DETAILED ACTION
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 .
Status of Claims
The amended claims filed 01/12/2026 are acknowledged and entered.
Claims 1 and 5 have been amended
Claim 6 is cancelled
Claims 1-5, 7, 8, 11 and 13 are pending and examined on their merits.
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Objections
Specification - Withdrawn
The disclosure was objected to because of the following informalities:
a) Paragraph [0006] reads as follows: “On the other hand, AIMP2 is an alternative splicing variant of AIMP2,….”. Paragraph [0007] reads as follows: “The previous study confirmed that AIMP2, a variant of AIMP2, occurs in cancer cells….”
AIMP2 cannot be AIMP2 and an alternative splicing variant of AIMP2 at the same time.
Applicant has corrected the informalities in the substitute specification and the objection is withdrawn.
Claim Rejections - 35 USC § 101 - Withdrawn
1. The rejection of claims 5, 7 and 8 under 35 U.S.C. 101 because the claims recite “nature-based products” as a limiting element or step without having markedly different characteristics than the nature-based product itself.is withdrawn in view of Applicant’s amendment of claim 5
Rejections Maintained
Claim Rejections - 35 USC § 103 - Maintained
Claims 1-5, 7-8, 11 and 13 (claim 6 has been deleted) remain rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Sondhi (previously cited) in view of Choi et al. (previously cited) and Kim (previously cited).
Applicant’s arguments have been fully considered and are not persuasive. Therefore, the rejections are maintained.
Applicant’s Arguments:
- (a) Claim 1 has been amended to recite: A method for producing an engineered stem cell with increased engraftability, comprising introducing, ex vivo, into a stem cell a recombinant vector encoding an exon 2-deleted AIMP2 variant, wherein the increased engraftability comprises:
(i) increased resistance to apoptosis under transplantation- related stress conditions; and
(ii) enhanced expression of extracellular matrix-associated engraftment proteins.
- (b) The combined teachings of the cited references do not teach or suggest the features of the amended claims. The Examiner relies on Sondhi for gene introduction into stem cells and an observed reduction in apoptosis, and interprets this effect as increased engraftability. Choi is cited for disclosing the apoptosis-suppressing effect of an exon 2-deleted AIMP2 variant, and Kim is cited for vector construction techniques for expressing such a variant. However, none of these references defines or describes engraftability, nor do they teach that reduced apoptosis alone constitutes or predicts increased engraftability in the context of stem cell transplantation.
Engraftability is distinct from apoptosis resistance and relates to the behavior of transplanted cells under transplantation-related conditions. The cited references address apoptosis or vector construction in isolation and do not describe ex vivo genetically engineered stem cells designed to improve engraftability during transplantation.
As amended, the claims clarify this distinction by expressly requiring ex vivo introduction of a recombinant vector into a stem cell and by defining increased engraftability as comprising both resistance to apoptosis under transplantation-related stress conditions and enhanced expression of extracellular matrix-associated engraftment proteins. These limitations are not taught or suggested by Sondhi, Choi, Kim, or any combination thereof.
Accordingly, the combination proposed by the Examiner relies on hindsight reconstruction,
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
- Regarding (a): The Applicant argues that engraftability is distinct from apoptosis resistance. The art recognizes that, generally, engraftability is evaluated on the ability of the organism to tolerate the heterologous cells/tissue/organ and therefore, apoptosis resistance is an attribute that is inherent for improved engraftability. Simply put, if the cells do not die of apoptosis (resistance) among other reasons, they will be able to engraft because the organism tolerates the cells. There is no discrepancy with these definitions as shown by the fact that amended claim 1 recites “…increased engraftability comprises: (i) increased resistance to apoptosis under transplantation-related stress conditions…”. Therefore, apoptosis resistance is needed for increased engraftability as discussed in the cited art. Similarly, the increased engraftability comprising enhanced expression of extracellular matrix-associated engraftment proteins is also an inherent attribute of the enhanced engraftability.
Paragraph 0034 provides a definition of engraftability which includes ability of transplanted cells to differentiate and implanted cells to replace lost or damaged cells. Reduction in apoptosis supports both these abilities at least and so the arguments cannot be found persuasive for this reason also.
In addition, the combination of the cited art provides the method for making an ex-vivo stem cell with the recited recombinant vector inserted with the required gene. A review of the breadth of the claims and evidence does not appear to require an unique amount or type of expression, simply insertion of the gene.
- Regarding (b): In addition, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant has not sufficiently described why there is no prima facie case for obviousness. See discussion provided in the Non-Final Rejection dated 10/27/2025 regarding the teachings of Sondhi, Choi and Kim relevant to the rejection under 35 U.S.C. 103 and the motivation to combine these references.
In response to applicant’s argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
No claims are allowed.
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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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671