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.
Status of Claims
Claims 31-37 and 42-47 are pending. Claims 1-30 are canceled. Claims 31-37 are withdrawn. Claims 46-47 are new. Claims 42-47 are under examination.
Withdrawn Rejections
In light of the amendments and arguments, the 35 U.S.C. 103 rejection is hereby withdrawn.
Specification
The disclosure is objected to because of the following informalities: The specification and claim 42 contain the phrase “alcoxy” in the limitation of [SPACER]. The phrase “alcoxy” should be amended to – alkoxy – because alcoxy is not a chemical structure term.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Appropriate correction is required.
Claim Objections
Claims 42-45 are objected to because of the following informalities:
Claim 42 is invoking a Markush language for the [SPACER] but the claim is reciting an “or” rather – and –. Thus, the Markush language is not proper. Additionally, the term “alcoxy” should be – alkoxy – because alcoxy is not a chemical structure term.
Claim 44 recites “is selected form” should be – is selected from the group consisting of – to properly invoke the Markush language and be consistent throughout the claim set.
Claim 45 recites “a compound” should be “the compound” to refer to the compound of claim 42.
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 42-47 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.
The amended claim 42 recites the limitations of “X1 and X2, when present, are selected from the group consisting of O, NH, and S” are unclear to the metes and bounds of the claimed formulas. X1 is present in formulas IIb and IIc. Similarly, X3 is present in formulas IIb and IIc but X3 does not contain the phrase “when present”. When the phrase is reciting in the alternative/optional form (i.e., [X1]0 or 1 and [X2]0 or 1), it is unclear to the metes and bounds of the chemical structure of the formulas when X1 and/or X2 is zero. In other words, how is X3 conjugated to the chemical structure of the fomulas. Claims 45-47 are rejected as being dependent on claim 42 and contains the formulas.
With respect to claim 43, the claim also recites the phrase “when present” for X1 and X2. Similarly, the claim is unclear to the metes and bounds of the formulas (see above). Claim 44 is rejected as being dependent from claim 43.
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 42-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (“Enhanced Cell Death Imaging Using Multivalent Zinc(II)-bis(dipicolylamine) Fluorescent Probes”, Mol. Pharmaceutics, 2013, vol. 10 (no. 9), pgs. 3296-3303, IDS submitted 01/07/2022, cite no. 12).
With respect to claim 42, Smith teaches a clinical need for imaging technologies that can accurately detect cell death in a multitude of pathological conditions and Zinc(II)-bis(dipicolylamine) (Zn2BDPA) coordination complexes (see abstract). Smith teaches Zn2BDPA has the chemical structure of
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Smith further teaches a probe of Tetra-ZN2BDPA-SR (also see Fig. 1), which is linking four ZN2BDPA groups into one probe. Smith teaches in Fig. 1 X1 is oxygen (O) and linked to a CH2 group in the Tetra-ZN2BDPA-SR and Bis-ZN2BDPA-SR. Smith also teaches ZN2+ in Fig. 1. In particular, Smith teaches benzyl group is connecting the dipicolylamine groups to form ZN2BDPA. It is noted that Smith’s Zn2BDPA would be able to bind to microvesicles as it contains Zinc(II)-bis(dipicolylamine).
With respect to the limitations of “each X1 and X2, when present, are selected from the group consisting of O, NH, and S (emphasis added), is being interpreted as alternative or optional limitations to the claimed compound. The compound may be present with X1 and/or X2. The broadest reasonable interpretation is that X1 and X2 are not required limitations to be present in the compound (i.e., [X1]0 or 1 and [X2]0 or 1). Thus, Smith’s chemical structure would read on the claimed compounds. Because X3 requires X1 and/or X2 to be present in the compound, X3 is not present when X1 and/or X2 are not present (i.e., [X1]0 and [X2]0).
With respect to the preamble recitation of “able to bind microvesicles”, the prior art’s compound is capable of binding to the microvesicles because the prior art’s compound reads on all the structural limitations of the claimed compound. Additionally, with respect to “for use in the detection, quantification or capture of microvesicles in a sample”, the limitation is intended use. Because the prior art’s compounds read all the structural limitations, of the claimed compound, the prior art’s compounds are capable of performing the intended use in a sample.
With respect to claims 43-44, the broadest reasonable interpretation is that X1 and X2 are not required limitations to be present in the compound. Thus, Smith’s chemical structure would read on the claimed compound. Because X3, [IMM] and [SPACER] require X1 and/or X2 to be present in the compound, X3 is not present when X1 and/or X2 are not present.
With respect to claims 45 and 46, Smith teaches Zn2BDPA coordination complexes are covalently conjugated to squaraine rotaxane (see structures of Fig. 1), which can be the support. Smith also teaches microscopy (see abstract) and coverslip system and wells (see pg. 3297, right col, under Cell Microscopy), which would read on solid support is glass, metal, or plastics.
With respect to claim 47, the interpretation is that X1 and X2 are not required limitations to be present in the compound. Also, m and p are zeros. Thus, Smith’s chemical structure would read on the claimed compound. Because X3, [IMM] and [SPACER] require X1 and/or X2 to be present in the compound, and m and p are represented by zeros, the present of [IMM] in the wherein limitation may be zero.
Response to Arguments
Applicant's arguments filed 05/12/2026 have been fully considered but they are not persuasive with respect to the Smith reference. Note that claim 38 has been canceled. The independent claim 42 is reciting the phrase X1 and X2 “when present”.
Applicant argues on pages 15-18 that the newly claimed compound in claim 42 is not obvious over Smith. Applicant argues on page 19 that a skilled artisan would be even less motivated to modify Smith to remove the flexible linkers and SR, and immobilize the resulting ligand on a solid support. Applicant further argues that it is hindsight for the modification.
The arguments are not found persuasive for the following reasons. The amended claim 42 is reciting that X1 and X2, when present, are selected from the group consisting of O, NH, and S (claim 42) and claims 43-44 are reciting X1 and X2, when present, are O. The limitation has broadened the scope of X1 and X2 to be interpreted as alternative/optional limitations of the formulas. X1 is present in formulas IIb and IIc. Similarly, X3 is present in formulas IIb and IIc but X3 does not contain the phrase “when present”. When the phrase is reciting in the alternative/optional form (i.e., [X1]0 or 1 and [X2]0 or 1). Smith’s
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would read on the claimed formulas IIb and IIc when X1 and X2 are zeros.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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