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 .
Amendments
Applicants’ amendments to the claims filed 2/19/2026 have been entered. Any objection\rejections from the previous office action filed 8/19/2025 not addressed below has been withdrawn.
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 1,20-21,23-30 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.
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 1 recites the broad recitation anionic end groups having functional groups selected from a carboxylate, phosphate, sulfonate and an amino-acid containing biomolecule, and the claim also recites wherein the one or more anionic end groups is selected from the group consisting of an amide- linked carboxylate, an ester-linked carboxylate, an ester-ethylene glycol-linked carboxylate, an amide-ethylene glycol-linked carboxylate, an ester-linked phosphate, an ester-ethylene glycol- linked phosphate, an amide-ethylene glycol-linked phosphate, an ester-linked sulfonate, and an ester-ethylene glycol-linked sulfonate, an amide-ethylene glycol-linked sulfonate which is the narrower statement of the range/limitation. 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. Claims 20-21,23-30 incorporate the indefiniteness by dependency. This new rejection was necessitated by amendment.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1,20-21 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Dosta et al., cited previously, for the reason set forth in the previous action filed 8/19/2025.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,20-21,23-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dosta et al., cited previously, in view of Xu et al. (US 20160082126 A1) in view of Liu et al. (US 20150071906 A1). This new rejection was necessitated by amendment.
Dosta is disclosed in the previous action.
While Dosta teaches delivery of nucleic acids it is silent with respect to the active agents of claims 23-30.
Xu is used for the disclosure within that saporin (meeting claims 23-24) was well known to be used in nanocomplex formulations for treating a variety of diseases including cancer. See entire disclosure, especially abstract, [0002],[0040]-[0042] and claims.
Liu is used for the teachings within on gRNA/CIS 9 complexes (meeting claims 25-27) and fluorescent proteins, including fluorescent green protein (GFP, meeting claims 28-30) in supercharged (cationic) polymer delivery systems. See abstract, [0005]-[0006],[0009] and claims.
Since Dosta suggest ionic interactions for delivery of nucleic acids using PBAE one of ordinary skill in the art in the art would have a high expectation of success in adding saporin and/or gRNA/CIS-9 complex and fluorescent protein to form an ionic complex. Reason to make such a modification would be to treat cancer or deliver RNA-programmable genome-editing enzymes by the particles of Dosta and image by fluorescent imaging. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 2/19/2026 have been fully considered but they are not persuasive.
Applicants assert Dosta does not teach an amide linked carboxylate which applicants believe has the following structure:
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Applicants’ argument is incorrect, an amide carboxylate is a much broader term of art than the specific structure above. An amide carboxylate only requires an amide group linked by any conceivable linkage, to a carboxylate. As noted in the previous action the negatively charged polypeptide end groups of Dosta read on the claimed amide carboxylate as it contains an amide and carboxylate.
Conclusion
No claims are allowed at this time.
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 extension fee 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 JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached on 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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