DETAILED ACTION
Claims 1, 3-9, 13 and 22-26 are currently pending. Claims 1, 7, 9 and 26 are currently under examination.
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 .
Withdrawn Rejections
The prior rejection of Claims 9 and 26 under 112(b) is withdrawn in light of Applicant’s amendments to clarify the structures of claim 9 and amend instant claim 26 to clearly convey the biologically active molecule is combined with the ECM.
The prior rejection of claim(s) 1, 7 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0171121 as evidenced by Griger is withdrawn in light of Applicant’s amendment to specify the nanomaterial is in the form of a multiple compartment nanomaterial that is a double compartment nanomaterial, comprised of two populations of self-assembled nanomaterials that form a multicompartment structure that ‘121 publication does not teach.
The double patenting rejection over US 10,364,440 and 11,608,340 are withdrawn based on Applicant’s claim amendments to specify the nanomaterial is a multiple compartment nanomaterial that is a double compartment nanomaterial.
Examiner’s Note
Applicant's amendments and arguments filed 02/20/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 02/20/2026, it is noted that claims 1, 7, 9 and 26 have been amended and no new matter or claims have been added.
New Objections/Rejections:
The following objections/rejections are newly applied based on Applicant’s claim amendments.
Claim Objections
Claims 1, 9 and 26 is objected to because of the following informalities:
Claim 1 is objected to for using “MAtn3” which appears to be a typographical error for Matn3.
Claim 9 is objected to as containing the limitation “wherein double compartment nanoparticle” which is grammatically awkward as not having “the” before double compartment.
Claim 26 contains the limitation “wherein said biologically active molecule TGF-ß” wherein “is” appears to have been deleted by error.
Appropriate correction is required.
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.
Claim(s) 1, 7, 9 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0362238 (previously applied) in view of Groschel (previously applied) and US 2016/0235670 as evidence by as evidenced by Griger (previously applied).
Regarding claim 1, the limitation of a self-assembled nanomaterial, comprising a Janus base nanotube having a biologically active molecule noncovalently adhered thereto, wherein the biologically active molecule comprises an extracellular matrix, a bioactive molecule or a combination thereof is met by the ‘238 publication teaching complexes of nanotubes and agents are useful for delivery agents into cells or bodily tissues (abstract). The nanotubes are made from compounds (I)-(VIII) which contain bicyclic core structures of various heteroatoms and substitutes with their varied orientation in space. These biomimetic structures can now self-assemble to form nanotubes, e.g. rosette nanotubes of various sizes and charge depending the formula chosen [0006]. Bioactive agents are taught to include transforming growth factor beta [0069]. The nanostructure can comprise cargo molecules, e.g. use as nanocarriers [0326]. Wherein the compounds are self-assembled into nanotube and the one or more agents are incorporated into the nanotube to form a complex of nano-tube agents, thereby delivering the agents ([0328]-[0329]), thus teaching noncovalently attached. Griger evidences Janu-based nanotubes are also known as rosette nanotubes (page 1, last paragraph).
The limitation of wherein the ECM molecule comprises Matn1 is met by the ‘238 publication teaches the cargo molecules include matrililin-3 by mixing the matrilin-3 to 5ug nanotubes wherein Matn1 is also taught ([0345]-[0346]).
The limitation of in the form of a multiple compartment nanomaterial is met by the ‘238 publication teaching nanostructures comprising any of the composition of Formula I, III, V, VII and/or compound A, Compound B, Compound C or Compound D which includes a nanotube [0038]. One or more compositions is taught to be formed [0325]. The ‘238 publication teaches the use of multiple formulas for forming the nanotubes and multiple compositions formed reads multiple compartments.
Regarding claim 7, the limitation of wherein the bioactive molecule comprise TGFbeta is met by the ‘238 publication teaching Bioactive agents are taught to include transforming growth factor beta [0069].
Regarding claim 9, the limitation of the Janus base nanotube comprises a compound of Formula (V) is met by the ‘238 publication teaching Formula V:
PNG
media_image1.png
248
346
media_image1.png
Greyscale
wherein n is 1,2,3,4,5 or 6, R11 is beta amino acid and R12 is H ([0184]-[0190]).
Regarding claim 26, the limitation of self-assembled nanomaterial according to claim 1, comprising a Janus base nanotube of Formula (V), a biologically active molecule noncovalently adhered thereto, wherein said biologically active molecule is TGF beta and further comprises ECM consisting of Matn1 is met by the ‘238 publication teaching complexes of nanotubes and agents are useful for delivery agents into cells or bodily tissues (abstract). The nanotubes are made from compounds (I)-(VIII) which contain bicyclic core structures of various heteroatoms and substitutes with their varied orientation in space. These biomimetic structures can now self-assemble to form nanotubes, e.g. rosette nanotubes of various sizes and charge depending the formula chosen [0006]. Bioactive agents are taught to include transforming growth factor beta [0069]. The nanostructure can comprise cargo molecules, e.g. use as nanocarriers [0326]. Wherein the compounds are self-assembled into nanotube and the one or more agents are incorporated into the nanotube to form a complex of nano-tube agents, thereby delivering the agents ([0328]-[0329]). Griger evidences Janu-based nanotubes are also known as rosette nanotubes (page 1, last paragraph). The nanomaterial compound is used in an implant which may also comprise a compound matrilin [0376]. Bioactive agents are taught to include transforming growth factor beta [0069]. The cargo molecules include matrililin-3 by mixing the matrilin-3 to 5ug nanotubes wherein Matn1 is also taught ([0345]-[0346]).
The ‘238 publication does not specifically teach a double compartment nanomaterial, comprised of two populations of self-assembled nanomaterials that form a multi-compartment structure (claim 1).
Groschel teaching Janus nanoparticle and exemplifying their interfacial properties and self-assembly capabilities (page 11844, second column, first paragraph). multicompartment nanostructures are taught including a micelle with a janus core (h) and homogeneous MCN with two core compartments (k-m) (figure 2). The use of compartmentalization of nanomaterial via self-assembly for the use of drug delivery is taught (page 11863).
The ’670 publication teaching emulsions with a plurality of droplets dispersed in a continuous liquid medium. These droplets can contain at least a first droplet liquid and a second droplet liquid (abstract). Multi-compartment o/w nanoemulsion, such as Janus and Cerberus nanodroplets, have been produced in a massively parallel process [0012]. The process of making multi-component oil-in water nanoemulsion by subjecting a premix emulsion of larger droplets of two or more types of immiscible oils stabilized by a surfactant at low-flow conditions to high flow rates, causing the droplets to be combined and also ruptured down to the nanoscale. Nanodroplets that have identifiable compartments and well-defined interfaces between different immiscible oils within the same droplet. Two component linear Janus nanodroplets are taught. Several different types of drugs are taught as loaded ([0037]-[0038]). Fused nanodroplets that contains separate internal compartments of oil is taught [0091].
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, a combination of TGF beta, Man1 and Formula V to form nanotubes) from within the prior art disclosure of the ‘238 publication, to arrive at the instantly claimed nanomaterial “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use multiple Janus nanotube bases to obtain a double compartment nanomaterial as the ‘238 publication teaches using multiple components of the RNT (e.g. Formula (I), (III), (V) and/or (VIII)) and teaches that various sizes and charges are used deponent on the formula chosen and the nanotubes being used for the delivery therapeutics and Groschell teaches multicompartment nanostructures formed of Janus material such double compartment micelles used for drug delivery and the ‘670 publication teaches using double compartment Janus materials was known to be used for drug delivery. Thus it would have been prima facia obvious to one of ordinary skill in the art before the filing date of the claimed invention to use multiple RNT formula to obtain a double compartment nanomaterial to obtain the desired drug delivery nanomaterial based on the teachings of the ‘238 publication, Groschell and the ‘670 publication. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to form a double compartment nanomaterial as the ‘670 publication teaches an advantage to include ensuring the delivery of several types of drug molecules [0034].
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the rejection over the ‘238 publication should be withdrawn as amended claim incorporated limitations of claims 20-21 which were not previously rejected.
In response, Applicant is referred to the newly applied rejections above based on Applicant’s claim amendments.
Applicant argues Ediriwickrema fails to teach two distinct JBNTs.
In response, Applicant is referred to the newly applied rejections above wherein Ediriwickrema is not used.
Applicant argues the double patenting rejections over 10,364,440 and 11,608,340 should be removed as they do not have the same inventive entity or a common Applicant and/or a common owner/assignee.
In response, the ‘340 patent and the ‘440 patent have a common invention, Yupeng Chen, and thus the double patenting rejections were proper. As noted in the withdrawn rejection section above, the double patenting rejections have been withdrawn based on Applicant’s claim amendments.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. 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.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
Prosecution Insights