DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
The Amendment filed on 02Mar2026 is acknowledged in which claim(s) 8-9 were canceled by Applicant.
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 02Mar2026 is acknowledged.
Claim(s) 1-7 is/are currently pending and presented for examination on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of Korea on 13Oct2020. It is noted, however, that applicant has not filed a certified copy of the KR10-2020-0132050 application as required by 37 CFR 1.55.
Claim Objections
Claim(s) 6 is/are objected to because of the following informalities: “…60 to 80%...4 to 5%...10 to 11%…” in lines 2-3 should be “…60% to 80%...4% to 5%...10% to 11%…”. Appropriate correction is required.
Claim(s) 7 is/are objected to because of the following informalities: “…120 to 170 ng/mL…” in line 2 should be “…120 ng/mL to 170 ng/mL…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 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.
Claim(s) 5 and 7 is/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 5 recites the limitation "wherein the lymphocytes are those cultured for 8 to 9 days" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, claim 5 is considered to read “wherein the lymphocytes are cultured for 8 to 9 days”. This rejection may be overcome by amending claim 5 to provide proper antecedent basis.
Claim 7 recites the phrase “the lymphocytes have an amount of IFN-y secretion of 120 to 170 ng/mL” in line 2, rendering the claim indefinite. Specifically, it is unclear if (1) each lymphocyte excretes 120 to 170 ng/mL of IFNy; (2) the average of all the lymphocytes excreting IFNy is 120 to 170 ng/mL; (3) the lymphocyte supernatant needs to comprise 120 to 170 ng/mL total of IFNy, (4) if the IFNy secretion is in a specific time period (e.g., 12 hours, 1 day, 2 days, 10 days); or (5) something else. For the purposes of compact prosecution, the phrase “the lymphocytes have an amount of IFN-y secretion of 120 to 170 ng/mL” will be considered to mean the total of all lymphocyte IFNy production is 120 to 170 ng/mL. This rejection may be overcome by amending claim 7 to clearly recite the limitations of the instant invention.
Claim Rejections - 35 USC § 112(a)
Claim(s) 1-7 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of COVID19 virus infection, does not reasonably provide enablement for prevention of COVID19 virus infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation."' (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (A) The nature of the invention; (B) The breadth of the claims; (C) The amount of direction provided by the inventor; (D) The existence of working examples; (E) The state of the prior art; (F) The level of predictability in the art; (G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure and (H) The level of one of ordinary skill. While all of these factors are considered, a sufficient amount for amount for a prima facie case are discussed below.
The nature of the invention
Claims 1-7 are drawn to a composition for preventing or treating COVID19 virus infection comprising administration of a composition comprising NK cells as an active ingredient.
The breadth of the claims
The claim is broad in that it encompasses the prevention of COVID19 virus infection.
As the instant disclosure does not define the term “prevention”, the ordinary meaning of ‘prevent’, “to keep from happening or existing”, as defined by Merriam-Webster (Dictionary webpage, 24 Apr 2025) is applied.
The amount of direction provided by the inventor/the existence of working examples
The examples of the instant disclosure studied the anti-COVID19 effect(s) of the instant claimed composition comprising NK cells as an active ingredient include: (1) immune cell phenotypes of cultured cells on D8 and D14 of culture [e.g., ¶ 0037; figs. 1A-B]; (2) the results of performing RT-PCR after co-cultivating the NK cells of the present invention with SAR-CoV-2 infected VeroE6 cells for 24 hours [e.g., ¶ 0038; fig. 2]; (3) the results of performing RT-PCR after co-cultivating the NK cells of the present invention with SAR-CoV-2 infected VeroE6 cells for 24 hours [e.g., ¶ 0039; fig. 3]; (4) method for producing immune cells comprising activated NK cells [e.g., ¶ 0041-0056]; and (5) Inhibitory effect of proliferation of COVID19 virus through activated NK cells [e.g., ¶ 0057-0062].
The examples provided do not demonstrate the prevention of COVID19 virus infection. Additionally, the disclosure does not discuss, or demonstrate through working examples, that COVID19 infection was prevented using claimed composition comprising NK cells as an active ingredient as there is no evidence that appropriate experiments were performed to determine that COVID19 infection was prevented. Specifically, all disclosed experiments test the effects of the composition comprising NK cells as an active ingredient on cells (e.g., VeroE6 cells) already infected with COVID19 virus, and therefore do not demonstrate the “prevention” of COVID19 virus infection.
The state of the art/the level of predictability in the art
There are no experimental results to establish that the occurrence of COVID19 infection can be prevented using the instant claimed composition comprising NK cells as an active ingredient in the prior art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Based on the instant disclosure and prior art, there is/are no disclosure and/or experimental result(s) which demonstrate that COVID19 virus infection was prevented using the instant claimed composition. Therefore, in order to practice the invention as claimed, one of ordinary skill in the art would have to perform undue experimentation to test and/or develop a composition comprising NK cells as an active ingredient that prevents COVID19 infection. Applicant is enabled for treatment of COVID19 infections only.
Conclusion
In view of the Wands factors as discussed above, one of ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the instant claimed invention. As such, instant claims 1-7 were determined to not meet the scope of enablement requirement of 35 USC § 112(a). Enablement can be met by amending claims 1-7 by removing phrases regarding “preventing” of tumors.
Claim Rejections - 35 USC § 102(a)
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/154886 A1 (hereinafter “WO886”).
Regarding instant claim(s) 1 , WO886 teaches Natural Killer (NK) cells for treatment of coronavirus infection [e.g., title, abstract; ¶ 0009-0015].
Regarding instant claim(s) 2 , WO886 further teaches that NK cells kill COVID19 infected cells [e.g., ¶ 0038].
Regarding instant claim(s) 3-5, WO886 further teaches that NK cells are harvested from peripheral blood [e.g., ¶ 0039, 0055], that NK cells are suspended and then cultured in growth medium, wherein the media is supplemented with IL2, IL15, and IL18, and that the media may further comprise anti-NKp46 [e.g., ¶ 0059]. WO886 further teaches the culture medium is exchanged (e.g., adding new media comprising IL2, IL15, IL18, anti-NKp46 after initial suspension), wherein media exchange occurs daily (e.g., more than once) [e.g., ¶ 0063-0064]. WO886 further teaches that NK cells are incubated (e.g., cultured) “about 10 days” [e.g., ¶ 0065], and defines “about” comprises one standard deviation, or +/- 10%, or up to 5-fold of a value [e.g., ¶ 0025].
Claim Rejections - 35 USC § 102/103
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2021/154886 A1 (hereinafter “WO886”).
The teachings of WO886 as recited above for claim 1 are applied.
Regarding claim(s) 7, WO886 teaches the composition of instant claim 1 (see 102 rejection above) and that NK cells produce IFNy [e.g., ¶ 0038]. Although the specific amount of IFNy secreted by the lymphocytes is not expressly recited by WO886, instant claim 7 recites no additional steps or modifications to the lymphocytes of instant claim 1 that a skilled artisan would expect to alter the lymphocytes and/or their production of IFNy. Therefore, specific IFNy secretion is considered a function of the composition comprising lymphocytes of instant claim 1. Given the above, WO886 is considered to necessarily teach the instant claimed specific IFNy secretion limitation by teaching the composition of claim 1.
Claim Rejections - 35 USC § 103
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/154886 A1 (hereinafter “WO886”) as applied to claim 1 above, and further in view of Market et al. (Front. Immuno. June 2020, Vol. 11, Article 1512; hereinafter “Market”).
The teachings of WO886 as recited above for claim 1 are applied.
Regarding claim(s) 6, WO886 further teaches the composition comprises NK cells and NK like T cells [e.g., ¶ 0060].
WO886 does not expressly teach that the lymphocytes comprise 60% to 80% NK cells, 4% to 5% NK-like T cells, and 10% to 11% T cells.
Regarding claim(s) 6, Market teaches treating COVID19 infections with compositions comprising NK cells [e.g., title, abstract; tbl. 1; fig. 2]. Market further teaches that in addition to NK cells, CD4+ T cells are important for COVID viral clearance because CD4+ T cell depletion resulted in enhanced lung immunopathology (e.g., greater disease burden) and delayed viral clearance [e.g., pg. 4, col. 2, ¶ 1]. Market further teaches that the first wave of cytokines and chemokines induce an accumulation of NK cells, CD4+ T cells, and NKT (e.g., NK like T cells) cells in coronavirus infected lungs [e.g., pg. 6].
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to combine the specific lymphocyte types (e.g., NK and NKT cells) in the composition for treating COVID19 infection comprising lymphocytes comprising NK cells as an active ingredient as taught by WO886, with the CD4+ T lymphocytes for COVID19 infection treatment as taught by Market, to arrive at a composition for treating COVID19 infection comprising NK cells, NKT cells, and CD4+ T cells. A PHOSITA would have been motivated to combine the specific lymphocyte types (e.g., NK and NKT cells) in the composition for treating COVID19 infection comprising lymphocytes comprising NK cells as an active ingredient as taught by WO886, with the CD4+ T lymphocytes for COVID19 infection treatment as taught by Market, because both WO886 and Market teach compositions comprising lymphocytes comprising NK cells for COVID19 therapy, and Market further teaches that CD4+ T lymphocytes (in addition to NK cells) are important for clearing COVID19 infected cells. There would have been a reasonable expectation of success for a PHOSITA to combine the specific lymphocyte types (e.g., NK and NKT cells) in the composition for treating COVID19 infection comprising lymphocytes comprising NK cells as an active ingredient as taught by WO886, with the CD4+ T lymphocytes for COVID19 infection treatment as taught by Market, because both WO886 and Market teach compositions comprising lymphocytes comprising NK cells for COVID19 therapy, and Market further teaches that CD4+ T lymphocytes increase clearing COVID19 infected cells (relative to no CD4+ T cells). This rationale aligns with the principle of applying a known technique to a known method to yield predictable results, supporting a conclusion of obviousness (see MPEP § 2143).
In regard to the specific percentages of NK cells, NKT cells, and T cells as recited in the instant claim 6 "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, the determination of the relative percentages of therapeutic cells is within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal relative percentages of NK, NKT, and T cells in the composition administered to achieve therapeutically effective doses. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed composition disclose the same comprising lymphocytes to achieve the same results. It would be conventional and within the skill of the art to determine the optimal composition(s). Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that optimization is obvious.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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