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 .
Shift of Invention
The general policy of the USPTO is that applicants are not permitted to shift to claim another invention after an election is made and an Office Action on the merits is made on the elected invention (MPEP 819).
Newly added claims 24-27 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: newly added independent claim 24, and its dependent claims 25-27, are directed to a supramolecular assembly comprising a PEI/lithocholic acid conjugate loaded with a chemotherapeutic drug and an immunoactive nucleic acid. This is a different and distinct invention with respect to previously pending composition and method claims.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, newly added claims 24-27 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claim Objections Withdrawn
The rejections of claims 1-11, 16 and 18-21, outlined in the previous Office Action, have been overcome by inventor’s amendment. With respect to claims 6, 8, 9, 16 and 19, the amendment cancels the claims. With respect to the remaining claims, the amendment corrects the claim texts as appropriate.
Claim Objections, NEW
Claims 22 and 23 are objected to because of the following informalities: the claims do not terminate with a period (after the structures). Claims must begin with a capital letter and end with a period. MPEP 608.01(m).
Appropriate correction is required.
112(a) Rejections Withdrawn
The rejection of claims 1-21 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 6, 8, 9, 16 and 19, the amendment cancels the claims. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that it is now enabled.
112(b) Rejections Withdrawn
The rejections of claims 5, 8, 9, 12-15, 18 and 19 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, have been overcome by inventor’s amendment. With respect to claims 8, 9 and 19, the amendment cancels the claims. With respect to claims 5, 12, 14, 15 and 18, the amendment clarifies the claims as appropriate. With respect to claim 13 (indefinite from indefinite), the rejection is moot.
Claim Rejections - 35 USC § 112, 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.
Claims 1 and 11 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 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.
Clarification is in order.
Claims 22 and 23 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 definitions of variables n and m in the diagramed structures are unclear because they are undefined.
Claims 2-5, 7, 10, 12-15, 17, 18 and 20 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.
Claims 2-5, 7, 10, 12-15, 17, 18 and 20 all depend, or ultimately depend, upon an indefinite claim yet do not relieve the indefiniteness. Dependent claims 2-5, 7, 10, 12-15, 17, 18 and 20 are also, therefore, indefinite.
102 Rejections Withdrawn
The rejection of claims 1-4, 7-15 and 17-19 under 35 USC 102(a)(1), outlined in the previous Office Action (US 2006/0127482 A1), has been overcome by inventor’s amendment. With respect to claims 8, 9 and 19, the amendment cancels the claims. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that the claims no longer read on the cited art.
The rejection of claims 6, 9, 16 and 19 under 35 USC 102(a)(1), outlined in the previous Office Action (Biomaterials (2018), 169, pp. 45-60), has been overcome by inventor’s amendment. The amendment cancels the claims.
The rejection of claims 4, 5 and 21 under 35 USC 102(a)(1), outlined in the previous Office Action (J. Nanopart. Res. (2014), 16:2784, 12 pages), has been overcome by inventor’s amendment. The amendment narrows the scope of the claimed subject matter such that the claims no longer read on the cited art.
Claim Rejections - 35 USC § 102, MAINTAINED
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.
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 1, 4, 10, 11, 14 and 15 remain rejected, and newly amended claim 18 is also now rejected, under 35 U.S.C. 102(a)(1) as being clearly anticipated by Biomaterials (2018), 169, pp. 45-60), prior art of record. Inventor’s amendments and arguments have been carefully considered but are not persuasive.
As noted in the previous Office Action, the reference teaches a pharmaceutical composition of matter comprising a covalently conjugated lithocholic acid (LCA) disulfide-linked polyethyleneimine (ssPEI) micelle nanoconstruct loaded with paclitaxel (a hydrophobic chemotherapeutic drug) utilized in a method for the intraperitoneal chemotherapeutic treatment of peritoneal carcinomatosis (abstract; page 57, 3. Conclusion). Administration is intraperitoneal (which is a form of systemic administration) (page 47, Fig. 1).
Inventor argues that, at a minimum, the reference does not disclose that the lithocholic acid is conjugated directly to the flank of the polyethyleneimine. The examiner respectfully disagrees. Inventor’s attention is drawn to page 48 of the reference, Fig. 2A. The molecular diagram of the covalently conjugated lithocholic acid disulfide-linked polyethyleneimine construct clearly shows that the lithocholic acid is conjugated to the “flank” of the polyethyleneimine molecule construct.
Allowable Subject Matter
Claim 21 is allowed.
Conclusion
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.
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 EST.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 2/21/2026