DETAILED ACTION
Reassignment of the Application
1. Please note that this application has been reassigned to Examiner Kaijiang Zhang, in Art Unit 1684. In order to expedite accurate processing of the application papers, all future correspondence with the Office should reflect this change.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
3. Applicant’s election without traverse of (1) the species “hematological cancer” in claim 3 with “leukemia” as the sub-species (thus claims 4 and 7 are withdrawn as being drawn to non-elected species or sub-species), and (2) the species “missense mutations” in claim 10, in the reply filed on 12/1/2025 is acknowledged.
4. Claims 1-10 are pending in the application. Claims 4 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3, 5-6 and 8-10 are currently under examination.
Claim Objections
5. Claims 3 and 8-9 are objected to because of the following informalities:
Claim 3 recites a list of genes in step (a) with “ASXL1” appearing twice (i.e., as the 3rd gene in the list and then as the last gene in the list).
Claim 8: the wherein clause should be changed to “wherein the plurality of DNA samples is obtained from one or more cells in blood samples comprising hematopoietic stem cells (HSCs), committed myeloid progenitor cells having long term self-[[ ]]renewal capacity, or mature lymphoid cells having long term self-renewal capacity” for more clarity.
Claim 9, line 1: “wherein the subjects exhibits” should be changed to “wherein the subject[[s]] exhibits” to correct the typographic error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-3, 5-6 and 8-10 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.
(1). Claim 1 is drawn to a “scalable multiplex method” for amplifying “a plurality of target DNA regions collectively 1kb to 100kb in size in a plurality of samples” (emphasis provided), comprising a first step of “pooling a plurality of samples containing input DNA” but without indexing or barcoding the “plurality of samples”. It is not clear how each of the “plurality of samples”, without any barcoding or indexing, could be individually identified after going through all the subsequent method steps as a combined pool.
In addition, it is unclear from the preamble whether each of the “plurality of samples” contains all target DNA regions of the “plurality of target DNA regions” or just one target DNA region of the “plurality of target DNA regions” (in which case the “plurality of samples” collectively contains all target DNA regions of the “plurality of target DNA regions”).
Claims 2-3, 5-6 and 8-10, each of which depends from claim 1, are also rejected for the same reason(s) as discussed above.
(2). Claim 1 recites the limitation “the normalized barcoded-DNA library” in line 16. There is insufficient antecedent basis for this limitation in the claim. Claims 2-3, 5-6 and 8-10 depend from claim 1 and thus are also rejected for the same reason.
Conclusion
8. No claim is currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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