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 .
Application Status – Continued Examination Under 37 CFR 1.114
Claims 1-3, 5-16, 19, and 20 were previously pending.
A final rejection office action was mailed 20 August 2025.
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withdrawn pursuant to 37 CFR 1.114.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 19 November 2025
has been entered.
In their request for continued examination, Applicant has amended claims 1, 3, 5, 7, and 9, and cancelled claims 2, 6, 8, 10, and 18-19. Therefore, claims 1, 3, 5, 7, 9, 11-16, and 20 are currently under examination and claims 21-29 remain withdrawn from consideration.
Priority
This application is a 371 of PCT/US2020/030401, which claims benefit of and finds full support in 62/839,970, filed on 29 April 2019.
Withdrawn Claim Rejections
In view of Applicant’s amendment to claim 1 and cancellation of claims 2, 6, 8, 10, and 18-19, all previous claim rejections are moot and hereby withdrawn.
Response to Applicant’s Arguments
The following are the prior rejections under 35 U.S.C. 103 relevant to respond to Applicant’s arguments in light of the newly filed claim amendments:
Claims 1, 8-11, 13, and 19 were previously rejected under 35 U.S.C. 103 as being unpatentable over Schneider (previously cited in prior office actions as: Minimizing the non-specific binding of nanoparticles to the brain enables active targeting of Fn-14 positive glioblastoma cells (Biomaterials) available online 13 December 2014) in further view of Kim (previously cited in prior office actions as: Non-degradative Intracellular Trafficking of Highly Compacted Polymeric DNA Nanoparticles (Journal of Control Release) published 28 February 2012).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (previously cited) in further view of Kim (previously cited) and Zhou (previously cited in prior office actions as: Development of human serine protease-based therapeutics targeting Fn14 and identification of Fn14 as a new target overexpressed in TNBC. Mol Cancer Ther. 2014 Nov;13(11):2688-705. Doi: 10.1158/1535-7163).
Claims 5 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (previously cited) in further view of Kim (previously cited) and Voges (previously cited in prior office actions as: Imaging-guided convection-enhanced delivery and gene therapy of glioblastoma (Annals of Neurology) published October 2003).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (previously cited) in further view of Kim (previously cited), Voges (previously cited) and Kurihara (previously cited in prior office actions as: Glioma/glioblastoma-specific adenoviral gene expression using the nestin gene regulator (Gene Therapy) published April 2000).
Applicant has amended claim 1 to include the limitations of prior dependent claim 2 (now cancelled; “a protein or peptide ligand having at least 90% homology to a TNF superfamily member 12 (TWEAK) protein”) and added an additional limitation requiring a plasmid comprising a suicide gene under the control of a glioma cell-specific promoter. In light of these amendments, the previously cited references – Schneider, Kim, Zhou, Voges, and Kurihara – together, would need to teach a method to treat glioblastoma by administering a DNA nanoparticle (DNP), wherein the DNP comprises:
A 30-mer lysine polymer substituted with 10kDa PEG;
A protein or peptide ligand having at least 90% identity to a TWEAK protein, is specific for the TWEAKR receptor, and is conjugated to the DNP; and
A plasmid comprising a suicide gene under the control of a glioma-specific promoter.
While a combination of references teaches each of these limitations in part, there is no motivation to combine the references to arrive at what is currently claimed in instant claim 1 without hindsight (as Applicant has argued in Remarks; see p. 7).
CLAIM INTERPRETATION
Claim 1 is drawn to a protein or peptide ligand having at least 90% homology to a TWEAK protein. As further discussed below, homology is qualitative, not quantitative, and should not be prefaced by a numerical value. Since the TWEAK protein is 249 aa long and claim 1 allows for a peptide ligand, Examiner will interpret this claim as 90% sequence identity.
New Claim Objections
Claim 9 recites the following: “[t]he method of claim 1, wherein the the [sic] lysine polymer comprises…” This is assumed to be a typographical error. Appropriate correction is required.
New Claim Rejections
Claim Rejections - 35 USC § 112(b)
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, 3, 5, 7, 9, 11-16, and 20 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “90% homology” in claim 1 is not consistent with acceptable terminology in the field as homology is qualitative (yes or no) and not quantitative. The term is indefinite because the specification does not clearly redefine the term and the current use is not consistent with its use in the art. Therefore, one of ordinary skill cannot determine the metes and bounds of the claim as currently written.
Claim 3 recites the limitation “TWEAK moieties” in claim 1. There is insufficient antecedent basis for this limitation in the claim. Of note: it appears Applicant has changed some of the possible nanoparticle embodiments to include “TWEAK protein or peptide ligands.” Such changes would overcome this rejection if applied to all variations included in claim 3 (e.g., at least three and at least 4 TWEAK moieties).
Conclusion
Claims 1, 3, 5, 7, 9, 11-16, and 20 are rejected. No claim is allowable.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644