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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/07/2026 has been entered.
Response to Arguments
The arguments presented in the remarks of 07/07/2026 are persuasive. Specifically, where applicant states that the amounts of halogenated xanthene in the instant claims “are far below any concentration disclosed in Eagle.” Applicant states “Eagle’s broadest stated range of 0.1% (w/v) to 20% (w/v) (Eagle, para. [0021]) corresponds to 1,000 to 200,000 mg/liter. Therefore, Eagle’s floor alone is approximately 13 times higher than the upper end of the adjuvant-effective amount recited in amended claims.” By itself, the claimed amounts would not be sufficient overcome obvious. However, the examiner notes that the results within the instant specification indicate that “treatment of 5 μM RB during the CD8-DC co-culture was able to significantly increase the number of IFN-gamma-producing CD8 cells for all three peptides. Increasing the concentration of RB seems to have a negative effect on the cells as the number of IFN-gamma spots decrease with the increasing concentration. (Figs. 3 and 4).” This effect is not disclosed by the cited references.
Therefore, the 103 rejections and the non-statutory double patenting rejections have been withdrawn.
New Rejections
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.
Claims 1-6, 8-9, 11, 22, 24-26, 28-29, 31-32 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.
Independent claims 1, 11, and 22 include the limitation “and the adjuvant-effective amount is less than a cytotoxic amount.”
The instant disclosure, beginning on p. 34, discusses cytotoxic amounts. The specification states “ a cytotoxic amount is the IC50 value amount for an oncology indication (e.g. neuroblastoma, leukemia, melanoma or other tumor), whereas for infectious disease, the cytotoxic amount is the IC50 for normal tissue (e.g., culture fibroblasts, kidney cells, and the like). The data shown in Tables 1 and 2 of U.S Patent no. 11,058,664 illustrate that the IC50 value for use of RB against thirteen pediatric solid tumor cells line in vitro is about 50 to about 100 μM, with a median of about 70 μM, for exposures at 96 hours post treatment. Similar treatments of normal fibroblast cell lines and a primary bone marrow sample provided IC50 values of about 73-143 μM with a mean of 104 μM. Similar data ae reported by one of the inventors and his research group for eleven pediatric leukemia cell lines with a mean IC50 value of 93 μM and a mean IC50 value of 122 μM for three primary leukemia samples. Given that the molecular weight of RB disodium is 1,018 g/mole, the above cytotoxic IC50 values calculates to about 50 to about 100 mg of RB/liter. Those values translate to approximately 10-4 to about 10-5 molar based on the IC50 values. Thus, a typical adjuvant-effective amount of a HX compound in a mammalian HX compound-adjuvanted vaccine composition based on RB as the HX compound is about 35 to about 75 mg/liter or about 7.5 x 10-5 to about 7.5 x 10-6 molar.”
The specification appears to contradict itself because in one instance it states the cytotoxic amount of rose bengal disodium but in the next instance states a less than cytotoxic amount of rose bengal disodium that significantly overlaps with the cytotoxic amount. Additionally, the molar concentrations of 7.5 x 10-5 to about 7.5 x 10-6 do not appear to be in line with the stated mg/liter concentrations. By the examiner’s calculations, 35 mg/liter is equal to approximately 34 x 10-6 molar and 75 mg/liter is equal to approximately 74 x 10-6 molar.
Because of the above contradiction, it is not clear whether the amounts above 50mg/liter are actually cytotoxic or less than cytotoxic.
Allowable Subject Matter
Claims 27, 30, and 33 are 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.
Conclusion
No claims allowed.
Allowable subject matter indicated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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