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 .
Status of the Application
Receipt is acknowledged of Applicant’s response to the Requirement for Restriction, filed 19 December 2025, in the matter of Application No. 18/003,462. Said documents have been entered on the record. Examiner further acknowledges the following:
Claims 1-31 were filed on 27 December 2022. As a result of the Preliminary Amendment, filed 17 August 2023, claims 18-23 and 27-31 were cancelled, claims 3-4, 6-7, 10, 13-15, 17, 24, and 26 were amended, and no claims were added. Therefore, claims 1-17 and 24-26 were previously pending.
A Requirement for Restriction office action was mailed 28 October 2025.
In Applicant’s response, received 19 December 2025, Applicant elected Group I, claims 1-17, without traverse.
Claims 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement between the composition and method.
Therefore, claims 1-17 are presented and represent all claims currently under consideration.
Information Disclosure Statement (IDS)
The IDS (1) filed on 17 August 2023 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Claim Objections
Claims 4, 6-7, 13-15, and 17 are objected to because of the following informalities: there does not appear to be a space between the claim and the claim number as recited in the body of the aforementioned claims (e.g., “claim1”) which is assumed to be a typographical error. Appropriate correction is required.
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 1-17 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.
Claim 1 recites the following limitation: “…wherein a proximal end of the nanotube is attached to a linker configured to bind a moiety located on the surface of the cell.” It is unclear what reference point ‘proximal’ is referencing (e.g., the cell? the cytoplasm? the cell membrane?) and therefore, claim 1 is indefinite because one of ordinary skill could not determine the metes and bounds of the claimed limitation. Claims 2-17 are included in this rejection because of their dependency upon a rejected claim.
Claim Rejections - 35 USC § 103
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.
Claims 1-6 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bangera (cited by Applicant on 26 April 2023 IDS as: US 2017/0173177; published: 22 June 2017).
Bangera discloses devices, compositions, and methods which provide a tubular nanostructure targeted to a lipid bilayer membrane (abstract). As it pertains to the instant application, Bangera is directed to functionalized nucleic acid nanostructures, including DNA nanotubes, that are modified with targeting ligands (e.g., antibodies), polyethylene glycol (PEG), fluorescent labels, and streptavidin/biotin systems for attachment to cells and delivery of payloads. See, e.g., [0025]-[0035], [0058]-[0065], [0088]-[0096].
Regarding instant claim 1, Bangera discloses several embodiments of devices, compositions, and methods comprising a tubular nanostructure that may include at least one ligand configured to bind to one or more cognates on the lipid bilayer membrane of a target cell as shown below:
PNG
media_image1.png
580
625
media_image1.png
Greyscale
PNG
media_image2.png
643
532
media_image2.png
Greyscale
(Fig. 1B and abstract).
These embodiments disclosed by Bangera meet the limitations of instant claim 1:
(1) A cell: Bangera teaches contacting nucleic acid nanostructures with cells, including mammalian cells, for targeting and delivery applications (Fig. 1B, [0068]-[0072]).
(2) A nucleic acid nanotube: Bangera expressly discloses nucleic acid nanostructures, including DNA nanotubes (Fig. 3, [0031], [0239] – claim 2).
(3) The proximal end of the nanotube attached to a linker: Bangera teaches functionalization of nucleic acid nanostructures at defined locations, including termini, via chemical modifications ([0056]-[0064]). Bangera further teaches attaching targeting ligands to the nanostructure via electrostatic forces ([0065]) or streptavidin-biotin interactions ([0068], [0078]).
Terminal functionalization of DNA nanostructures for oriented attachment is a conventional design in the art and is expressly contemplated by Bangera’s disclosure of site-specific modifications. Accordingly, Bangera teaches attachment of a linker at a defined region of the nanotube, which reasonably encompasses attachment at the proximal end.
(4) A linker configured to bind a moiety located on the surface of the cell: Bangera teaches targeting cell-surface proteins using antibodies and other binding ligands conjugated to nucleic acid nanostructures ([0034], [0068]-[0071]). Bangera further teaches such ligands bind cell surface receptors ([0073]) and other surface proteins ([0071]).
Therefore, Bangera discloses embodiments of a nucleic acid nanotube proximally linked to an antibody or antibodies configured to bind to a moiety located on the surface of a cell.
Regarding instant claim 2, Bangera discloses embodiments of the DNA nanotube linked to one or more ligands wherein the ligands are configured to bind to one or more cognates associated with the lipid bilayer membrane of a target cell ([0071]). The target cell, Bangera discloses, may be a tumor cell and/or other diseased cell type in a mammalian subject ([0071]), thereby meeting the limitations set forth in instant claim 2.
Regarding instant claim 3 and as previously discussed, Bangera discloses embodiments of the nanotube that explicitly include a DNA nanotube ([0007]).
Regarding instant claim 4, Bangera discloses the hydrophilic surface region of the tubular nanotube includes polyethylene glycol (PEG) ([0033]). Bangera further discloses the PEG comprises repeating units represented by the structure (--CH2CH2O--)n ([0033]), thereby meeting the limitations set forth in instant claim 4.
Regarding instant claim 5, Bangera discloses the PEG on the surface of the nanotube should have a molecular weight less than 200 kDa ([0033]). The claimed range (“approximately 20 kDa”) falls within the range disclosed by Bangera (see MPEP 2144.05(I)), which would have been a matter of routine optimization of a known variable, absent a showing of criticality. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.).
Regarding instant claim 6, Bangera discloses the nanotube may be functionalized with a fluorescent marker ([0009]), which can include fluorescent dyes ([0034]) or fluorescent markers that may be used to facilitate imaging of the tubular nanostructure in association with target cells or organelles ([0103]).
Regarding instant claims 13 and 14, Bangera discloses the moiety includes one or more cell surface receptors or cells surface markers in the lipid bilayer membrane that can be a protein ([0010]). For example, the nanotube disclosed by Bangera includes ligands which bind to cognates associated with tumor cells such as: TNF receptor (a membrane receptor protein) ([0073]).
Regarding instant claims 15 and 16, Bangera discloses functionalizing the tubular nanotube with small chemical compound drugs ([0069]) linked via cross linking agents ([0070]).
Regarding instant claim 17, Bangera discloses the tubular nanostructures embodiments include devices ([0005]).
Bangera discloses embodiments of tubular nanotube attached to a moiety located on the surface of the cell. The nanotube, as disclosed by Bangera, can be selected from a DNA nanotube and further comprise each of the limitations required by instant claims 1-6 and 13-17. The difference between the applied reference and the claimed invention is that the
applied references may not teach the instantly claimed method with particularity so as to amount
to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is
contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d
1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is
not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d
831, 15 USPQ2d 1566 (Fed. Cir. 1990). Bangera discloses various embodiments of the tubular nanotube requiring the skilled artisan to choose from those embodiments to arrive at the currently claimed invention.
With that said, the applied reference discloses the elements of the claimed composition with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date,. Bangera discloses all the claim limitations with a reasonable expectation of success –it would have been obvious to pick and choose from the disclosed components, together forming embodiments of tubular nanotube compositions, because Bangera discloses successful creation of compositions from those disclosed components. Therefore, Bangera makes obvious the invention claimed in instant claims 1-6 and 13-17.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bangera (previously cited) as applied to claims 1-6 and 13-17 above, and further in view of Dai cited by Applicant on 26 April 2023 IDS as: US 2009/0166560; published: 02 July 2009).
As discussed above, Bangera discloses a DNA nanotube attached to a linker configured to bind a moiety located on the surface of the cell via a ligand. Bangera further discloses embodiments comprised of the following:
The ligand may include at least a portion of an antibody ([0028]); the nanostructure may further include at least one second ligand configured to bind to one or more cognates on the lipid bilayer membrane ([[0010]); one or more elements further includes at least one second ligand configured to reversibly bind a cognate of interest ([0008]); and the at least one second ligand includes a monospecific antibody or bispecific antibody ([0008]).
Additionally, Bangera teaches:
A single chain antibody attached to the tubular nanostructure whereby the antibody may also incorporate streptavidin as part of the fusion protein to facilitate attachment of the antibody to the tubular nanostructure via a biotin-streptavidin linkage ([0080]);
Use of secondary antibodies and conjugation systems ([0105]-[0106]);
A bifunctional antibody that may be two or more intact antibodies that are linked to one another by chemical conjugation, crosslinking, and/or linker moieties ([0192]).
However, Bangera does not explicitly disclose the sandwiched antibody configuration with the particularity required by instant claims 7-10.
Dai discloses methods and materials including carbon nanotubes which have a strong Raman and/or fluorescent signal which have been modified with an amphiphilic molecule having available functional linking groups for linking to a biological compound (abstract).
Regarding the instantly claimed invention, Dai teaches PEG-functionalized single walled nanotubes (SWNTs), specifically analogous to the architecture of antibodies as recited in instant claim 7 as shown below:
PNG
media_image3.png
435
152
media_image3.png
Greyscale
PNG
media_image4.png
215
228
media_image4.png
Greyscale
Dai teaches this configuration includes a goat anti-mouse antibody labeled with an SWNT ([0090]). Additionally, this formulation comprises a fluorescently-tagged cy3-conjugated donkey anti-goat antibody attached to the goat anti-mouse secondary antibody ([0025] and [0089]-[0092]). Finally, Dai teaches the disclosed nanoparticle conjugates can be used as specific probes for cell surface receptors, using specific biological labeling molecules such as antibodies ([0073]).
Regarding instant claim 8, Bangera discloses use of streptavidin protein modification to facilitate antibody attachment to the tubular nanostructure ([0065], [0080]).
Regarding instant claim 9, Bangera discloses an alternative conjugation where the nanotube may be functionalized with streptavidin by non-covalent interactions and a biotinylated antibody attaches to the nanotube via a streptavidin-biotin linkage ([0210]).
Regarding instant claim 10, Bangera discloses DNA or RNA aptamers may be linked to the nanotube via a streptavidin-biotin linkage whereby the biotin is introduced into the DNA or RNA aptamer during synthesis of the aptamer and then bound to streptavidin associated with the nanotube ([0068]).
While Bangera discloses many antibody configurations involving two antibodies attached to a tubular nanotube, Bangera does not disclose the structural configuration with specificity as required by instant claim 7. However, this structure is made obvious in view of Dai, which discloses a particular antibody configuration whereby one antibody is attached to a nanotube and another antibody, with specificity for a cell-surface receptor, is attached to that antibody. Dai’s disclosure makes obvious the particular configuration as required by instant claim 7. Bangera then discloses useful attachment and linking strategies for these two antibodies and, in addition, conjugation strategies for polynucleotide attachment to the tubular nanotube.
Therefore, regarding instant claims 7-10, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to modify the attachment of two antibodies to a nanotube, as disclosed by Bangera, to mimic the attachment strategy disclosed by Dai. One would have been motivated to do so because Dai discloses use of this configuration as a fluorescent detection strategy to confirm ligand selectivity. Additionally, one of ordinary skill could easily pick and choose from the conjugation strategies disclosed by Bangera to achieve the antibody-antibody-tubular nanotube configuration disclosed by Dai to arrive at what is claimed in instant claims 8-10. This would involve one of ordinary skill using a known technique (Dai) to improve upon similar compositions (Bangera) in the same way and combining prior art elements according to known methods to yield predictable results. Therefore, instant claims 7-10 are obvious over Bangera in view of Dai.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bangera (previously cited) and Dai (previously cited) as applied to claims 7-10 above, and further in view of Lu (“Self-assembled branched nanostructures of single-walled carbon nanotubes with DNA as linkers,” published online: 27 December 2005).
Bangera in further view of Dai renders obvious the limitations of instant claims 7-10.
While Bangera contemplates self-assembly of the nanoparticles ([0054]-[0055] and Dai contemplates SWNTs ([0018]), neither reference discloses that which is required by instant claims 11-12.
Lu discloses self-assembly of DNA functionalized single-walled carbon nanotubes (SWNTs) which form highly branched structures (abstract). The formation of the branched structures was explained by the hybridization of DNA attached to the ends and sides of SWNTs based on the DNA complementary sequence-specific pairing interactions (abstract). Lu discloses the branched structure formation was attributed to the hybridization of two complementary single-strand DNA (ssDNA) attached on SWNTs (p. 390, right column). Furthermore, Lu discloses that the interconnected degree of self-assembled SWNTs via DNA hybridization is seven times more than that of single strand DNA functionalized SWNTs (p. 390, right column).
While Bangera and Dai contemplate antibodies and polynucleotides attached to a tubular nanotube, neither reference disclosed he structural configuration of polynucleotide attachment with specificity as required by instant claims 11 and 12. However, this structure is made obvious in view of Lu, which discloses hybridization of DNA attached to the ends of SWNTs leads to self-assembly and a significantly higher interconnected degree compared to that of ssDNA functionalized SWNTs. Lu teaches this is attributed to DNA complementary sequence-specific pairing interactions.
Therefore, regarding instant claims 11-12, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to modify the attachment of polynucleotide to a nanotube, as disclosed by a combination of Bangera and Dai, to mimic the attachment strategy disclosed by Lu. One would have been motivated to do so because Lu discloses this strategy produces self-assembled and highly branched SWNTs with a higher interconnected degree. Therefore, one of ordinary skill could use the strategy taught by Lu to modify the tubular nanotubes disclosed by Bangera and Dai to arrive at that which is claimed in instant claims 11 and 12 with an expectation of success. This would involve one of ordinary skill using a known technique (Lu) to improve upon similar compositions (Bangera and Dai) in the same way and combining prior art elements according to known methods to yield predictable results. Therefore, instant claims 11-12 are obvious over Bangera and Dai in view of Lu.
Conclusion
Claims 1-17 are rejected. No claim is allowed.
Correspondence
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-Th 7:30a to 5:30p (MST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIA A ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615