DETAILED ACTION
Notice of Pre-AIA or AIA Status
The text of those sections of Title 35, U.S. Code not included in this action can
be found in a prior Office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the papers filed on 06/29/2026. Claims 1, 16-18, 22-24, 31-33, 46, 51, and 52 are currently pending as per claims filed on 06/29/2026. Claims 3, 4, 6-8, 10, 12-15, 19, 21, 27, 30 are cancelled and claims 1, 16-18, 22, 32, 33, 46, 51, and 52 have been amended by Applicants’ amendment filed on 06/29/2026.
Applicant’s election with traverse of Group I, claims 1, 3, 4, 6-8, 10, 12-19, 21-24, 27, 30, and 46 in the reply filed on 01/05/2026 was previously acknowledged. No new claims were added.
Claims 31-33, 51, and 52 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected groups of inventions, there being no allowable generic or linking claim. The requirement was previously made FINAL.
Therefore, claims 1, 16-18, 22-24, and 46 are under examination to which the
following grounds of rejection are applicable. Claim 1, 22, and 46 are independent claims.
Priority
Applicant's claim for the benefit of a prior-filed application 63/355,948 filed 06/27/2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Thus, the earliest possible priority for the instant application is 06/27/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2026 was filed before the mailing date of the current office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn objections/rejection in response to Applicants’ arguments or
Amendment
Claim Rejections - 35 USC § 103
The amendments combined with applicants’ arguments are sufficient to
overcome the rejection. Applicant asserts that the combined references of MacDonald, Herndler-Brandsetter, Yan, Devoy, and NCBI do not provide reason to combine, or the combination of the elements disclosed separately by the cited is a predictable use of the elements. The applicant asserted that Herndler-Brandstetter, Yan, and Devoy does not suggest humanized mouse should be created for any gene that is important for development and function of immune cells and there is no establishment that Clec9a would be essential for the development of human immune cells from hematopoietic stem cells injected in mouse as recited in Herndler-Brandstetter.
Applicants’ arguments are moot in view of the withdrawn rejection.
Claim Rejections - 35 USC § 112 (b)
The amendments combined with applicants’ arguments are sufficient to
overcome the rejection. Applicant asserts that one of ordinary skill in the art would understand that “endogenous” means the “native” or “wild-type” rodent version.
Applicants’ arguments are moot in view of the withdrawn rejection..
Claim Rejections - 35 USC § 112(a) Scope of Enablement
The amendments combined with applicants’ arguments are sufficient to
overcome the rejection. Applicant has amended the claims to define the humanized Clec9a polypeptide as comprising the amino acid sequence of SEQ ID NO: 7.
Applicants’ arguments are moot in view of the withdrawn rejection.
Maintained and/or modified rejections in response to Applicants’ arguments or
Amendment
Claim Rejections - 35 USC § 112 (a) Written Description
Claim 1, 16-18, 22-24, and 46 remains 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. This is a modified rejection necessitated by Applicant’s amendments filed 06/29/2026.
M.P.E.P. § 2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.” Further, the written description inquiry is limited to that which is contained within the four corners of the specification, not the extent to which the skilled artisan, given his or her knowledge of the art, would have considered it to expand with only routine experimentation. See Ariad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); see also id. at 1352 (“[I]t is the specification itself that must demonstrate possession A description that merely renders the invention obvious does not satisfy the requirement.").
Claim 1 is directed to a genetically modified rodent comprising in its genome: a humanized Clec9a gene comprising: a rodent Clec9a nucleic acid sequence, and a human CLEC9A nucleic acid sequence, wherein the humanized Clec9a gene encodes a humanized Clec9a polypeptide comprising the amino acid sequence of SEQ ID NO: 7, wherein the humanized Clec9a gene is operably linked to the endogenous rodent Clec9a promoter at an endogenous rodent Clec9a locus, wherein the rodent expresses the humanized Clec9a polypeptide on dendritic cells. The specification only discloses a genetically modified mouse wherein a 7,138 bp genomic region corresponding to the ectodomain of the mouse Clec9a protein was replaced by a human CLEC9A fragment of 4,809 bp such that the mouse Clec9a genomic fragment that was replaced only included the entire exon 3 through stop codon of the last coding exon (exon 6) of mouse Clec9a gene (page 25, para 0083). Hence, exon 1 and 2 of the mouse Clec9a gene is unaltered. Furthermore, the genetically modified rodent has only a single copy of the humanized Clec9a gene inserted at a single location of the Clec9a endogenous locus.
The specification does not disclose that the humanized Clec9a gene is operably linked to the endogenous rodent Clec9a promoter at any location of the endogenous rodent Clec9a locus or that any number of copies of the humanized Clec9a gene can be at the endogenous rodent Clec9a promoter. Rather, the specification only discloses a mouse whose genome comprises a genetic modification wherein the genetic modification is a replacement of the entire exon 3 through stop codon of the last coding exon (exon 6) of mouse genomic Clec9a gene with a human CLEC9A fragment of 4,809 bp (Figure 1A and 1B, Example 1), thus exon 1 and 2 of mouse Clec9a gene remains, and the humanized Clec9a gene is at a single location of the Clec9a locus as a single copy. Furthermore, this is the only genetic modification resulting in expression of the humanized Clec9a polypeptide on dendritic cells, indicating that control of expression through the endogenous rodent Clec9a promoter, which is operably linked to the humanized Clec9a gene, is specific to elicit expression only in dendritic cells. The specification provides no indication of other structures of the humanized Clec9a gene, other than with replacement of the entire exon 3 through stop codon of the last coding exon (exon 6) of mouse genomic Clec9a gene with a human CLEC9A fragment of 4,809 bp, which would cause expression of the human ectodomain of the human Clec9a protein in dendritic cells and no other cell type. In other words, there are no indications of other modifications made to the mouse Clec9 genomic locus (i.e. no other described structure such as being at any location of the endogenous mouse Clec9a locus, at any level of copy number, and the humanized Clec9a gene is located at the locus in addition to presence of the endogenous Clec9a gene) which would provide the function of being expressed properly on dendritic cells. The specification discloses that the humanization of the endogenous Clec9a gene in mice was restricted to dendritic cells (para 0087, page 28) and other cell types tested did not show expression.
Structural features that would distinguish the genetically modified rodent comprising nucleic sequences of humanized Clec9a gene from others not encompassed by the genus of genetically modified rodents are missing from the disclosure. No common structural attributes identify the members of the genus and there is no indication of the relationship of the structure (the humanized Clec9a gene comprising amino acid sequence of SEQ ID NO: 7 which is operably linked to the endogenous rodent Clec9a promoter at an endogenous rodent Clec9a locus) required for its claimed function of the humanized Cle9a polypeptide being expressed on dendritic cells of a mouse. The broad and generic scope of the humanized Clec9a gene being inserted into any domain of an endogenous mouse Clec9a locus and not necessarily requiring replacing the endogenous mouse Clec9a gene (page 25, para 0083) and at any copy number for the mouse to express the human ectodomain of the human Clec9a protein on dendritic cells renders the invention unpredictable. An adequate description of the materials, which provide the means for practicing the invention, i.e. produce a genetically modified rodent comprising in its genome a humanized Clec9a gene as claimed, is required.
Applicant were referred to the guidelines for Written Description Requirement
published January 5, 2001 in the Federal Register, Vol.66, No.4, pp.1099-1110 (see
http://www.uspto.gov). The disclosure of a single species is rarely, if ever, sufficient to
describe a broad genus, particularly when the specification fails to describe the features
of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue
Pharma L. P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000). The possession may
be shown by actual reduction to practice, clear depiction of the invention in a detailed
drawing, or by describing the invention with sufficient relevant identifying characteristics
(as it relates to the claimed invention as a whole) such that a person skilled in the art
would recognize that the inventor had possession of the claimed invention. See, e.g.,
Pfaff v. WellsElectronics, Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,
1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai
Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991).
The “written description” requirement may be satisfied by using such descriptive
means as words, structures, figures, diagrams, formulas, etc., that fully set forth the
claimed invention. See Noelle v. Lederman, 355 F.3d 1343, 1349, 69 USPQ2d 1508,
1514 (Fed. Cir. 2004) and Lockwood v. American Airlines, Inc., 107 F.3d at 1572, 41
U.S.P.Q.2d at 1966. A definition by function alone “does not suffice” to sufficiently describe a coding sequence “because it is only an indication of what the gene does,
rather than what it is.” Regents of the University of California v. Eli Lilly & Co., 119 F.3 at
1568, 43 USPQ2d at 1406 (Fed. Cir. 1997) (discussing Amgen Inc. v. Chugai
Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016 (Fed. Cir. 1991)). In Fiers v.
Ravel, 984 F.2d at 1169-71, 25 U.S.P.Q.2d at 1605-06 (1993), the CAFC found that “a
mere wish or plan for obtaining the claimed chemical invention” is not sufficient to
describe a chemical invention (discussed in Eli Lilly at 1404).
In view of the large breadth of genetically modified rodents comprising humanized Clec9a gene which encodes a humanized Clec9a polypeptide comprising the amino acid sequence of SEQ ID NO: 7 inserted at any location of the endogenous rodent Clec9a locus, not necessary replacing the entire endogenous mouse Clec9a locus, the humanized Clec9a gene at any copy number, and operably linked to the endogenous rodent Clec9a promoter, which are claimed by their function of being expressed on dendritic cells of a genetically modified mouse, and the lack of adequate description of the structure-function relationship of the claimed genus, one of ordinary skill in the art would not have recognized Applicant as being in possession of the claimed genus. The limited disclosure in the specification is not deemed sufficient to reasonably convey to one skilled in the art that the applicants were in possessions of the genera of genetically modified rodents as recited in the claims at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genera.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliana Candelaria whose telephone number is (571)272-5488. The examiner can normally be reached Monday - Friday 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANA IRENE CANDELARIA/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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