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 .
Response to Amendment
The Amendment filed 09/16/2025 in which claims 29, 40-42, 45-47, 49, 51, 55, 56 were amended; new claims 59-64 were added; claims 43-44, 48, 50, 57-58 were canceled, has been entered. Claims 1-28 and 30-39 were previously canceled.
Claim 29, 40-42, 45-47, 49, 51-56, 59-64 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 09/16/2025 after the mailing date of the Non-Final Office Action mailed on 06/16/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 09/16/2025 have overcome the objections previously set forth in the Non-Final Office Action mailed on 06/16/2025. It is noted that the new title of instant application as presented in the amended Specification is “Modified portal proteins and uses thereof”.
Claim Objections
(Previous objections, withdrawn as to claims 40 and 48). Applicant’s amendments to claims 40 have overcome previous objections to claim 40. The previous objection of claim 48 is moot in view of Applicant’s cancelation of this claim.
(New objections, as to claims 47, 59, 60). Claims 47, 59, and 60 are objected to because of the following informalities:
The recitation on claim 47 of “phi29 portal protein-comprises addition and/or deletion…” should read “phi29 portal protein comprises an addition and/or a deletion…” (no hyphen between words “protein” and comprises” is needed).
The recitation on claim 59 of “phi29 portal protein comprises deletion of 7…” should read “phi29 portal protein comprises a deletion of 7…”
The recitation on claim 60 of “comprises addition of isoleucine (I) and leucine (L) residues at the N-terminus” should read “comprises an addition of an isoleucine (I) and a leucine (L) residues at the N-terminus”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
(Previous interpretation – withdrawn as to claims 55 and 56) Claims 55 and 56 were previously interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof, given the previous recitations of “means for applying a voltage potential” and “means for detecting” in claims 55 and 56.
See claims 55 and 56 as submitted on 09/16/2025.
Based on Applicant’s amendments to claims 55 and 56, which no longer recite “means for applying a voltage potential” and “means for detecting”, the previous interpretation of these claims under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is no longer invoked.
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.
(Previous rejection, withdrawn as to claims 45, 46, 55 and 56) Claims 45, 46, 55 and 56 were 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.
See claims 45, 46, 55 and 56 as submitted on 09/16/2025.
Applicant’s amendments to claims 45, 46, 55 and 56 have overcome previous rejections to those claims.
(Previous rejection, withdrawn as to claims 55 and 56) Claims 55 and 56 were indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph for failing to clearly link the structure recited within the instant disclosure for the recited “means.”
See claims 55 and 56 as submitted on 09/16/2025.
Based on Applicant’s amendments to claims 55 and 56, which no longer recite “means for applying a voltage potential” and “means for detecting”, the previous rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph for failing to clearly link the structure recited within the instant disclosure for the recited “means” is herein withdrawn.
(New rejection, necessitated by amendment as to claim 47) Claim 47 is 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.
See claim 47 as submitted on 09/16/2025.
Regarding claim 47, the amended claim recites “the modified phi29 portal protein-comprises addition and/or deletion of one or more amino acid residues at the N-terminus relative to the portal protein…” It is unclear if this recitation refers to the modification already recited in claim 29 (“wherein the modified phi29 portal protein comprises one or more hydrophobic amino acid residues introduced within 30 amino acids of its N-terminus”) or if the indicated recitation in claim 47 refers to a second modification of the modified phi29 portal protein. The indicated recitation in claim 47 lacks the term “further comprising” or equivalent to introduce a second modification. Therefore, the claim is indefinite. For purposes of compact prosecution and applying prior art, claim 47 was interpreted herein as referring to the same modification as recited in claim 29 and/or a second modification of the modified phi29 portal protein.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
(Previous rejection, withdrawn as to claims 29, 40-58) Claims 29, 40-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 29, 40-58 as submitted on 09/16/2025.
In view of Applicant’s amendments to the instant claims indicating the narrower language “phi29 portal protein” and “within 30 amino acids of its N-terminus” in claim 29 and specific insertion sites in claims 45, 46, the previous rejection under 35 U.S.C. 112(a) is herein withdrawn.
(Previous rejection, withdrawn as to claims 55 and 56) Claims 55 and 56 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 55 and 56 as submitted on 09/16/2025.
Applicant’s amendments to claims 55 and 56, which no longer recite “means for applying a voltage potential” and “means for detecting”, have overcome previous rejection to those claims.
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.
(Previous rejection, withdrawn as to claims 29, 40-44, 47-50, 52, 54-58) Claims 29, 40-44, 47-50, 52, 54-58 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Guo (prior art of record).
See claims 29, 40-44, 47-50, 52, 54-58 as submitted on 09/16/2025.
The previous rejections of claims 43, 44, 48, 50, 57, 58 is moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to instant claims has overcome previous rejection to claims 29, 40-42, 47, 49, 52, 54-56. Specifically, Applicant’s amendments to independent instant claim 29 which recites the narrower language “phi29 portal protein” and “within 30 amino acids of its N-terminus” in claim 29 has overcome previous rejection to the instant claims.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 45, 46, 51 and 53; expanded as to claims 29, 40-42, 47, 49, 52, 54-56, 59-64) Claims 45, 46, 51, 53, 29, 40-42, 47, 52, 54-56, 49 and 59-64 are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Hague et al. (prior art of record).
See claims 45, 46, 51, 53, 29, 40-42, 47, 52, 54-56, 49 and 59-64 as submitted on 09/16/2025.
Regarding claim 29, it is noted that the amendment filed on 09/16/2025 introduced two new limitations. First, with respect to the new limitation of “a modified phi29 portal protein”, it is noted that this limitation is already disclosed by Guo (columns 5, 6).
With respect to the new limitation of “one or more hydrophobic residues introduced within 30 amino acids of its N-terminus”, It is noted that Guo teaches DNA-packaging motor connector proteins modified for retention and functional incorporation in membrane layers such as phospholipid bilayers by insertion of hydrophobic amino acid side chains (columns 23, 33, 34), for example a flexibility domain comprising a polypeptide of 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 or 18 contiguous uncharged (hydrophobic) amino acids fused at the N-terminus (columns 8, 9, claim 1). Guo does not explicitly teach wherein the hydrophobic amino acid residues are “introduced within 30 amino acids of its N-terminus.”
However, Hague et al. teach a modified phi29 portal protein gp10 wherein hydrophobic residues are introduced within 30 amino acids of its N-terminus to facilitate functionalization of nanopores or insertion in membranes (page 8). For example, Hague et al.’s SEQ ID NO:36 (page 16) comprises a modified phi29 portal protein gp10 wherein the hydrophobic residue leucine is introduced at a position corresponding to R10, within 30 amino acids of its N-terminus.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the amino acid modifications as taught by Hague et al. to the phi29 portal protein gp10 taught by Guo for the benefit of facilitating functionalization of nanopores or insertion in membranes
One of ordinary skill in the art would have had reasonable expectation of success in introducing the mutations taught by Hague et al. to the pg10 protein of Guo given that the methods of mutagenesis are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29. Further, as previously explained, Guo teaches all of the other limitations of the method of claim 29. Specifically, Guo teaches a method of characterizing a target analyte comprising DNA packaging motor proteins, for example a modified phi29 portal protein (Abstract, columns 1, 5, 6, 11, Fig. 21), the method comprising the following steps:
a) contacting a modified portal protein inserted in a membrane with the target analyte, wherein the modified portal protein comprises a modified bacteriophage phi29 procapsid containing a reengineered motor connector protein having an insertion of hydrophobic amino acid side chains (columns 23, 33, 34), for example a flexibility domain comprising a polypeptide of 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 or 18 contiguous uncharged (hydrophobic) amino acids fused at the N-terminus (columns 8, 9).
b) applying a voltage potential across the membrane such that the target analyte translocases through the aperture of the connector phi29 protein to one side of the conductive channel-containing membrane (“moves with respect to the modified portal protein”, as recited in claim 29) (columns 8, 11, 12; Figs.1, 4, 5, 21)
c) taking one or more measurements as the target analyte moves with respect to the modified phi29 portal protein, thereby determining the presence, absence or one or more characteristics of the target analyte (columns 11, 12).
Regarding amended claim 40, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29. Guo further teaches a method of characterizing a target analyte (Abstract, columns 1, 11, Fig. 21), as described above, wherein the modified phi29 portal protein comprises an additional hydrophobic polypeptide attached to its surface-exposed side chains in such a manner as to alter ( e.g., increase or decrease in a statistically relevant manner relative to an appropriate control) interactions with a membrane (columns 33, 34, 57).
Regarding claims 41 and 42, it is noted that the only amendment to claims 41 and 42 is the recitation of “phi29” which is already taught by Guo as explained above. As previously indicated, Guo teaches a viral DNA packaging motor connector protein wherein its outer surface polypeptide sequence is modified by substitution or insertion of one or more amino acids (column 34).
Regarding claim 47, as discussed above, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29. Hague et al. teach a modified phi29 portal protein gp10 wherein hydrophobic residues are added or deleted within 30 amino acids of its N-terminus to facilitate functionalization of nanopores or insertion in membranes (page 8). For example, Hague et al.’s SEQ ID NO:36 (page 16) comprises a modified phi29 portal protein gp10 wherein the hydrophobic residue leucine is introduced at a position corresponding to R10, and the sequence bears a deletion of 7 amino acid residues at the N-terminus (page 16).
Regarding claim 52, as previously indicated, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29. Guo further teaches wherein the membrane is a lipid membrane (Abstract, column 17, Fig 6).
Regarding claim 54, as previously indicated, Guo further teaches an array of two or more membranes (column 14, Fig. 1D).
Regarding claims 55 and 56, it is noted that the amended claims no longer recite “means for applying a voltage potential” and “means for detecting”. The amended claims recite instead “an electrode that provides a voltage potential…” and “a detector that detects electrical charges…” These limitations are already taught by Guo. Specifically, Guo teaches an array (column 14, Fig. 1D) comprised in a device with synchronous optical and electrical design setup such as electrodes capable of supplying voltage potential, as well as an imaging system capable of generating an output or readout (detector, as recited in claim 55) (columns 53, 60, Examples 4, 9). Further, Guo teaches a planar bilayer membrane (BLM) systems comprising a microfluidic chamber (fluidics system, as recited in claim 56) comprising a buffer that supplies a sample to the membranes of the array (columns 58, 60, Example 9).
Regarding claims 45, 59-61, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29 as explained in detail above. Guo does not explicitly teach one of the one or more amino acid residues is introduced at a position corresponding to R10, E14, R17, Q18, R22, F24 and/or L28 of a portal protein of a wild type phi29 DNA packaging motor.
However, as explained above Hague at al. teach a modified phi29 portal protein gp10, SEQ ID NO:36 (page 16), wherein one or more amino acids is introduced at a position corresponding to R10, E14, R17. Hague at al. teach such modifications facilitate functionalization of nanopores or insertion in membranes (page 8). Further, Hague’s SEQ ID NO:36 comprises a deletion of 7 amino acid residues at the N-terminus, and an addition of an isoleucine (I) and a leucine (L) residues at the N-terminus (N-ter-I-L) relative to a portal protein of a wild type phi29 DNA packaging motor. The combined modifications in Hague’s SEQ ID NO:36 result in the following mutations: R10L, E14V, R17L, N-ter-7A, and N-ter-I-L which corresponds to the species in d) of claim 61 (page 16).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the amino acid modifications as taught by Hague et al. to the phi29 portal protein gp10 taught by Guo for the benefit of optimizing portal proteins for pore assembly.
One of ordinary skill in the art would have had reasonable expectation of success in introducing the mutations taught by Hague et al. to the pg10 protein of Guo given that the methods of mutagenesis are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding amended claim 46, the teachings of Guo and Hague et al. in combination render obvious the method of claim 40 wherein the modified phi29 portal protein comprises an additional hydrophobic polypeptide attached to its surface-exposed side chains in such a manner as to alter ( e.g., increase or decrease in a statistically relevant manner relative to an appropriate control) interactions with a membrane (columns 33, 34, 57). Hague et al. teach many mutation points along a phi29 portal protein sequence. For example, Hague et al. teach A79, E135, Q168 as the mutation points (pages 8, 37, 52, SEQ ID NO:35). The teachings of Guo and Hague et al. in combination render the limitations of amended claim 46 obvious. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding amended claims 49 and 51, the teachings of Guo and Hague et al. in combination teach the method of claims 40 and 46. As previously explained, Hague et al. further teach a hydrophobic molecule comprising porphyrin conjugated to the modified phi29 portal protein via cysteine residues (cysteine's sulfhydryl groups) or a non-natural amino acid for the benefit of facilitating insertion of the portal protein into a membrane (page 35).
Regarding claim 53, as previously explained, Hague et al. further teach a diblock or triblock copolymer membrane which offers stability due to the presence of a thick and rigid bilayer and contain a hydrophilic core that provides a protein-affable environment (page 35).
Regarding claims 62 and 63, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29 as explained in detail above. Guo further teaches the limitations recited in claims 62 and 63 of “wherein multiple target analytes are characterized”, and “wherein the target analyte is a polynucleotide, protein, peptide, carbohydrate or metabolite”. Specifically Guo teaches the method of claim 29 wherein a plurality of target analytes are provided in a solvent such as an aqueous solvent (columns 19, 20) and wherein the target analytes include biopolymers ( e.g., proteins, glycoproteins, peptides, glycopeptides, oligosaccharides, polysaccharides, lipids, glycolipids, phospholipids, etc.) and other biomolecules ( e.g., soluble mediators, cofactors, vitamins, bioactive lipids, metabolites, and the like) (column 19).
Regarding claim 64, as previously indicated, the teachings of Guo and Hague et al. in combination render obvious the method of amended claim 29. Guo further teaches wherein the membrane is a lipid membrane (Abstract, column 17, Fig 6).
Accordingly, the limitations of claims 45, 46, 51, 53, 29, 40-42, 47, 52, 54-56, 49 and 59-64 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
The rejection is maintained for reasons of record.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Previous rejection, withdrawn as to claims 29 and 40-44, 47-58) Claims 29 and 40-44, 47-58 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 24 of copending application No. 16969518.
See claims 29 and 40-44, 47-58 as submitted on 09/16/2025.
See copending claims 1 and 24 as submitted on 10/10/2025.
The previous rejections of claims 44, 48, 50, 57, and 58 is moot in view of Applicant’s cancelation of these claims.
In view of Applicant’s amendments to independent instant claim 29 which recites the narrower language “phi29 portal protein” and “within 30 amino acids of its N-terminus” in claim 29, the previous provisional rejection on the ground of nonstatutory double patenting is herein withdrawn.
(Previous rejection, withdrawn as to claims 29 and 40-44, 47-58) Claims 29 and 40-44, 47-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of US patent No. 11980849 B2 to Jordan, Lakmal et al.
See claims 29 and 40-44, 47-58 as submitted on 09/16/2025.
The previous rejections of claims 44, 48, 50, 57, and 58 is moot in view of Applicant’s cancelation of these claims.
In view of Applicant’s amendments to independent instant claim 29 which recites the narrower language “phi29 portal protein” and “within 30 amino acids of its N-terminus” in claim 29, the previous rejection on the ground of nonstatutory double patenting is herein withdrawn.
(Previous rejection, withdrawn as to claims 29 and 40-44, 47-58) Claims 29 and 40-44, 47-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23 of copending application No. 18661820.
See claims 29 and 40-44, 47-58 as submitted on 09/16/2025.
See copending claims 1 and 23 as submitted on 05/13/2024.
The previous rejections of claims 44, 48, 50, 57, and 58 is moot in view of Applicant’s cancelation of these claims.
In view of Applicant’s amendments to independent instant claim 29 which recites the narrower language “phi29 portal protein” and “within 30 amino acids of its N-terminus” in claim 29, the previous provisional rejection on the ground of nonstatutory double patenting is herein withdrawn.
Response to Arguments
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive.
Applicant contends on page 14 of the Remarks submitted on 09/16/2025:
“Rejections Under 35 U.S.C. § 103
The combination of Guo and Hague is not sufficient to establish a prima facie case of obviousness with respect to the amended claims because none of the cited references, alone or in combination, discloses each element of the amended claims. Guo does not teach or suggest one or more hydrophobic amino acid residues introduced within about 30 amino acids of the N-terminus of a monomer of a modified phi29 portal protein. Hague does not remedy this deficiency at least because Hague also does not disclose or suggest the claim elements missing from Guo. For at least this reason, the combination of cited references is not sufficient to establish a prima facie case of obviousness with respect to the amended claims”.
In response:
As explained in detail above, the combination of the teachings of Guo and Hague et al. accounts for the exact and complete limitations recited in the instant claims. For example, Hague et al.’s SEQ ID NO: 36 bears the exact modifications of a phi29 portal protein gp10 as recited in instant claims 45, 59-61. Further, Hague et al. teaches the exact species recited in instant claims, Hague et al.’s SEQ ID NO: 36 comprises the following modifications: R10L, E14V, R17L, N-ter-7A, and N-ter-I-L which corresponds to the exact species in d) of claim 61 (page 16). Further, as evidenced by the teachings of Guo and Hague et al. it is noted that the phi29 portal protein has been extensively studied. Mutations sites, modifications, etc within the phi29 portal protein sequence have been mapped out and are well known in the art. The phenotypes corresponding to said mutations and modifications have also been extensively characterized. Accordingly, it is herein submitted that the claimed invention is rendered obvious by the cited prior art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached on (571)270-0684. 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.
/MARLENE V BUCKMASTER/Examiner, Art Unit 1671
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672