DETAILED ACTION
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 status
Applicants reply filed 3/11/2026 is acknowledged.
Claims 5 is/are cancelled and claims 98 is/are newly added. Claims 4, 8, 9, 11-13, 15, 16, 20, 27-29, 31, 35, 49, 66, 72, 75-77, 79, 80, 84, 89 and 98 is/are currently pending with claims 66, 72, 75-77, 79, 80, 84, 89 is/are withdrawn. Claims 4, 8, 9, 11-13, 15, 16, 20, 27-29, 31, 35, 49, and 98 is/are under examination.
Drawings
Objections to the drawings are withdrawn in light of amendment to the specification and replacement drawings.
Claim Objections – New, necessitated by claim amendment
Objections to claim 4 and 5 are withdrawn in light of claim amendment/cancellation.
Claim 16 is objected to because of the following informalities: Claim is amended to recite “ENSUMUST00000023352.8” (emphasis added). The annotation is incorrect due to inclusion of extra U after ENS (see bolded letter). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Rejection of Claim 8 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of discussion on page 10, paras 5 and 6 in the remarks filed 3/11/2026.
Same as examiners interpretation presented in the U.S.C. 112b rejection of this claim (“claim 8 limits the loss-of-function mutations of a, b in claim 4 to the specific loss-of-function mutations of NSGW41, NBSGW, or NSG transgenic mice.”), Applicant states “Applicant submits that the recited genotypes in claim 8 is to limit the loss-of-function mutations of a) and b) in claim 4. Applicant submits that claim 8 meets the requirement for definiteness of 35 U.S.C. § 112.”
Rejection of Claim 9 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 withdrawn in light of claim amendment.
Claims 16, 20 remain and claim 98 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.
Claim 16 is amended to recite “wherein the loss-of-function mutation in the gene that encodes for the protein kinase, DNA-activated, catalytic polypeptide comprises a T to A transversion point mutation at a position corresponding to codon 4046 (codon 4095 in transcript ENSUMUST00000023352.8).” It is unclear if the limitation recited in parenthesis is an optional or a required limitation. Further, it remains unclear which gene sequence for Prkdc gene is “codon 4046” referring to? At least three gene sequences are available for mouse Prkdc gene using just the most recent mouse Genome Reference library on NCBI (Gene ID: 19090; ref of record). Disclosure of the sequence in the form of a SEQ ID NO and recitation of this SEQ ID in the claim is recommended.
Claim 20 continues to recites “wherein the loss-of-function mutation in the gene that encodes for the KIT receptor comprises a G to A point mutation in a kinase domain at nucleotide 2519”. It is unclear which gene sequence for Kit gene is the “kinase domain at nucleotide 2519” referring to? Furthermore, protein domains such as “kinase domains” generally identify protein sequence and not nucleotide sequences. At least two gene sequences are available for mouse Kit gene using just the most recent mouse Genome Reference library on NCBI (See Gene ID: 16590; ref of record). Disclosure of the sequence in the form of a SEQ ID NO and recitation of this SEQ ID in the claim is recommended.
Claim 98 recites “wherein the one or more human thymocytes are derived from the human non-hematopoietic stem cell progenitors.”
First the term “non-hematopoietic stem cell progenitors” is unclear. The specification does not define this term and it is unclear if the cell type being referred to is a progenitor of a non- hematopoietic stem cell or is progenitor that is not a hematopoietic stem cell. Para [108] in the specification lists “lymphoid tissue organizer cells (lymphoid tissue organizer cells differentiate into lymphoid tissue inducer cells), marginal reticular cells, follicular dendritic cells and fibroblastic reticular cell precursors” as examples for “non-hematopoietic stem cell progenitors” and provides the following function for this cell type: “the one or more human non-hematopoietic stem cell progenitors are capable of improving secondary lymphoid development and structure; forming a human microenvironment within the secondary lymphoid; increasing the recruitment of human lymphocytes to secondary lymphatic tissues through human cytokine and chemokine production promoting chemotaxis; improving the development of the peripheral germinal center or germinal center-like structures or secondary lymphoid organizations; increasing human cytokine production, including human IL-6 and human BAFF; increasing antigen presentation by human cells; and improving T-lymphocyte dependent and T-lymphocyte independent antibody response.”. Thus, it appears that the claimed “non-hematopoietic stem cell progenitors” are progenitor cells that is not a hematopoietic stem cell, for example a lymphoid tissue organizer cells, marginal reticular cells, follicular dendritic cells and fibroblastic reticular cell precursors that performs immune supportive functions but are not immune cells such as thymocytes that give rise to T-cells.
Second, the claim requires derivation of thymocytes (precursors to T-cells) from these progenitor cells that are not hematopoietic stem cells. None of the cell types provided as examples for claimed “non-hematopoietic stem cell progenitors” are capable of generating thymocytes that are derived from cells derived from hematopoietic stem cells. For the purpose of compact prosecution, the claim(s) 98 is/are interpreted as “wherein the one or more human thymocytes are derived from the human s
Claim Rejections - 35 USC § 112(d) - Moot
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Rejection Claim 5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is moot due to claim cancellation.
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.
Rejection of Claim(s) 5 under 35 U.S.C. 102(a)(1) as being anticipated by Rahmig et al (Stem Cell Reports, Vol. 7, 591–601, October 11, 2016; ref of record) as evidenced by NSGW41 (Strain# 026497 available from Jackson Lab; strain information ref of record) is moot due to claim cancellation.
Rejection of Claim(s) 4, 8, 9, 11-13, 15, 16, 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahmig et al (Stem Cell Reports, Vol. 7, 591–601, October 11, 2016; ref of record) as evidenced by NSGW41 (Strain# 026497 available from Jackson Lab; strain information ref of record) is withdrawn due to claim amendment requiring engraftment of human non-hematopoietic stem cell progenitors.
Claim(s) 4, 8, 9, 11-13, 15, 16, 20 and 98 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahmig et al (Stem Cell Reports, Vol. 7, 591–601, October 11, 2016; ref of record) as evidenced by NSGW41 (Strain# 026497 available from Jackson Lab; strain information ref of record). Additional evidence is included from Matsumoto et al (Non-Hematopoietic Stem Cells in Umbilical Cord Blood. International Journal of Stem Cells Vol. 2, No. 2, 2009) to show CD45+ human cord blood cells inherently comprise non-hematopoietic stem cells progenitors and Cosgun et al (Cell Stem Cell 15, 227–238, August 7, 2014; IDS 7/13/2022) to show that NSGW41 engrafted with CD34+ progenitor cells derived from human umbilical cord blood samples comprise human thymocytes
Regarding claims 4, 8 and 98, Rahmig discloses a NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ KitW41/W41 mice, also known as NSGW41 transgenic mouse that comprises a loss-of-function mutation in the mouse Prkdc gene (=a) and in the mouse Il2rg gene (=b), as evidenced by Genetic background provided in NSGW41 strain details from Jackson Lab (Experimental Procedures: Mice).
Rahmig discloses engraftment of NSGW41 mice with CD34+ progenitor cells derived from human umbilical cord blood samples (Experimental Procedures: Human Donor Cells, Transplantation). Matsumoto evidences that CD34+ progenitor cells derived from human umbilical cord blood samples inherently comprise both human hematopoietic stem cells and human non-hematopoietic stem cells progenitors (Introduction, para 1; Table 1; see section “Multilineage progenitor cells (MLPCs)”).
Rahmig discloses that NSGW41 mice engrafted with CD34+ progenitor cells derived from human umbilical cord blood samples comprise human CD45 expressing cells (Experimental Procedures: Human Donor Cells, Transplantation; Figure 1).
Cosgun also engrafts NSGW41 mice with CD34+ progenitor cells derived from human umbilical cord blood samples same as Rahmig (Experimental Procedures: Mice, Human Donor Cells), and thus evidences that Rahmig’s NSGW41 mice which are engrafted with CD34+ progenitor cells derived from human umbilical cord blood samples inherently comprise thymocytes since they comprise human CD4+ T-cells that are produced from thymocytes which are produced from HSC (as required by claim 98 based on claim interpretation presented in the 112b rejection above; Supplementary Figure S1).
Regarding claim 9, Rahmig discloses that the human hematopoietic stem cells used for engraftment are CD34+ (=claimed human CD34-postitive cells; Experimental Procedures: Human Donor Cells, Transplantation).
Regarding claim 11, it recites “wherein the mouse is treated with estrogen”. This is a process step using the mouse of claim 4. According to MPEP 2113, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps”. However, in the instant case, the structure of the product i.e. the mouse of claim 4 is already provided by the elements in claim 4 and administration of estrogen to the mouse does not provide any additional structure since the mouse claim 4 already produces estrogen. Thus, the product of claim 11 is not patentably distinct from product of claim 4.
Rahmig’s NSGW41 mice inherently produce estrogen and are patentably indistinct from the claimed mouse that comprises some estrogen.
Regarding claim 12, Rahmig’s NSGW41 mice comprise human CD45 expressing cells, human CD33+ myeloid cells, human CD19+ B - cells, human CD3+ T- cells (Figure 1A).
Regarding claim 13, Rahmig’s NSGW41 mice is NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ KitW41/W41 i.e. it comprises the W41 loss-of-function mutation in the Kit receptor gene, as evidenced by Genetic background provided in NSGW41 strain details from Jackson Lab (Experimental Procedures: Mice).
Regarding claim 15, it recites “the mouse has a functional human immune system”. The specification states that “As used herein, the term "functional human immune system" can include one or more or all of the human hematopoietic stem cell lineage cells.” [0074]. Therefore, a mouse comprising at least one human hematopoietic stem cell lineage cells is considered to have a “functional human immune system”. Furthermore, this limitation presents a phenotypic feature of the mouse that is already structurally defined by claim 4 and phenotypic features necessarily flow from the genotypic features. Thus, mouse meeting the structural limitations of claim 4, necessarily has a functional human immune system.
Rahmig’s NSGW41 mice have at least one human hematopoietic stem cell lineage cells, such as CD45 expressing cells, human CD33+ myeloid cells, human CD19+ B - cells, human CD3+ T- cells (Figure 1A). Thus, Rahmig’s NSGW41 mice have a functional human immune system.
Regarding claim 16, Rahmig’s NSGW41 mice comprise the scid loss-of-function mutation in the Prkdc gene which is “A T-to-A transversion point mutation at a position corresponding to codon 4046 (codon 4095 in transcript ENSMUST00000023352.8) created a premature stop codon (p.Y4046)” as evidenced by Molecular Note in Prkdcscid allele Genetic Background provided in NSGW41 strain details from Jackson Lab.
Regarding claim 20, Rahmig’s NSGW41 mice comprise the W41 loss-of-function mutation in Kit receptor gene which in “Comparison of the coding sequence of this allele with normal c-kit indicated a G-to-A point mutation in the kinase domain at nucleotide 2519 that results in a valine to methionine substitution at amino acid 831 (p.V831M).” as evidenced by Molecular Note in KitW-41J allele Genetic Background provided in NSGW41 strain details from Jackson Lab.
Therefore, Rahmig anticipates the claimed invention.
Claim Rejections - 35 USC § 102/103
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.
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.
Rejection of Claim(s) 27-29, 31, 35, 49 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rahmig is withdrawn due to withdrawal of the previous U.S.C. 102 rejection of the claims over Rahmig.
Claim(s) 27-29, 31, 35, 49 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rahmig.
The teachings of Rahmig as detailed in the U.S.C. 102 rejection are relied upon for the instant rejection.
Claims 27, 28, 29, 31, 35 and 49 recite additional phenotypic features without reciting any structure in addition to the structure of claim 4.
Rahmig is silent regarding the specifically recited phenotypic features. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the transgenic mouse of Rahmig is distinct from, and if so to what extent, from applicant’s claimed transgenic mouse.
Rahmig discloses a transgenic mouse with loss-of-function mutations in Prkdc gene, Il2rg gene and Kit gene wherein the mouse is engrafted with human HSCs, which is the same as applicant’s transgenic mouse of claim 4, additionally comprising the Kit receptor loss-of-function mutation of claim 13. The specific mutations in Rahmig’s transgenic and Applicants transgenic (as recited in claims 16 and 20) are also identical.
For claim 27, Rahmig’s mouse was also engrafted with human HSCs and since it has the structure identical to claimed mouse, it is expected to comprise human hematopoietic lineage cells that are maintained up to 40 weeks. To this end, Rahmig also teaches that their mouse engrafted with human HSCs comprises human CD45 expressing cells, human CD33+ myeloid cells, human CD19+ B - cells, human CD3+ T- cells at least up to 28 weeks (Figure 1A)
For claim 28, Rahmig’s mouse engrafted with human HSCs shows some animals with about 95% human CD45 expressing cells in the blood and nearly 100% in the bone marrow (Figure 1A).
For claim 29, 35 and 49, since Rahmig teaches the mouse of claim 4, it is expected to be capable of the functions recited in claims 29, 35, 49. Furthermore, regarding claim 49, since Rahmig’s mouse has the structure identical to claimed mouse, it is expected present the same response to pristane as recited in claim 49.
For claim 31, Rahmig’s mouse was engrafted with human HSCs and comprises human CD45 expressing cells, human CD33+ myeloid cells, human CD19+ B - cells, human CD3+ T- cells (Figure 1A). Rahmig does not explicitly investigate each of the other cell types recited in claim 31 or a response to estrogen stimulation, however, since Rahmig’s mouse has the structure identical to claimed mouse, it is expected to comprise the cells of claim 31 and present the same response to estrogen.
Where an examiner cannot determine whether or not the reference inherently possesses properties which anticipate, or render obvious, the claimed invention a rejection under §§102/103 is appropriate. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the transgenic mouse of Rahmig is either identical or sufficiently similar to the claimed transgenic mouse that whatever differences exist, they are not patentably significant. Therefore, the burden of establishing novelty or non-obviousness by objective evidence is shifted to applicants. See MPEP § 2112(v). Clear evidence that the transgenic mouse of Rahmig does not possess a critical characteristic that is possessed by the claimed transgenic mouse would advance prosecution and might permit allowance of the claims. Applicant is requested to specifically point out the support for any amendments made to the disclosure and arguments in response to this Office Action, including the claims. See MPEP §§ 714.02 and 2163.06. Applicant is also requested to refer to pages and line numbers in the as-filed specification. It is noted that other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Response to Arguments
Applicant's arguments filed 3/11/2026 with respect to the U.S.C. 112(b) rejection of claims 16 and 20 have been fully considered but they are not persuasive.
Regarding claim 16, Applicants argue that “one of ordinary skill in the art would at the time of the invention would have understood this common nomenclature based on at least the following publication: Araki, et al., "Nonsense mutation at Tyr-4046 in the DNA-dependent protein kinase catalytic subunit of severe combined immune deficiency mice", PNAS, Vol. 94, No. 6, pp. 2438- 2443, 1997 (also submitted herewith).” (page 11, para 2). This is not persuasive because gene and protein sequences are updated and could change over time. As noted in the rejection, at least three gene sequences are available for mouse Prkdc gene using just the most recent mouse Genome Reference library on NCBI (Gene ID: 19090; ref of record). This results in indefiniteness because it is unclear which of at least these three sequences is the claim referring to. The amended claim includes a limitation in parenthesis. This Ensembl gene sequence is also updated. Disclosure of the sequence in the form of a SEQ ID NO and recitation of this SEQ ID in the claim is recommended.
Regarding claim 20, Applicants argue that “at the time of the invention the gene that encodes for the KIT receptor was known.” referencing NPLs (page 11, para 4). This is not persuasive because gene and protein sequences are updated and could change over time. As noted in the rejection, at least two gene sequences are available for mouse Kit gene using just the most recent mouse Genome Reference library on NCBI (See Gene ID: 16590; ref of record). This results in indefiniteness because it is unclear which of at least these sequences is the claim referring to. Disclosure of the sequence in the form of a SEQ ID NO and recitation of this SEQ ID in the claim is recommended.
Applicant’s arguments with respect to claim(s) U.S.C 102 rejection of claims 4, 8, 9, 11-13, 15, 16 and 20 have been considered but are moot because the new ground of rejection were necessitated by claim amendments.
Arguments pertinent to instant U.S.C 102 rejection of claims 4, 8, 9, 11-13, 15, 16 and 20 are addressed below.
Applicant argue that “Neither Rahmig nor NSGW41 recite a transgenic mouse, comprising "an engraftment of...human non-hematopoietic stem cell progenitors" and "wherein the mouse comprises one or more human thymocytes." Rahmig as evidenced by NSGW41 fail to disclose the claimed transgenic mouse, and, more specifically, fails to teach "wherein the mouse further comprises an engraftment of...human non-hematopoietic stem cell progenitors" and "wherein the mouse comprises one or more human thymocytes" as currently claimed.” (page 13, para 1). This is not persuasive because Rahmig’s NSGW41 mouse that is engrafted with human CD34+ progenitors from umbilical cord blood inherently comprise human non-hematopoietic stem cell progenitors and also human thymocytes. Matsumoto and Cosgun provide the relevant evidence for this inherency (See details in the rejection above).
Applicant’s arguments with respect to claim(s) U.S.C 102/103 rejection of claims 27-29, 31, 35 and 49 have been considered but are moot because the new ground of rejection were necessitated by claim amendments.
Arguments pertinent to instant U.S.C 102/103 rejection of claims 27-29, 31, 35 and 49 are addressed below.
Applicant essentially argue that since Rahmig does not anticipate the mouse of claim 4 reiterating the argument presented for the U.S.C 102 rejection, thus Rahmig does not anticipate (page 14) or render obvious (page 16) the claims 27-29, 31, 35 and 49. This is not persuasive because arguments pertaining to the U.S.C 102 rejection above were not persuasive.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr. can be reached at (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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/MATASHA DHAR/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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