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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/24/2026 has been entered.
Clarification
The examiner notes for clarity of the record that the status identifiers of claims 24-27 indicates that the claims are withdrawn, yet no claim text appears for these claims. This manner of making an amendment to the claims is not consistent with the guidelines for amending claims as outlined MPEP 1.121(c). Since there are no claim texts presented for examination, the examiner must assume that claims 24-27 have been canceled and will be treated as such for purposes of this Office Action.
Claim Objections Withdrawn
The objection to claims 22 and 23, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
112(b) Rejections Withdrawn
The rejection of claim 1 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 22 and 23 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
The rejection of claims 2-5, 7, 10, 12-15, 17, 18 and 20 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action (indefinite from indefinite), is withdrawn. In light of inventor’s latest amendments, the rejection has been reformulated below. (The amendment cancels claims 2 and 12.)
Claim Rejections - 35 USC § 112(b), MAINTAINED AND NEW
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.
Claim 3 is 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 dependency of the claim is unclear because it depends from a canceled claim.
The examiner respectfully suggests that claim 3 should properly depend from claim 1 (not claim 2).
Claim 4 is 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.
There is insufficient antecedent basis for the limitation “…or a hydrophobic molecule…” in the claim. Furthermore, the compounds listed in the claim are all, in fact, hydrophobic chemotherapeutic drugs. It thus becomes unclear why the pertinent limitation is recited as “…the hydrophobic chemotherapeutic drug or a hydrophobic molecule…”. Why the verbiage?
The examiner respectfully suggests the pertinent limitation should simply be: “…the hydrophobic chemotherapeutic drug…is paclitaxel, sorafenib, [etc.]”.
Claim 11 remains 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 term flank in the limitation “…the lithocholic acid is conjugated to the flank of the polyethyleneimine…” is unclear. What is, or is not, the flank of a polyethyleneimine molecule would seem to be an ambiguous, subjective determination. This is particularly true since the term, when referring to a chemical compound, is an unusual choice of vocabulary.
Inventor states in the Remarks (7/24/2026) that the term has been deleted from the claim. However, the term has not, in fact, been deleted.
Claim 13 is 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 dependency of the claim is unclear because it depends from a canceled claim.
The examiner respectfully suggests that claim 13 should properly depend from claim 11 (not claim 12).
Claims 14, 15, 17 and 18 are also 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 claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 14, 15, 17 and 18 are also, therefore, indefinite.
102 Rejections Withdrawn
The rejection of claims 1, 4, 10, 11, 14 and 15 under 35 USC 102(a)(1), maintained in the previous Office Action, has been overcome by inventor’s amendment. The amendment narrows the scope of the claim set such that it no longer reads on the cited art.
Allowable Subject Matter
Claims 1, 5, 7, 10, 20 and 21 are allowed. The subject matter of the remaining claims would be allowable once the 112 rejections outlined above have been overcome. The examiner also respectfully suggests a conformation of the cancelation of claims 24-27. The following is a statement of reasons for the indication of allowable subject matter:
With respect to claims 1, 3-5, 7, 10, 11, 13-15, 17, 18 and 20, the key to the instant invention is the nature of the compositions of matter as taught in independent claims 1 and 11. International Journal of Nanomedicine (2012), 7, pp. 4269-4283 appears to be the closest representative prior art. The reference teaches PLGA-PEI nanoparticles which codeliver paclitaxel and Stat3 siRNA and may be utilized in the treatment of lung cancer (abstract; page 4270, column 2, Preparation of PLGA-PEI NPs for the codelivery of paclitaxel and Stat3 siRNA). Significantly, the reference teaches a polymer conjugate which is not that of the instant invention (PEI conjugated with lithocholic acid). Nor is there any motivation - either in the cited art itself or the general knowledge of one of ordinary skill in the art - for one of ordinary skill to substitute the polymer conjugate of the cited art with that of the instant invention.
With respect to independent claim 21, the closest prior art appears to be Biomaterials (2019), 217, #119296 (8 pages), cited in the IDS. The reference teaches a method of gene delivery utilizing a lithocholic acid-polyethyleneimine conjugate. The reference does not, however, teach, show, suggest or make obvious the instant diagnostic composition of matter comprising a polyethyleneimine-lithocholic acid conjugate and a hydrophobic dye.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/28/2026
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