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
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.
Election/Restrictions
Applicant’s election without traverse of Invention III, claims 19-21, in the reply filed on Sept. 17, 2025 is acknowledged.
Claims 1-16 and 18-21 remain pending in the current application, claims 1-16 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I-III is still deemed proper and is therefore made FINAL.
Claims 19-21 have been considered on the merits.
Status of the Claims
Claims 1-16 and 18-21 are currently pending.
Claims 1-16 and 18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claim 17 is cancelled.
Claims 19-21 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities:
the term “CSF1R” is misspelled “CSFR1” throughout the specification, and
the term “CSF1R” is misspelled “CSR1R” in para. 0029 and 0057 of the published specification.
Appropriate correction is appreciated.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 19 at lines 2-3, the term “CSF1R” is misspelled “CSFR1”.
Claim 20 at lines 2-3, the term “CSF1R” is misspelled “CSR1R”.
Claim 21 is objected to in the recitation of “Colony Stimulating Factor 1 Receptor (CSFR1)”, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “CSF1R”, since the acronym was previously defined in claim 19 and to correct for the misspelling of the acronym.
Appropriate correction is appreciated.
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 19-21 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 claims 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.
The instant claims are drawn to a method of preparing a ablation-resistant donor microglia by engineering a donor microglia to express a constitutively active variant Colony Stimulating Factor 1 Receptor (CSF1R) that is resistant to a CSF1R inhibitor. In addition, claim 21 is drawn to a variant CSF1R that comprises one of the following substitutions or deletions: L301S, Y571D, Y969F or delta706-712. These substitutions and deletions relate to the human CSF1R protein.
For a constitutively active variant CSF1R that is resistant to a CSF1R inhibitor, the specification describes L301S, Y571D, Y969F and delta706-712 CSF1R mutations resistant to PLX5622 killing (0011, 0029 and 0057 of the published application). The claims are broadly drawn to any mutation in any CSF1R wild-type or variant that is resistant to any CSF1R inhibitor. A CSF1R inhibitor can have a wide array of activities and/or effects. Therefore, the claims are considered genus claims that encompass a wide array of mutations and potential CSF1R inhibitors. The claims encompass any mutation in any CSF1R which are not described by their function, structure or relation thereto. This is compounded by the claim encompassing any CSF1R inhibitor which are also not described by their function, structure or relation thereto. The genus for both the mutation in the CSF1R and the CSF1R inhibitor are highly variant, inclusive to numerous structural variants because a significant number of structural differences between genus members is permitted.
For a constitutively active variant CSF1R containing the mutations of L301S, Y571D, Y969F or delta706-712, it is noted that “comprises” is considered open language which allows the CSF1R protein to contain other mutations in addition to those listed in claim 20. As such, the claims encompass any mutant CSF1R protein sequence with these mutations and any other mutation, including fragments and variant CSF1R sequences. The claim is not limited to the known wild-type CSF1R sequences with the only mutation being one of those listed in claim 20. Therefore, the claims encompass a vast genus of modified CSF1R proteins that includes those listed and any other mutation. The claim requires that the mutant CSF1R have specific function characteristics: is constitutively active and resistant to the CSF1R inhibitor, PLX5622. The specification only discloses the four specific mutants with these functions. Therefore, the application has indicated possession of four specific CSF1R mutants that have the required function, but does not provide evidence of possession of any other CSF1R mutations with the required function.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all of the potential species of antagonists that may exhibit one, all, of or any of the claimed activity. The possible variations of compounds are limitless with potentially thousands of compounds that may exhibit the claimed activities. The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
The limited disclosure of the specification in view of the genus of molecules encompassed by the claims does not adequately describe the entire genus of molecules encompassed by the claims.
The specification provides insufficient description or guidance that would allow one of skill to identify the CSF1R mutants which meet the structural limitations of the claims and also have the required functional characteristics without empirical determination. Thus, one of skill at the time of filing of the claimed invention could not have concluded that the Applicant was in possession of the genus of CSF1R mutants encompassed by the claims.
Similarly, the specification provides insufficient description or guidance that would allow one of skill to identify the CSF1R inhibitors which meet the structural limitations of the claims and also have the required functional characteristics without empirical determination. The specification lacks sufficient variety of species of compounds to reflect this variance in the genus since the specification only provides some examples of such a genus of compounds (see published application 0024-0025). Accordingly, the specification fails to provide adequate written description for the genus of “CSF1R inhibitor” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these compounds, the specification does not describe the claimed inhibitor in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these extracts at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
It is noted that limiting the inhibitor to PLX5622 and the CSF1R mutants to any of the four specific mutants identified as L301S, Y571D, Y969F or delta706-712, but not variants thereof that comprise other mutations, would overcome this rejection.
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)(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 19 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bennett et al. (US 2023/0081264 A1, priority to Sept. 10, 2018).
With respect to claim 19, Bennett teaches a method of preparing ablation-resistant donor microglia (abstract and 0020). Bennett teaches genetically engineering donor myeloid cells to express a genetically-modified CSF1R (0020). Bennett teaches the method where the genetically modified CSF1R is resistant to a CSF1R inhibitor and therefore would be constitutively active (0031 and 0136-0137). In addition, the myeloid cells differentiate and generate into microglia cells in vivo (0020-00222). Therefore, the method of Bennett engineers donor microglial to express a constitutively active CSF1R and provides ablation-resistant donor microglia.
With respect to claim 21, Bennet teaches engineering the myeloid cells with the CSF1R variant using viral vector (viral infection) or a CRISPR/Cas9 system (0141 and 0161-0162).
Therefore, the reference anticipates the claimed subject matter.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY A CORDAS/Primary Examiner, Art Unit 1632