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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, drawn to a liposomal formulation comprising liposomes and an encapsulated capturing agent-active agent complex, in the reply filed on 11/17/2025, is acknowledged.
Applicant’s species elections, in the reply filed on 11/17/2025, are acknowledged:
Capturing agent-active complex:
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Aromatic diol (Tiron):
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170
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Boronic acid containing acid agent (Bortezomib):
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Claims 9, 11-12, 15-18 and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Broad to Narrow Limitations and Indefinite Language
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 5 and 13 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 broad to narrow limitations, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 5 recites the broad recitations of the lipids, and the claim also recites the lipids in parentheses, which are the narrower statements of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 13 recites the broad recitations of the drugs, and the claim also recites the drugs in parentheses, which are the narrower statements of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parentheses from claims 5 and 13.
The Examiner notes that claim 6 is not rejected as indefinite because it does not appear that DSPE-PEG has a meaning other than as PEG conjugated DSPE, whereas DSPG (claim 5) can refer to the lipid, or the abbreviation can refer, for example, to the “Data Science for the Public Good”, and hence, the term in the parenthesis is indefinite.
Further regarding claim 13, the phrase "for example" or “e.g.” renders the claim indefinite, because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The Applicant is encouraged to remove the indefinite language, as well as the parentheses (see above), from claim 13.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-8, 10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Caligiuri et al (US 2016/0347791 A1) in view of Zou et al (Clin Cancer Res, 2006; 12(1), January 1, 2006).
Caligiuri taught liposomal formulations formed from vesicle-forming lipids (e.g., phospholipids (e.g., DSPC [0267]), lipids (e.g., cholesterol) and PEG-conjugated lipids (e.g., DSPE-PEG)) [0152-0154, 0208, 0215]. The liposomes generally contained boronic acid compounds [0009], complexed via the boron moiety of bortezomib (BTZ) [0164, Examples 1-6; see also ¶s 0147-0148]. Said boronic acid compounds, entrapped in the liposomes, were sequestered in the central aqueous compartment, or within a bilayer of the liposomes [0151].
Although Caligiuri taught liposomes generally containing boronic acid compounds, Caligiuri did not specifically teach
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, as instantly elected.
Zou taught that Tiron
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forms a direct chemical bond
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with the boronic acid moiety
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of bortezomib
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, which reads on the instantly elected capturing agent-active agent complex [see Zou at Figs. 1 and 7a; see also Zou’s abstract; page 276, right column and 1st ¶; and the penultimate paragraph of page 279]. Reproductions are below:
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535
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.
Since Caligiuri generally taught boronic acid compounds, complexed via the boron moiety of bortezomib, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Caligiuri, Tiron, as taught by Zou. The ordinarily skilled artisan would have been guided by Zou’s teachings that Tiron forms a direct chemical bond with the boronic acid moiety of bortezomib, as taught by Zou et al.
Caligiuri, in view of Zhou, reads on claims 1-8, 10 and 13-14.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612