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 .
Claim Objections
Claims 6 and 17 are objected to because of the following informalities:
Claim 6 recites the abbreviation “PNA” and claim 17 recites the abbreviations “GP120, Gp160, gP41, VPU and Nef” without indicating what the abbreviation means. The Examiner suggests amending the claims to recite the full term with the abbreviation in parentheses in the first instance that such appears in the 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.
Claims 4-8 and 14-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4-7 recites the limitation "the binding agent". There is insufficient antecedent basis for this limitation in the claim. Claims 4-7 depends from claim 3, which depends from claim 1. Claim 3 recites “one or more binding agents” which encompasses multiple binding agents. Thus, it is unclear whether just one, more than one, or all of the binding agents are being referenced and must, for example, comprise an antibody as suggested in claim 4. Amending claims 4-7 to recite “wherein the one or more binding agents…”, would overcome this rejection.
Claims 14, 16, 18, 20 and 22 recite the limitation "the target". There is insufficient antecedent basis for this limitation in the claim. The claims depend from claim 9, but claim 9 does not recite a “target” limitation. Therefore, it is unclear what this limitation refers to and how to interpret the claim.
Claims 15, 17, 19, 21 and 23 recites the limitation "the antigen". There is insufficient antecedent basis for this limitation in the claim. Claims 15, 17, 19, 21 and 23 depends from claims 14, 16, 18, 20 and 22, respectively, which depends from claim 9. Claim 9 recites “one or more antigens” which encompasses multiple antigens. Thus, it is unclear whether just one, more than one, or all of the antigens are being referenced and must, for example, be selected from the group consisting of Merozoite Surface Protein 1 (MSP1), MSP2, MSP3, MSP4, MSP5, MSP6, MSP7, MSP8, MSP9, and MSP10 as suggested in claim 15. Amending claims 15, 17, 19, 21 and 23 to recite “wherein the one or more antigens…”, would overcome this rejection.
Claim 8 has been included in the instant rejection because the claims directly or indirectly depend from claim 7.
Allowable Subject Matter
Claims 1-10 and 14-23 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action.
The claimed methods are free of the prior art. The prior art does not teach the claimed method step of “administering to the subject an effective amount of streptavidin crosslinking agent to rupture the biotinylated complex”, which are recited in both independent claims 1 and 9. More specifically, the claim requires “the effective amount of streptavidin” to be an amount that can “rupture the biotinylated complex” that was administered in the previous step. Although there is a plethora of prior art that teaches a biotin-avidin type complex used in drug delivery, it does not teach a second administration step, wherein streptavidin ruptures the previously administered biotinylated. Furthermore, since such is not taught by the prior art, one of ordinary skill in the art would not know an amount that would be effective for such step.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hyde et al. (US 2011/0070153; in IDS dated 5/10/24; considered an X reference in the parent PCT application) teach a therapeutic composition that is administered in an amount to the subject depending on the type and severity of the disease ([0098]), wherein the composition comprises red blood cells loaded with one or more molecular agents ([0232]). In order to form the modified red blood cells, Hyde et al. teach that biotinylated cells are reacted with biotinylated antibody in the presence of streptavidin ([0201]). That is, the composition that is administered to the subject comprises all the claimed components but in one composition and not in two, wherein the two are administered separately. It is also noted, that Hyde et al. do not teach wherein there is an “effective amount of streptavidin crosslinking agent to rupture the biotinylated complex”. In fact, streptavidin is part of the biotinylated complex of Hyde et al. prior to any administration(s).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617