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 .
DETAILED ACTION
Pursuant to the preliminary amendment dated 6/30/2023, claims 2, 5-7, 9, 10, 15, 17-19, 26 and 34 are amended. No claims are newly added or canceled.
Election/Restrictions
Applicants’ election, without traverse, for the invention of Group 1, encompassing claims 1-15, in the reply filed on 10/24/2025 is acknowledged. It is acknowledged that the restriction requirement of 7/24/2025 listed Group 4 as encompassing claims 1-15, which was an error and should have read that Group 4 encompasses claims 19-33.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 1-15 will be examined on the merits herein.
Priority
The application is a National Stage entry of PCT/US2021/014763 filed on 1/22/2021, which claims priority to provisional application 63/079399 filed on 9/16/2020 and 62/964588 filed on 1/22/2020.
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.
Claims 1-15 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1, 9 and 15 contain the phrases “preferably” or “such as”. The term "such as" or “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account preferences or examples.
NOTE: For claim interpretation purposes, any limitation following a “preferably” or “such as” phrase, will not be considered a required claim limitation.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites “wherein each polyanion-containing block co-polymer is an, optionally linear, deblock and/or triblock co-polymer.” This claim does not further limit base claim 6 because the only phrase describing a further limitation is an optional limitation. Since an optional limitation may be absent, such a phrase does not properly narrow the scope of base claim 6. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3-5, 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2016/0235863 A1, PTO-892).
Gao et al. discloses a composition comprising a dually derivatized (DD) chitosan nucleic acid polyplex, where the DD chitosan is derivatized with arginine and a hydrophilic polyol, specifically gluconic acid, threonic acid or glucose, further where the polyplex is a complex of the DD chitosan and a therapeutic nucleic acid. (Example 1; Claims 1-12) The therapeutic nucleic acid is part of a construct comprising a coding region and an expression control region, where the expression control region comprises elements such as promoters, enhancers, introns, etc. (¶0092-0098)
Gao does not exemplify or claim that the therapeutic nucleic acid is effective for treating a lung disorder. However, Gao does suggest that the therapeutic nucleic acids envisioned to be part of the polyplex may be selected to treat several different diseases/conditions, including lung/respiratory conditions, such as cystic fibrosis. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exemplified/claimed polyplexes of Gao to incorporate a therapeutic nucleic acid useful to treat lung conditions, thereby arriving at the instant invention.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 2, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2016/0235863 A1, PTO-892), in view of Ran et al. (Inter. J. Pharm., 2014, PTO-892).
The disclosure of Gao is referenced as discussed above. Gao does not teach coating of the DD chitosan nucleic acid polyplex.
Ran et al. discloses coating of cationic nanoparticles carrying therapeutic nucleic acids with a PEGylated hyaluronic acid coating, where upon delivery to the target cell the coating is degraded to release the naked nanoparticle to the target cell. (Abstract; Scheme 1) Ran discloses that the coated nanoparticles had the advantages of stability in serum and enhanced delivery. (Sec. 5) The PEGylated hyaluronic acid coating of Ran meets the limitation of being “polyanion-containing block co-polymer comprises at least one polyanionic anchor region and at least one hydrophilic tail region”, as per the specification at ¶0061, 0087 and Sec. 1.3.1-1.3.2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the DD chitosan-nucleic acid polyplex of Gao could be modified to be coated with the PEG-HA coating of Ran, thereby arriving at the instant invention. One of ordinary skill in the art would be motivated to modify Gao in this way because Ran teaches that he coated nanoparticles had the advantages of stability in serum and enhanced delivery.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 3-5, 8, 9, 11, 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2016/0235863 A1, PTO-892), in view of Illum (WO 98/01160 A2, 1998, PTO-892), further in view of Ghaedi et al. (US 2016/0312190 A1, PTO-892).
The disclosure of Gao is referenced as discussed above. Gao does not teach that the therapeutic nucleic acid has identifier NM_000492 or encodes the protein cystic fibrosis transmembrane conductance regulator (CFTR), with identifier NP_000483.
Illum discloses chitosan-nucleic acid polyplexes for delivery of a nucleic acid to the lungs (Claim 22), where the nucleic acid in the polyplex may be a DNA expression vector, such as a plasmid, containing an insert in proper orientation and correct reading frame for expression by the desired host cells. An example of such a DNA is the reporter gene plasmid pCAT-DNA driven by a CMV promoter. The nucleic acid may encode a gene product which may act as a therapeutic agent for an inherited or acquired disease, which may include therapeutic agents for treatment of local conditions such as Crohn' s disease, ulcerative colitis, asthma, cystic fibrosis and cancer…Gene products include but are not limited to alpha 1-antitrypsin, growth hormone synthase, factor VIII, factor IX, TNF, cytokines, antigen genes (hepatitis B, influenza, cholera), the cystic fibrosis transmembrane conductance regulator (CTFR), cancer genes (p53, K-ras, HS-Ek), sucrose-isomaltase, lactasephlorizin hydrolase and maltase-glucoamylase. The nucleic acid-chitosan formulations described in this invention may be delivered to endothelial surfaces or into tissues, particularly the muscles or into body compartments such as the joints and lung (by aerosolisation). (p. 8, Ln. 19 thru p. 9, Ln. 16, emphasis added) Further examples are delivery of DNA to the lungs to produce cystic fibrosis transmembrane conductance regulator (CFTR) for treatment of cystic fibrosis. (p. 14, Ln. 11-13, emphasis added)
Ghaedi et al. discloses CFTR is a protein involved in the transport of chloride ions across cell membranes. Exemplary CFTR sequences include human CFTR sequence found at GenBank Accession No. NM_000492 or NP_000483. (¶0146)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the DD chitosan-nucleic acid polyplex of Gao could be modified such that the nucleic acid is selected to have the sequence NM_000492, which encodes the CFTR protein, with sequence NP_000483, and used to treat cystic fibrosis by aerosol delivery. One would be motivated to modify Gao in this manner because Gao suggests that the DD chitosan-nucleic acid polyplex may be used to treat lung conditions like cystic fibrosis and Illum teaches that chitosan-nucleic acid polyplexes are known in the art to be used to treat cystic fibrosis by containing DNA encoding CFTR proteins. The specific DNA and protein sequences claimed would be an obvious modification of Gao/Illum based on the teaching in Ghaedi that such sequences are known in the art to be specific for CFTR and the nucleic acid encoding CFTR. The teachings of Illum would also render obvious modifications to Gao such that the nucleic acid is part of a plasmid construct comprising a promoter (i.e. CMV).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 3-5, 8, 9, 13, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2016/0235863 A1, PTO-892), in view of Illum (WO 98/01160 A2, 1998, PTO-892), further in view of Huizinga et al. (US 2019/0317092 A1, PTO-892), with Iversen et al. (US 2001/0024783 A1, PTO-892).
The disclosure of Gao is referenced as discussed above. Gao further teaches that rheumatoid arthritis is among the diseases envisioned to be treated. (¶0207) Gao does not teach that the therapeutic nucleic acid encodes the protein human alpha-antitrypsin, with identifier AAB59375.1.
Illum discloses chitosan-nucleic acid polyplexes for delivery of a nucleic acid to the lungs (Claim 22), where the nucleic acid in the polyplex may be a DNA expression vector, such as a plasmid, containing an insert in proper orientation and correct reading frame for expression by the desired host cells. An example of such a DNA is the reporter gene plasmid pCAT-DNA driven by a CMV promoter. The nucleic acid may encode a gene product which may act as a therapeutic agent for an inherited or acquired disease, which may include therapeutic agents for treatment of local conditions such as Crohn' s disease, ulcerative colitis, asthma, cystic fibrosis and cancer…Gene products include but are not limited to alpha 1-antitrypsin, growth hormone synthase, factor VIII, factor IX, TNF, cytokines, antigen genes (hepatitis B, influenza, cholera), the cystic fibrosis transmembrane conductance regulator (CTFR), cancer genes (p53, K-ras, HS-Ek), sucrose-isomaltase, lactasephlorizin hydrolase and maltase-glucoamylase. The nucleic acid-chitosan formulations described in this invention may be delivered to endothelial surfaces or into tissues, particularly the muscles or into body compartments such as the joints and lung (by aerosolisation). (p. 8, Ln. 19 thru p. 9, Ln. 16, emphasis added) Further examples are delivery of DNA to the lungs to produce cystic fibrosis transmembrane conductance regulator (CFTR) for treatment of cystic fibrosis. (p. 14, Ln. 11-13, emphasis added)
Huizinga et al. discloses method of treating rheumatoid arthritis by administering a protein, which is a (part of) a human protein that is known to be subject to post-translational modification such as citrullination, homo-citrullination and/or acetylation in patients with RA…In another preferred embodiment the peptide is a peptide derived from human alpha-1-antitrypsin (¶0111), where the human alpha-1-antitrypsin accession code is AAB59375.1. (¶0064)
Iversen discloses that the nucleic acid encoding human alpha-antitrypsin has the identifier K01396. (¶0156)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the DD chitosan-nucleic acid polyplex of Gao could be modified such that the nucleic acid is selected to have the sequence K01396, which encodes the human alpha-antitrypsin protein, with sequence AAB59375.1. One would be motivated to modify Gao in this manner because Gao suggests that the DD chitosan-nucleic acid polyplex may be used to treat rheumatoid arthritis and Illum teaches that chitosan-nucleic acid polyplexes are known in the art to be used to deliver DNA encoding human alpha-antitrypsin. The specific DNA and protein sequences claimed would be an obvious modification of Gao/Illum based on the teaching in Huizinga/Iversen that such sequences are known in the art to be specific for human alpha-antitrypsin, for treating rheumatoid arthritis. The teachings of Illum would also render obvious modifications to Gao such that the nucleic acid is part of a plasmid construct comprising a promoter (i.e. CMV).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2016/0235863 A1, PTO-892), in view of Illum (WO 98/01160 A2, 1998, PTO-892), further in view of Merzouki et al. (US 2013/0210717 A1, PTO-892).
The disclosure of Gao is referenced as discussed above. Gao does not teach use of a plasmid selected from those claimed.
Illum discloses chitosan-nucleic acid polyplexes for delivery of a nucleic acid to the lungs (Claim 22), where the nucleic acid in the polyplex may be a DNA expression vector, such as a plasmid, containing an insert in proper orientation and correct reading frame for expression by the desired host cells. An example of such a DNA is the reporter gene plasmid pCAT-DNA driven by a CMV promoter. The nucleic acid may encode a gene product which may act as a therapeutic agent for an inherited or acquired disease, which may include therapeutic agents for treatment of local conditions such as Crohn' s disease, ulcerative colitis, asthma, cystic fibrosis and cancer…Gene products include but are not limited to alpha 1-antitrypsin, growth hormone synthase, factor VIII, factor IX, TNF, cytokines, antigen genes (hepatitis B, influenza, cholera), the cystic fibrosis transmembrane conductance regulator (CTFR), cancer genes (p53, K-ras, HS-Ek), sucrose-isomaltase, lactasephlorizin hydrolase and maltase-glucoamylase. The nucleic acid-chitosan formulations described in this invention may be delivered to endothelial surfaces or into tissues, particularly the muscles or into body compartments such as the joints and lung (by aerosolisation). (p. 8, Ln. 19 thru p. 9, Ln. 16, emphasis added) Further examples are delivery of DNA to the lungs to produce cystic fibrosis transmembrane conductance regulator (CFTR) for treatment of cystic fibrosis. (p. 14, Ln. 11-13, emphasis added)
Merzouki et al. discloses that chitosan is used as a vehicle to deliver nucleic acid using a plasmid expression vector, specifically the plasmid pVAX. (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the DD chitosan-nucleic acid polyplex of Gao could be modified such that the nucleic acid is part of a plasmid expression vector, specifically pVAX, thereby arriving at the instant invention. The teachings of Illum/ Merzouki render obvious modifications to Gao such that the nucleic acid is part of a plasmid construct (e.g. pVAX) comprising a promoter (i.e. CMV) because Illum/ Merzouki teach that chitosan polyplexes are known to deliver therapeutic nucleic acids in this manner.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 3-5 and 15 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 8 of Park US 8,431,543 B2, in view of Illum (WO 98/01160 A2, 1998, PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because: Park claims a pharmaceutical composition comprising a chitosan nucleic acid polyplex, where the chitosan is derivatized with arginine and PEG, but Park does not claim that the nucleic acid is effective for treating a lung disorder. However, Illum discloses that chitosan polyplexes are known to be effective for treating cystic fibrosis when the nucleic acid in the polyplex encodes for CFTR. Thus, it would be an obvious modification of Park to have the nucleic acid be one that encodes CFTR, based on the teaching of Illum.
Claims 1, 3-5 and 15 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 26 of Gao US 9,623,112 B2, in view of Illum (WO 98/01160 A2, 1998, PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because: Gao claims a pharmaceutical composition comprising a chitosan nucleic acid polyplex, where the chitosan is derivatized with arginine and gluconic acid, but Gao does not claim that the nucleic acid is effective for treating a lung disorder. However, Illum discloses that chitosan polyplexes are known to be effective for treating cystic fibrosis when the nucleic acid in the polyplex encodes for CFTR. Thus, it would be an obvious modification of Gao to have the nucleic acid be one that encodes CFTR, based on the teaching of Illum.
Claims 1, 3-5 and 15 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 10 of Gao US 10,046,066 B2, in view of Illum (WO 98/01160 A2, 1998, PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because: Gao claims a pharmaceutical composition comprising a chitosan nucleic acid polyplex, where the chitosan is derivatized with arginine and threonic acid, but Gao does not claim that the nucleic acid is effective for treating a lung disorder. However, Illum discloses that chitosan polyplexes are known to be effective for treating cystic fibrosis when the nucleic acid in the polyplex encodes for CFTR. Thus, it would be an obvious modification of Gao to have the nucleic acid be one that encodes CFTR, based on the teaching of Illum.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693