DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
Claim(s) 1-25 is/are pending.
The Amendment filed on 10May2024 is acknowledged in which claim(s) 1-20 were canceled by Applicant.
Claim(s) 21-25 is/are presented for examination on the merits.
Drawings
The drawings are objected to because:
Figs. 8B-D, 12: not clearly legible.
Figs. 10B, 11: axes are not clearly legible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., pg. 7, line 20). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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 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.
Claim(s) 21-25 is/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.
Regarding instant claim(s) 21 (and dependent claims 22-25), recites the phrase “wherein the AML LSC is capable of engrafting and initiating AML in an immunodeficient mouse.” In lines 13-14 of claim 21, rendering the claim indefinite. The specification and the claim(s) fail to define what qualities make AML LSCs that are “capable of engrafting and initiating AML in an immunodeficient mouse”. The specification does provide that NOD/SCID mice were used for CD34+/CD38-/CD45RA+/CD123+ AML engraftment in the case of the instant invention [e.g., pg. 25, lines 8-25; fig. 5]. Further, Applicant figures 5A and 5D (pg. 9) show that not all primary AML samples were “capable of engrafting” in Applicant’s own studies. Additionally, at the time of filing Pearce et al. (BLOOD, 1 FEBRUARY 2006, VOLUME 107, NUMBER 3; hereinafter “Pearce”) taught that approximately half of primary AML samples were unable to initiate leukemia in NOD/SCID mice [e.g., title, abstract; pg. 1168, “Results”]. For the purposes of compact prosecution, the phrase “wherein the AML LSC is capable of engrafting and initiating AML in an immunodeficient mouse.” Is considered to mean any AML LSCs. This rejection may be overcome by amending claim 1 to remove the phrase “wherein the AML LSC is capable of engrafting and initiating AML in an immunodeficient mouse”. Dependent claims 22-25 can overcome this rejection by amending claim 21 as described above.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21-25 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Sarry et al. (JCI 2011 Jan;121(1):384-95. Epub 2010 Dec 13. PMID: 21157036; PMCID: PMC3007135; hereinafter “Sarry”).
Regarding instant claim(s) 21, Sarry teaches a method of sorting (e.g. detecting) AML LSCs comprising contacting a primary AML sample with an antibody cocktail comprising CD34, CD38, CD123, and CD45RA [e.g., pg. 386, col. 1, ¶ 2; pg. 389, col. 1, ¶ 3]. Sarry further teaches that AML LSCs are historically considered CD34+/CD38- [e.g., pg. 384, col. 2, ¶ 2], that AML cells were sorted based on CD34, CD38, and CD45RA expression [e.g., pg. 385, col. 1, ¶ 2;], and that CD123 (e.g., CD123+) on AML LSCs is known to be important for growth and engraftment [e.g., pg. 385, col. 1 ¶ 1].
Regarding instant claim(s) 22-24, Sarry further teaches FACS cell sorting of primary AML samples comprising PE-Cy5.5-conjugated anti-CD34, APC-conjugated anti-CD38, PE-conjugated anti-CD123, and PE-Cy7-conjugated anti-CD45RA [e.g., pg. 394, col. 2, “Cell sorting.”¶].
Regarding instant claim(s) 25, Sarry further teaches contacting the primary AML sample with an anti-CD19 antibody [e.g., pg. 394, col. 2, “Cell sorting.”¶].
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643