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 .
Response to Amendment
The preliminary amendment received on 06/28/2024 is acknowledged. Claims 3, 6-7 have been amended. Claims 9-14 have been added.
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 1-14 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 inventors, at the time the application was filed, had possession of the entire claimed invention.
The analysis of Written Description stated in MPEP 2163 Provides determining: 1) What the claims as a whole covers; 2) A review of the entire application to understand how Applicant provides support for the claimed invention including each element and/or step; 3) Determination of whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed, including analyzing if a claim drawn to a genus, or more than one embodiment, provides description of a representative number of species to adequately describe the genus or embodiments.
Regarding claims 1-14 the claims are drawn to a method of inducing cell death of solid tumor cells, and treating a patient, using a mutated protein or polynucleotide encoding the protein in which the residue (G) at position 12 is mutated. As defined in the specification, mutation refers to deletion, substitution or insertion. Dependent claims add further limitations including specific mutants and conjugates. The specification describes the creation of a single species of a substitution of G12R. The instant specification further tests the use of this mutant on solid tumor cells
The state of the art is represented by applicant’s application, as well as Lagresle-Peyrou (“A gain-of-function RAC2 mutation is associated with bone-marrow hyploplasia and an autosomal dominant form of severe combine immunodeficiency”, Haematologica, vol. 106, no. 2, 404-411, January 9 2020/IDS submited), and Lagresle-Peyrou (WO2021009336/IDS submitted). The prior art teaches the surprising finding of a gain of function G12R mutant as well as methods of using the mutant to kill and ablate cells posing hematopoiesis as well as killing hematopoietic cancer cells. In all cases the on only mutant described it eh G12R substitution mutant. No insertions, deletions or other substitutions are described.
In the case of a chemical invention, adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus (see MPEP 2163).
It is the Examiner’s position that applicant only provided adequate written description to show possession of the use of proteins and polynucleotides encoding the peptide, having the G12R substitution. And has not provided description adequate to show position of other members of the claimed genus, e.g. mutants including insertions and deletions (e.g., the specification does not provide any guidance, such as a structure-function relationship, that would allow one of ordinary skill in the art to identify additional species representative of the claimed genus).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
Prosecution Insights