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 .
DETAILED ACTION
Status of Application/Election/Restrictions
Applicant’s election without traverse of Group I directed to peptides (claims 1-3, 5-6, 8, 11-13, 15, 62-67, 69-80, 83-87, 90-94 and 106-108), -ENLKHQPG-(SEQ ID NO:470) and -ENLKHQPGCC-(SEQ ID NO:785) in the reply filed on December 02, 2025 is acknowledged.
Claims 4, 7, 9-10, 14, 16-61, 68, 81-82 and 88-89 are canceled. Claims 6, 15, 69, 74 and 79 amended. Claims 1-3, 5-6, 8, 11-13, 15, 62-67, 69-80, 83-87 and 90-111 are pending in this application. Claims 109-111 are directed to a kit comprising the nucleic acid immunotherapy of claim 96, which are grouped into Group II (nucleic acid). Claims 95-105 and 109-111 are withdrawn without traverse (filed 12/02/2025) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 12, 63-67 and 70 are also withdrawn from further consideration because of non-elected SEQ ID NOs:. Election was made without traverse in the reply filed on December 02, 2025.
Claims 1-3, 5-6, 8, 11, 13, 15, 62, 69, 71-80, 83-87, 90-94 and 106-108 are under examination with respect to peptides -ENLKHQPG-(SEQ ID NO:470) and -ENLKHQPGCC-(SEQ ID NO:785) in this office action.
Claim Objections
Claims 12, 63-67, 70 and 109-111 are objected to because of the following informalities: the status of the claims 12, 63-67, 70 and 109-111 is incorrect because these claims are withdrawn from consideration. Appropriate correction is required.
See MPEP 714 & 37 CFR 1.121.
“In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).”
Claims 87 and 90 are objected to because of the following informalities: The recitations “QS-21, TQL-1055, QS-18, QS-17, QS-7” “CpG” are not unique or common abbreviation in the art. Applicants are required to spell out TSLP at the first usage. Appropriate correction is required.
Improper Markush Grouping
Claims 3 and 13 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of different SEQ ID NOs: recited in claims 3 and 13 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The recited alternative species of SEQ ID NOs: do not share a single structural similarity, as each species of SEQ ID NO: has a different chemical structure because it comprises different amino acid sequences derived from Tau. Each peptide of SEQ ID NO: has a different activity or immunogenicity. Thus, the peptides of different SEQ ID NOs: do not share a single structural similarity or biological activity. See MPEP § 706.03(y).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim 87 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 pre-AIA the applicant regards as the invention.
Regarding claim 87, the phrase "such as" recited in claim 87 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).
Claim 87 contains the trademark/trade name “AddaVaxTM” “MF59®”. 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, 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 adjuvant and, accordingly, the identification/description is indefinite
Claim Rejections - 35 USC § 112
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 1-2, 5-6, 8, 62, 69, 71-80, 83-87, 90-94 and 106-108 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claims 1-2, 5-6, 8, 62, 69, 71-80, 83-87, 90-94 and 106-108 encompass a genus of peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750.
Applicant has not disclosed sufficient species for the broad genus of peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is in possession of and what Applicant is claiming.
M.P.E.P. § 2163 instructs:
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. . . .
An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. . . .
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.”
This standard has not been met in this case. The specification only describes peptides with specific sequences shown in Tables 4 possess immunogenicity and capable of inducing antibody titers. Based on Applicant’s own admission, the peptide of SEQ ID NO:781 does not induce antibody generation (see p. 49, table 4). The specification only describes specific peptides shown in table 5 can generate antibodies capable of inhibiting tau binding to heparin (see p. 52-54, table 5). The specification only describes mouse sera raised against specific peptides capable of binding to pathological Tau in Alzheimer’s brain (see p. 55, Table 6). Based on Applicant’s own admission, sera raised against the p peptides of SEQ ID NOs: 782-783, 963-965 cannot bind pathological Tau in AD’s brain.
However, Applicant is not in possession of other structurally and functionally undefined peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750. The specification provides definitive structural or functional features of the claimed genus of peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750. There is no well-established structural and functional relationship or correlation between the claimed genus of peptides and specific peptides having specific sequences for generation antibody titers capable of inhibiting tau binding to heparin or binding to pathological tau in AD’s brain. There is no description of the conserved regions which are critical to the function of the claimed genus. There is no description of the sites at which variability may be tolerated and there is no information regarding the relation of structure of other peptides to the function of specific peptides shown in Tables 4-6. Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750 might be.
Since the common characteristics/features of other peptides are unknown, a skilled artisan cannot envision the functional correlations of the genus with the claimed invention. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750.
Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, the peptides comprising 3-13 amino acids (aa) or 7-13 aa or 5-13 aa from residues 244-400 of SEQ ID NO:1 or aa 1-150 of SEQ ID NO:750 have not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement. See MPEP § 2161.01 and 2163.
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.
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.
(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 1-3, 5-6, 8, 11, 13, 15, 62, 69, 71-79, 83-86 and 91-94 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhaskar et al. (WO2016154522, published Sep 29, 2016, priority Mar 25, 2015).
Bhaskar et al. (WO2016154522) teach a MAPT peptide comprising the amino acid sequence of SEQ ID NO:16, which comprises -ENLKHQPG-(instant SEQ ID NO:470)-GGC and is 100% identical to instant SEQ ID NO:785 (see the sequence alignment below; p. 12, ) and a pharmaceutical composition comprising the MAPT peptide, which meet the limitations recited in claims 1-3, 5-6, 8, 11, 13, 15, 62, 69, 71-79, 83-86 and 91-94. The MAPT peptide disclosed by Bhaskar comprises -ENLKHQPG-(instant SEQ ID NO:470)-GGC, which meets the limitations “3-13 aa (in claim 1)”, “7-13 aa (in claim 8)”, “5-13 aa” (in claim 62) from aa 244-400 of SEQ ID NO:1 or 1-150 of SEQ ID NO:750, and comprises a C-terminal Cysteine (-C) (in claim 5), a C-terminal GGC (in claims 6, 15, 69). Bhaskar teaches an immunogen including an antigen presentation component and a microtubule-associated tau protein (MAPT) component linked to at least a portion of the antigen presentation component wherein the antigen presentation component can include a virus-like particle (VLP) and the VLP can include bacteriophage Qβ or MS2 (see p.). Bhaskar teaches a VLP-based immunogenic component comprising the MAPT peptide conjugated to the VLP including bacteriophage Qβ or MS2, and wherein the MAPT containing single free cysteine residues easily linked to primary amine groups on the surface-exposed lysines on the VLP or via a bi-functional cross-linker as in claim 71-76 (p. 11-12) Bhaskar teaches a pharmaceutical composition comprising the MAPT peptide or the MAPT peptide-conjugated to a VLP and at least one pharmaceutically acceptable carrier or diluent as in claims 77-79, 83-86 and 92-94 (p. 17-18), or a pharmaceutical composition comprising the MAPT peptide and at least one adjuvant comprising a liposomal formulation as in claim 91 (p. 17-18). Thus, claims 1-3, 5-6, 8, 11, 13, 15, 62, 69, 71-79, 83-86 and 91-94 are anticipated by Bhaskar et al. (WO2016154522).
The sequence search results disclose as follows:
SEQ ID NO: 785
BDG14549
ID BDG14549 standard; peptide; 15 AA.
XX
AC BDG14549;
XX
DT 17-NOV-2016 (first entry)
XX
DE Human MAPT polypeptide sequence, SEQ ID 16.
XX
KW MAPT protein; Tau protein; alzheimers disease; brain disease; cell line;
KW cognitive disorder; degeneration; frontotemporal dementia;
KW immune stimulation; immunotherapy; microtubule-associated tau protein;
KW neurodegenerative disease; neuroprotective; nootropic; parkinsonism;
KW progressive supranuclear palsy; therapeutic; transgenic animal;
KW traumatic brain injury; vulnerary.
XX
OS Homo sapiens.
OS Synthetic.
XX
FH Key Location/Qualifiers
FT Modified-site 3
FT /note= "Residue is phosphorylated"
FT Misc-difference 13..15
FT /note= "Residues are optionally absent; C-terminal Cys is
FT conjugated to a virus-like particle (VLP)"
XX
CC PN WO2016154522-A1.
XX
CC PD 29-SEP-2016.
XX
CC PF 25-MAR-2016; 2016WO-US024174.
XX
PR 25-MAR-2015; 2015US-0138015P.
PR 27-APR-2015; 2015US-0153099P.
XX
CC PA (STCU-) STC.UNM.
CC PA (BHAS/) BHASKAR K.
CC PA (MAPH/) MAPHIS N.
CC PA (PEAB/) PEABODY D S.
CC PA (CHAC/) CHACKERIAN B.
CC PA (PEAB/) PEABODY J.
CC PA (CROS/) CROSSEY E.
XX
CC PI Bhaskar K, Maphis N, Peabody DS, Chackerian B, Peabody J;
CC PI Crossey E;
XX
DR WPI; 2016-61072K/70.
XX
CC PT New immunogen comprising an antigen presentation component and a
CC PT microtubule-associated tau protein component, useful for treating and
CC PT preventing a tauopathic condition.
XX
CC PS Claim 3; SEQ ID NO 16; 68pp; English.
XX
CC The present invention relates to a novel immunogen, useful for treating
CC and preventing a tauopathic condition. The immunogen comprises an antigen
CC presentation component and a microtubule-associated tau protein (MAPT)
CC component linked to a portion of the antigen presentation component. The
CC invention further relates to: (1) a method for treating a subject having
CC or at risk of having a tauopathic condition by administering the
CC immunogen to ameliorate a symptom or clinical sign of the tauopathic
CC condition; (2) a polynucleotide that encodes the immunogen; (3) a cell
CC comprising the polynucleotide; (4) a pharmaceutical composition
CC comprising the immunogen; and (5) a transgenic mouse line comprising
CC brain cells that comprise a polynucleotide encoding human MAPT, a
CC deletion of a portion of an endogenous mouse MAPT, and a forebrain neuron
CC -specific deletion of a polynucleotide that encodes myeloid
CC differentiation primary response gene 88 (MyD88). The immunogen and
CC pharmaceutical composition of the invention can be used for treating and
CC preventing a tauopathic condition and ameliorating a symptom or clinical
CC sign of the tauopathic condition. The tauopathic condition comprises
CC Alzheimer's disease, progressive supranuclear palsy (PSP), corticobasal
CC degeneration (CBD), Pick's disease (PiD), frontotemporal dementia and
CC Parkinsonism linked to chromosome-17 Tau Type (FTDP-17T), argyrophilic
CC grain dementia (AGD), traumatic brain injury (TBI), or chronic traumatic
CC encephalopathy (CTE). The symptom or clinical sign of the tauopathic
CC condition comprises neurodegeneration or cognitive impairment. The
CC present sequence is a human MAPT polypeptide sequence comprising a linker
CC peptide, used in the invention for preparing the immunogen which is
CC useful in treating and preventing a tauopathic condition.
XX
SQ Sequence 15 AA;
Query Match 100.0%; Score 67; Length 15;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ENLKHQPGGGC 11
|||||||||||
Db 5 ENLKHQPGGGC 15
SEQ ID NO: 470
BDG14549
ID BDG14549 standard; peptide; 15 AA.
XX
AC BDG14549;
XX
DT 17-NOV-2016 (first entry)
XX
DE Human MAPT polypeptide sequence, SEQ ID 16.
XX
KW MAPT protein; Tau protein; alzheimers disease; brain disease; cell line;
KW cognitive disorder; degeneration; frontotemporal dementia;
KW immune stimulation; immunotherapy; microtubule-associated tau protein;
KW neurodegenerative disease; neuroprotective; nootropic; parkinsonism;
KW progressive supranuclear palsy; therapeutic; transgenic animal;
KW traumatic brain injury; vulnerary.
XX
OS Homo sapiens.
OS Synthetic.
XX
FH Key Location/Qualifiers
FT Modified-site 3
FT /note= "Residue is phosphorylated"
FT Misc-difference 13..15
FT /note= "Residues are optionally absent; C-terminal Cys is
FT conjugated to a virus-like particle (VLP)"
XX
CC PN WO2016154522-A1.
XX
CC PD 29-SEP-2016.
XX
CC PF 25-MAR-2016; 2016WO-US024174.
XX
PR 25-MAR-2015; 2015US-0138015P.
PR 27-APR-2015; 2015US-0153099P.
XX
CC PA (STCU-) STC.UNM.
CC PA (BHAS/) BHASKAR K.
CC PA (MAPH/) MAPHIS N.
CC PA (PEAB/) PEABODY D S.
CC PA (CHAC/) CHACKERIAN B.
CC PA (PEAB/) PEABODY J.
CC PA (CROS/) CROSSEY E.
XX
CC PI Bhaskar K, Maphis N, Peabody DS, Chackerian B, Peabody J;
CC PI Crossey E;
XX
DR WPI; 2016-61072K/70.
XX
CC PT New immunogen comprising an antigen presentation component and a
CC PT microtubule-associated tau protein component, useful for treating and
CC PT preventing a tauopathic condition.
XX
CC PS Claim 3; SEQ ID NO 16; 68pp; English.
XX
CC The present invention relates to a novel immunogen, useful for treating
CC and preventing a tauopathic condition. The immunogen comprises an antigen
CC presentation component and a microtubule-associated tau protein (MAPT)
CC component linked to a portion of the antigen presentation component. The
CC invention further relates to: (1) a method for treating a subject having
CC or at risk of having a tauopathic condition by administering the
CC immunogen to ameliorate a symptom or clinical sign of the tauopathic
CC condition; (2) a polynucleotide that encodes the immunogen; (3) a cell
CC comprising the polynucleotide; (4) a pharmaceutical composition
CC comprising the immunogen; and (5) a transgenic mouse line comprising
CC brain cells that comprise a polynucleotide encoding human MAPT, a
CC deletion of a portion of an endogenous mouse MAPT, and a forebrain neuron
CC -specific deletion of a polynucleotide that encodes myeloid
CC differentiation primary response gene 88 (MyD88). The immunogen and
CC pharmaceutical composition of the invention can be used for treating and
CC preventing a tauopathic condition and ameliorating a symptom or clinical
CC sign of the tauopathic condition. The tauopathic condition comprises
CC Alzheimer's disease, progressive supranuclear palsy (PSP), corticobasal
CC degeneration (CBD), Pick's disease (PiD), frontotemporal dementia and
CC Parkinsonism linked to chromosome-17 Tau Type (FTDP-17T), argyrophilic
CC grain dementia (AGD), traumatic brain injury (TBI), or chronic traumatic
CC encephalopathy (CTE). The symptom or clinical sign of the tauopathic
CC condition comprises neurodegeneration or cognitive impairment. The
CC present sequence is a human MAPT polypeptide sequence comprising a linker
CC peptide, used in the invention for preparing the immunogen which is
CC useful in treating and preventing a tauopathic condition.
XX
SQ Sequence 15 AA;
Query Match 100.0%; Score 46; Length 15;
Best Local Similarity 100.0%;
Matches 8; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ENLKHQPG 8
||||||||
Db 5 ENLKHQPG 12
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 80, 87, 90 and 106-108 are rejected under 35 U.S.C. 103 as being unpatentable over Bhaskar et al. (WO2016154522) in view of Watson et al. (US10124050), Didierlaurenet et al. (J. Immunology, 2014; 193:1920-1930) and Martin et al. (US11324821, issued May 10, 2022, priority Oct 17, 2017).
Bhaskar is set forth above but fails to teach different carriers or adjuvants recited in claims 80, 87, 90 or an immunization kit comprising the claimed immunotherapy composition in a first container and the adjuvant in a second container recited in claims 106-108.
Watson et al. (US10124050) teaches an immunogenic composition comprising a carrier including serum albumins, immunoglobulin molecules, thyroglobulin, ovalbumin, tetanus toxoid (TT), diphtheria toxoid (DT), a genetically modified cross-reacting material (CRM) of diphtheriatoxin, CRM197, meningococcal outer membrane protein complex (OMPC) and H. influenzae protein D (HiD), rEPA (Pseudomonas aeruginosa exotoxin A), KLH (keyhole limpet hemocyanin) as in claim 80 (see col. 4, line 65-col.6, line 24), or adjuvant including aluminum hydroxide, aluminum phosphate, aluminum sulfate, 3 De-O-acylated monophosphoryl lipid A (MPL), QS-21, Complete Freund's Adjuvant (CFA), Incomplete Freund's Adjuvant (IFA), oil in water emulsions (such as squalene or peanut oil), CpG, polylysine, MF59®, and combinations thereof as in claim 87 (see col. 82, lines 10-col. 88, line63), and an immunization kit comprising an immunotherapy composition in one container and an adjuvant in a separate container (see col. 76, lines 54-col. 78, line 3).
Didierlaurenet teaches the use of the ASO1 adjuvant, which is a combination of MPL and QS-21 as in claim 90 provides the best immunization (see p.1920, abstract; p. 1920-1921).
Martin et al. (US11324821) teaches GEN-AS2 adjuvant which is a combination of TQL-1055 is an analog of QS-7 and QS-21 and possesses potent adjuvant activity (col.4, lines 8-15).
A person of ordinary skill in the art would have recognized that selecting and applying the known different carriers, the known different adjuvants, the known adjuvant comprising a combination of MPL and QS-21 or MPL and TQL-1055, the known immunization kit comprising the immunotherapy composition in one container and an adjuvant in a sperate container and the known technique disclosed by Watson, Didierlaurenet and Martin to the Bhaskar’s immunogenic composition would have yielded the predictable result of generation of immunotherapy composition comprising the claimed peptide, the claimed carrier and the claimed adjuvant and the claimed immunization kit comprising the claimed immunotherapy composition in one container and an adjuvant in a second container, and resulted in an improved product.
Using different known carriers or adjuvants and the known adjuvant combination recited in claims 80, 87, 90 and the known immunization kit comprising the claimed immunotherapy composition in a first container and the adjuvant in a second container recited in claims 106-108 in the Bhaskar’s immunogenic composition would induce an immune response for antibody generation, and expand application of the Bhaskar’s immunogenic composition, and would increase patient’s satisfaction with reducing tau aggregation and treatment of Alzheimer’s disease using tau-immunotherapy because these carriers or adjuvants and the adjuvant combination and the immunization kit are known and routine practice in the art as taught by Watson, Didierlaurenet and Martin.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known different carriers, the known different adjuvants, the known adjuvant comprising a combination of MPL and QS-21 or MPL and TQL-1055, the known immunization kit comprising the immunotherapy composition in one container and an adjuvant in a sperate container and the known technique disclosed by Watson, Didierlaurenet and Martin to the Bhaskar’s immunogenic composition, and yield the predictable result of induce immune response and generation of anti-Tau antibody for reducing tau aggregation and treatment of Alzheimer’s disease.
Conclusion
NO CLAIM IS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sigurdsson et al. (WO2010144711) teaches an immunogenic composition comprising a tau peptide having the amino acid sequence of SEQ ID NO: 470 (see the sequence alignment) and a carrier including serum albumins, immunoglobulin molecules, tetanus toxoid (TT), diphtheria toxoid (DT), meningococcal outer membrane protein complex (OMPC) and H. influenzae protein D (HiD), KLH (keyhole limpet hemocyanin) as in claim 80 (see [0043]-[0045]), or adjuvant including aluminum hydroxide, aluminum phosphate, aluminum sulfate, 3 De-O-acylated monophosphoryl lipid A (MPL), Complete Freund's Adjuvant (CFA), Incomplete Freund's Adjuvant (IFA), oil in water emulsions (such as squalene or peanut oil), polyglutamic acid, polylysine, MF59®, and combinations thereof as in claim 87 (see [0049]).
SEQ ID NO: 470
AYN10537
ID AYN10537 standard; peptide; 16 AA.
XX
AC AYN10537;
XX
DT 17-FEB-2011 (first entry)
XX
DE Human tau protein epitope fragment sequence #2.
XX
KW Tau protein; alzheimers disease; antibody therapy; antimicrobial-gen.;
KW antiparkinsonian; brain disease; central nervous system disease;
KW cerebral amyloid angiopathy; cerebroprotective;
KW creutzfeldt jakob disease; degeneration; dementia; diagnostic test;
KW down syndrome; encephalitis; epitope; frontotemporal dementia;
KW genetic-disease-gen.; gerstmann-straussler-scheinker syndrome;
KW growth-disorder-gen.; hallervorden-spatz syndrome; metabolic-gen.;
KW motor neurone disease; multiple system atrophy; muscular-gen.; myositis;
KW myotonic dystrophy; neurodegenerative disease; neuroprotective;
KW niemann pick disease type c1; niemann pick disease type c2; nootropic;
KW parkinsons disease; prion infection; progressive supranuclear palsy;
KW prophylactic to disease; protein targeting; protein therapy; therapeutic.
XX
OS Homo sapiens.
OS Synthetic.
XX
FH Key Location/Qualifiers
FT Modified-site 3
FT /note= "Ser is phosphorylated"
XX
CC PN WO2010144711-A2.
XX
CC PD 16-DEC-2010.
XX
CC PF 10-JUN-2010; 2010WO-US038184.
XX
PR 10-JUN-2009; 2009US-0185895P.
XX
CC PA (UYNY ) UNIV NEW YORK STATE.
XX
CC PI Sigurdsson EM;
XX
DR WPI; 2010-Q35949/02.
XX
CC PT Treating or preventing Alzheimer's disease or other tauopathy in a
CC PT subject comprises administering to the subject, one or more immunogenic
CC PT tau peptides or one or more antibodies recognizing an immunogenic tau
CC PT epitope.
XX
CC PS Example 9; Page; 83pp; English.
XX
CC The present invention relates to a method for treating or preventing
CC Alzheimer's disease or other tauopathy in a subject. The method involves:
CC administering to the subject, one or more immunogenic tau peptides, or
CC one or more antibodies recognizing immunogenic tau epitopes (AYN10434-
CC AYN10507, AYN10533-AYN10535), under conditions effective to treat or
CC prevent Alzheimer's disease or other tauopathy in the subject. The
CC invention further relates to: (1) a method for promoting clearance of tau
CC aggregates from the brain of a subject by administering the immunogenic
CC tau peptides to the subject; (2) a method for slowing progression of a
CC tau-pathology related behavioral phenotype in a subject; (3) an isolated
CC immunogenic tau peptide; (4) a pharmaceutical composition comprising one
CC or more isolated immunogenic tau peptides and a pharmaceutical carrier;
CC (5) an antibody or its binding portion having antigenic specificity for
CC the tau peptide; (6) a combination immunotherapeutic comprising the
CC antibody and one or more antibodies or its binding portions recognizing
CC one or more different amyloidogenic proteins or peptides; (7) a method
CC for diagnosing Alzheimer's disease or other tauopathy in a subject by
CC detecting the tau protein using a diagnostic reagent comprising the
CC antibody, or its active binding fragment; and (8) a diagnostic kit
CC comprising the isolated antibody and a detectable label. The methods of
CC the invention can be used for: diagnosing, treating or preventing
CC Alzheimer's disease or other tauopathy (frontotemporal dementia,
CC parkinsonism linked to chromosome 17 (FTDP-17), progressive supranuclear
CC palsy, corticobasal degeneration, Pick's disease, progressive subcortical
CC gliosis, tangle only dementia, diffuse neurofibrillary tangles with
CC calcification, argyrophilic grain dementia, amyotrophic lateral sclerosis
CC parkinsonism-dementia complex, dementia pugilistica, Down syndrome,
CC Gerstmann-Straussler-Scheinker disease, Hallervorden-Spatz disease,
CC inclusion body myositis, Creutzfeld-Jakob disease, multiple system
CC atropy, Niemann-Pick disease type C, prion protein cerebral amyloid
CC angiopathy, subacute sclerosing panencephalitis, myotonic dystrophy, non-
CC guanamian motor neuron disease with neurofibrillary tangles, chronic
CC traumatic encephalopathy, and postencephalitic parkinsonism) in a subject
CC ; promoting clearance of tau aggregates from the brain of a subject; and
CC slowing progression of tau-pathology related behavioral phenotype in
CC subject. It can also be used for targeting immunogenic tau peptides. The
CC present sequence is a human tau protein epitope fragment sequence, used
CC in the invention. Note: The present sequence is not shown in the
CC specification but is derived from the human tau protein epitope fragment
CC sequence given in example 9 (see AYN10444).
XX
SQ Sequence 16 AA;
Query Match 100.0%; Score 46; Length 16;
Best Local Similarity 100.0%;
Matches 8; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ENLKHQPG 8
||||||||
Db 5 ENLKHQPG 12
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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Chang-Yu Wang
March 6, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675