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
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 09/29/2025 is acknowledged.
The traversal was found unpersuasive in the action filed 01/09/2026 and the requirement was deemed proper and made Final.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/KR2021/007092, filed 06/07/2021.
Applicant' s claim for the benefit of a prior-filed parent application KR10-2021-0046106, filed on 04/08/2021, KR10-2020-0069854 filed 06/09/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is 06/09/2020.
Claims Status
Claims 4 is canceled, claims 5-15 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-3 have been considered on the merits. All arguments have been considered.
Withdrawn Objections & Rejections
Applicant's response filed 04/16/2026 has been considered. Rejections and/or objections not reiterated from the previous Office action mailed 01/09/2026 are hereby withdrawn.
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application.
Terminal Disclaimer
The terminal disclaimer filed on 04/09/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 17/996,569 has been reviewed and is accepted. The terminal disclaimer has been recorded and the ODP rejection is withdrawn.
Specification
The substitute specification filed 04/09/2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because:
A marked-up copy of the substitute specification has not been supplied (in addition to the clean copy).
Nucleotide and/or Amino Acid Sequence Disclosures (Maintained)
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Identifiers (Seq ID NOs) are required for the nucleotide sequences in Table 1 of the instant specification (p18).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 3 is objected to because of the following informalities: There is an improper full stop after “L-ascorbic acid.”. If the claim were amended to recite “L-ascorbic acid[.]” the objection would be overcome. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (New)
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection. The rejection is required by the amendments to the claims.
Regarding claim 3: The claim recites “the DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium”.
The instant specification (filed 10/19/2022) teaches DS medium is DMEM culture medium supplemented with 4.5g/L of glucose and 584 mg/L of glutamine (p20 ¶5). It is noted that the amended specification filed on 04/09/2026 was not entered. See above.
The instant specification is silent on medium containing 2-mercaptoethanol, ethanolamine, L-ascorbic acid and sodium selenite, as recited in instant claim and thus the limitation “DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium” is not considered supported by the disclosure.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
Claim 3 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.
The rejection is required by the amendments to the claims.
Regarding Claim 3: The claim recites “wherein the feeder cell is
cultured in DS medium, wherein the DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium includes a nucleic acid encoding mbIL-18 and mbIL-21”.
It is unclear if the nucleic acid encoding mbIL-18 and mbIL-21 is intended to be included in the medium or the feeder cell. For purposes of compact prosecution the nucleic acid is interpreted as being included in the feeder cell because the previous claims set was worded as such.
If the claim were amended to read “wherein the feeder cell is cultured in DS medium, wherein the DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium and includes a nucleic acid encoding mbIL-18 and mbIL-21” the rejection would be overcome.
Claim Rejections - 35 USC § 103 (new)
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 rejection is essentially repeated from the action filed 01/09/2026, but is altered to include new limitations to the claims introduced in the amendment to claim 3 (a DS medium supplemented with 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid and sodium selenite in DMEM).
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kamiya et al (WO 2018/182511 A1, as cited in the IDS filed on 03/07/2024 and cited previously) in view of Llames et al (Tissue engineering: Part B (2015)21:4; cited previously).
Regarding claims 1 and 3: The claims recite “feeder cell”. The instant specification defines "feeder cell” as a “supporting cell" and “a cell that does not have the ability to divide due to irradiation, but has metabolic activity so that it produces various metabolites and helps target NK cells proliferate” (p4 ¶2).
The process step of claim 3 “is cultured in DS medium, wherein the DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium includes” is considered a product-by-process limitation which does not provide a structural limitation to the product.
Turning to the art, Kamiya teach a genetically engineered cell population that is co-cultured with NK immune cells (abstract). Kamiya further teach the genetically engineered cell wherein co-culture of said engineered cell with a population of immune cells results in the activation and expansion of at least one subpopulation of immune cells (claim 1).
Kamiya teach a genetically engineered cell which expresses membrane bound IL18 and mbIL21 (claims 14 and 16, 33-35 and 62-64). For a cell to express a protein the cell must comprise a nucleic acid encoding the protein. Furthermore, Kamiya teach the cell comprises the nucleic acid sequence encoding mbIL-18 (Seq ID NO:8) and mbIL-21 (Seq ID NO:10) (claims 33-34 and 35-36).
Kamiya also teach coculture of NK cells with irradiated K562 cells expressing mbIL15 and mbIL18 (p31 ¶0076]. Kamiya does not explicitly teach the feeder cell expressing mbIL18 and mbIL21 is an irradiated cell.
It would have been obvious to one of ordinary skill in the art to adapt the feeder cell taught by Kamiya, which expresses membrane bound IL18 and mbIL21, with irradiated feeder cell that expresses mbIL15 and mbIL18, also taught by Kamiya.
One of ordinary skill in the art would have been motivated to modify the feeder cell expressing mbIL18 and mbIL21 to use an irradiated feeder cell expressing mbIL18 and mbIL21 because Llames teach feeder cells provide signals and factors to support the culture of target cells, but must be prevented from overgrowing the culture, and thus feeder cells must be in a nonmultiplying but metabolically active state (p353 col2 ¶2). Llames further teach that feeder cells are often irradiated so that they will not proliferate (p353 ¶1).
One would have had a reasonable expectation of success because Kamiya teach a feeder cell that is irradiated and supports NK expansion and one of ordinary skill in the art would understand that irradiating a feeder cell is a common practice that would not impair feeder cell function, but could reasonably be expected to improve feeder cell function by preventing feeder cell overgrowth.
Regarding claim 2: Kamiya further teach the feeder cell is derived from the cell line K562 (claim 6).
Thus the teachings of Kamiya and Llames render obvious the invention as claimed.
Response to Arguments
The responses are directed to the Arguments filed 04/16/2026, all arguments have been considered.
Regarding Arguments directed to 35 USC § 112(d):
Applicant submits the amendments to claims 3 and 4 overcome this rejection.
The argument is persuasive and the rejection is withdrawn.
Regarding Arguments directed to the objections:
Regarding claims 1 and 2: The claims have been amended to overcome the objection. Specifically, the claims have been amended to improve grammar and clarity of the claims.
The objections to the claims are withdrawn.
Regarding the specification: Table 1 of the substitute specification has been amended to include Seq Id NOs which would overcome the objection if the substitute specification were entered. As discussed above, the substitute specification has not been entered, therefore the objection is maintained.
Regarding Arguments directed to 35 USC § 103:
Regarding claims 1-3: Applicant argues that the combination of factors taught by Kamiya is entirely different from the composition of the recited claim 1. The instant claim 1 recites a feeder cell engineered to express membrane bound interleukin-18 (mbIL-18) and membrane bound interleukin-21 (mbIL-21). Applicant essential argues that Kamiya does not present experimental data directed to the combination of IL-18 and IL-21.
As discussed in the previous action (and in the instant rejection over 103), it would have been obvious to one of ordinary skill in the art to adapt the feeder cell taught by Kamiya, which expresses membrane bound IL18 and mbIL21, with the irradiated feeder cell that expresses mbIL15 and mbIL18, also taught by Kamiya. Claim 35 of Kamiya teaches an engineered cell population wherein the cell expresses membrane bound IL21 and depends from claim 33 which recites a cell population which expresses membrane bound IL18. Irradiating feeder cells is well known in the art and it would have been obvious to one of ordinary skill in the art to modify the feeder cell of Kamiya which expresses membrane bound IL18 and membrane bound IL21 to use an irradiated feeder cell as also taught by Kamiya and discussed above.
Thus the argument is unpersuasive.
Applicant argues that neither Kamiya nor Llames discloses or suggests a synergistic effect of combining IL-18 and IL-21, thus the combination could not have been predicted from the relied upon teachings of the art.
As discussed in the previous action (and in the instant rejection over 103), one of ordinary skill in the art would have been motivated to modify the feeder cell expressing mbIL18 and mbIL21 to use an irradiated feeder cell expressing mbIL18 and mbIL21 because Llames teach feeder cells provide signals and factors to support the culture of target cells, but must be prevented from overgrowing the culture, and thus feeder cells must be in a nonmultiplying but metabolically active state (p353 col2 ¶2). Llames further teach that feeder cells are often irradiated so that they will not proliferate (p353 ¶1).
Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a synergistic effect of IL-18 and IL21) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding claim 3: Applicant argues that claim 3 differs from the rejection as written because amended claim recites “cultured in DS medium, wherein the DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium”.
The feeder cell is considered a product-by-process. The process step “is cultured in DS medium, wherein the DS medium is a supplemented medium containing 2-mercaptoethanol (2ME), ethanolamine, L-ascorbic acid. and sodium selenite in DMEM culture medium includes” is not considered to provide a structural limitation to the product.
However, amendment to the claim 3 is not addressed in the previous action. The arguments are persuasive and the rejection is withdrawn. A new rejection is entered to address the claim amendments (see above).
Conclusion
No claims are 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 ANDREA LYNNE MORRIS SPENCER whose telephone number is (571)272-3328. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/TAEYOON KIM/Primary Examiner, Art Unit 1631
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