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 .
The Examiner would like to note that the instant application was published 28 August 2025.
Status of the Claims
Applicant’s submission filed 22 December 2025 has been entered. Claims 1-8, 15-23, and 26-27 are pending. Claims 1-5, 8, 15-18, 20, 22-23, and 26 have been amended. Therefore, prosecution on the merits continues for claims 1-8, 15-23, and 26-27. 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: Nucleotide and/or amino acid sequence disclosures
Applicant has traversed the objection, asserting in Page 7 of the Remarks that the substitute Specification entered into the application file comprised the Incorporation by Reference paragraph in compliance with 37 CFR 1.821(c)(I). In response, the Examiner finds Applicant’s traversal persuasive.
Therefore, the objection is withdrawn.
RE: Objection to the Specification
The substitute Specification filed 22 December 2025 is acknowledged and entered into the application file. With that, the substitute Specification has amended the title and removed all reference
to colors within the disclosure.
Therefore, the objections are withdrawn.
RE: Objection to claims 4, 16, and 23
Applicant’s amendments to each of instant claims 4, 16, and 23 correct the minor informalities of the claims, thus obviating the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 1-2, 4-8, 15-23, and 26-27 under 35 USC 112(a)
Applicant’s amendments to the instant claims limiting the “lymphocyte” to a “T lymphocyte” obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 2 and 16 under 35 USC 112(b)
Applicant’s amendments to instant claim 2 removing the exemplary language and to instant claim 16 correcting the dependency obviate the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 23 and 27 under 35 USC 101
Applicant’s amendments to independent claim 23 requiring the pharmaceutical composition to be a sterile suspension suitable for various administration routes obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-8, 18-21, 23, and 26-27 under 35 USC 102 over Yee et al
Applicant’s amendments to independent claims 1 and 26 requiring the T lymphocytes to be cultured in the presence of TGF-β and IL-7 – which is a newly required limitation (emphasis added) – obviate the rejections of record concerning those claims and their dependents thereof. Furthermore, Applicant’s amendments to independent claim 23 requiring the pharmaceutical composition to be a sterile suspension suitable for various administration routes obviate the rejection of record concerning that claim and its dependents thereof.
It is of note, however, that Applicant has not traversed the Examiner’s product-by-process interpretation of independent claim 23.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-8, 15-16, 18-23, and 26-27 under 35 USC 103 over Yee et al in view of Forman et al
Applicant’s amendments to independent claims 1 and 26 requiring the T lymphocytes to be cultured in the presence of TGF-β and IL-7 – which is a newly required limitation (emphasis added) – obviate the rejections of record concerning those claims and their dependents thereof. Furthermore, Applicant’s amendments to independent claim 23 requiring the pharmaceutical composition to be a sterile suspension suitable for various administration routes obviate the rejection of record concerning that claim and its dependents thereof.
Therefore, the rejections are withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the claims as currently written:
Applicant has traversed the rejection, asserting in Pages 10-11 of the Remarks filed 22 December 2025 that Yee et al fail to disclose the culture of T cells with IL-7 and TGF-β when generating the tissue-resident memory T cells, which unexpectedly results in an increased number of tissue-resident memory T cells when transferred into an animal host compared to T cells cultured with TGF-β and IL-2 or IL-15. Applicant cites Figures 21-23 of the instant disclosure to support these assertions, wherein the T cells cultured with IL-15 and TGF-β (Group 1) or IL-2 and TGF-β (Group 4) represent embodiments of Yee et al, and Group 2 represents the method of the instant claims. In response, the Examiner respectfully finds these assertions persuasive when considering the disclosure of Yee et al, as Yee et al do not reduce to practice the claimed method. However, a new ground of rejection of is made in view of Ma et al, wherein Ma et al disclose the generation of kidney-resident memory T cells via the culture of T cells with IL-7 and TGF-β. See rejection below. Therefore, since Ma et al anticipate the claimed tissue-resident memory T cells, the Examiner may utilize Yee et al as a secondary reference to render obvious other aspects of the claimed embodiments.
It is also of note that the asserted unexpected results are not commensurate in scope with the instant claims, as the instant claims are directed to a method for producing tissue-resident memory T cells wherein T lymphocytes are (i) cultured with TGF-β and IL-7, and/or (ii) co-cultured with regulatory T cells. Therefore, the instant claims do not necessarily require culturing the T lymphocytes with TGF-β and IL-7.
RE: Rejection of claims 1-8, 17-21, 23, and 26-27 under 35 USC 103 over Yee et al in view of Mansour et al
Applicant’s amendments to independent claims 1 and 26 requiring the T lymphocytes to be cultured in the presence of TGF-β and IL-7 – which is a newly required limitation (emphasis added) – obviate the rejections of record concerning those claims and their dependents thereof. Furthermore, Applicant’s amendments to independent claim 23 requiring the pharmaceutical composition to be a sterile suspension suitable for various administration routes obviate the rejection of record concerning that claim and its dependents thereof.
Therefore, the rejections are withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the claims as currently written:
Applicant has traversed the rejection, citing the same assertions presented within Pages 10-11 of the Remarks filed 22 December 2025 in regards to Yee et al. In response, the Examiner respectfully directs Applicant to the discussion of Yee et al within the 35 USC 103 rejection over Yee et al in view of Forman et al.
Applicant has further traversed the rejection, asserting in Page 12 of the Remarks filed 22 December 2025 that Mansour et al fail to teach the differentiation of standard T cells into tissue-resident memory T cells. In response, the Examiner respectfully submits that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Mansour et al was a secondary reference relied upon to teach the culturing of T cells in medium comprising lipids.
New Grounds of Rejection
Claim Objections
Claims 1, 8, and 26-27 are objected to because of the following informalities:
Regarding claim 1: The instant claim is objected for reciting “TGFb” instead of “TGFβ” in Line 1. It is of note that the prior claim set correctly recited the term as “TGFβ”.
Appropriate correction is required.
Regarding claim 8: The instant claim is objected for failing to recite “further” prior to “comprising” in Line 1, as the culturing step is further limited within the claimed method.
Appropriate correction is required.
Regarding claim 26: The instant claim is objected to for reciting an extraneous “of” immediately preceding the recitation of “cancer” within Line 1.
Furthermore, the instant claim is objected for reciting “TGFb” instead of “TGFβ” in Line 4. It is of note that the prior claim set correctly recited the term as “TGFβ”.
Appropriate correction is required.
Regarding claim 27: The instant claim is objected to for being directed to “[t]he pharmaceutical compositions of claim 23” (emphasis added), wherein claim 23 is directed to a singular pharmaceutical composition. Therefore, Applicant must remove the plural from preamble.
Appropriate correction is required.
Claim Interpretation
Under the broadest reasonable interpretation of each claim, the optional limitations in claims 5, 8, and 18 are not required.
Instant claims 23 and 27 are directed to a pharmaceutical composition comprising a therapeutically effective amount of an expanded population of tissue-resident memory T cells derived from a T lymphocyte cultured in the presence of transforming growth factor beta and IL-7, and/or co-cultured with a regulatory T cell, wherein the composition is a sterile solution or suspension suitable for intramuscular, intrathecal, epidural, intraperitoneal, intravenous and/or particularly subcutaneous injection administration. This is a product-by-process limitation. Product-by-process limitations are considered only in so far as the method of production affects the structure of the final product. In the instant case, there is no evidence that the culturing of the T lymphocyte in the presence of transforming growth factor beta and IL-7, and/or co-culturing it with a regulatory T cell, imparts any particular structure or significance to the composition other than the cell being a tissue-resident memory T cell. Thus, the claims will be interpreted as if a sterile pharmaceutical composition comprising tissue-resident memory T cells derived from any source or production method fulfills the recited claim limitations. See MPEP § 2113.
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)(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 1-7, 18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al (J Immunol, 2016).
Ma et al disclose the formation of kidney-resident memory T cells via the culturing and expansion of naïve CD8+ T cells derived from murine tissues with 2.5 ng/mL TGF-β and 5 ng/mL IL-7 (Abstract; Pages 3, 6-7; Figure S2A). Ma et al further disclose that the kidney-resident memory T cells are KLRG1-negative, CD8-positive, and CD69-positive (Pages 1-2, 4-6; Figures 4-5).
Ma et al further disclose the culturing of the naïve CD8+ T cells with a GP33-41 lymphocytic choriomeningitis virus (LCMV) antigen epitope (Page 3).
Accordingly, Ma et al anticipate the claims as follows:
Regarding claims 1, 3-4, and 21: Ma et al disclose the formation of kidney-resident memory T
cells via the culturing and expansion (claim 21) of naïve CD8+ T cells (claim 3) with 2.5 ng/mL TGF-β (claim 4) and 5 ng/mL IL-7. This therefore reads on the method of instant claim 1.
Regarding claims 2 and 19: Following the discussion of claim 1, Ma et al are silent to the co-culture of the T cells with regulatory T cells (claim 2). As the regulatory T cells are absent, this therefore reads on the method of instant claim 19.
Regarding claim 5: Following the discussion of claim 1, Ma et al further disclose that the T cells are obtained from murine tissues. As a mouse is a non-human animal, this therefore reads on the method of the instant claim.
Regarding claim 6: Following the discussion of claim 1, Ma et al further disclose that the kidney-resident memory T cells express CD69 and CD8. This therefore reads on the method of the instant claim.
Regarding claim 7: Following the discussion of claim 1, Ma et al further disclose that the kidney-resident memory T cells do not express KLRG1. This therefore reads on the method of the instant claim.
Regarding claim 18: Following the discussion of claim 1, Ma et al further disclose that the naïve CD8+ T cells are cultured with a GP33-41 LCMV antigen epitope. This therefore reads on the method of the instant claim.
Claims 23 and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Borrello et al (WO 2021/173948 A1). Borrello et al has an effective filing date of 28 February 2020.
Borrello et al disclose methods for enriching or isolating tumor specific marrow infiltrating lymphocytes (MILs), and compositions containing the MILs (Abstract).
As such, Borrello et al disclose that MILs comprise hypoxic-activated MILs, which include tissue-resident memory T cells (Paragraphs [0004], [0037], [0042], [0068], [0070], [0110]; Example 1). Borrello et al further disclose sterile pharmaceutical compositions comprising a therapeutically effective amount of the hypoxic-activated MILs and a pharmaceutically acceptable excipient, wherein the sterile pharmaceutical composition is suitable for intramuscular, intravenous, or intraperitoneal administration (Paragraphs [0018], [0052], [0082], [0086]-[0087], [0089]).
Accordingly, Borrello et al anticipate the claims as follows:
Regarding claims 23 and 27: The instant claims comprise a product-by-process limitation that is interpreted as set forth above and incorporated herein.
Accordingly, Borrello et al disclose a sterile pharmaceutical composition comprising a therapeutically effective amount of hypoxic-activated MILs and a pharmaceutically acceptable excipient (claim 27), wherein the sterile pharmaceutical composition is suitable for intramuscular, intravenous, or intraperitoneal administration. As the hypoxic-activated MILs comprise tissue-resident memory T cells, this therefore reads on the pharmaceutical composition of instant claim 23.
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 1-8, 18-21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al (J Immunol, 2016) in view of Yee et al (WO 2020/081987 A1, of record on IDS filed 17 November 2022).
The discussion of Ma et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Ma et al anticipate claims 1-7, 18-19, and 21. Yee et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 8: As aforementioned in the discussion of claim 1 above, Ma et al disclose the culturing of naïve CD8+ T cells with TGF-β and IL-7 in order to form kidney-resident memory T cells.
Ma et al do not disclose further culturing the naïve CD8+ T cells in the presence of IL-2, IL-4, IL-12, IL-15, and/or IL-21, as required by instant claim 8.
Yee et al, however, disclose the production of tissue-resident memory T cells via culturing naïve CD8+ T cells with TGF-β and IL-2 or IL-15 (Paragraphs [005], [007]-[008], [0010], [0036]-[0037], [0045], [0080], [00102], [00121]; Figures 1-2).
Yee et al further disclose that growth factors known to promote the growth and activation of tissue-resident memory T cells comprise IL-2, IL-7, IL-15, and IL-12, which include the combination of IL-2 and IL-7; IL-7 and IL-15; and IL-2, IL-7 and IL-15 (Paragraph [0080]).
Therefore, it would have been prima facie obvious to have modified the method of Ma et al such that the naïve CD8+ T cells are further cultured with IL-2 or IL-15, as detailed in Yee et al. One of ordinary skill before the effective filing date of the invention would have been motivated to include growth factors that are known to work in combination to activate and/or proliferate the tissue-resident memory T cells within the culture medium, and would have had a reasonable expectation of success given that the disclosures of both Ma et al and Yee et al are concerned with the generation of tissue-resident memory T cells from naïve CD8+ T cells. See MPEP § 2143(I)(G).
Consequently, Ma et al as modified by Yee et al render obvious a method of forming kidney-resident memory T cells wherein the naïve CD8+ T cells are further cultured with IL-2 or IL-15. This therefore renders obvious the method of the instant claim.
Regarding claim 20 and 26: Following the discussion of claim 1 above, Ma et al further disclose the stimulation of the naïve CD8+ T cells with a GP33-41 LCMV antigen epitope (Page 3). Ma et al further disclose that kidney-resident memory T cells are required for optimal protection against local infections and reinfections (Pages 1-2, 4, 8-9).
Ma et al do not disclose that the naïve CD8+ T cells are cultured with a dendritic cell, as required by instant claim 20.
Yee et al, however, disclose the culturing of naïve CD8+ T cells in medium comprising mature dendritic cells presenting a viral antigen of interest (Paragraphs [008], [0010], [0024], [0026], [0033], [0045], [0048]). Yee et al further disclose the administration of the produced viral antigen-specific tissue-resident memory T cells to a subject suffering from a viral infection (Paragraphs [0033], [0056], [0064]-[0066], [0072], [0076], [0083]).
Therefore, it would have been prima facie obvious to have substituted the antigen epitope presentation method within Ma et al with the dendritic cell presentation method in Yee et al, as doing so would have been a simple substitution of one antigenic presentation technique for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two presentation techniques are functionally comparable, as they both result in the stimulation of the naïve CD8+ T cells with the antigen of interest, and thereby would have been able to substitute the presentation techniques with predictable results.
Consequently, Ma et al as modified by Yee et al render obvious a method of forming kidney-resident memory T cells, wherein the naïve CD8+ T cells are cultured in medium comprising mature dendritic cells presenting a viral antigen of interest (claim 20). As these viral antigen-specific tissue-resident memory T cells can further be administered to a subject suffering from a viral infection, this therefore renders obvious the method of instant claim 26.
Claims 1-7, 15-16, 18-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al (J Immunol, 2016) in view of Xue et al (J Nutr Biochem, 2007).
The discussion of Ma et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Ma et al anticipate claims 1-7, 18-19, and 21. Xue et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 15-16: Following the discussion of claim 1 above, Ma et al further disclose that the naïve CD8+ T cells may be isolated from the spleen (Pages 3, 6-7; Figures 1, 3-5).
Ma et al do not disclose culturing the naïve CD8+ T cells in culture media comprising at least one aryl hydrocarbon receptor (AhR) ligand, as required by instant claim 15.
Xue et al, however, disclose the culture of splenocytes with 3,3’-Diindolylmethane (DIM) and IL-2, which enhanced the proliferation of the splenocytes – including naïve splenocytes – compared to controls (Pages 337, 339-341; Figure 1). It is of note that the instant Specification lists diindolylmethane as a dietary derived aryl hydrocarbon. See Page 16 of the instant Specification.
Therefore, it would have been prima facie obvious to have modified the method of Ma et al such that the naïve CD8+ T cells are cultured with DIM, as detailed in Xue et al. One of ordinary skill before the effective filing date of the invention would have been motivated to culture the naïve CD8+ T cells with a compound that enhances proliferation, and would have had a reasonable expectation of success given that the disclosure of Ma et al and Xue et al concern the culture of splenic lymphocytes. See MPEP § 2143(I)(G).
Consequently, Ma et al as modified by Xue et al render obvious a method of forming kidney-resident memory T cells, wherein the naïve CD8+ T cells are cultured in medium comprising DIM. As DIM is inherently a dietary derived aryl hydrocarbon, this therefore renders obvious the method of instant claims 15-16. See MPEP § 2112.
Regarding claim 22: Following the discussion of claim 15, Ma et al further disclose that the produced tissue-resident memory T cells are cultured in the presence of IL-2 (Page 3; Figures 5-6). This therefore reads on the method of the instant claim.
Claims 1-7, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al (J Immunol, 2016) in view of Mansour et al (US 2021/0024882 A1, of record).
The discussion of Ma et al regarding claim 1 can be observed above and is relied upon herein,
the content of which is incorporated in its entirety. Ma et al anticipate claims 1-7, 18-19, and 21.
Mansour et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 08 July 2019.
Regarding claim 17: Following the discussion of claim 1 above, Ma et al further disclose that the T cells are cultured within RPMI culture media (Page 3, incorporated reference 52).
Ma et al do not disclose that the culture media comprises at least one lipid, as required by instant claim 17.
Mansour et al, however, disclose improvements in cell culture methods (Abstract). As such, Mansour et al disclose the addition of lipids to basal culture medium to enhance the expansion of T cell subsets – including tissue resident memory T cells – wherein the basal culture medium is RPMI (Paragraphs [0052], [0060]-[0063], [0092], [0096], [0112], [0159]).
Therefore, it would have been prima facie obvious to have substituted the RPMI culture media of Ma et al with the RPMI culture medium comprising lipids of Mansour et al, as doing so would be a simple substitution of one known tissue-resident memory T cell culture medium for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two culture mediums are functionally comparable, as they both are comprised of RPMI basal medium and are utilized for the culture of tissue-resident memory T cells, and thereby would have been able to substitute the culture mediums with predictable results.
Consequently, Ma et al as modified by Mansour et al render obvious the culturing of the naïve CD8+ T cells in culture medium comprising a lipid. 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
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