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
The election without traverse filed January 9, 2026, is acknowledged and has been entered. Applicant has elected Group I.
Claims 1-24 are pending in the application.
Claims 9-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1-8 are under examination.
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 1-7 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The claims are indefinite in the recitation of “optionally” in claim 1 “a first period (optionally 8-10 days)” and “a second period (optionally 14-16 hours)” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examples and preferences in a claim may lead to confusion over the intended scope of the claim. The description of examples or preferences is properly set forth in the specification rather than the claims.
It is noted that limitations designated as “optional” will not be considered required for the purposes of applying prior art under 35 U.S.C. § 102 and 103 because of this ambiguity.
Claim Rejections - 35 USC § 103
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 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/187207 A1 (Saxena et al) and Ndhlovu et al (Blood, 119(16):3734-3743, 2012).
Saxena et al disclose methods of generating memory-like cytokine enhanced natural killer (M-CENK) cells from a blood sample, the method comprising: a) purifying NK cells from whole blood, incubating the NK cells with IL-15 or N-803 (IL-15 analog) to expand the NK cells and then activating the cells with a cytokine composition comprising IL-15, IL-18 and IL-12 to produce CD56+ M-CENK cells (see pages 5 and 16). Saxena et al disclose that the cytokine composition comprises IL-15 at 50 ng/mL, IL-18 at 50 ng/mL, and IL-12 at 10 ng/mL (see pages 4 and 6). Saxena et al disclose that the NK cells can be autologous NK cells from cancer patients (see Figure 39 and pages 1 and 6). Saxena et al disclose that the M-CENK cells are a potent killer of ovarian, breast and leukemia cells (see Figures and page 3).
Saxena et al disclose that the step of incubating is performed over until the NK cells are enriched to at least 65% of all live cells (see page 2).
Saxena et al do not disclose using separation techniques to remove CD3+ cells and CD14+ cells from the blood sample to obtain NK cells.
Ndhlovu et al disclose methods of isolating NK cells by methods using FACS sorting that remove CD3+ cells and CD14+ cells (see page 3735).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine these references and incorporate the methods of isolating NK cells as disclosed by Ndhlovu et al from whole blood of ovarian, breast and leukemia cancer patients to remove CD3+ cells and CD14+ cells to enrich for NK cells that are CD3- and CD14- cells and then incubating those cells with IL-15 or N-803 (IL-15 analog) to expand the NK cells until they are at least 65% of the cells and then activating the cells with a cytokine composition comprising IL-15 at 50 ng/mL, IL-18 at 50 ng/mL, and IL-12 at 10 ng/mL to produce CD56+ M-CENK cells because this method has the advantage of enriching NK cells as desired by Saxena et al which can be used to produce autologous CD56+ M-CENK cells that can be used to treat the patient. In this case, one of ordinary skill in the art would see these methods as combining prior art elements according to known methods to yield predictable results. Furthermore, one of skill in the art would have expected success in practicing such methods as the prior art discloses how to enrich NK cells from whole blood and how to obtain M-CENK cells from those NK cells
Then with respect to the first incubating period of 7-12 days as set forth in claim 8, Saxena et al demonstrates that the NK cells should be enriched to at least 65% of cells and this enrichment time would vary based on the percent of starting NK cells and how fast the NK cells expand, so a first incubating period of 7-12 days would be considered obvious because the incubation period was considered a result-effective variable. As set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the first incubating period of Saxena would be seen as routine optimization, absent a showing otherwise.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/187207 A1 (Saxena et al) and Ndhlovu et al (Blood, 119(16):3734-3743, 2012), as applied to claims 1-6 and 8 above and in further view of US 2020/0281977 A1 (Mantovani et al).
The above 103 rejection suggests and teaches that which is set forth above.
Mantovani et al disclose that magnetic cell sorting can be used to enrich NK cells (see page 12).
Thus it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to substitute magnetic cell sorting for FACS of Ndhlovu et al to enrich NK cells in the methods suggested above because either step could be used to enrich NK cells so one of skill in the art would see that this would be considered as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results and would have reasonably expected success in substituting magnetic cell sorting for FACS.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, absent a showing otherwise.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
February 19, 2026