQTPLTLSVTIGQPASISCKSSQSLLDSDGKTYLNWLLQRPGQSPKRLIYLVSKLD 60
Hou_13166 DVVMTQTPLTLSVTIGQPASISCKSSQSLLDSDGKTYLNWLLQRPGQSPKRLIYLVSKLD 60
************************************************************
instant_11 SGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPYTFGGGTKLEIK- 112
Hou_13166 SGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPYTFGGGTKLEIKR 113
****************************************************
Hou further teaches that the antibody may encode humanized polypeptides (pg 3, para 0019).
Claim 12
Regarding claim 12, Hou teaches that the antibody includes a complete heavy chain and light chain (pg 367, para 0849), these being included in the same 5’ to 3’ string (pg 367, pg 0853). Hou teaches the payloads may comprise a maxibody where a bivalent scFv is fused to the amino terminus of the Fc domain of an IgG, thus meeting the limitation of a “complete antibody” that has both a heavy chain and a light chain that are fused together (pg 137, para 0340). Hou teaches that the antibody shares 100% sequence identity to one or more of the polypeptides in Table 11, from which one could construct a complete antibody by selecting the appropriate parts (pg 359, para 0835).
Claim 13
Regarding clam 13, Hou teaches the heavy chain constant region of instant SEQ ID NO: 176 (SEQ ID NO: 13189), shown below.
instant_176 ----------------------------------------------------ASTKGPSV 8
Hou_13189 DPKFQGKATITADTSSNTAYLQLGSLTSEDTAVYFCSTLDFWGQGTTLTVSSASTKGPSV 120
********
instant_176 FPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSV 68
Hou_13189 FPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSV 180
************************************************************
instant_176 VTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP 128
Hou_13189 VTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP 240
************************************************************
instant_176 KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSV 188
Hou_13189 KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSV 300
************************************************************
instant_176 LTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL 248
Hou_13189 LTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL 360
************************************************************
instant_176 TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSC 308
Hou_13189 TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSC 420
************************************************************
instant_176 SVMHEALHNHYTQKSLSLSPGK 330
Hou_13189 SVMHEALHNHYTQKSLSLSPGK 442
**********************
Claim 17
Regarding claim 17, Hou teaches the light chain constant region of instant SEQ ID NO: 177 (SEQ ID NO: 13190), shown below.
instant_177 ----------------------------------------------------RTVAAPSV 8
Hou_13190 SGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPYTFGGGTKLEIKRTVAAPSV 120
********
instant_177 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 68
Hou_13190 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
************************************************************
instant_177 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
Hou_13190 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
***************************************
Claim 22
Regarding claim 22, Hou teaches that it is beneficial to introduce mutations into the framework region/Fc region of the antibody, altering its binding (pg 129, para 0297).
Claim Rejections – 35 USC § 102(a)(1-2)
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 6-24 are rejected under 35 U.S.C. 102(a)(1-2) as being anticipated by Nijjar et. al. (WO2020180819).
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1, 8-9
Regarding claims 1, 8, and 9, Nijjar teaches a method of inhibiting or reducing aggregation of tau comprising administering an anti-tau antibody to a subject at risk of developing a tau-mediated amyloidosis, thus meeting the claim limitation of reducing 1) a tau-induced toxicity, 2) marker of tau pathology, or 3) reducing development of tau pathology in a subject in need thereof (claim 45). Nijjar teaches the anti-tau antibody comprises the heavy chain CDRs of instant SEQ ID NOs: 8, 9, and the sequence LDF (SEQ ID NO:180), underlined below.
instant_180 -------------------EVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRP 41
Najjir_180 MMSFVSLLLVGILFHATQAEVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRP 60
*****************************************
instant_180 GQGLEWIGWIDPENGDTVYDPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDF 101
Najjir_180 GQGLEWIGWIDPENGDTVYDPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDF 120
************************************************************
Nijjar also teaches the light chain CDRs of instant SEQ ID NO: 12, 13, and 14 (SEQ ID NO: 181), underlined below.
instant_181 MMSFVSLLLVGILFHATQADVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWL 60
Nijjar_181 MMSFVSLLLVGILFHATQADVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWL 60
************************************************************
instant_181 QQRPGQSPRRLIYLVGKRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPY 120
Nijjar_181 QQRPGQSPRRLIYLVGKRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPY 120
************************************************************
instant_181 TFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS 180
Nijjar_181 TFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS 180
************************************************************
instant_181 GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 238
Nijjar_181 GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 238
**********************************************************
Nijjar further teaches the light chain CDRs of instant SEQ ID NO: 12, 168, and 14 (SEQ ID NO: 181), underlined below.
instant_179 -------------------DVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWL 41
Nijjar_181 MMSFVSLLLVGILFHATQADVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWL 60
*****************************************
instant_179 QQRPGQSPRRLIYLVGKRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPY 101
Nijjar_181 QQRPGQSPRRLIYLVGKRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPY 120
************************************************************
instant_179 TFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS 161
Nijjar_181 TFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS 180
************************************************************
instant_179 GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
Nijjar_181 GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 238
**********************************************************
Claim 6, 7
Regarding claims 6 and 7, Nijjar teaches the method of instant claim 1, wherein the subject has pathological features of Alzheimer’s disease (claim 48), or is Alzheimer’s disease (claim 49).
Claim 10
Regarding claim 10, Nijjar teaches the heavy chain variable region of instant SEQ ID NO: 18 (SEQ ID NO:18), shown below.
instant_18 EVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRPGQGLEWIGWIDPENGDTVY 60
Nijjar_18 EVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRPGQGLEWIGWIDPENGDTVY 60
************************************************************
instant_18 DPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDFWGQGTLVTVSS 112
Nijjar_18 DPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDFWGQGTLVTVSS 112
****************************************************
Nijjar further teaches the light chain variable region of instant SEQ ID NO: 122 (SEQ ID NO:122), shown below.
instant_122 DVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWLQQRPGQSPRRLIYLVGKRD 60
Nijjar_122 DVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWLQQRPGQSPRRLIYLVGKRD 60
************************************************************
instant_122 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPYTFGGGTKLEIK 112
Nijjar_122 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPYTFGGGTKLEIK 112
****************************************************
Claim 11
Regarding claim 11, Nijjar teaches the method of instant claim 1, wherein the antibody is a humanized version of a mouse antibody (pg 18, para 0083-0084) comprising the heavy chain variable region of instant SEQ ID NO: 7 (SEQ ID NO: 7).
instant_7 EVQLQQSGADLVRPGALVKLSCKASGFNIKDYYLHWVRQRPEQGLEWIGWIDPENGDTVY 60
Nijjar_7 EVQLQQSGADLVRPGALVKLSCKASGFNIKDYYLHWVRQRPEQGLEWIGWIDPENGDTVY 60
************************************************************
instant_7 DPKFQGKATITADTSSNTAYLQLGSLTSEDTAVYFCSTLDFWGQGTTLTVSS 112
Nijjar_7 DPKFQGKATITADTSSNTAYLQLGSLTSEDTAVYFCSTLDFWGQGTTLTVSS 112
****************************************************
Nijjar further teaches the antibody comprising light chain variable region of instant SEQ ID NO: 11 (SEQ ID NO: 11).
instant_11 DVVMTQTPLTLSVTIGQPASISCKSSQSLLDSDGKTYLNWLLQRPGQSPKRLIYLVSKLD 60
Nijjar_11 DVVMTQTPLTLSVTIGQPASISCKSSQSLLDSDGKTYLNWLLQRPGQSPKRLIYLVSKLD 60
************************************************************
instant_11 SGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPYTFGGGTKLEIK 112
Nijjar_11 SGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPYTFGGGTKLEIK 112
****************************************************
Claim 12
Regarding claim 12, Nijjar teaches the antibody comprises a light chain comprising the mature light chain variable region fused to a light chain constant region and a heavy chain comprising the mature heavy chain variable region fused to a heavy chain constant region (claim 19).
Claim 13
Regarding claim 13, Nijjar teaches the antibody comprising the heavy chain variable region of instant SEQ ID NO: 176 (SEQ ID NO:176), with or without the terminal lysine (pg 14, para 0065).
instant_176 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 60
Nijjar_176 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 60
************************************************************
instant_176 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 120
Nijjar_176 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 120
************************************************************
instant_176 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN 180
Nijjar_176 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN 180
************************************************************
instant_176 STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 240
Nijjar_176 STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE 240
************************************************************
instant_176 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 300
Nijjar_176 MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 300
************************************************************
instant_176 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 330
Nijjar_176 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 330
******************************
Claim 14
Regarding claim 14, Nijjar teaches the mature heavy chain variable region being fused to the heavy chain constant region, comprising instant SEQ ID NO: 178 (SEQ ID NO:178), with or without the C-terminal lysine (pg 78, para 0396).
instant_178 EVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRPGQGLEWIGWIDPENGDTVY 60
Nijjar_178 EVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRPGQGLEWIGWIDPENGDTVY 60
************************************************************
instant_178 DPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDFWGQGTLVTVSSASTKGPSV 120
Nijjar_178 DPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDFWGQGTLVTVSSASTKGPSV 120
************************************************************
instant_178 FPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSV 180
Nijjar_178 FPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSV 180
************************************************************
instant_178 VTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP 240
Nijjar_178 VTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP 240
************************************************************
instant_178 KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSV 300
Nijjar_178 KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSV 300
************************************************************
instant_178 LTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL 360
Nijjar_178 LTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL 360
************************************************************
instant_178 TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSC 420
Nijjar_178 TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSC420
************************************************************
instant_178 SVMHEALHNHYTQKSLSLSPGK 442
Nijjar_178 SVMHEALHNHYTQKSLSLSPGK 442
**********************
Claim 15
Regarding claim 15, Nijjar teaches a signal peptide (claim 24).
Claim 16
Regarding claim 16, Nijjar teaches instant SEQ ID NO: 180 (SEQ ID NO:180) with or without the C-terminal lysine.
instant_180 -------------------EVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRP 41
Najjir_180 MMSFVSLLLVGILFHATQAEVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRP 60
*****************************************
instant_180 GQGLEWIGWIDPENGDTVYDPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDF 101
Najjir_180 GQGLEWIGWIDPENGDTVYDPKFQGRATITADTSTDTAYLQLGSLTSEDTAVYFCSTLDF 120
************************************************************
instant_180 WGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSG 161
Najjir_180 WGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSG 180
************************************************************
instant_180 VHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTC 221
Najjir_180 VHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTC 240
************************************************************
instant_180 PPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHN 281
Najjir_180 PPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHN 300
************************************************************
instant_180 AKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREP 341
Najjir_180 AKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREP 360
************************************************************
instant_180 QVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFL 401
Najjir_180 QVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFL 420
************************************************************
instant_180 YSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 442
Najjir_180 YSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 461
*****************************************
Claim 17
Regarding claim 17, Nijjar teaches the light chain constant region comprising instant SEQ ID NO: 177 (SEQ ID NO: 177), with or without the C-terminal lysine (pg 79, para 0398).
instant_177 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
Nijjar_177 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
************************************************************
instant_177 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
Nijjar_177 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
***********************************************
Claim 18
Regarding claim 18, Nijjar teaches the mature light chain variable region fused to a light chain constant region, comprising instant SEQ ID NO: 179 (SEQ ID NO:181).
Claim 19
Regarding claim 19, Nijjar teaches the light chain comprising instant SEQ ID NO: 181 (SEQ ID NO:181).
instant_181 MMSFVSLLLVGILFHATQADVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWL 60
Nijjar_181 MMSFVSLLLVGILFHATQADVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWL 60
************************************************************
instant_181 QQRPGQSPRRLIYLVGKRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPY 120
Nijjar_181 QQRPGQSPRRLIYLVGKRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPY 120
************************************************************
instant_181 TFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS 180
Nijjar_181 TFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS 180
************************************************************
instant_181 GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 238
Nijjar_181 GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 238
**********************************************************
Claim 20
Regarding claim 20, Nijjar teaches the heavy chain of instant SEQ ID NO: 178 (SEQ ID NO:178) with or without the C-terminal lysine (pg 78, para 0396). Nijjar further teaches the light chain of instant SEQ ID NO: 179 (SEQ ID NO: 179).
instant_179 DVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWLQQRPGQSPRRLIYLVGKRD 60
Nijjar_179 DVVMTQSPLSLPVTLGQPASISCKSSQSLLDSDGKTYLNWLQQRPGQSPRRLIYLVGKRD 60
************************************************************
instant_179 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPYTFGGGTKLEIKRTVAAPSV 120
Nijjar_179 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPYTFGGGTKLEIKRTVAAPSV 120
************************************************************
instant_179 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
Nijjar_179 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
************************************************************
instant_179 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
Nijjar_179 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
***************************************
Claim 21
Regarding claim 21, Nijjar teaches the heavy chain comprising instant SEQ ID NO: 180 (SEQ ID NO: 180) with or without the C-terminal lysine (pg 78, para 0396). Nijjar further teaches the light chain comprising instant SEQ ID NO: 181 (SEQ ID NO: 181).
Claim 22, 23
Regarding claims 22-23, Nijjar teaches the antibody comprises at least one mutation in the constant region, wherein the mutation reduces complement fixation or activation by the constant region or reduces binding to Fc receptor relative to the natural human heavy chain constant region (pg 78, para 0396).
Claim 24
Regarding claim 24, Nijjar teaches the antibody comprising a mutation at 241, 264, 265, 270, 296, 297, 318, 320, 322, 329, and 331 by EU numbering or alanine at positions 318, 320 and 322 (pg 78, para 0396).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hou et. al. (WO2020223279) and further in view of Yoles et. al. (EP3725370) and Payne et. al. (WO2018204546). The previous teaching of Hou in the 102 rejections above apply here as well.
Claim 15
Regarding claim 15, Hou does not teach a signal peptide.
Yoles teaches a signal peptide attached to an anti-PD-L1 antibody (SEQ ID NO: 88), shown below.
instant_180 MMSFVSLLLVGILFHATQAEVQLVQSGAEVVKPGATVKISCKASGFNIKDYYLHWVRQRP 60
Yoles_88 MMSFVSLLLVGILFHATQA----------------------------------------- 19
*******************
Yoles teaches that the signal peptide is useful to effectively process the expressed antibody (pg 34, para 0157).
It would’ve been obvious to combine Hou and Yoles, arriving at an anti-Tau antibody with a signal peptide, since Yoles discloses that it is advantageous to control the processing of the antibody, and both Hou and Yoles teach that their antibodies are effective in treating Alzheimer’s Disease.
Claim 23, 24
Regarding claims 23-24, Hou teaches that it is beneficial to introduce mutations into the framework region/Fc region of the antibody, altering its binding (pg 129, para 0297).
Hou does not teach that the mutation in the constant region reduces complement fixation or activation by the constant region or reduces binding to a Fcγ receptor relative to wild type. Hou also does not teach mutating the specified positions.
Payne teaches anti-Tau antibodies wherein some may have at least one mutation in the constant region, such as a mutation that reduces complement fixation or activation by the constant region (pg 21, para 0087). Payne further teaches an anti-Tau antibody that contains mutations at position 241, 264, 265, 270, 296, 297, 318, 320, 322, 329, and 331 by EU numbering. Payne also teaches some antibodies have an alanine at positions 318, 320, and 322 (pg 21, para 0087).
It would have been obvious to combine the teachings of Hou and Payne, arriving at an anti-Tau antibody with a mutated Fc region that has reduced complement fixation. One of skill in the art would have had a reasonable expectation of success because Payne teaches that this mutation produces the desired result in another anti-tau antibody.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
US10961302
Claims 1 and 6-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10961302. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims the same anti-Tau antibodies that contain the same set of instantly claimed CDRs as instant claim 1 (claim 1).
The reference claims the same VH and VL and their “mature” versions as instant claims 10-12 and 18 (claims 3, 12, 31). The reference claims the same heavy chains and light chains of instant SEQ ID NO: 177-179 and 180-181 (with or without the C-terminal Lysine) and the constant region of SEQ ID NO: 176 as instant claims 13-14, 16-17 and 19-21 (claims 10, 14, 16-17). The reference claims a signal peptide and includes the same mutations to the Fc region to alter Fcγ receptor binding as instant claims 15, 22-24 (claims 12 and 19-21).
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. If claims to the compound’s use and the compound were subject to a restriction requirement, and the compound was elected, a nonstatutory double patenting rejection may not be appropriate in a divisional application claiming the restricted compound’s use. See MPEP § 804.01. However, subject matter disclosed in the reference patent or application that does not fall within the scope of a reference claim cannot be used to support a nonstatutory double patenting rejection as this would effectively be treating the reference patent or application as prior art. See MPEP § 804(B)(1).
Regarding instant claims 1 and 6-7, the limitations of “reducing internalization of tau by cells, reducing tau-induced toxicity, reducing or delaying onset of a behavioral deficit, reducing a level of a marker of tau pathology, or reducing development of tau pathology in a subject” which has been simplified to “treating a neurodegenerative disorder” (e.g. Alzheimer’s Disease) in the following analysis: The specification of this reference describes a method of treating a neurodegenerative disorder comprising administering antibody of the invention to a subject in need thereof (abstract, col 1, para 6; col 10, para 5-9; col 11, para 1-4). At the time of filing, the method of treating a neurodegenerative disorder using the instantly claimed antibody was a known use, thus rendering obvious the method of treating a neurodegenerative disorder in the instant application.
US11926659
Claims 1 and 6-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11926659. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims the same anti-Tau antibodies that contain the same set of instantly claimed CDRs as instant claim 1, 8-9 (claim 1).
The reference claims the same VH and VL and their “mature” versions as instant claims 10-12 and 18 (claims 1, 4-5). The reference claims the same heavy chains and light chains of instant SEQ ID NO: 177-179 and 180-181 (with or without the C-terminal Lysine) and the constant region of SEQ ID NO: 176 as instant claims 13-14, 16-17 and 19-21 (claims 12, 16-18). The reference claims a signal peptide and includes the same mutations to the Fc region to alter Fcγ receptor binding as instant claims 15, 22-24 (claims 14, 20-21).
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. If claims to the compound’s use and the compound were subject to a restriction requirement, and the compound was elected, a nonstatutory double patenting rejection may not be appropriate in a divisional application claiming the restricted compound’s use. See MPEP § 804.01. However, subject matter disclosed in the reference patent or application that does not fall within the scope of a reference claim cannot be used to support a nonstatutory double patenting rejection as this would effectively be treating the reference patent or application as prior art. See MPEP § 804(B)(1).
Regarding instant claims 1 and 6-7, the limitations of “reducing internalization of tau by cells, reducing tau-induced toxicity, reducing or delaying onset of a behavioral deficit, reducing a level of a marker of tau pathology, or reducing development of tau pathology in a subject” which has been simplified to “treating a neurodegenerative disorder” (e.g. Alzheimer’s Disease) in the following analysis: The specification of this reference describes a method of treating a neurodegenerative disorder comprising administering antibody of the invention to a subject in need thereof (abstract, col 1, para 6; col 10, para 5-9; col 11, para 1-4). At the time of filing, the method of treating a neurodegenerative disorder using the instantly claimed antibody was a known use, thus rendering obvious the method of treating a neurodegenerative disorder in the instant application.
Relevant Prior Art
See Seubert et al. (US2020/0123239) who teaches antibodies to inhibit or delay tau-associated pathologies (abstract) via binding tau to induce its phagocytosis (pg 2, para 0029). These antibodies also comprise mature heavy and light chain sequences and mutations within the constant region (pg 1, para 007-0012).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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