DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, 9-10, 14-16, 18-19, 21 and 23 in the reply filed on 20 July 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-7, 9-10, 14-16, 18-19, 21, 23, 27-30 and 36-40 are pending; Claims 27-30 and 36-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-7, 9-10, 14-16, 18-19, 21 and 23 are subject to examination on the merits.
Priority
The instant application is a 371 of PCT/US2022/012360 filed 13 January 2022 which claims benefit US provisional application 63136762 filed 13 January 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 July 2023 has been considered by the examiner. See initialed and signed PTO/SB/08.
Drawings
Figures 1(a), 1(b), 1(e), Figure 4, Figure 5, should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Said drawings are featured as Figures 1(b), 1(a), 1(e), Figures 5(a) and 5(b), respectively, in Nepal et al., (JACS, 2016 – cited on previous PTO-892).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraph 0114.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 16 is objected to because of the following informalities: for consistency purposes, as the claim is dependent upon claim 15, it would be more consistent to state, “wherein the His-tagged EGFP is….”. 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.
Claim 23 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 23 states that the trimeric variant is encoded by SEQ ID NO: 1. However, SEQ ID NO: 1 is a peptide which does not encode anything. Rather nucleic acid sequences would encode SEQ ID NO: 1.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-7, 9-10, 14-16, 18-19, 21 and 23 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor had possession of the claimed invention.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The claims are drawn to a supramolecular assembly comprising:
a first set of peptide units, each peptide unit of the first set comprising a trimeric coiled-coil peptide comprising a first metal-binding ligand fused to a first end of a trimeric variant of a GCN4 peptide and a second metal-binding ligand fused to a second end of the trimeric variant of a GCN4 peptide, and the first set of peptide units forming a three-dimensional (3D) crystal; and at least one histidine-tagged (His-tagged) cargo reversibly incorporated into the 3D crystal, each cargo retaining a native structure and functional activity thereof and independently organized within or on the 3D crystal. The “variant of a GCN4 peptide” limitation makes the genus of supramolecular assemblies very large and very diverse. While GNC4 protein is well known in the art as an approximately 280 amino acid protein, what is not known and discerned from the art, other than that disclosed by Nepal et al., exactly which peptides and peptide variants of GCN4 will readily be able to form a supramolecular assembly comprised of GCN4 trimeric peptides that self assemble into 3D crystal with metal ligands being essential to the assembly process. The specification only provides one example of self-assembly via metal binding of GCN4 peptides and that is SEQ ID NO: 1 which is a 23 amino acid peptide. SEQ ID NO: 2, another GCN4 peptide variant having the glycines at each terminus removed, which can form crystals but only when mixed with SEQ ID NO: 1 and metal ions. SEQ ID NOs: 3-6 are variants of these two peptides with distinct amino acid requirements, however, none were utilized to make any 3-D crystals. However, there are no other examples of GCN4 peptides which form this function/capabilities. Even for SEQ ID NO: 1 (and SEQ ID NO: 2), it is unclear which amino acids of each sequence having as little as 75% sequence identity thereof can be tolerated and still form the required 3-D crystals (claims 19, 21 and 23). The unpredictability of forming 3-D protein/peptide crystals is considerable in the art (See, for example, Introduction of Nepal et al., 2016 – cited on previous PTO-892). The two single representative examples (e.g. SEQ ID NO: 1/GCN4-2pL or SEQ ID NO: 2+1 in a ratio of 2:1, respectively, are the only examples of the entire large, variable and unpredictable genus, however, this is not deemed representative of the genus as claimed in terms of structure and function.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nepal et al. (JACS, 2016 – cited on previous PTO-892).
Nepal et la. teach:
Regarding claims 1 and 6, a supramolecular assembly comprising: a first set of peptide units, each peptide unit of the first set comprising a trimeric coiled-coil peptide comprising a first metal-binding ligand fused to a first end of a trimeric variant of a GCN4-p2L peptide and a second metal-binding ligand fused to a second end of the trimeric variant of a GCN4 peptide; specifically metal binding ligands are NTA fused to the N-terminus and a di-histidine (His2) at the C-terminus, with glycine residues acting as linkers, and the first set of peptide units forming a three-dimensional (3D) crystal upon addition of a metal ion; and histidine-tagged (His-tagged) fluorophores reversibly incorporated into the 3D crystal, each cargo retaining a native structure and functional activity thereof and independently organized on or within the 3D crystal – See Abstract, Figure 1 (reproduced below), p. 11053, 2nd col., Assembly as a Function of Metal Ions, p. 11054, 2nd Col., His-Tag-Directed Inclusion of Guests within Crystals, Figure 6.
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Regarding claim 2, the addition of the chelator EDTA results in complete dissolution of the 3-D crystal and thus release of the cargo (See p. 11053, 2nd col., Assembly as a Function of Metal Ions).
Regarding claims 3-5, the metal ion Zn(II) was used for self assembly, however, Co(II), Cu(II) and Ni(II) were also successful in form crystals - (See p. 11053, 2nd col., Assembly as a Function of Metal Ions; Figures 1 and 2).
Regarding claims 7 and 10, His-tagged fluorescein cargo having 0.1 mM of was incorporated into a 3-D crystal made by a 1:1 ratio of GCN4-p2L peptide and metal – See p. 11054-11055, His-Tag-Directed Inclusion of Guests).
Finally, it is noted that the GCN4-p2L peptide has 100% sequence identity to instant SEQ ID NO: 1 (See Figure 1).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 15 September 2026
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