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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9, 13, 14, 16, 18, 19, 22 and 23) and of the species With regard to the election of a species KiHs-s, HLA DR (DRA), DR beta 4 (DRB4) and IL-2 in the reply filed on 06/22/2026 is acknowledged. Claims 1-9, 13, 14, 16, 18, 19, 22-25 and 28-30 are pending; claims 24-25 and 28-30 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1-9, 13, 14, 16, 18, 19, 22 and 23 are examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/19/2025 was considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 5-7 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.
Specifically:
Claim 5 contains references to KiHs-s, HA-TF, ZW-1, 7.8.60, DDKK, EW-RVT, EW-RVTs-s, and A107 sequences without any SEQ ID NOs.
Claim 6 contains references to a substitution of C77, without any SEQ ID NO:, which makes the C77 immaterial. Also, the claims mention (i) a TGF-β receptor ("TβR")I or TβRI ectodomain polypeptide sequence, a TβRll ectodomain polypeptide sequence, or a TβRlll ectodomain polypeptide sequence with no SEQ ID NOs.
Claim 7 presents a string of letter (amino acid residues?) without any indication of SEQ ID NOs.
As such, the metes and bounds of the claims could not be determined.
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 1-9, 13, 14, 16, 18, 19, 22 and 23 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 inventors, at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). (emphasis added). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
In the instant case, the claim are drawn to a multimeric antigen-presenting polypeptide (MAPP) comprising:
(i) a framework polypeptide comprising a dimerization sequence and a multimerization sequence,
(ii) a dimerization polypeptide comprising a counterpart dimerization sequence complementary to the dimerization sequence of the framework polypeptide, the dimerization sequence and counterpart dimerization sequence dimerizing through covalent and/or non-covalent interactions to form a MAPP heterodimer, and
(iii) at least one presenting sequence and/or presenting complex;
wherein:
(a) each presenting sequence comprises in a single polypeptide:
(i) a peptide epitope, and
(ii) MHC Class II α1, α2, β1, and β2 domain polypeptide sequences;
(b) each presenting complex comprises a presenting complex 1st sequence and a presenting complex 2nd sequence, wherein
the presenting complex 1st sequence or presenting complex 2nd sequence
comprises the peptide epitope and at least one of the α1, α2, β1, and β2 polypeptide sequences, and the presenting complex 1st sequence and presenting complex 2nd sequence together comprise the peptide epitope and MHC Class II α1, α2, β1, and β2 domain polypeptide sequences,
(c) one or both of the dimerization polypeptide and/or the framework polypeptide comprises a presenting sequence or a presenting complex 1st sequence,
(d) the framework polypeptide or dimerization polypeptide comprises at least one masked TGF-β immunomodulatory polypeptide(s) ("masked TGF-β MOD"), each masked TGF-β MOD comprising (i) a TGF-β polypeptide sequence and (ii) a TGF-β receptor polypeptide sequence as a masking sequence that reversibly binds and masks the TGF-β polypeptide sequence; and( e) at least one framework polypeptide, dimerization peptide, presenting sequence, or presenting complex optionally comprises one or more independently selected additional MOD and/or additional variant MOD polypeptide sequences; and wherein the framework polypeptide, dimerization polypeptide, presenting sequence, presenting complex 1st sequence and/or presenting complex 2nd sequence optionally comprise one or more linker sequences that are selected independently, and multimerization and/or dimerization does not result from interaction between MHC sequences.
Further claimed is a duplex or higher order multimeric antigen-presenting polypeptide (MAPP) comprising at least a first MAPP heterodimer and a second MAPP heterodimer wherein:
(i) the first MAPP heterodimer comprises (1) a first framework polypeptide comprising a first multimerization sequence and a first dimerization sequence, (2) a first dimerization polypeptide comprising a first counterpart dimerization sequence complementary to the first dimerization sequence, the first dimerization sequence and first counterpart dimerization sequence dimerizing through covalent and/or non-covalent interactions to form a MAPP heterodimer, and (3) at least one presenting sequence and/or presenting complex, wherein one or both of the first dimerization polypeptide and/or the first framework polypeptide comprises a presenting sequence or a presenting complex 1st sequence; and
(ii) the second MAPP heterodimer comprises (1) a second framework polypeptide comprising a second multimerization sequence and a second dimerization sequence, (2) a second dimerization polypeptide comprising a second counterpart dimerization sequence complementary to the second dimerization sequence, the second dimerization sequence and
second counterpart dimerization sequence dimerizing through covalent and/or non-covalent interactions to form a MAPP heterodimer, and (3) at least one presenting sequence and/or presenting complex, wherein one or both of the second dimerization polypeptide and/or the second framework polypeptide comprises a presenting sequence or a presenting complex 1st sequence; and wherein:
(a) each presenting sequence comprises in a single polypeptide (i) a peptide epitope, and (ii) MHC Class II α1, α2, β1, and β2 domain polypeptide sequences;
(b) each presenting complex comprises a presenting complex 1st sequence and a presenting complex 2nd sequence, wherein the presenting complex 1st sequence or presenting complex 2nd sequence comprises the peptide epitope and at least one of the α1, α2, β1, and β2 polypeptide sequences, and the presenting complex 1st sequence and presenting complex 2nd sequence together comprise a peptide epitope and MHC Class II α1, α2, β1, and β2 domain polypeptide sequences,
(c) the framework polypeptide and/or dimerization polypeptide comprise (i) a TGF-β sequence, (ii) a masking sequence, or (iii) at least one masked TGF-β
immunomodulatory polypeptide(s) ("masked TGF-β MOD"), each masked TGF-β
MOD comprising a masking sequence and TGF-β sequence wherein each masking
sequence reversibly binds and masks the TGF-β polypeptide sequence;
(d) at least one framework polypeptide, dimerization peptide, presenting sequence, or presenting complex optionally comprises one or more independently selected additional MOD and/or additional variant MOD polypeptide sequences;
(e) the framework polypeptide, dimerization polypeptide, presenting sequence, presenting complex 1st sequence and/or presenting complex 2nd sequence optionally comprise one or more linker sequences that are selected independently;
(f) the dimerization and multimerization sequences are independently selected noninterspecific sequences or interspecific sequences, and the first and second framework polypeptides are associated by binding interactions between the first and second multimerization sequences optionally including one or more interchain covalent
bonds, and the multimerization sequences are not the same as, and do not substantially
associate with or bind to, the dimerization sequences or counterpart dimerization
sequences, and multimerization and/or dimerization does not result from interaction
between MHC sequences; and
(g) the duplex or higher order MAPP comprises at least one masked TGF-β MOD with the masking sequence and the TGF-β sequence in cis or in trans. Within the duplex, the non-interspecific sequences are selected from the group consisting of immunoglobulin heavy chain constant regions, collectin family, coiled-coil domains,
and leucine-zipper domains; and the interspecific sequences are selected from the group consisting of Fos polypeptides that pair with Jun polypeptides, lg CH1 and lg CLκ, lg CH1 and lg CLλ,, knob-in-hole without disulfide ("KiH"), knob-in hole with a stabilizing disulfide bond ("KiHs-s"), HA-TF, ZW-1, 7.8.60, DDKK, EW-RVT, EW-RVTs-s, and A107 sequences.
As may be easily observed, the amount of compounds claimed is enormous, due to the consideration of any epitope, any dimerization sequences, any MHC II chain sequences or any non- interspecific sequences.
The specification discloses a grand total of 8 constructs that abide by limitation of the claims (Proteins # 1-8) which comprise TXA23 or OVA as peptide epitopes, IL-2 as MOD and comprising different linkers, TGF-β MOD with the masking sequence and the TGF-β sequence in cis or in trans and two murine MHC Class II α1, α2, β1, and β2 domain polypeptide sequences. The proteins 1-8 comprise SEQ ID NOs: 4421-4426 in different arrangements.
Given the huge diversity of potential partners that are possible for each element of the MPAPs claimed, it is clear that showing possession of just eight constructs is not enough for a person of ordinary skill in the art to conclude that Applicant was in possession of a representative number of species for the genus claimed.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 13, 14, 16, 22 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/287,754 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because, if allowed first, would anticipate the instant Application.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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