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 .
Application Status
Amended claims were filed on 3/27/2026, such that claims 1-4,6-17, 19-25, 27-29 are under examination in this Office action. Claims 5, 18, 26 have been cancelled.
Any rejection or objection not reiterated herein has been overcome by amendment. The replacement drawing of 3/27/2026 for Fig 1A has been accepted. This overcomes the Drawings objection. The Specification submission of 3/27/2026 overcomes the Specification objection regarding trademarks.
Applicant’s Remarks of 3/27/2026 pertain directly to objections/rejections that have been withdrawn in view of amendments, and as such, necessitate no further comment.
Applicant’s amendments and arguments have been thoroughly reviewed but are not persuasive to place the claims in condition for allowance for reasons that follow.
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 1-4, 6-12, 13, 14, 15-17, 19-21, 22 and 23-25, 27-29 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 pre-AIA the applicant, regards as the invention.
Claims 1, 13, 14 and 22 are indefinite in the recitation of “at least one forward PCR primer …wherein the at least one forward primer targets at least one portion of the KMT2A exonic cDNA selected from KMT2A exon 7 and KMT2A exon 9… at least one KMT2A probe…each KMT2A probe configured to anneal to the KMT2A exonic cDNA between the primer binding site on the KMT2A exonic cDNA and the fusion site” because it is unclear how to interpret the plurality of primers in combination with reference to a spatial location of “the primer binding site” since it is unclear whether, when more than one primer is used, they would all bind to the exact same singular primer binding site (which is not articulated in the claim if true, and which is scientifically improbable in one interpretation of the claim), rendering unclear which of the primer binding sites for the plurality of primers is “the” primer binding site. Further, since “the primer binding site” is used in the claim to indicate where the probe is configured to anneal, it is now unclear between which “the primer binding site” and the fusion site, the probe anneals. The issue additionally becomes more complex and therefore more confusing when more than one probe of the at least one probe in step b. is employed, regarding where these are configured to anneal.
The same issue exists for the at least one partner gene probe when there is more than one partner gene probe and a singular “the primer binding site” on the partner gene exonic cDNA.
Claims 2-4, 6-12 depend from claim 1, and claims 15-17, 19-21 depend from claim 14, and claims 23-25, 27-29 depend from claim 22, do not resolve the issues, and therefore are indefinite for the same reason.
Claim 11 is indefinite in the recitation of “the abundance of expression falls above a threshold value of .001% and is calculated as a fraction of KMT2A fusion transcript abundance and the sum of KMT2A fusion transcript abundance and KMT2A non-fusion (wild-type) transcript abundance as measured by ddPCR because as stated there is confusion regarding particularly to when measurable residual disease is identified since “the abundance of expression” fall above a threshold and does not clearly articulate expression of what falls above the threshold. The amendment regarding the calculation indicates that expression is calculated as a fraction of fusion transcript abundance “and the sum” of fusion transcript abundance “and” nonfusion transcript abundance as measured by ddPCR, which is not entirely clear as written.
Claims 1, 13, 14 and 22 recite the limitation "the primer binding site". There is insufficient antecedent basis for this limitation in the claims. It is unclear to which primer binding site the phrase intends, since there may be more than one. Claims 2-4, 6-12 depend from claim 1, and claims 15-17, 19-21 depend from claim 14, and claims 23-25, 27-29 depend from claim 22, do not resolve the issues, and therefore are indefinite for the same reason.
Conclusion
All claims rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LISA HORTH/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
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