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 .
DETAILED ACTION
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 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.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1, 6, 8, 13, 24 and 25, in the reply filed on May 4, 2026 is acknowledged. Claims 1, 6, 8-9, 12-13, 18-19, 21, 24-26, 30, 38-39, 43, 45, 50-51, and 54 remain pending in the current application, claims 9, 12, 18-19, 21, 26, 30, 38-39, 43, 45, 50-51, and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Applicant argues that the claims in Groups III, V and VII depend directly or indirectly from claim 1 and share the technical features of claim 1 and the composition claims of Groups IV and VI are made by methods that ultimately depend from claims 1 and share the required special technical feature (Remarks pg. 2 para. 5).
The traversal is on the grounds that the groups of inventions share the special technical feature. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 6, 8, 13, 24 and 25 are presented for examination on the merits.
Status of the Claims
Claims 1, 6, 8-9, 12-13, 18-19, 21, 24-26, 30, 38-39, 43, 45, 50-51, and 54 are currently pending.
Claims 9, 12, 18-19, 21, 26, 30, 38-39, 43, 45, 50-51, and 54 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 2-5, 7, 10-11, 14-17, 20, 22-23, 27-29, 31-37, 40-42, 44, 46-49, 52-53, and 55-56 are cancelled.
Claims 1, 6, 8, 13, 24 and 25 have been considered on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks and containing an embedded hyperlink in paras. 0099, 00228, 00229, 00238, 00240, and 00250.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
The use of the terms AggreWell™ in 0058, 00168, 00178, 00181; Matrigel® in 0010, 0109; TrypLE™ Express in 00111, 00167, 0168; StemPro™-34 in 00113, Table 1, 2; CryoStor® CS10 in 00168; StemSpan™ SFEM II in 00172; StemSpan™ T Cell Progenitor Maturation Supplement in 00172; B27™ in 00224 Table 4; and QuickExtract™ DNA Extraction Solution in 00229, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities: minor grammatical errors in claims.
Claim 1 is objected to because of the following informalities: The periods after the letters denoting the steps need to be removed. For example, in claim 1 "A.)" should be corrected to "A)". In other words, a claim should only contain one period. Please see MPEP 608.01(m).
Claims 6 and 8 are objected to because of the following informalities: the first time an acronym is utilized in a claim-set, said acronym should be spelled out in its entirety followed by said acronym in parenthesis (e.g. vascular cell adhesion protein 1 (VCAM-1); delta-like canonical Notch ligand 4 (DLL4)).
Appropriate correction is appreciated.
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.
Claim 13 is 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.
In claim 13, the phrase:
“(i) the blood progenitor cells are characterised in that they express the cell surface markers: SPN, PTPRC, HLF and THY1; or (ii) the blood progenitor cells are characterised in that they express the cell surface markers: HLF, THY1, SPN, ERG, HOXA9, HOXA10, LCOR, RUNX1 and SP11”,
renders the claim and its dependents indefinite, since at least HLF, ERG, HOXA9, HOXA10, LCOR, RUNX1 and SPI1 are not surface markers. HLF, ERG, HOXA9, HOXA10, LCOR, RUNX1 and SPI1 are transcription factors which tend to reside in the nucleus. For the purposes of compact prosecution, the phrase in the claim will be interpreted to mean:
“(i) the blood progenitor cells are characterised in that they express the cell surface markers: SPN, PTPRC, and THY1; or (ii) the blood progenitor cells are characterised in that they express the cell surface markers: THY1 and SPN”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 8, 13, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zandstra et al. (WO 2017/173551 A1) (ref. of record).
With respect to claims 1 and 25, Zandstra teaches a method of producing and enhancing the production of progenitor T cells (blood progenitor cells) containing an endothelial to hematopoietic transition step (abstract and 0005-0007).
With respect to claim 1 step A) and claims 6 and 8, Zandstra teaches exposing the stem and/or progenitor cells in a media to Notch ligand Delta-like 4 (DL4), where the DL4 is immobilized to a substrate, and VCAM-1 (in a media formulated to and under conditions that enhance Notch signaling pathway activation) (abstract). It is noted that claim 6 recites that the vascular cell adhesion ligand can optionally be VCAM-1 and the term “optionally” does not require that the vascular cell adhesion ligand be VCAM-1.
With respect to claim 1 step B), Zandstra teaches obtaining a cell culture containing progenitor T cells (0002, 0005 and 0012).
With respect to claim 1 step C), Zandstra teaches obtaining an isolated population of progenitor T cells (0013). It is noted that claim 1 recites that the isolating and selecting for the cells can optionally be performed and the term “optionally” does not require that the isolating and selecting for the cells to be performed. Since claim 1 does not require this step, dependent claims 13 and 24, which further limit step C) are also considered optional and the claims not require that the isolating and selecting for the cells to be performed.
Therefore, the reference anticipates the claimed subject matter.
Claims 1, 6, 8, 13, 24, and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shah (US 2024/0180961 A1, priority to Mar. 31, 2021).
With respect to claims 1 and 25, Shah teaches a method of producing and enhancing the production of hematopoietic stem cells (blood progenitor cells) from hemogenic endothelial cells containing an endothelial to hematopoietic transition (EHT) step (0004, 0006 and 0008).
With respect to claim 1 step A) and claims 6 and 8, Shah teaches exposing the stem and/or progenitor cells in a media to Notch ligand Delta-like 4 (DLL4), where the DLL4 is immobilized to a substrate, and VCAM-1 (in a media formulated to and under conditions that enhance Notch signaling pathway activation) (0005 and 0066). It is noted that claim 6 recites that the vascular cell adhesion ligand can optionally be VCAM-1 and the term “optionally” does not require that the vascular cell adhesion ligand be VCAM-1.
With respect to claim 1 step B), Shah teaches obtaining a cell culture containing hematopoietic stem cells (0004, 0006 and 0008).
With respect to claim 1 step C), Shah teaches obtaining an isolated population of progenitor T cells (0003). It is noted that claim 1 recites that the isolating and selecting for the cells can optionally be performed and the term “optionally” does not require that the isolating and selecting for the cells to be performed. Since claim 1 does not require this step, dependent claims 13 and 24, which further limit step C) are also considered optional and the claims not require that the isolating and selecting for the cells to be performed.
Although optional, with respect to claims 13 and 24, Shah teaches sorting cells based on expression of cell surface markers including CD34 and CD43 and selecting for CD34 and CD43 positive cells (0051). Shah teaches the HSC population can be identified based on the expression of CD34 (0011). It is noted that claim 13 recites that the blood progenitor cells can optionally be characterised in that they express the cell surface markers: (i) SPN, PTPRC, and THY1; or (ii) the cell surface markers: THY1 and SPN (as these phrase are being interpreted as explained in the rejection under 35 U.S.C. §112 (b)) and the term “optionally” does not require that the cells have these cell surface markers.
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 8, 13, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Zandstra et al. (WO 2017/173551 A1) (ref. of record) in view of Rajesh et al. (US 2010/0279403 A1).
With respect to claims 1 and 25, Zandstra teaches a method of producing and enhancing the production of progenitor T cells (blood progenitor cells) containing an endothelial to hematopoietic transition step (abstract and 0005-0007).
With respect to claim 1 step A) and claims 6 and 8, Zandstra teaches exposing the stem and/or progenitor cells in a media to Notch ligand Delta-like 4 (DL4 or DLL4), where the DL4 is immobilized to a substrate, and VCAM-1 (in a media formulated to and under conditions that enhance Notch signaling pathway activation) (abstract). It is noted that claim 6 recites that the vascular cell adhesion ligand can optionally be VCAM-1 and the term “optionally” does not require that the vascular cell adhesion ligand be VCAM-1.
With respect to claim 1 step B), Zandstra teaches obtaining a cell culture containing progenitor T cells (0002, 0005 and 0012).
With respect to claim 1 step C), Zandstra teaches obtaining an isolated population of progenitor T cells (0013). It is noted that claim 1 recites that the isolating and selecting for the cells can optionally be performed and the term “optionally” does not require that the isolating and selecting for the cells to be performed. Since claim 1 does not require this step, dependent claims 13 and 24, which further limit step C) are also considered optional and the claims not require that the isolating and selecting for the cells to be performed.
Zandstra does not teach the method of isolating the cell as recited in claim 13, where the cells are selected for using genetic expression and/or cell surface markers that are characteristic of said cells, and optionally wherein: (i) the blood progenitor cells are characterised in that they express the cell surface markers: SPN, PTPRC, and THY1; or (ii) the blood progenitor cells are characterised in that they express the cell surface markers: THY1 and SPN (as these phrase are being interpreted as explained in the rejection under 35 U.S.C. §112 (b)). Similarly, Zandstra does not teach the method wherein the blood progenitor cells are isolated and selected for by selecting cells comprising CD34+ and CD43+ or CD43+ cell surface markers as recited in claim 24.
However, Rajesh teaches after preparing hematopoietic precursor cells (blood progenitor cells) it may be desirable to purify or separate one or more sub-populations of the differentiated cells. Rajesh further teaches isolating CD34+ and CD43+ cells, which are hematopoietic cells from differentiated hESCs using a magnetic activated cell sorter (MACS) or fluorescence activated cell sorting (FACS) based on the expression of CD34 and CD43 (0165-0171).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Zandstra to include the isolating and selecting for blood progenitor cells by selecting for cells expressing CD34 and CD43 for the benefit of separating cells to have a substantially pure population type as taught by Rajesh. It would have been obvious to one of ordinary skill in the art to modify the method of Zandstra to include the isolating and selecting for blood progenitor cells by selecting for cells expressing CD34 and CD43, since these are known blood progenitor markers as taught by Rajesh. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the method of Zandstra, since Zandstra teaches isolating and selecting for the cells and Rajesh teach this can be successfully performed by using cell surface markers.
It is noted that claim 13 recites that the blood progenitor cells can optionally be characterised in that they express the cell surface markers: (i) SPN, PTPRC, and THY1; or (ii) the cell surface markers: THY1 and SPN (as these phrase are being interpreted as explained in the rejection under 35 U.S.C. §112 (b)) and the term “optionally” does not require that the cells have these cell surface markers.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1, 6, 8, 13, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US 20240180961 A1, priority to Mar. 31, 2021) in view of Lange et al. (Cellular and Molecular Life Sciences, Feb. 9, 2021).
With respect to claims 1 and 25, Shah teaches a method of producing and enhancing the production of hematopoietic stem cells (blood progenitor cells) from hemogenic endothelial cells containing an endothelial to hematopoietic transition (EHT) step (0004, 0006 and 0008).
With respect to claim 1 step A) and claims 6 and 8, Shah teaches exposing the stem and/or progenitor cells in a media to Notch ligand Delta-like 4 (DLL4), where the DLL4 is immobilized to a substrate, and VCAM-1 (in a media formulated to and under conditions that enhance Notch signaling pathway activation) (0005 and 0066). It is noted that claim 6 recites that the vascular cell adhesion ligand can optionally be VCAM-1 and the term “optionally” does not require that the vascular cell adhesion ligand be VCAM-1.
With respect to claim 1 step B), Shah teaches obtaining a cell culture containing hematopoietic stem cells (0004, 0006 and 0008).
With respect to claim 1 step C), Shah teaches obtaining an isolated population of progenitor T cells (0003). It is noted that claim 1 recites that the isolating and selecting for the cells can optionally be performed and the term “optionally” does not require that the isolating and selecting for the cells to be performed. Since claim 1 does not require this step, dependent claims 13 and 24, which further limit step C) are also considered optional and the claims not require that the isolating and selecting for the cells to be performed.
Although optional, with respect to claims 13 and 24, Shah teaches sorting cells based on expression of cell surface markers including CD34 and CD43 and selecting for CD34 and CD43 positive cells (0051). Shah teaches the HSC population can be identified based on the expression of CD34 (0011). It is noted that claim 13 recites that the blood progenitor cells can optionally be characterised in that they express the cell surface markers: (i) SPN, PTPRC, and THY1; or (ii) the cell surface markers: THY1 and SPN (as these phrase are being interpreted as explained in the rejection under 35 U.S.C. §112 (b)) and the term “optionally” does not require that the cells have these cell surface markers.
Shah does not teach the method of isolating the cell as recited in claim 13, where (i) the blood progenitor cells are characterised in that they express the cell surface markers: SPN, PTPRC, and THY1; or (ii) the blood progenitor cells are characterised in that they express the cell surface markers: THY1 and SPN (as these phrase are being interpreted as explained in the rejection under 35 U.S.C. §112 (b)).
However, Lange teaches early emerged hematopoietic committed cells (hematopoietic stem cells) can be identified by the cell surface markers CD43 (SPN), CD34, CD90 (THY-1) and CD45 (PTPRC) (pg. 4146 Col. 2 para. 1).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Shah to include the isolating and selecting for blood progenitor cells by selecting for cells expressing SPN, THY-1 and PTPRC for the benefit of isolating hematopoietic stem cells using known cell surface markers as taught by Lange. It would have been obvious to one of ordinary skill in the art to modify the method of Shah to include the isolating and selecting for blood progenitor cells by selecting for cells expressing SPN, THY-1 and PTPRC, since these are known hematopoietic progenitor cells (blood progenitor markers) as taught by Lange. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the method of Shah, since Lange teaches isolating and selecting for the cells using surface markers and Lange teaches these are known hematopoietic progenitor cell surface markers. It is noted that claim 13 recites that the blood progenitor cells can optionally be characterised in that they express the cell surface markers: (i) SPN, PTPRC, and THY1; or (ii) the cell surface markers: THY1 and SPN (as these phrase are being interpreted as explained in the rejection under 35 U.S.C. §112 (b)) and the term “optionally” does not require that the cells have these cell surface markers.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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