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
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.
Response to Amendment
The objection(s) to the drawings, and/or the specification have been withdrawn in view of the Amendment filed on 04May2026.
All other previously presented rejection(s) are maintained for reasons given in the "Response to Arguments" below. Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Minimally Modified Rejections
Claim Rejections - 35 USC § 112(b)
The rejections of claim(s) 21-25 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, is maintained for the reasons of record and for the reasons set forth below.
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]. 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.
Response to Arguments
Applicant argues (1) one of ordinary skill in the art would know how to perform the experiments to determine which AML sample(s) are capable of engraftment, and (2) that instant figures 5A and 5D “
In response, (1) the knowledge of skill in the art of how to TEST for (e.g., conduct experiments to determine) a recited limitation does not make the meets and bounds of said limitation clear. For instance, in the review of prior art, if all elements except capability to engraft and initiate AML in an immunodeficient mouse, it would be unclear if the art could be applied in the case of the instant invention. Further, as recited in the rejection above, at the time of filing, Pearce et. al. taught that approximately half of primary AML samples were unable to initiate leukemia in NOD/SCID mice. Therefore, a PHOSITA would understand that not all primary AML samples would be capable of engraftment, and further determination of which samples are would require laboratory testing (e.g., is not clearly defined). In response to (2) above, the line regarding figures 5A and 5D has been deleted. Per MPEP 1207.03(III), the minor modification above is not considered a new grounds of rejection.
Maintained Rejections
Claim Rejections - 35 USC § 102
The rejection of 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”) is maintained for the reasons of record and for the reasons set forth below.
Response to Arguments
Applicant argues (1) Sarry discloses CD34, CD38, CD123, and CD45RA among many others as linage markers, (2) Sarry did not analyze the presence or absence of the claimed marker profile on a single blood cell – there was no such FACS gating employed in figure 1. Therefore, Sarry does not clearly an unambiguously disclose AML cells that are CD34+/CD45RA+/CD123+/CD38- that are capable of engrafting and initiating AML in an immunodeficient mouse. Applicant cites Sarry teaching (provided below) and assets this means that Sarry does not disclose the claimed method and (3) actually teaches away from the instant claimed method.
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In response to (1) above, independent claim 21 recites “A method…comprising: 1) obtaining a blood sample from the patient; 2) contacting the ample with…”. MPEP 211.03(I) provides “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)”. Therefore as the method recites comprising steps, prior art disclosing more surface markers is considered applicable.
In response to (2) above, regarding “clearly and unambiguously”, Applicant is advised that the standard recited by MPEP 2131 is "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987)…”. Additionally, the previous rejection did not rely up (e.g., cite) figure 1 for the teachings of the recited markers, and Applicant arguments are directed to steps not claimed (e.g., specific gating strategies). Additionally, Sarry figure 1 is a representative comparison of different primary AML samples and is not indicated to be the full gating strategy of all cell populations in the study. Rather, as provided in the previous rejection, Sarry teaches methods of sorting AML LSCs comprising FACS cell sorting 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.”¶] (see previous rejection for additional details). A PHOSITA would understand flow cytometry to be single cell analysis and FACS to be sorting of individual cells into groups based on shared markers.
In response to (3) above, Sarry’s teachings that the cell surface markers couldn’t consistently segregate AML-initiating and self-renewing cells is not considered to expressly teach away. Briefly, the art does not say NONE of the cells engrafted and initiated self-renewal, but that the results were mixed. Additionally, the statement further supports that the metes and bounds of “capable of engrafting and initiating AML in an immunodeficient mouse” are unclear, see 112(b) rejection above for details.
Conclusion
No claims are currently allowed.
THIS ACTION IS MADE FINAL. 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 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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/AMY M. CHATTIN/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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