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 .
Claims 1-41 have been canceled. Claims 42-61 are pending.
Election/Restrictions
Applicants elected Group III, claims 48-52, without traverse in the reply filed on 10-13-25.
Claims 42-47, 53-61 have been withdrawn.
Claims 48-52 are under consideration.
Request for Information under 37 CFR § 1.105
Applicants and the Assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application:
Pg 133, lines 1-8, teach stem cell-derived neutrophils were “synthesized according to standard techniques”, but the specification does not teach those “standard techniques” or the starting “stem cells” used to derive those neutrophils. Please provide specific protocols for how the “neutrophils” were “derived” from stem cells.
Pg 135, lines 1-12, says proteomics analysis was carried on neutrophils, but the specification does not teach how the neutrophils were prepared or cultured after being “synthesized according to standard techniques” on pg 133. Please provide specific protocols for how the “neutrophils” used in proteomics analysis on pg 135 were cultured or processed after being derived from stem cells on pg 133.
Pg 135, line 4, says “low CKA controls” were used to determine proteomic expression patterns, but the specification does not teach what “low” CKAs are or when CKAs are considered “low”. Please provide information about the metes and bounds of “low CKAs”. This appears to be essential to determine the proteomic expression pattern in neutrophils. It is also part of claim 48, but the metes and bounds of the control cannot be determined.
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 48-52 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.
The metes and bounds of “neutrophils unsuitable for treating cancer” in claim 48 cannot be determined. The specification does not define when neutrophils “unsuitable for treating cancer”, so the metes and bounds of the “reference standard” for marker analysis cannot be determined. Moreover, those of skill would not know whether the test neutrophils are suitable or unsuitable for treating cancer, so the comparison with neutrophils “unsuitable for treating cancer” does not make sense. Next, it is unclear whether applicants are attempting to claim stem cells made by a particular process or whether applicants are attempting to claim stem cells capable of making neutrophils by a particular process. Therefore, it is unclear whether applicants are attempting to claim a product-by-process or not. Overall, it is unclear how to perform the comparison because the metes and bounds of the control (“neutrophils unsuitable for treating cancer”) cannot be determined and because it is unclear how the marker pattern of the neutrophils further limits the structure/function of the stem cells when pg 133 line 5 says any stem cell derived neutrophils “synthesized according to standard techniques” are encompassed by claim 48.
It is unclear how the expression pattern of the neutrophil in claim 48 further limits the structure/function of the stem cell capable of differentiating into the neutrophil. claim 48 is limited to stem cells capable of differentiating into neutrophils. As written on pg 133, it appears that claim 48 encompasses any stem cell derived neutrophils “synthesised according to [any] standard techniques”, so it is unclear how the marker pattern further limits the structure/function of the stem cells claimed. Perhaps applicants are attempting to distinguish the stem cells of claim 48 from stem cells that cannot differentiate into neutrophils having the marker pattern claimed, but this is contrary to applicant’s statement on pg 133, line 5.
The metes and bounds of “AGE-albumin” in claim 50 cannot be determined. It cannot be determined if the phrase encompasses any albumin or if it limited to a certain type of albumin. If the phrase is limited to a certain type of albumin, the metes and bounds of “AGE-albumin” cannot be determined because the specification and art do not teach the definition of “AGE-albumin”.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
A) Claims 48, 50, 52 are rejected under 35 U.S.C. 102a1 as being anticipated by Sweeney (Stem Cells, 2016, Vol. 34, pg 1513-1526).
Sweeney taught human iPS cells in media capable of differentiating into neutrophils (pg 1514, “Materials and Methods”). The neutrophils inherently MUST have the expression pattern in claim 48 as compared to “neutrophils unsuitable for treating cancer” because the iPS cells and neutrophils were “synthesized according to standard techniques” as required on pg 133. The media of Sweeney is the “pharmaceutically acceptable carrier in item b) of claim 48.
Sweeney used G-CSF (pg 1515, col. 1), glutamine (pg 1514, col. 2, 5th full para), IL6 (pg 1514, col. 2, 5th full para), IL3 (pg 1514, col. 2, 6th full para), flt ligand (pg 1514, col. 2, 6th full para), thrombopoietin (pg 1514, col. 2, 6th full para), FBS (pg 1514, col. 2, 5th full para) as required in claim 50.
Sweeney used induced pluripotent stem (iPS) cells as required in claim 52.
B) Claims 48-52 are rejected under 35 U.S.C. 102a1 as being anticipated by Saito (Int J Hematol, 2008, Vol. 88, pg 64-72).
Saito taught human CD34+ cells isolated from peripheral blood in media (pg 64, abstract; pg 65, “Cell Preparations”) capable of differentiating into neutrophils (pg 56, col. 2, 2nd full paragraph, last sentence) and neutrophil progenitors (pg 67, section 3.3). The neutrophils inherently MUST have the expression pattern in claim 48 as compared to “neutrophils unsuitable for treating cancer” because the iPS cells and neutrophils were “synthesized according to standard techniques” as required on pg 133. The media of Saito is the “pharmaceutically acceptable carrier in item b) of claim 48.
Saito cultured the CD34+ cells with TNFα as required in claim 49 (pg 66, col. 2, Section 3.1) as required in claim 49
Saito used GM-CSF (pg 71, last para), G-CSF (pg 66, col. 2, Section 3.1), IL3 (pg 65, Section 2.2), IL4 (pg 71, last para), TNFα (pg 66, col. 2, Section 3.1), FLT ligand (pg 71, last para), fetal bovine serum (pg 76, section 2.1) as required in claim 50.
Saito used GM-CSF and INFα together (pg 71, last para) as required in claim 51
Saito used CD34+ cells which are a “hematopoietic stem cell” or “a precursor cell” as required in claim 52.
Conclusion
No claim is allowed.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638