DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-15, 33, 34 have been canceled. Claims 16-32 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 16-28, in the reply filed on 6-26-26 is acknowledged.
The restriction is hereby withdrawn.
The targeting vector and cells in Groups I-III are used to make the transgenic mouse in Group I in the restriction sent 8-16-12 in parent application 13/466225 (now 8658853). The cells in Group II are a broader genus of the lymphocytes in parent application 16530336 (now 11020495).
Specification
The title should be changed to more closely reflect the claims are drawn to a ---TARGETING VECTOR FOR MAKING HUMANIZED FCγR MICE---.
The first paragraph of the specification will have to be updated.
Claim objections
The term “ES” cell in claim 31 should be spelled out before being abbreviated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
A) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 8658154 (12/971080). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the transgenic mouse in ‘154, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse in ‘154.
B) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 6 of U.S. Patent No. 8658853 (13/466225). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to inactivate the mouse FcγR α chain genes in the transgenic mouse in ‘853, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse in ‘853.
C) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 6 of U.S. Patent No. 9089599 (14152106). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the transgenic mouse in ‘599, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse in ‘599.
D) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 8883496 (13/113677). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the lymphocytes obtained from transgenic mice in ‘496, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse used to obtain the lymphocytes in ‘496.
E) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9221894 (14/508782). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the lymphocytes obtained from transgenic mice in ‘894, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse used to obtain the lymphocytes in ‘894.
F) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9056130 (14/152090). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the ES obtained from transgenic mice in ‘130, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse used to obtain the ES cells in ‘130.
G) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9687566 (14/800253). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the transgenic mouse in ‘566, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse in ‘566.
H) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10426848 (15601363). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the transgenic mouse in ‘848, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse in ‘848.
I) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11020495 (16530336). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the lymphocytes obtained from transgenic mice in ‘495, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse used to obtain the lymphocytes in ‘495.
J) Claims 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12036288 (17/241763). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other. The nucleic acid sequence in this case is used to replace mouse FcγR α chain genes with human FcγR sequences in the transgenic mouse in ‘288, so the claims are related as intermediate-final product. The nucleic acid sequence in this case is used solely to make the transgenic mouse in ‘288.
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 16-33 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 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 16 is drawn to a targeting vector comprising:
(i) a 5' homology arm comprising a nucleic acid sequence that is homologous to a genomic sequence upstream of an endogenous mouse low affinity FcyR α-chain locus,
(ii) a contiguous human nucleic acid sequence encoding at least two low affinity human FcyR α-chain genes, and
(iii) a 3' homology arm comprising a nucleic acid sequence that is homologous to a genomic sequence downstream of an endogenous mouse low affinity FcyR α-chain locus.
The term locus in claim 16 lacks written description. The term “locus” is singular, and “loci” is plural (Wikipedia definition of “locus”, 2023; National Human Genome Res. Institute definition of “locus”, 2023). A locus (singular) is a position in space or an address on a chromosome. The specification is limited to the homology regions being upstream or downstream of the entire mouse FcγR gene and not just any “locus” within the mouse FcγR gene. Fig. 1 and 4 are limited to homology arms being upstream or downstream of the entire mouse FcγR gene.
The targeting vector must be capable of replacing a plurality of mouse nucleotides (at a plurality of contiguous “loci” (plural), i.e. replacing a nucleic acid sequence encoding mouse FcγR α-chain) with the “contiguous human nucleic acid sequence”.
The “contiguous human nucleic acid sequence” must be flanked by the homology arms which is missing from claim 16.
The concept of a “contiguous human nucleic acid sequence encoding at least two human [ ] FcγR α chain genes” lacks written description. The specification appears to be limited to using a nucleic acid sequence encoding at least two human FcγR α chains (Fig. 4). The specification does not teach they are “genes” (which inherently must contain its own promoter, introns, exons, and 3’ regulatory elements). The specification and the art do not teach the hFcγR α chain coding sequences in Fig. 4 are “genes” as claimed. The FcγR gene is one thing, but the hFcγR α chain coding sequences within it are another. Perhaps they are more aptly named “gene segments” similar to the variable Ig gene segments within a immunoglobulin gene. Fig. 4 also does not support the idea of hFcγR coding sequences being “contiguous” as claimed because they are separated by a hHSP76 coding sequence.
The specification lacks written description for a homology arm “upstream of an endogenous mouse low affinity FcγR α-chain” gene as broadly encompassed by items i) and iii) in claim 16. The term “mouse” further limits the structure of the homology arm and says the sequence must be from a “mouse FcγR α chain” [gene]. However, the term “endogenous” fails to further limit the claim because the term is relative and there is no baseline for what the sequence is “endogenous”. If it “endogenous” is the same as “mouse”, then “endogenous” is redundant and fails to further limit the mouse FcγR α chain [gene segment].
Claims 17-23 lack written description for reasons set forth above regarding a FcγR α chain gene [segment].
Claim 23 lacks written description for reasons set forth above regarding homology arms.
Claims 24-26 have support in Fig. 4.
Claim 27 has support on pg 2, para 8; pg 22, para 95; et al.
The method of claims 31-32 lack written description as broadly written without modifying the genome of the cell. As written, the claims encompass introducing the vector of claim 16 into an isolated mouse ES cell for the purpose of modifying it without any limitations that clearly state a genetic modification occurs or the structures/functions of the genetic modification. The specification and the art at the time of filing is limited to introducing a homology vector into an isolated mouse ES cell such that the genome of the cell comprises a replacement of an endogenous nucleic acid sequence with an exogenous nucleic acid sequence in the homology vector. The specification and the art at the time of filing is limited to introducing the vector of claim 16 into isolated mouse ES cell such that the genome of the cell comprises a replacement of an endogenous FcγR α-chain gene [segment?] with the nucleic acid sequence encoding the at least two human FcγR α chain [gene segments]. Claims 31 and 32 are missing the essential elements of the genetic modification in the ES cell after the vector is introduced into the ES cell. Accordingly, the claims lacks written description.
Claims 16-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a targeting vector comprising a nucleic acid sequence encoding at least two human low affinity FcγR α-chain gene [segments?] flanked by homology arms that bind upstream and downstream of a mouse low affinity FcγR gene, does not reasonably provide enablement for the targeting vector as broadly encompassed by claim 16. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Claim 16 is recited above.
The term locus in claim 16 is not enabled. The term “locus” is singular, and “loci” is plural (Wikipedia definition of “locus”, 2023; National Human Genome Res. Institute definition of “locus”, 2023). A locus (singular) is a position in space or an address on a chromosome. The specification is limited to the homology regions being upstream or downstream of the entire mouse FcγR gene and not just any “locus” within the mouse FcγR gene. Fig. 1 and 4 are limited to homology arms being upstream or downstream of the entire mouse FcγR gene.
The targeting vector must be capable of replacing a plurality of mouse nucleotides (at a plurality of contiguous “loci” (plural), i.e. replacing a nucleic acid sequence encoding mouse FcγR α-chain) with the “contiguous human nucleic acid sequence”.
The “contiguous human nucleic acid sequence” must be flanked by the homology arms which is missing from claim 16.
The concept of a “contiguous human nucleic acid sequence encoding at least two human [ ] FcγR α chain genes” is not enabled. The specification appears to be limited to using a nucleic acid sequence encoding at least two human FcγR α chains (Fig. 4). The specification does not teach they are “genes” (which inherently must contain its own promoter, introns, exons, and 3’ regulatory elements). The specification and the art do not teach the hFcγR α chain coding sequences in Fig. 4 are “genes” as claimed. The FcγR gene is one thing, but the hFcγR α chain coding sequences within it are another. Perhaps they are more aptly named “gene segments” similar to the variable Ig gene segments within a immunoglobulin gene. Fig. 4 also does not support the idea of hFcγR coding sequences being “contiguous” as claimed because they are separated by a hHSP76 coding sequence.
The specification does not enable a homology arm “upstream of an endogenous mouse low affinity FcγR α-chain” gene as broadly encompassed by items i) and iii) in claim 16. The term “mouse” further limits the structure of the homology arm and says the sequence must be from a “mouse FcγR α chain” [gene]. However, the term “endogenous” fails to further limit the claim because the term is relative and there is no baseline for what the sequence is “endogenous”. If it “endogenous” is the same as “mouse”, then “endogenous” is redundant and fails to further limit the mouse FcγR α chain [gene segment].
Claims 17-23 are not enabled for reasons set forth above regarding a FcγR α chain gene [segment].
Claim 23 are not enabled for reasons set forth above regarding homology arms.
Claims 24-26 have support in Fig. 4.
Claim 27 has support on pg 2, para 8; pg 22, para 95; et al.
The method of claims 31-32 are not enabled as broadly written without modifying the genome of the cell. As written, the claims encompass introducing the vector of claim 16 into an isolated mouse ES cell for the purpose of modifying it without any limitations that clearly state a genetic modification occurs or the structures/functions of the genetic modification. The specification and the art at the time of filing is limited to introducing a homology vector into an isolated mouse ES cell such that the genome of the cell comprises a replacement of an endogenous nucleic acid sequence with an exogenous nucleic acid sequence in the homology vector. The specification and the art at the time of filing is limited to introducing the vector of claim 16 into isolated mouse ES cell such that the genome of the cell comprises a replacement of an endogenous FcγR α-chain gene [segment?] with the nucleic acid sequence encoding the at least two human FcγR α chain [gene segments]. Claims 31 and 32 are missing the essential elements of the genetic modification in the ES cell after the vector is introduced into the ES cell. Accordingly, the claims are not enabled as broadly written.
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.
Claims 16-33 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.
The term locus in claim 16 makes the claim indefinite. The term “locus” is singular, and “loci” is plural (Wikipedia definition of “locus”, 2023; National Human Genome Res. Institute definition of “locus”, 2023). A locus (singular) is a position in space or an address on a chromosome. The specification is limited to the homology regions being upstream or downstream of the entire mouse FcγR gene and not just any “locus” within the mouse FcγR gene. Fig. 1 and 4 are limited to homology arms being upstream or downstream of the entire mouse FcγR gene. While the homology arms may be upstream or downstream from any “position” or “locus” within a mouse FcγR gene, the claim fails to capture that the homology arms must be outside of any of the mouse FcγR gene “positions” or “loci”. Therefore, the terminology does not make sense with what is being claimed, thereby making the claim indefinite.
The term “endogenous” in the phrase “endogenous mouse” in claim 16 makes the claim indefinite. It is unclear how the term “endogenous” further limits the “mouse” gene. If “endogenous” refers to “mouse”, then the term “endogenous” is redundant and meaningless. Clarification is required.
The term “contiguous” in the phrase “contiguous human nucleic acid sequence encoding at least two low affinity human FcyR α-chain genes” makes claim 16 indefinite. The specification appears to be limited to using a nucleic acid sequence encoding at least two human FcγR α chains (Fig. 4). The specification does not teach they are “genes” (which inherently must contain its own promoter, introns, exons, and 3’ regulatory elements). The specification and the art do not teach the hFcγR α chain coding sequences in Fig. 4 are “genes” as claimed. The FcγR gene is one thing, but the hFcγR α chain coding sequences within it are another. Perhaps they are more aptly named “gene segments” similar to the variable Ig gene segments within a immunoglobulin gene. Fig. 4 also does not support the idea of hFcγR coding sequences being “contiguous” as claimed because they are separated by a hHSP76 coding sequence. Since the specification fails to describe two “contiguous” hFcγR α-chain gene segments, it is unclear how the term “contiguous” further limits the two hFcγR α-chain gene segments.
The method of claims 31-32 is indefinite because it is missing essential elements. The claims encompass introducing the vector of claim 16 into an isolated mouse ES cell for the purpose of modifying it without any limitations that clearly state a genetic modification occurs or the structures/functions of the genetic modification. The specification and the art at the time of filing is limited to introducing a homology vector into an isolated mouse ES cell such that the genome of the cell comprises a replacement of an endogenous nucleic acid sequence with an exogenous nucleic acid sequence in the homology vector. The specification and the art at the time of filing is limited to introducing the vector of claim 16 into isolated mouse ES cell such that the genome of the cell comprises a replacement of an endogenous FcγR α-chain gene [segment?] with the nucleic acid sequence encoding the at least two human FcγR α chain [gene segments]. Claims 31 and 32 are missing the essential elements of the genetic modification in the ES cell after the vector is introduced into the ES cell. Accordingly, the claims are indefinite.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
Prosecution Insights