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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/19/2022 and 04/04/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II drawn to genetically engineered cell having an engineered receptor and reduced B2M expression in the reply filed on 11/24/2025 is acknowledged.
Status of Claims
Claims 1-20 are pending. Claims 11, 13-14 and 18 are under exam. Claims 1-10, 12, 15-17, and 19-20 are withdrawn.
Claim Rejections - 35 USC § 112
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 11, 13-14 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claims 11 and 18: The claim requires a genetically-modified eukaryotic cell wherein cell surface expression of beta-2 microglobulin on said genetically-modified eukaryotic cell is reduced by 10% to 95% compared to cell surface beta- 2 microglobulin expression on a control cell.
It is not clear from the language of the claim as to what constitutes a control cell. Paragraph [0228] of the specification gives a very broad definition of a control cell, including a wild type cell or a cell of the same genotype as the genetically-modified cell but which has been transformed with a null construct or a cell genetically identical to the genetically-modified cell but which is not exposed to conditions, stimuli, or further genetic modifications that would induce expression of altered genotype or phenotype. It is not clear from the claim as to what definition of the control cell is applied in the claims. Appropriate clarification is required.
Claims 13-14 are rejected because of their dependency on the rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
It is noted that claim 18 depends from claim 14. The claim requires reduction in cell surface expression of MHC Class I molecule "consist of two polypeptide chains, a and β. In humans, the α chain consists of three subunits, α1, α2, and α3, which are encoded by polymorphic human leukocyte antigen (HLA) genes" (See specification [0005]). Further the specification disclosed that "[t]he β chain of MHC class I molecules consists of beta-2 microglobulin, which is encoded by the non-polymorphic beta-2 microglobulin (B2M) gene" (See specification [0006]). As such, the claim encompasses reduction in expression of a broader class of molecules that are inhibited by the modified cell of claim 11. By reciting MHC Class 1 molecules broadly, the claim encompasses embodiments that do not necessarily reduce B2M and therefore does not further limit the composition of claim 18. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 11, 13-14 and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Meissner et al (US 2016/0348073A1, as supported by U.S. Provisional Application Number 62/139,479; filed on 04/03/2016; hereinafter "Meissner;" See PTO-892).
Regarding claims 11 and 13-14: Meissner taught a modified primary human T cell or population thereof, each cell comprising a genomic modification in which B2M gene on chromosome 15 has been edited to delete a stretch of nucleic acid to reduce or eliminate MHC Class I molecule in the cell and cell comprising at least one chimeric antigen receptor. (See Meissner claim 1). The specification of Meissner indicates that "reduced," can mean a decrease by at least 10% as compared to a reference level, for example a decrease by at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, … or any decrease between 10-100% as compared to a reference level. (See Meissner p. 6, lines 20-32). As such Meissner discloses all elements of claims 11, 13-14.
Regarding claim 18: Claim 34 of Meissner is directed to treatment of cancer, GVHD or a chronic infectious disease by administering the modified T-cell of claim 1 of Meissner. As such every element of the claim is anticipated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633