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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 46-53) in the reply filed on October 27, 2025 is acknowledged.
Claims 54-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-IV, there being no allowable generic or linking claim.
Status of Application
Receipt of the Preliminary Amendments filed on June 8, 2023 and November 3, 2023 is acknowledged.
Claims 46-63 are pending in this application.
Claims 1-45 have been cancelled.
Claims 46-63 are new.
Per the election noted above, claims 46-53 are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on June 8, 2023; August 22, 2025; August 26, 2025; and December 17, 2025 is acknowledged. Signed copies are attached to this office action.
The reference “New Technology and Product Development for Pharmaceutical Preparations”, edited by Hong Yi, Huazhong, University of Science and Technology Press, November 30, 2020 supplied is illegible. The Examiner was unable to locate a copy. The entry was “Lined Out”.
Claim Objections
Claims 51-52 are objected to because of the following informalities:
Regarding claim 51, the claim recites “sorbitan stearate (Span 60)”, however, Span 60 is trademark and its recitation is unnecessary and redundant. It is suggested Applicant delete the term from the claim.
Appropriate correction is required.
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 49 and 52 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.
Regarding claim 49, the claim recites alternatives of the surfactant. It is unclear if the surfactant is a single component or if it’s a combination of surfactants. After a review of the specification, the Examiner was unable to ascertain combinations of surfactants used tin the adjuvant preparation, as such, the Examiner has interpreted the components recited in the claim to be in the alternative.
Regarding claim 52, it is unclear if the self-sustained release immune adjuvant further comprises the imiquimod suspension or if the adjuvant is the imiquimod suspension. Clarification is requested.
Claim Rejections - 35 USC § 102
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.
Claims 46-52 and 53 (in part) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (CN 110917345; cited on IDS dated June 8, 2023).
Chao discloses chemotherapy-immune combination drug useful for treating colon cancer comprising a first mixture comprising immunoadjuvant and second mixture comprising chemotherapy drug causing immunogenic death (abstract).
The immunoadjuvant is imiquimod R837 (lipid soluble immune adjuvant), and also includes poloxamer 188 (surfactant) and sodium alginate ALG. The imiquimod emulsion has a particle size of 0.2 to 3 mm, which is a microparticle dispersion. The emulsion can be mixed with oxaliplatin and water (dispersing medium) (Novelty).
Regarding claim 47, as noted above, the adjuvant is imiquimod.
Regarding claim 48, as noted above, the imiquimod emulsion has a particle size of 0.2 to 3 mm (Novelty).
Regarding claims 49-50, as noted above, Poloxamer 188 is disclosed which is a surfactant with a higher fatty acid chain.
Regarding claim 51, additional surfactants disclosed include polysorbate 80, polyethylene glycol-12-hydroxystearate, egg yolk lecithin, polyethylene glycol (35) castor oil, vitamin E succinic acid polyethylene glycol ester or sodium hydroxymethyl cellulose (Description).
Regarding claim 52, as noted above, the immunoadjuvant is imiquimod R837 (lipid soluble immune adjuvant), and also includes poloxamer 188 (surfactant) and sodium alginate ALG. The emulsion can be mixed with oxaliplatin and water (dispersing medium) (Novelty).
Regarding claim 53, the mass ratio of the imiquimod R837 to the poloxamer 188 is 1:(0.1-5) (preferred components). Example 1, step 1 discloses the final concentration of imiquimod is 2.5-5 mg/mL (detailed description).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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