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 .
Status of Application, Amendments and/or Claims
Claims 1-21 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 4-10, drawn to a method of culturing a monocyte cell, in the reply filed on 25 March 2026 is acknowledged.
Claims 1-3 and 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 25 March 2026.
Claims 4-10 are under consideration in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 June 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) and/or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
In the first line of the instant specification, Applicant indicates that International Patent Applicant No. PCT/US2017/052399 was filed on September 20, 2018. However, after reviewing the document, the international patent application was actually filed on 20 September 2017.
The application data sheet filed 18 February 2026 lists the correct year (2017). Therefore, appropriate correction is only required in the instant application to update the first line of the specification to reflect that International Patent Applicant No. PCT/US17/52399 was filed on 20 September 2017.
Drawings
The replacement drawings were received on 12 June 2024. These drawings are acceptable.
Claim Objections
1. Claims 5, 6, 8, 9, and 10 are objected to because of the following informalities:
1a. Claims 5, 6, 8, 9, and 10 recite the acronyms “PMA”, “LPS”, “MCSF”, and/or “DEX” without first defining what they represent. While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym and/or in each independent claim.
1b. Claim 5, line 1 should be amended to recite “culturing monocyte cells” (rather than “a monocyte cell”) for consistency with independent claim 4.
1c. Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
2. Claims 4, 6, and 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.
2a. Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: culturing isolated monocyte cells in the presence of PMA, LPS, MCSF, and DEX. See page 30 of the instant specification filed 12 June 2024.
2b. Claims 6 and 8 recite the limitation "monocyte cell line" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims. Claim 4, from which claims 6 and 8 depend, only recites “culturing monocyte cells”.
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 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.
3. Claims 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tippett et al. (PLoS ONE 6(5): e19968, 2011; cited on the IDS of 19 June 2024).
Tippett et al. teach the isolation of monocytes from whole blood that express CD14, CD16, and CD163 proteins, meeting the limitations of instant claim 4 (see page 4, columns 1-2, “results”; Figures 1B, 1C, 2A, 2B). Tippett et al. also disclose that monocytes are cultured in LPS or M-CSF, meeting the limitations of instant claims 5 and 6 (page 4, column 1, first paragraph; page 4, column 2, last paragraph through page 5, top of column 1; page 5, column 1, 2nd full paragraph; Table 1; Figure 2).
4. Claims 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Genois et al. (J Leukoc Biol 68: 854-864, 2000; cited on the IDS of 19 June 2024).
Genois et al. teach that Mono Mac 1 cells are monocytes derived from the Mono Mac parental cell line, which was established from the peripheral blood of a patient diagnosed with an acute peripheral monoblastic leukemia (page 855, column 1, last paragraph). Genois et al. disclose that Mono Mac 1 cells express CD4 protein, meeting the limitations of instant claim 4 (page 856, column 2, 1st full paragraph; Figure 1). Genois et al. teach culturing Mono Mac 1 cells in PMA or LPS for 72 hours, meeting the limitations of instant claims 5-7 (page 855, column 1, last paragraph; page 856, top of column 2).
5. Claims 4-6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guyre et al. (US 2001/0041177).
Guyre et al. teach that culturing monocytes alone with LPS or DEX induces CD163 expression, meeting the limitations of instant claims 4-6 (page 2, [0021]). Guyre et al. also disclose that when monocytes are cultured for 48 hours with a combination of DEX and LPS, there is a synergistic increase in CD163 expression, meeting the limitations of instant claim 8 (page 2, [0021]).
6. Claims 4-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapralov et al. (J Biol Sci 284(44): 30395-30407, 2009).
Kapralov et al. teach THP-1 monocyte cells are cultured with PMA for 4 days followed by dexamethasone for 24 hours to trigger CD163 expression, meeting the limitations of instant claims 4-9 (page 30396, column 1, 2nd full paragraph; column 2, 2nd full paragraph; page 30402, column 2, last paragraph; Figure 6A).
Conclusion
Claims 4-9 are rejected. Claim 10 is objected.
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BEB
Art Unit 1647
11 May 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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