DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on 10/27/2023 and 02/19/2025 are acknowledged and the references cited therein have been considered.
Priority
3. The present application is a 371 National Stage Application of PCT International Application No. PCT/CN2021/131612, filed 11/19/2021, which claims the benefit of Chinese Patent Application No. CN202110501688.1, filed 05/08/2021, and Chinese Patent Application No. CN202110485551.1, filed 04/30/2021. Applicant' s claim for the benefit of prior-filed application is acknowledged.
Status of Claims
4. Applicant’s preliminary amendments received 10/27/2023 and 11/01/2023 are acknowledged.
5. Claims 1-13 are pending in the instant application.
6. Applicant’s election of Group I, claims 1-4, without traverse, is acknowledged, which is directed to a chimeric antigen receptor.
7. Claims 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
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.
8. Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 broadly claims a genus of F2A peptide that spliced, while claim 3 specifically claims F2A as SEQ ID NO: 25. Thus, the genus of F2A claimed in instant claim 2 lacks sufficient structure-functional relationship.
The claims are not supported by a description that satisfies 35 U.S.C. § 112(a) or 35 U.S.C. § 112, first paragraph. "[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Phanns., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane).
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." Id. at 1350. "[A]n adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials." Id.
"[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function." Id. "But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Id.
"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" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69).
The specification discloses one example of an F2A peptide, and only the peptide consisting of SEQ ID NO: 25 is recited in claim 3 as an F2A peptide.
With respect to representative number of species, see AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014). Also, see MPEP 2163 Il(A)(3)(a))(ii):
A representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See Abb Vie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., Koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Thus, one of ordinary skill in the art cannot envision from the disclosed species provided in the instant claim 2, the breadth of F2A peptides of the instant invention comprising an F2A peptide. Therefore, in view of the breadth of the claim and the limited disclosure, artisans would reasonably conclude that the applicant was not in possession of the full breadth of F2A peptide encompassed by the claim at the time the instant application was filed.
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.
9. Claims 2-4 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.
A. Regarding instant claim 2, the phrase “further spliced” renders the instant claim indefinite, as it is not clear if the proteins recited are being removed or added. Base claim 1 lacks the claimed elements (splicing E2A peptides, IL-7, and CCL19) recited in claim 2, yet claim 2 reciting those elements are spliced.
B. Regarding instant claims 3-4, the phrase “represented by” implies any member of a genus that is “represented by” the respective SEQ ID NO:. Such language fails to establish the metes and bounds of cDNAs encompassed by the instant claim language; therefore the claims are indefinite.
Allowable Subject Matter
11. Claim 1 constitutes allowable subject matter. The following is a statement of reasons for the indication of allowable subject matter: The only difference between the closest prior art (CN 110590960 A – IDS Reference, submitted 10/27/2023) and the instant SEQ ID NO: 1 is three amino acids. See sequence alignment below.
Qy 1 EVQLQQSGAELVKPGASVKLSCTASGFNIKDTYIHWVKRRPEQGLEWIGRIDPANGNTKY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLQQSGAELVKPGASVKLSCTASGFNIKDTYIHWVKRRPEQGLEWIGRIDPANGNTKY 60
Qy 61 DPKFQGKATITADTSSNTAYLQLSSLTSEDTAVYYCARRGLDYWGQGTLVTVSAGGGGSG 120
|||||||||||||||||||||||||||||||||||||||| |||||||||||||||||
Db 61 DPKFQGKATITADTSSNTAYLQLSSLTSEDTAVYYCARRGGVDWGQGTLVTVSAGGGGSG 120
Qy 121 GGGSGGGGSDVVMTQTPLTLSVTIGQPASISCKSSQSLLDGDGKTYLNWLLQRPGQSPKR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGGSGGGGSDVVMTQTPLTLSVTIGQPASISCKSSQSLLDGDGKTYLNWLLQRPGQSPKR 180
Qy 181 LIYLVSKLDSGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPRTFGGGTKLEI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LIYLVSKLDSGVPDRFTGSGSGTDFTLKISRVEAEDLGVYYCWQGTHFPRTFGGGTKLEI 240
Qy 241 K 241
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Db 241 K 241
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN ALFANO whose telephone number is (571)272-3092. The examiner can normally be reached M-F 8-5 EST.
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/ALAN ALFANO/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641
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