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 OFFICE ACTION
This Office Action is in response to the papers filed on 23 July 2026.
APPLICANT’S ELECTION
Applicants’ election without traverse of Group I (Claims 1-8; drawn to a composition for culturing NK cells) in the reply filed on 23 July 2026 is acknowledged. Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
CLAIMS UNDER EXAMINATION
Claims 1-8 have been examined on their merits.
PRIORITY
KR10-2022-0012882, filed on 28 January 2022, is acknowledged. A certified translation has not been provided.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are 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 1 recites “NK cells”. It is unclear what the abbreviation “NK” means. If the Applicant means “Natural Killer”, the claim should be rewritten to recite “Natural Killer (NK) cells”. Appropriate correction is required. All dependent claims are included in this rejection.
Regarding claims 1, 3 and 5: The claims recite a polypeptide “represented by an amino acid sequence of any one of SEQ ID Nos: 1~4”. It is unclear what “represented by” means. It is unclear if the claim means the amino acid sequence “is” one of the recited SEQ IDs. Appropriate correction is required. All dependent claims are included in this rejection.
Regarding claims 1, 3 and 5: The claims recite “SEQ ID NOs: 1~4”: The tilde is the wavy symbol ~ used in mathematics to indicate that two values are approximately equal. It is therefore unclear what sequences are being claimed. If the claims are directed to SEQ ID NOs.1-4, the claim should be rewritten. Appropriate correction is required. All dependent claims are included in this rejection.
Claim 3 recites “IL-2; and IL-12, IL-5, OKT-3, or a combination thereof”. It is unclear if the claim requires IL-2 in addition to at least one of IL-12, IL-15 and OKT-3. The metes and bounds of the claim are unclear. Claim 8 is included in this rejection because it depends from claim 3. Appropriate correction is required.
Claim 4 recites FBS or autologous plasma, human serum albumin, insulin, transferrin or a combination thereof. It is unclear if the claim requires FBS or autologous plasma in addition to one of human serum albumin insulin and transferrin, or if claim only requires selecting at least one of FBS, autologous plasma, human serum albumin, insulin or transferrin. Appropriate correction is required.
Claim 7 recites “the Il-2”, “the Il-12”, “the IL-15” and “the OKT-3” in “the cell culture medium”. There is a lack of antecedent basis for these components in the base claim. It is unclear what the Applicant is referring to. Appropriate correction is required.
Claim 8 recites “the FBS or autologous plasma”, “the human serum albumin”, “the insulin” and “the transferrin” in “the culture medium”. There is a lack of antecedent basis for these components in the base claim. It is unclear what the Applicant is referring to. Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Alloferons-immunomodulatory peptides. US7462360B2).
Kim teaches a composition comprising alloferon (Example 2). As evidenced by the specification, the SEQ ID NO:1 taught by Kim in Example 2 reads on the claimed SEQ ID NO: 1 (see Table 1 on page 11). Because the polypeptide is anticipated, it can be used for culturing NK cells. Therefore claim 1 is anticipated.
Therefore Applicant’s invention is anticipated as claimed.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bae et al. (The effect of alloferon on the enhancement of NK cell cytotoxicity against cancer via the up-regulation of perforin/granzyme B secretion. Immunobiology. Volume 218, Issue 8, August 2013, Pages 1026-1033).
Bae teaches alloferon increases killing activity of NK cell (Abstract). Bae teaches alloferon consists of 13 amino acids: HGVSGHGQHGVHG (see page 1026, right column, second paragraph). As evidenced by the specification, this reads on SEQ ID NO: 1 (see Table 1 on page 11). Natural Killer (NK) cells are incubated with alloferon (first paragraph of Materials and Methods section). Therefore Bae anticipates the claimed composition for culturing NK cells. Claim 1 is anticipated.
Therefore Applicant’s invention is anticipated as claimed.
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.
Claims 2-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bae et al.
Claim 1 is rejected on the grounds set forth above. The teachings of Bae are reiterated. Bae teaches alloferon increases killing activity of NK cell (Abstract). Bae also teaches IL-2, IL-12 and IL-15 are commonly used cytokines to increase cellular cytotoxicity of NK cells (see first paragraph of “Discussion” section). NK cells were used in the experiment after incubation in the absence or presence of 2 and 4 μg/ml (2-4 mg/L) of alloferon (first paragraph of Materials and Methods section). The art teaches alloferon increases NK cell cytotoxicity in a dose-dependent manner (see first paragraph of “Results” section on page 1028; Figure 1A and 1B). Alloferon also enhances the production of IFN-γ and TNF-α (see page 1030, section titled “Alloferon enhances the production of IFN-γ and TNF-α from NK cells; see Figure 3A). Bae teaches the effector function of NK cells against cancer cells is mediated by the production of IFN-γ and TNF-α (same section).
While Bae teaches IL-2, IL-12 and IL-15 are commonly used cytokines, the art does not do so with sufficient specificity to anticipate claims 2-3.
It would have been obvious to include at least one of IL-2, IL-12 and IL-15 in the composition taught by Bae. One would have been motivated to do so since Bae teaches IL-2, IL-12 and IL-15 are commonly used cytokines to increase cellular cytotoxicity of NK cells. One would ordinary skill would have been motivated to combine two compositions each of which is taught by the prior art to be used for that very same purpose. Therefore, then, barring unexpected results, one would reasonably expect enhanced, additive, or synergistic activity to be observed by combining the compositions or materials. See In re Kerkoven Therefore claim 2 is rendered obvious.
It would have been obvious to include IL-2, IL-12 and IL-15 in the composition taught by Bae. One would have been motivated to do so since Bae teaches IL-2, IL-12 and IL-15 are commonly used cytokines to increase cellular cytotoxicity of NK cells. One would ordinary skill would have been motivated to combine compositions each of which is taught by the prior art to be used for that very same purpose. Therefore, then, barring unexpected results, one would reasonably expect enhanced, additive, or synergistic activity to be observed by combining the compositions or materials. See In re Kerkoven Therefore claim 3 is rendered obvious.
While Bae teaches alloferon is effective in a dose dependent manner, the art does not explicitly teach the range recited in claim 6.
It would have been obvious to culture cells in 6 mg/L alloferon. Bae teaches alloferon enhances NK cytotoxicity in a dose-dependent manner. One of ordinary skill would try optimizing the concentration taught by to enhances cancer cell killing. One would have had a reasonable expectation of success since Bae teaches the effect is dose-dependent. See MPEP 2144.05(I). Therefore claim 6 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claims 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Oh et al. (Kit containing medium for culturing natural killer cells and method of effectively culturing natural killer cells using the same. US20210355445A1).
Claim 1 is rejected on the grounds set forth above. The teachings of Bae are reiterated.
The art is silent regarding the presence of FBS or autologous plasma (claim 4).
The art does not teach culturing NK cells in a medium comprising IL-2, IL-12, IL-15 and OKT-3 (claim 5) at the concentrations recited in claim 7.
Oh teaches culturing natural killer cells (NK cells) in a basic medium containing IL-2, IL-12, IL-15 and anti-CD3 antibody ([0020]). As evidenced by the PG Pub of the specification. It is OKT-3 is anti-CD3 antibody ([0015]). Oh teaches ([0021]-[0027]):
IL-2 at a concentration of 2,000 to 4,000 IU/mL, preferably 3,000 to 4,000 IU/mL.
IL-12 at a concentration of 0.5 to 5 ug/mL, preferably 0.5 to 3 ug/mL.
IL-15 at a concentration of 0.5 to 5 ug/mL, preferably 0.5 to 3 ug/mL.
the CD3 at a concentration of 0.1 to 20 ug/mL, preferably 0.5 to 5 ug/mL.
Oh teaches a final volume of 10 L ([0045]).
Cytokines such as IL-2 and antibodies such as anti-CD3 antibody are used to activate and proliferate immune cells, especially NK cell ([0009]). Cytokines such as IL-2 and IL-12 improve NK cytotoxicity, secretory and proliferative functions ([0006]). Oh teaches adding autologous plasma to stimulate NK cells ([0028]). Oh teaches a medium comprising the autologous plasma of the present invention may be commercially available FBS ([0030]).
It would have been obvious to use autologous plasma in the composition taught by Bae. Bae cultures NK cells and Oh cultures NK cells in a composition comprising autologous plasma. One would have been motivated to do so since Oh teaches autologous plasma stimulates NK cells. One would have had a reasonable expectation of success since Oh teaches NK cells can be cultured with autologous serum. One would have expected similar results since Bae and Oh are both directed to methods of culturing NK cells. Therefore claim 4 is included in this rejection.
It would have been obvious to include IL-2, IL-12, IL-15 and OKT-3 in the composition taught by Bae. Bae cultures NK cells and Oh cultures NK cells in a composition comprising IL-2, IL-12, IL-15 and OKT-3. One would have been motivated to do so since Bae is directed to NK activation and Oh teaches the claimed components activate NK cells and improve NK cytotoxicity, secretory and proliferative functions. One would have had a reasonable expectation of success since Oh teaches NK cells can be cultured with IL-2, IL-12, IL-15 and OKT-3. One would have expected similar results since Bae and Oh are both directed to methods of culturing NK cells. Therefore claim 5 is included in this rejection.
It would have been obvious to include IL-2, IL-12, IL-15 and OKT-3 in the claimed amounts. One would have been motivated to do so since the ranges taught by Oh overlap with the claimed ranges. One would ordinary skill would optimize the concentrations based on the final volume of media. See MPEP 2133.03. Therefore, the examiner asserts the claimed concentration is prima facie obvious. Therefore claim 7 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Hariri et al. (Methods of generating natural killer cells. US20220259563A1) with priority to US Patents 14547084 filed on 18 November 2014 and 13182250 filed on 13 July 2011).
Claim 1 is rejected on the grounds set forth above. The teachings of Bae are reiterated.
The art does not teach culturing cells in a medium comprising FBS or autologous plasma, human serum albumin, insulin and transferrin as recited in claim 8.
Hariri teaches methods of producing Natural Killer cells (Abstract). The art teaches a second medium in which stem cells expand further and differentiate into natural killer cells ([0007]). The second medium comprises one or more of: human serum (e.g., human serum AB), fetal bovine serum (FBS) or fetal calf serum (FCS), e.g., 5%-15% FCS v/v; IL-2, e.g., 10 IU/mL to 1000 IU/mL; transferrin, e.g., 10 μg/mL to 50 μg/mL; insulin, e.g., 5 μg/mL to 20 μg/mL ([0010]).
It would have been obvious to culture NK cells in the claimed components. Bae cultures NK cells and Hariri teaches culturing NK cells with FBS, human serum albumin, insulin and transferrin. The skilled artisan would use media components known for culturing NK cells. One would have been motivated to do so since the ranges taught by Hariri overlap with the claimed ranges. One would ordinary skill would optimize the concentrations based on the final volume of media. See MPEP 2133.03. One would have had a reasonable expectation of success since Hariri teaches NK cells can be cultured with the claimed components. One would have expected similar results since Bae and Hariri are both directed to methods of culturing NK cells. Therefore claim 8 is rendered obvious as claimed.
Therefore Applicant’s Invention is rendered obvious as claimed.
Double Patenting
Claims 1-3 and 5-6 of this application is patentably indistinct from claims 1-3 of Application No. US20250073270A1. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 5-6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 of copending Application No. US20250073270A1. (Composition for preventing or treating cancer, comprising nk cells cultured using alloferon. US20250073270A1).
This is a provisional nonstatutory double patenting rejection.
Yoo et al. teach a composition for preventing or treating cancer comprising NK cells cultured in the presence of a polypeptide represented by the amino acid sequence of SEQ ID NOs: 1-4 or a combination thereof (claim 1). Therefore Yoo teaches a composition comprising one of SEQ ID NOs: 1-4 that can be used to culture NK cells. The copending Application reads on instant claim 1.
Yoo teaches the NK cells are cultured in a medium containing 6 mg/L to 40 mg/L of the polypeptide or a combination thereof (claim 2). The copending Application reads on instant claim 6.
Yoo teaches the NK cells are cultured in a medium containing a polypeptide represented by any one of the amino acid sequences of SEQ ID NOs: 1-4 or a combination thereof; and IL-2, IL-12, IL-15, OKT-3, or a combination thereof (claim 3). The copending Application reads on instant claims 2, 3 and 5. Therefore claims 1-3 and 5-6 are obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
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