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 .
Status of the Claims
Applicant’s submission filed 08 October 2025 has been entered. Claims 28-38 are pending. Claims 32 and 34 have been amended, while claim 38 has been newly added. Therefore, prosecution on the merits continues for claims 28-38. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to the Specification
The substitute Specification filed 08 October 2025 is acknowledged and entered into the application file. However, Applicant has failed to address the embedded hyperlinks or otherwise browser-executable code within the table on Page 36.
Therefore, the objection is maintained.
RE: Nucleotide/Amino Acid Sequence Disclosure
The substitute Specification filed 08 October 2025 is acknowledged and entered into the application file. With that, the addition of sequence identifiers for the sequences detailed on Page 24 and within Figure 19C obviates the objections of record.
Therefore, the objections are withdrawn.
RE: Objection of claims 32 and 34
Applicant’s amendments to each of instant claims 32 and 34 obviate the current objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 28-29, 31-32, and 35-37 under 35 USC 103 over Vodyanyk et al
Applicant’s arguments filed 08 October 2025 have been fully considered but are not found persuasive.
Applicant has traversed the rejection, asserting in Pages 5-8 of the Remarks filed 08 October 2025 that the ordinary artisan would not have been motivated to select naïve T cells and memory T cells as the starting population of cells from the disclosure of Vodyanyk et al without the use of impermissible hindsight. In response, the Examiner first respectfully submits that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would not have been outside the skillset of the ordinary artisan to select naïve T cells and memory T cells as the starting population of cells, as the teachings of Vodyanyk et al reasonably suggesting a purified starting population of T cells that can comprise the naive and memory subsets (Paragraph [0009], [0089]). In addition, the Examiner respectfully submits that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant has further traversed the rejection, asserting in Pages 8-10 of the Remarks filed 08 October 2025 that the cell populations produced according to the claimed methods exhibit potent antigen-specific anti-tumor activities when compared to conventional CAR T cells generated from donor matched PBMCs. Applicant supports these assertions with Examples 1-4 of the instant disclosure. In response, the Examiner respectfully reminds Applicant that, in submitting evidence asserted to establish unobvious results, there is a burden on Applicant to indicate how the examples asserted to represent the claimed invention are considered to relate to the examples intended to represent the prior art and, particularly, to indicate how those latter examples do represent the closest prior art. The evidence relied upon should also be reasonably commensurate in scope with the subject matter claimed and illustrate the claimed subject matter relative to the prior art subject matter. See MPEP § 2145. It should also be established that the differences in the results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP § 716.02(b). In the instant case, Applicant has failed to indicate how the alleged unexpected results differ from the closest prior art, and has instead referenced conventional CAR T cells to support the purported “unexpected results”.
Therefore, the rejection is maintained.
RE: Rejection of claims 28-32 and 35-37 under 35 USC 103 over Vodyanyk et al in view of Blazar et al
Applicant’s arguments filed 08 October 2025 have been fully considered but are not found persuasive.
Applicant has traversed the rejection, asserting in Pages 10-11 of the Remarks filed 08 October 2025 that Blazar et al fail to cure the deficiencies of Vodyanyk et al, as Blazar et al teach numerous T cell subsets that can be utilized within the starting population of cells. In response, the Examiner respectfully submits that Blazar et al disclose the isolation of naïve T cells and T stem memory cells from donor blood (Paragraphs [0222]-[0242]), thereby disclosing a starting population of naïve T cells and memory T cells.
Applicant has further traversed the rejection, asserting in Pages 11-12 of the Remarks filed 08 October 2025 that Blazar et al do not explicitly disclose whether the T cell subsets are CD25−. In response, the Examiner respectfully submits that the disclosure of Blazar et al reasonably suggests that the population of CD8+ CD62L+ CD45RA+ CCR7+ CD95− CD45RO− naïve T cells and CD8+ CD62L+ CD45RA+ CCR7+ CD95+ CD45RO− T stem memory cells are CD25−, as it is not a highlighted expression marker. Furthermore, the ordinary artisan would recognize that the naïve T cells and T stem memory cells are isolated and sorted prior to stimulation, and would thereby reasonably be CD25− (Paragraph [0064]).
Therefore, the rejection is maintained and amended to include the newly added claim.
RE: Rejection of claims 28-29, 31-33, and 35-37 under 35 USC 103 over Vodyanyk et al in view of Gschweng et al
Applicant has traversed the rejection, citing the same assertions presented within Pages 5-10 of the Remarks filed 08 October 2025 in regards to the rejection over Vodyanyk et al. In response, the Examiner respectfully directs Applicant to the discussion of 35 USC 103 rejection over Vodyanyk et al.
Therefore, the rejection is maintained.
RE: Rejection of claims 28-29, 31-32, and 35-37 under 35 USC 103 over Vodyanyk et al in view of Dzhoyashvili et al
Applicant has traversed the rejection, citing the same assertions presented within Pages 5-10 of the Remarks filed 08 October 2025 in regards to the rejection over Vodyanyk et al. In response, the Examiner respectfully directs Applicant to the discussion of 35 USC 103 rejection over Vodyanyk et al.
Therefore, the rejection is maintained.
New/Maintained Grounds of Rejection
Specification
The disclosure filed 08 October 2025 remains objected to because it contains an embedded hyperlink and/or other form of browser-executable code within the table on Page 36. 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 § 103
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 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 28-29, 31-32, and 35-37 remain rejected under 35 U.S.C. 103 as being unpatentable over Vodyanyk et al (WO 2018/195175 A1, of record on IDS filed 05 July 2024).
Vodyanyk et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 28 and 36-37: Vodyanyk et al disclose methods for the production of antigen-specific effector T cells and NK cells from pluripotent stem cells which express a chimeric antigen receptor (CAR) (Abstract).
As such, Vodyanyk et al disclose a method of producing antigen-specific effector T cells and NK cells, the method comprising: reprogramming a starting population of blood cells into induced pluripotent stem cells (iPSCs); contacting the iPSCs with a vector encoding a CAR, thereby generating CAR iPSCs; differentiating the CAR iPSCs into CD34+ hematopoietic progenitor cells (HPCs); and further differentiating the CD34+ HPCs into CAR T cells or CAR NK cells (Paragraphs [0005]-[0010], [0054]-[0055], [0088]-[0089], [00155]).
Vodyanyk et al further disclose that the starting population of blood cells is a population of T cells, including the subsets of naïve T cells and memory T cells (Paragraphs [0009], [0030], [0058]-[0059], [0089]-[0090]).
Therefore, the disclosure of Vodyanyk et al encompasses the subject matter of instant claim 28. The only difference between Vodyanyk et al and the instant claims is that Vodyanyk et al does not teach the starting population of T cells as a combination of the naïve and memory T cell subsets with sufficient specificity to be anticipatory. The specific combination of cells claimed is disclosed within the teachings of Vodyanyk et al, but such “picking and choosing” within several variables (cells) does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any explicit motivation to select this specific combination of cells (starting population of naïve T cells and memory T cells), anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed T cell subsets (i.e. a starting population of naïve T cells and memory T cells) from within the disclosure of Vodyanyk et al to arrive at a starting population “yielding no more than one would expect from such an arrangement.”
Consequently, Vodyanyk et al render obvious a method of producing CAR T cells and CAR NK cells, the method comprising: reprogramming a starting population of naïve T cells and memory T cells into induced pluripotent stem cells (iPSCs); contacting the iPSCs with a vector encoding a CAR, thereby generating CAR iPSCs; differentiating the CAR iPSCs into CD34+ hematopoietic progenitor cells (HPCs); and further differentiating the CD34+ HPCs into the CAR T cells (claim 36) or CAR NK cells (claim 37). This therefore renders obvious the method of instant claim 28.
Regarding claim 29: Following the discussion of claim 28, Vodyanyk et al further disclose that the T cells are isolated from human blood (Paragraphs [0068], [0088]-[0091]). This therefore reads on the method of the instant claim.
Regarding claim 31: Following the discussion of claim 28, Vodyanyk et al further disclose that the iPSCs are generated by contacting the T cells with Oct 3/4, Sox2, c-Myc, Klf4, and Lin28 (Paragraphs [0054], [0081]). This therefore reads on the method of the instant claim.
Regarding claim 32: Following the discussion of claim 28, Vodyanyk et al further disclose that the iPSCs are genetically modified to express the CAR (Paragraph [00139]). This therefore reads on the method of the instant claim.
Regarding claim 35: Following the discussion of claim 28, Vodyanyk et al further disclose that the CAR comprises an antigen binding – or targeting – domain, a linker – or spacer, a transmembrane domain, a co-stimulatory domain, and a CD3ζ intracellular – or signaling – domain (Paragraphs [0015], [0072], [00146]). This therefore reads on the method of the instant claim.
Claims 28-32 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Vodyanyk et al (WO 2018/195175 A1, of record on IDS filed 05 July 2024) in view of Blazar et al (US 2018/0362927 A1).
The discussion of Vodyanyk et al regarding claim 28 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Vodyanyk et al render obvious claims 28-29, 31-32, and 35-37. Blazar et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 30: As aforementioned in the discussion of claim 28 above, Vodyanyk et al teach that the starting population of cells can be naïve T cells and memory T cells.
Vodyanyk et al do not disclose that the naïve T cells and memory T cells are CD14-, CD25-, and CD62L+, as required by instant claim 30.
Blazar et al, however, disclose methods of generating CAR-expressing iPSCs from T cell subsets (Abstract).
As such, Blazar et al disclose that the starting population of T cells comprises CD62L+ naïve T cells and T stem memory cells (Paragraphs [0003], [0005], [0007], [0065]-[0066], [0070]-[0071], [0075], [0110]). Blazar et al further disclose that the naïve T cells and memory stem cells are sorted from blood, wherein CD14+ cells are excluded (Paragraphs [0222]-[0242]; Example 3). This indicates that the naïve T cells and T stem memory cells are CD14-. It is also of note that naïve T cells are inherently CD25-, as they are defined as having an expression profile of CD8+ CD62L+ CD45RA+ CCR7+ CD95− CD45RO−, as are T stem memory cells, since they are defined as having an expression profile of CD8+ CD62L+ CD45RA+ CCR7+ CD95+ CD45RO− (Paragraph [0075]).
Therefore, it would have been prima facie obvious to modify the method of Vodyanyk et al such that the starting population of T cells comprises the naïve T cell and T stem memory cell subsets, as disclosed in Blazar et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to utilize a starting population of cells that produces iPSCs that can provide a virtually limitless source of long-lasting cells for adoptive therapy (Blazar et al, Paragraph [0072]), and would have had a reasonable expectation of success since the disclosures of both Vodyanyk et al and Blazar et al concern the generation of CAR-iPSCs from a starting population of T cells. See MPEP § 2143(I)(G).
Consequently, Vodyanyk et al as modified by Blazar et al render obvious a method of generating a CAR T cell or CAR NK cell, wherein the starting population of T cells comprises the naïve T cell subset and T memory stem cell subset, which are CD14-, CD25-, and CD62L+. This therefore renders obvious the method of the instant claim.
Regarding claim 38: As aforementioned in the discussion of claim 32 above, Vodyanyk et al disclose that the iPSCs are genetically modified to express CARs.
Vodyanyk et al do not disclose that the iPSCs are genetically modified to comprise a knock out of one or more of a TRAC, TRBC, B2M, or CIITA gene, as required by instant claim 38.
Blazar et al, however, disclose methods of generating CAR-expressing iPSCs from T cell subsets (Abstract). As such, Blazar et al disclose that iPSCs derived from naïve T cells and T stem memory cells are genetically modified to knock out the TRAC gene (Paragraph [0122]).
Therefore, it would have been prima facie obvious to modify the method of Vodyanyk et al such that the T cell-derived iPSCs are genetically modified to comprise a TRAC knockout, as disclosed in Blazar et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to utilize iPSCs that have a diminished or eliminated endogenous TCR signaling (Blazar et al, Paragraph [0122]), and would have had a reasonable expectation of success since the disclosures of both Vodyanyk et al and Blazar et al concern the generation of CAR-iPSCs from a starting population of T cells. See MPEP § 2143(I)(G).
Consequently, Vodyanyk et al as modified by Blazar et al render obvious a method of generating a CAR T cell or CAR NK cell, wherein the T cell-derived iPSCs are genetically modified to knock out the TRAC gene. This therefore renders obvious the method of the instant claim.
Claims 28-29, 31-33, and 35-37 remain rejected under 35 U.S.C. 103 as being unpatentable over Vodyanyk et al (WO 2018/195175 A1, of record on IDS filed 05 July 2024) in view of Gschweng et al (WO 2019/161271 A1, of record on IDS filed 05 July 2024).
The discussion of Vodyanyk et al regarding claim 28 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Vodyanyk et al render obvious claims 28-29, 31-32, and 35-37. Gschweng et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 33: As aforementioned in the discussion of claim 28 above, Vodyanyk et al teach a method of producing CAR T cells and CAR NK cells, the method comprising: reprogramming a starting population of naïve T cells and memory T cells into induced pluripotent stem cells (iPSCs); contacting the iPSCs with a vector encoding a CAR, thereby generating CAR iPSCs; differentiating the CAR iPSCs into CD34+ hematopoietic progenitor cells (HPCs); and further differentiating the CD34+ HPCs into the CAR T cells or CAR NK cells.
Vodyanyk et al do not disclose that the CAR iPSCs are first differentiated into embryonic mesodermal progenitors (EMPs), wherein the EMPs are CD56+ and CD326-, as required by instant claim 32.
Gschweng et al, however, disclose a method of generating modified T cells from engineered stem cells for use in an autologous or allogeneic setting for engineered immunotherapy (Abstract).
As such, Gschweng et al disclose a method, wherein iPSCs derived from T cells are modified to comprise a CAR, and induced to generate a T cell (Paragraphs [0018], [0032], [0059]-[0060], [0110], [0116], [0129]). Gschweng et al further disclose that the induction of the CAR iPSCs into CAR T cells comprises an intermediate step, wherein the CAR iPSCs are first differentiated into embryonic mesodermal progenitors (Paragraphs [0063]-[0064], [0071], [0085], [0137], [0145], [0263]; Figures 4, 12). Gschweng et al further disclose that the embryonic mesodermal progenitors are CD56+ and CD326- (Figure 12).
Therefore, it would have been prima facie obvious to substitute the intermediate step of differentiating CAR iPSCs into HPCs in the method of Vodyanyk et al for the intermediate step of differentiating CAR iPSCs into EMPs in the method of Gschweng et al, as doing so would be a simple substitution of one intermediate step for another. See MPEP § 2143(I)(B). One of ordinary skill before the effective filing date of the invention would have recognized that the two intermediate steps are functionally comparable since both are utilizing T cell-derived CAR iPSCs to generate CAR T cells, and thereby would have been able to substitute these intermediate steps with predictable results. See, for example, Paragraphs [0063]-[0064] of Gschweng et al, which list mesodermal progenitors and hematopoietic progenitors as equal alternatives for the T cell lineage differentiation.
Consequently, Vodyanyk et al as modified by Gschweng et al render obvious a method of generating a CAR T cell, wherein the method comprises differentiating the CAR iPSCs into CD56+ CD326- embryonic mesodermal progenitors (EMPs), and further differentiating the EMPs into the CAR T cells. This therefore renders obvious the method of the instant.
Claims 28-29, 31-32, and 34-37 remain rejected under 35 U.S.C. 103 as being unpatentable over Vodyanyk et al (WO 2018/195175 A1, of record on IDS filed 05 July 2024) in view of Dzhoyashvili et al (Adv Healthcare Mater, 2015).
The discussion of Vodyanyk et al regarding claim 28 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Vodyanyk et al render obvious claims 28-29,
31-32, and 35-37. Dzhoyashvili et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 34: Following the discussion of claim 28 above, Vodyanyk et al further disclose that the CAR iPSCs are cultured and differentiated into a CAR T cell or CAR NK cell on a MATRIGEL™- or Vitronectin layer, which are matrix components (Paragraphs [00195], [00204]-[00205]).
Vodyanyk et al do not disclose that the CAR iPSCs are cultured on a nanofiber matrix-based culture system, as required by instant claim 34.
Dzhoyashvili et al, however, disclose natural and synthetic materials for self-renewal, long-term maintenance, and differentiation of iPSCs (Title).
As such Dzhoyashvili et al disclose that MATRIGEL™ is a commercial substrate that is successfully and most commonly utilized for iPSC culture, as it supports iPSC attachment and growth (Page 2343, Column 1; Page 2344, Column 1). Dzhoyashvili et al further disclose synthetic PVA nanofibers that are modulated with extracellular matrix components, including, vitronectin and hyaluronan (HA) (Page 2348). With that, Dzhoyashvili et al disclose that the PVA nanofibers support iPSC growth with a similar proliferation rate and viability efficacy as Matrigel (Page 2348).
Therefore, it would have been prima facie obvious to substitute the MATRIGEL™ layer utilized within the iPSC culture system of Vodyanyk et al for the PVA/HA/vitronectin nanofiber layer of Dzhoyashvili et al, as doing so would be a simple substitution of one iPSC culture system for another. See MPEP § 2143(I)(B). One of ordinary skill before the effective filing date of the invention would have recognized that the two techniques – and supporting layer therein – are functionally comparable since both support iPSC growth, and thereby would have been able to substitute these techniques with predictable results. Furthermore, it is of note that the ordinary artisan would have even been motivated to switch to the synthetic PVA nanofiber system, as it is highly tunable through the substrate stiffness, surface topography, and dimensional structure, and avoids the use of an animal-derived substance (Dzhoyashvili et al, Pages 2343-2344). See MPEP § 2143(I)(G). In this case, the ordinary artisan would have had a reasonable expectation of success since both disclosures concerns the culturing of iPSCs.
Consequently, Vodyanyk et al as modified by Dzhoyashvili et al render obvious a method of generating a CAR T cell or CAR NK cell, wherein the CAR iPSCs are cultured and differentiated within a synthetic PVA/HA/vitronectin nanofiber matrix-based culture system. This therefore renders obvious the method of the instant claim.
Conclusion
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 ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633