DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant's arguments filed 11-18-25 have been fully considered but they are not persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-21, 23-27, 29-37, 39 remain canceled. Claims 22, 28, 38 remain pending.
Election/Restrictions
Applicants elected Group I, claims 22-33, in the response filed 3-18-24. Group IV, claim 36, was combined with Group I in the office action sent 6-28-24 (pg 3, 2nd paragraph).
Claims 22, 28, 38 remain under consideration.
Specification
The Patent numbers for the patent applications were updated in the first paragraph as indicated in the amendment to the specification filed 9-27-24.
Claim objections
Product claim 22 remains confusing because it has an active method step of human Ig Vκ and Jκ gene segments “participating in rearrangement”. While the human Ig Vκ and Jκ gene segments may have capabilities, product claims do not have method steps.
Claim 22 remains confusing because the term “direct” in the phrase “wherein the first homology arm and the second homology arm direct the targeting vector to a mouse Ig heavy chain gene” also reads as an active method step in a product claim. It would simpler to say ---wherein the of a mouse Ig heavy chain gene with the one or more human Ig light chain Vκ [and Jκ gene segments and operably linking them to a mouse Igμ heavy chain gene]---.
The phrase “and such that the one or more human Ig Vκ [and Jκ] gene segments [ ] are operably linked with the Igμ gene of the mouse Ig heavy chain gene” in the last 3 lines of claim 22 remains confusing because “the mouse Ig heavy chain gene” lacks antecedent basis, because it is unclear whether the phrase is intended to impart a capability of the homology vector, and because it is unclear whether the phrase is intended to further limit a structure of the vector.
These suggestions are not meant to be allowable because of the written description and indefiniteness issues with the homology arms (see below). It is merely an attempt to simplify the claim and clarify the function of the vector once it has been integrated into the genome of a mouse.
Double Patenting
The rejection of claims 22, 28, 29, 31 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 9,516,868 was withdrawn for reasons set forth in the office action sent 1-17-25.
The rejection of claims 22, 28, 29, 31 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 9686970 was withdrawn for reasons set forth in the office action sent 1-17-25.
The rejection of claims 22, 28, 29, 31 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 10965310 was withdrawn for reasons set forth in the office action sent 1-17-25.
The rejection of claims 32, 33, 36 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 9,516,868 has been withdrawn because the claims have been canceled.
The rejection of claims 32, 33, 36 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 9686970 has been withdrawn because the claims have been canceled
The rejection of claims 32, 33, 36 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 10965310 has been withdrawn because the claims have been canceled.
Claim Rejections - 35 USC § 112
Written Description
Claims 22, 28, 38 remain 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.
Pending rejections
The specification lacks written description for 1st and 2nd homology arms that “direct the targeting vector to a mouse Ig heavy chain gene” as required in lines 13-14 of claim 22 such that a replacement of a plurality of mouse Ig VK gene segments, all mouse Ig DK gene segments, and all mouse Ig JK gene segments occurs as required as required in lines 15-20. The term “directing” in the phrase “wherein the first homology arm and the second homology arm direct the targeting vector to a mouse Ig heavy chain gene” reads as an active method step in a product claim which lacks written description. While the homology arms may have capabilities, they do not actively “direct” anything anywhere when they are just in a targeting vector. Likewise, the targeting vector may have capabilities, but the targeting vector does not actively “direct” anything anywhere because it’s just a vector. The specification and the art at the time of filing are limited to a targeting vector capable of replacing all Ig Vκ, Dκ, and Jκ gene segments in the genome of a mouse with a nucleic acid sequence comprising a plurality of human Ig Vκ gene segments and all human Ig Jκ gene segments (Fig. 2), wherein the rodent expresses a functional chimeric heavy chain comprising a human Ig Vκ domain and a mouse IgM domain (pg 39, Example 1).
The active method step of human Ig Vκ and Jκ gene segments “participating in rearrangement” lacks written description because while the human Ig Vκ and Jκ gene segments may have capabilities, they do no “participate” in anything while in the targeting vector of claim 22.
The specification lacks written description for the phrase “and such that the one or more human Ig Vκ [and Jκ] gene segments [ ] are operably linked with the Igμ gene of the mouse Ig heavy chain gene” in the last 3 lines of claim 22 because “the mouse Ig heavy chain gene” lacks antecedent basis, because it is unclear whether the phrase is intended to impart a capability of the homology vector, and because it is unclear whether the phrase is intended to further limit a structure of the vector.
Pg 33, para 174-177 discuss class switching, but none of them teach a specific pair of homology arms that allow class switching. Nor do the paragraphs discuss using a 1st and 2nd homology arms that target a mouse Ig heavy chain gene such that one or more human Ig Vκ and Jκ gene segments are operably linked to a mouse heavy chain Igμ constant gene. Pg 40, para 209, discusses using a genomic mouse fragment with a heavy chain intronic enhancer, IgM switch region and an IgM gene as a 3’ homology arm, but the specification and the art at the time of filing do not teach the specific structure a 3’ homology arm that imparts the ability to class switch. Therefore, the concept lacks written description.
Indefiniteness
Claims 22, 28, 38 remain 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.
Pending rejections
The metes and bounds of 1st and 2nd homology arms that “direct the targeting vector to a mouse Ig heavy chain gene” as required in lines 13-14 of claim 22 such that a replacement of a plurality of mouse Ig VK gene segments, all mouse Ig DK gene segments, and all mouse Ig JK gene segments occurs as required as required in lines 15-20 cannot be determined. The homology arms may have a capability, but they do not “direct” anything while just sitting in a targeting vector. The term “directing” is an active step for a method and has no place in a product claim. The homology arms do not perform any active method step as claimed in a product as claimed. This makes the claim indefinite.
The active method step of human Ig Vκ and Jκ gene segments “participating in rearrangement” makes the claim indefinite. While the human Ig Vκ and Jκ gene segments may have capabilities, they do no “participate” in anything while just sitting in the targeting vector of claim 22. The term “participate” is an active step for a method and has no place in a product claim. The human Ig Vκ and Jκ gene segments do not perform any active method step as claimed in a product as claimed. This makes the claim indefinite.
The phrase “and such that the one or more human Ig Vκ [and Jκ] gene segments [ ] are operably linked with the Igμ gene of the mouse Ig heavy chain gene” in the last 3 lines of claim 22 makes the claim indefinite because “the mouse Ig heavy chain gene” lacks antecedent basis, because it is unclear whether the phrase is intended to impart a capability of the homology vector, and because it is unclear whether the phrase is intended to further limit a structure of the vector.
Claim Rejections - 35 USC § 103
The rejection of claims 22-33 and 36 under 35 U.S.C. 103(a) as being unpatentable over Bradley et al., (US Pub 2012/0167237, claiming priority to provisional 61/355,666 filed on June 17, 2010; and provisional 61/223960 filed on July 8, 2009; of record) was withdrawn in view of the Declaration filed 9-27-24 which says the invention was reduced to practice before the effective filing date of Bradley (6-17-10).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638