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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9, 12, 13, 16-18, and 24) drawn to a composition; and Applicants’ election of species without traverse of SEQ ID NO: 1
(VLTTGLPALISWIRRRHRRHC) in the reply filed on June 10, 2026 is acknowledged.
The species of group I, therefore claims 1-9, 12, 13, 16-18, and 24 which read on the elected species has been considered.
Claims 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 10, 2026.
Priority
This application is a 371 of PCT/US2022/023609, filed April 6, 2022.This application claims the benefit of priority to United States Provisional Application No. 63/171,176, filed April 6, 2021.
Status of Claims
Claims 1-9, 12, 13, 16-24 are pending. Claims 19-23 are withdrawn for further consideration.
Claims 1-9, 12, 13, 16-18, and 24 are currently examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2023 and 12/13/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 5, [0049], line 31). 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.
The use of the terms Therma Scientific, Tween, Span, and Brij, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology and correct spellings; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
Claims 1-5, 9, 12, 13, 16, 18, and 24 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 20200353036 (published November 12, 2020, cited in IDS filed 10/06/2023).
For claim 1: US’036 discloses a pharmaceutical composition comprising a peptide-polynucleotide complex, the peptide-polynucleotide complex comprising: a peptide; a polynucleotide; and hyaluronic acid; wherein the peptide is non-lytic and capable of affecting the release of a polynucleotide from an endosome of a cell; and wherein the peptide comprises an amino acid sequence with at least 80% identity to the amino acid sequence of SEQ ID NO: 1 (VLTTGLPALISWIRRRHRRHC) (see claim 1, and [0008]).
US’036 teaches wherein the non-coding RNA is an siRNA (see claim 9). US’306 discloses the polynucleotide is an RNA; in some embodiments, the polynucleotide is a non-coding RNA capable of regulating or inhibiting the expression of a nucleic acid sequence; in some embodiments, the non-coding RNA is an siRNA (see [0011]). US’036 also discloses the polynucleotide is a non-coding RNA capable of regulating or inhibiting the expression of a nucleic acid sequence (see claim 8). This is in correlation with the instant specification which defines “small interfering RNA (siRNA) which is capable of regulating or inhibiting the expression of a viral ribonucleotide expressed in a virus-infected cell. In general, an siRNA of the present disclosure is capable of disrupting expression of a viral ribonucleotide sequence expressed in a virus-infected cell. As used herein, "disrupting expression of a viral polynucleotide" may be used to describe any decrease in the expression level of a viral ribonucleotide, or a protein translated from the viral ribonucleotide, when compared to a level of expression of the viral ribonucleotide in a virus-infected cell that was not treated with a peptide-siRNA complex of the present invention (see instant Specification, page 10-11).
For claim 2: US’036 discloses the peptide-polynucleotide complex is about 10 nm to about 150 nm in diameter (see claim 2).
For claim 3: US’036 discloses in some embodiments, the peptide-polynucleotide complex is about 40 nm to 60 nm in diameter (see [0071]); in some embodiments, the peptide-polynucleotide complex is about 60 nm to 80 nm in diameter(see [0071]).
For claim 4: US’036 discloses the composition wherein the hyaluronic acid coats the peptide-polynucleotide complex (see claim 4).
For claim 5: US’036 discloses the composition wherein the hyaluronic acid is integrated into the peptide-polynucleotide complex (see claim 5).
For claim 9: US’036 teaches the peptide comprises an amino acid sequence with at least 85% identity to the amino acid sequence of SEQ ID NO: 1; in some embodiments, the peptide comprises an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1; in some embodiments, the peptide comprises an amino acid sequence with at least 95% identity to the amino acid sequence of SEQ ID NO: 1 (see [0012]).
For claim 12: US’036 teaches that the composition wherein the peptide comprises SEQ ID NO: 1 (see claim 12) (i.e., SEQ ID NO:1 has amino acid sequence VLTTGLPALISWIRRRHRRHC).
For claim 13: US’036 teaches the peptide consists of an amino acid sequence with at least 80% identity to the amino acid sequence of SEQ ID NO: 1; wherein the peptide consists of an amino acid sequence with at least 85% identity to the amino acid sequence of SEQ ID NO: 1; in some embodiments, the peptide consists of an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1; and in some embodiments, the peptide consists of an amino acid sequence with at least 95% identity to the amino acid sequence of SEQ ID NO: 1 (see [0013]).
For claim 16: US’036 teaches that the composition wherein the peptide consists SEQ ID NO: 1 (see claim 13) (i.e., SEQ ID NO:1 has amino acid sequence VLTTGLPALISWIRRRHRRHC).
For claim 18: US’036 teaches the peptide-polynucleotide complex comprises a ratio of peptide:polynucleotide that is more than about 50:1 and less than about 200:1 (see [0014]); wherein the polynucleotide is a non-coding RNA (see claim 8); wherein the non-coding RNA is an siRNA (see claim 9).
For claim 24: US’036 teaches a kit for preparing a peptide-polynucleotide complex, the kit comprising a first composition comprising a peptide, a second composition comprises a polynucleotide, and a third composition comprising hyaluronic acid (HA) (see claim 20). US’306 discloses the polynucleotide is an RNA; in some embodiments, the non-coding RNA is an siRNA (see [0011]).
Accordingly, the claims are anticipated.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-9, 12, 13, 16-18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200353036 (published November 12, 2020, cited in IDS filed 10/06/2023), as previously applied to claims 1-5, 9, 12, 13, 16, 18, and 24, and further in view of US 20070203082 (published on August 30, 2007, cited in IDS filed 10/06/2023), and Ullah et. al. (“Nanoparticles-assisted delivery of antiviral-siRNA as inhalable treatment for human respiratory viruses: A candidate approach against SARS-COV-2”; Ata Ullah, Javaria Qazi, Lutfur Rahman, Antonios G. Kanaras, Waheed S. Khan, Irshad Hussain, Asma Rehman; Nano Select 2020;1:612–621; published October 12, 2020).
US’036 teaches about nanoparticles and methods for polynucleotide transfection (see [0003]) and discloses pharmaceutical composition comprising a peptide-polynucleotide complex, the peptide-polynucleotide complex comprising: a peptide; a polynucleotide; and hyaluronic acid; wherein the peptide is non-lytic and capable of affecting the release of a polynucleotide from an endosome of a cell (see [0008]). As noted above, this reference anticipates claims 1-5, 9, 12, 13, 16, 18, and 24.
The difference between this reference and the remaining claims is that it does not specify the additional components of the composition, i.e., siRNA interfering with RNA genome of severe acute respiratory syndrome coronavirus.
US’082 teaches compositions and methods that are useful for the treatment of severe acute respiratory syndrome (SARS), nucleic acid agents such as siRNA molecules and their analogues that target respiratory infections including SARS coronavirus and their methods of use, for clinical treatments of SARS (see Abstract). US’082 teaches mechanism of action of SARS-CoV specific siRNA duplexes for inhibition of the viral infection and replication in mammals (see [0009]), and target sequences for siRNA-mediated disruption of corona virus viral RNA genome in coding and non-coding regions (see [0011]).
US’082 discloses novel RNA interference (RNAi) agents and delivery methods for the inhibition of SARS-coronavirus (SARS-CoV) activity or other virus; provides inhibition of viral production of key proteins required for replication, infection, and other functions critical to the virus lifecycle; and also provides disruption of the viral genome RNA directly (see [0005]). US’082 provides sequences of RNAi agent, small interfering RNA (siRNA), that can be chemically synthesized or vector expressed, in vitro transcribed and vector expressed shRNA; siRNA, miRNA and other types of siRNA molecules, having potent antiviral activity in mammalian cells and animals (see [0006]). This reference links peptide-polynucleotide complex comprising: a peptide; a polynucleotide; and hyaluronic acid composition taught by US’036 to specific siRNA (i.e., siRNA of SARS-CoV) components of the composition in the instant therapeutic composition. Therefore, it would have been obvious to combine the teaching of US’036 and US’082 before the effective filing date of the claimed invention by considering a peptide-polynucleotide complex, comprising a peptide; a polynucleotide; and hyaluronic acid as an effective and stable nanoparticles and methods of SARS-CoV siRNA polynucleotide transfection as in the instantly claimed invention. One of ordinary skill in the art would have been motivated to utilize the novel nanoparticles taught by US’036 as potent siRNA therapeutics modified for enhanced activity with a reasonable expectation of success in improving delivery efficiency and maximize therapeutic windows of RNA therapeutics (see US’036 [0005]) in addition to providing novel RNA interference agents and delivery methods for the inhibition of SARS-coronavirus (SARS-CoV) activity or other virus (see US’082 [0005]). Thus, one skilled in the art can combine the teachings to formulate composition or use in methods of delivering polynucleotides into cells and for use in improved therapeutic and pharmaceutical compositions (see US’036 [0005]) for efficient delivery of siRNA into the airways of animal model for treating SAR-CoV (see US’082 [0008]).
Regarding claim 17; US’082 teaches novel RNA interference (RNAi) agents and delivery methods for the inhibition of SARS-coronavirus (SARS-CoV) activity or other virus; provides inhibition of viral production of key proteins required for replication, infection, and other functions critical to the virus lifecycle; and also provides disruption of the viral genome RNA directly (see [0005]).
Both US’036 and US’082 are silent about hyaluronic acid-ACE2 conjugates that specifically recognizes or binds to SARS-CoV-2.
Ullah et. al. discusses nanodelivery systems to assist the endosomal release of siRNA into cytosol to induce RNA interference pathway; features incorporated to the nanocarriers for efficient release of siRNA payload on targeted site; once the RNA interference pathway becomes active, it leads to the cleavage of viralRNA at the targeted sites to block the viral replication reducing the viral load and helping to cure the viral infection (see page 617, right col). Ullah et. al. teaches sequence specific siRNA is proven to be effective against human respiratory viruses and hence can be potentially utilized against SARS-CoV-2; and siRNA encapsulation in multifunctional nanocarriers is very likely to address the siRNA delivery issues and facilitate their controlled, sustained and unprecedented stimuli responsive targeted delivery (see page 618, left col).
Regarding claims 6-8, Ullah et. al specifically discusses about the nanocarriers functionalized with anti-ACE2 antibodies could be utilized to target the ACE2 cell surface markers and deliver siRNA cargos (see page 617, left col). Ullah et. al further teaches about the conjugation of targeting moiety (antibodies) against ACE2 markers to nanocarriers could be to target all the cells and organs having ACE2 surface markers and, therefore, broadens the scope of siRNA based therapy spectrum (see page 617, left col-right col).
Therefore, it would have been obvious to combine the teachings of US’036, US’082, and Ullah et. al. before the effective filing date of the claimed invention by considering a peptide-polynucleotide complex, comprising a peptide; a polynucleotide; and hyaluronic acid as an effective and stable nanoparticles and methods for polynucleotide transfection through targeting of the ACE2 surface marker in the instantly claimed invention. One of ordinary skill in the art would have been motivated to utilize the novel hyaluronic acid coated and/or integrated nanoparticles taught by US’036 as potent siRNA therapeutics modified for improved activity (see US’082) by modifying the targeting moiety for ACE2 receptor (see Ullah et. al. page 617, Figure 3) with a reasonable expectation of success to enhance delivery efficiency and maximize therapeutic windows of RNA therapeutics (see US’036 [0005]) in addition to providing novel RNA interference agents and delivery methods for the inhibition of SARS-coronavirus (SARS-CoV) activity or other virus (see US’082 [0005]). Thus, one skilled in the art can combine the teachings to formulate composition or use in methods of delivering polynucleotides into cells and for use in improved therapeutic and pharmaceutical compositions (see US’036 [0005]) for efficient delivery of siRNA into the airways of animal model for treating (see US’082 [0008]) and address the siRNA delivery issues and facilitate their controlled, sustained and unprecedented stimuli responsive targeted delivery in SARS-CoV-2 (see Ullah et. al., page 618, left col).
Therefore, the presently claimed invention was prima facie obvious to one of ordinary skill in the art at the time of the effective filing date.
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.
Claims 1-5, 9, 12, 13, 16, 18, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8, 9, 11, and 12 of Patent No. 11,529,388, issued December 20, 2022. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 recites a pharmaceutical composition comprising a peptide polynucleotide complex, the peptide-polynucleotide complex comprising: a peptide; a polynucleotide; and hyaluronic acid; wherein the peptide is non-lytic and capable of affecting the release of a polynucleotide from an endosome of a cell; and wherein the peptide comprises SEQ ID NO: 1; wherein the polynucleotide is a non-coding RNA (see claim 8); wherein the non-coding RNA is an siRNA (see claim 9).
SEQ ID NO: 1 claimed by US’388 is a species of the instantly claimed amino acid sequence of SEQ ID NO: 1 i.e., VLTTGLPALISWIRRRHRRHC. Therefore, the reference claims anticipate instant claim 1.
Regarding claim 2: US’388 recites the composition of claim 1, wherein the peptide-polynucleotide complex is about 10 nm to about 150 nm in diameter (claim 2).
Regarding claim 3: US’388 specifies in some embodiments, the peptide-polynucleotide complex is about 40 nm to 60 nm in diameter (see col 12, line 7-8); in some embodiments, the peptide-polynucleotide complex is about 60 nm to 80 nm in diameter(see col 12, line 3-5).
Regarding claim 4: US’388 recites the composition wherein the hyaluronic acid coats the peptide-polynucleotide complex (see claim 4).
Regarding claim 5: US’388 recites the composition wherein the hyaluronic acid is integrated into the peptide-polynucleotide complex (see claim 5).
Regarding claim 9: US’388 specifies the peptide comprises an amino acid sequence with at least 85% identity to the amino acid sequence of SEQ ID NO: 1; in some embodiments, the peptide comprises an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1; in some embodiments, the peptide comprises an amino acid sequence with at least 95% identity to the amino acid sequence of SEQ ID NO: 1 (see [0012]). SEQ ID NO: 1 (see claim 1) claimed by US’388 is a species of the instantly claimed amino acid sequence of SEQ ID NO: 1 i.e., VLTTGLPALISWIRRRHRRHC.
Regarding claim 12: US’388 recites that the composition wherein the peptide comprises SEQ ID NO: 1 (see claim 11) (i.e., SEQ ID NO:1 has amino acid sequence VLTTGLPALISWIRRRHRRHC).
Regarding claim 13: US’388 specifies the peptide consists of an amino acid sequence with at least 80% identity to the amino acid sequence of SEQ ID NO: 1; wherein the peptide consists of an amino acid sequence with at least 85% identity to the amino acid sequence of SEQ ID NO: 1; in some embodiments, the peptide consists of an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1; and in some embodiments, the peptide consists of an amino acid sequence with at least 95% identity to the amino acid sequence of SEQ ID NO: 1 (see col 2, line 39-48).
Regarding claim 16: US’388 recites that the composition wherein the peptide consists SEQ ID NO: 1 (see claim 11) (i.e., SEQ ID NO:1 has amino acid sequence VLTTGLPALISWIRRRHRRHC).
Regarding claim 18: US’388 recites the peptide-polynucleotide complex comprises a ratio of peptide:polynucleotide that is more than about 50:1 and less than about 200:1 (see claim 12); wherein the polynucleotide is a non-coding RNA (see claim 8); wherein the non-coding RNA is an siRNA (see claim 9).
Regarding claim 24: US’388 specifies a kit for preparing a peptide-polynucleotide complex, the kit comprising a first composition comprising a peptide, a second composition comprises a polynucleotide, and a third composition comprising hyaluronic acid (HA) (see col 2, line 65-67, col 3, line 1-2). US’306 discloses the polynucleotide is an RNA; in some embodiments, the non-coding RNA is an siRNA (see col 2, line 22-26). US’388 recites a pharmaceutical composition comprising a peptide polynucleotide complex, the peptide-polynucleotide complex comprising: a peptide; a polynucleotide; and hyaluronic acid; wherein the peptide is non-lytic and capable of affecting the release of a polynucleotide from an endosome of a cell; and wherein the peptide comprises SEQ ID NO: 1 (see claim 1) (i.e., SEQ ID NO:1 has amino acid sequence VLTTGLPALISWIRRRHRRHC); wherein the polynucleotide is a non-coding RNA (see claim 8); wherein the non-coding RNA is an siRNA (see claim 9).
Claims 1-9, 12, 13, 16-18, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8, 9, 11, and 12 of U.S. Patent No. 11,529,388, issued December 20, 2022 as discussed above and in view of Ullah et. al. (“Nanoparticles-assisted delivery of antiviral-siRNA as inhalable treatment for human respiratory viruses: A candidate approach against SARS-COV-2”; Ata Ullah, Javaria Qazi, Lutfur Rahman, Antonios G. Kanaras, Waheed S. Khan, Irshad Hussain, Asma Rehman; Nano Select 2020;1:612–621; published October 12, 2020).
The claims of US’388 are as discussed above.
The claims of US’388 differ from the instant claims in that they do not claim that the additional components of the composition, i.e., siRNA interfering with RNA genome of severe acute respiratory syndrome coronavirus (SARS-CoV) nor claim about conjugation of hyaluronic acid-ACE2 that specifically recognizes or binds to SARS-CoV-2.
The teachings of Ullah et. al. are discussed above.
Ullah et. al. specifies about the nanocarriers functionalized with anti-ACE2 antibodies could be utilized to target the ACE2 cell surface markers and deliver siRNA cargos (see page 617, left col). Ullah et. al further teaches about the conjugation of targeting moiety (antibodies) against ACE2 markers to nanocarriers could be to target all the cells and organs having ACE2 surface markers and, therefore, broadens the scope of siRNA based therapy spectrum (see page 617, left col-right col). Ullah et. al. further teaches sequence specific siRNA is proven to be effective against human respiratory viruses and hence can be potentially utilized against SARS-CoV-2 (see page 618, left col).
It would have been prima facie obvious to one of ordinary skill in the art to modify the claims of US’388 to include the use of novel hyaluronic acid coated and/or integrated nanoparticles by modifying the targeting moiety for ACE2 receptor, including those taught by Ullah et. al. An ordinarily skilled artisan would have had a reasonable expectation of success in modifying the claims of US’388 and Ullah et. al. to formulate composition or use in methods of delivering polynucleotides into cells and for use in improved therapeutic and pharmaceutical compositions to enhance delivery efficiency and maximize therapeutic windows of RNA therapeutics and facilitate targeted delivery in SARS-CoV-2.
Claims 1-9, 12, 13, 16-18, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8, 9, 11, and 12 of U.S. Patent No. 11,529,388, issued December 20, 2022 as discussed above, and in view of Ullah et. al. (“Nanoparticles-assisted delivery of antiviral-siRNA as inhalable treatment for human respiratory viruses: A candidate approach against SARS-COV-2”; Ata Ullah, Javaria Qazi, Lutfur Rahman, Antonios G. Kanaras, Waheed S. Khan, Irshad Hussain, Asma Rehman; Nano Select 2020;1:612–621; published October 12, 2020), and further in view of claims 1, 4-6, 12-15 of Patent No. 9,987,371, issued June 5, 2018 (cited in IDS filed December 13, 2024).
The claims of US’388 anticipate instant claims 1-5, 9, 12, 13, 16, 18, and 24 as discussed above.
The teachings of Ullah et. al. render obvious instant claims 6, 8 and 17 as discussed above.
Regarding claims 1 and 18, US’371 recites a pharmaceutical composition comprising a peptide-polynucleotide complex, the peptide-polynucleotide complex comprising a ratio of peptide:polynucleotide that is more than about 50:1 and less than about 200:1, wherein the peptide is (a) non-lytic, non-cytotoxic, and capable of affecting the release of a polynucleotide from an endosome of a cell, and (b) comprises an amino acid sequence with (i) at least 80% identity to an amino acid sequence chosen from SEQ ID NO: 1, ….; and (ii) two or more contiguous, basic amino acids (a cationic region) and one or more histidine residues located adjacent to the cationic region (see claim 1). US’371 claims the composition wherein the polynucleotide is a non-coding RNA capable of regulating or inhibiting the expression of a nucleic acid sequence (see claim 5); wherein the polynucleotide is a small interfering RNA (siRNA) or an microRNA (miRNA) (see claim 6); wherein the peptide comprises an amino acid sequence that has 100% identity to an amino acid sequence chosen from SEQ ID NO: 1 (see claim 15).
SEQ ID NO: 1 claimed by US’371 is a species of the instantly claimed amino acid sequence of SEQ ID NO: 1 i.e., VLTTGLPALISWIRRRHRRHC.
Regarding claim 9, US’371 recites the composition wherein the peptide comprises an amino acid sequence with at least 90% identity to an amino acid sequence chosen from SEQ ID NO: 1 (see claim 4). US’371 specifies a peptide of the invention comprises an amino acid sequence that has at least 80% identity to SEQ ID NO: 1, wherein the peptide is non-lytic and is capable of affecting the release of a polynucleotide from an endosome of a cell. The peptide comprising an amino acid sequence that has at least 80% identity to SEQ ID NO: 1, can have about 80%, preferably about 85%, more preferably about 90%, more preferably about 95% identity to the amino acid sequence of SEQ ID NO: 1 (see col 11, line 47-55, claims 12-14).
It would have been prima facie obvious to one of ordinary skill in the art to modify the claims of US’388 to include the use of novel hyaluronic acid coated and/or integrated nanoparticles by modifying the targeting moiety for ACE2 receptor, including those taught by Ullah et. al. along with the teachings of US’371. An ordinarily skilled artisan would have had a reasonable expectation of success in modifying the claims of US’371 to formulate composition or use in methods of delivering polynucleotides into cells by use of hyaluronic acid coating as taught by US’388 and Ullah et. al. for improved delivery efficiency and maximize therapeutic windows of RNA therapeutics and facilitate targeted delivery in SARS-CoV-2.
Conclusion
No claim is allowed.
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/KOYELI BANERJEE/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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