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 .
Applicant’s election without traverse of Group I , claims 1, 4, 19, 23-24, and 35, drawn to a method for ameliorating, minimizing, reversing, or preventing persistent viral infection, or minimizing or preventing viral infection-derived mortality or lethality, in a subject in the reply filed on 08/24/2026 is acknowledged.
Claims 40-47 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/24/2026.
Priority
PCT/US2021/062632 is a continuation of application number 17/115,968 filed on 12/09/2020 now abandoned.
This application claims the benefit of priority to Patent Application 17115968.
Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application
Number 17/115,968, filed on 12/09/2020.
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional Applications 63/158,726 and 63/210,869, filed on 03/09/2021 and 06/15/2021 respectively.
This application claims the benefit of priority to Patent Application PCT/US2021/062632. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/US2021/062632, filed on 12/09/2021.
Information Disclosure Statement
The IDS filed 06/30/2023, 01/05/2024 and 04/11/2025 has been considered by the Examiner.
Status of Claims
Claims 1-4, 19-24, and 35 are under examination.
Claim 5-18, 22, 25-34, and 36-47 are cancelled.
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.
Claims 1-4, 20-24 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pyle et al. (US 2016/0046943 Al).
Regarding claim 1, Pyle et al. teach a method a disease or disorder in a subject in need thereof by inducing type I interferon production in a cell of the subject (page 2, paragraph 0013). Pyle et al. teach the method comprises contacting the cell with a nucleic acid molecule, wherein the molecule comprises a double-stranded section of less than 19 base pairs and at least one blunt end (page 2, paragraph 0013).
Regarding claim 2, Pyle et al. teach the method for preventing and/or treating diseases or conditions in which inducing IFN production would be beneficial including tumors and cancers (page 9, paragraph 0091). Pyle et al. teach inducing apoptosis of a tumor cell in a mammal (page 19, paragraph 0220).
Regarding claim 3, Pyle et al. teach treatment of immune compromised individuals with human immunodeficiency virus (HIV). Pyle et al. teach immunodeficiencies include, but are not limited to, spontaneous immunodeficiency, acquired immunodeficiency (including AIDS), drug-induced immunodeficiency or immunosuppression (such as that induced by immunosuppressants used in transplantation and chemotherapeutic agents used for treating cancer), and immunosuppression caused by chronic hemodialysis, trauma or surgical procedures (pages 19-20, paragraph 0234).
Regarding claim 4, (a) Pyle et al. teach the therapeutic formulations may be administered to the subject either prior to or after a diagnosis of disease (page 20, paragraph 0242). (f) Pyle et al. teaches the infection is a viral infection hepatitis C, hepatitis B, influenza virus, RSV, HPV, HSVl , HSV2, and CMV (page 19, paragraph 0228). (p) Pyle et al. teaches nucleic acids for use in this disclosure include ribonucleic acids (RNA) (page 5, paragraph 0031). (q) Pyle et al. teach molecule comprises a double-stranded nucleic acid molecule and two blunt ends (page 38, claim 3).
Regarding claim 20, Pyle et al. teach the tumor comprises biliary tract cancer, brain cancer, breast cancer, cervical cancer, choriocarcinoma, colon cancer, endometrial cancer, esophageal cancer, gastric cancer, intraepithelial neoplasm, leukemia, lymphoma, liver cancer, lung cancer, melanoma, myelomas, neuroblastoma, oral cancer, ovarian cancer, pancreatic cancer, prostate cancer, rectal cancer, sarcoma, skin cancer, testicular cancer, thyroid cancer and renal cancer (page 19, paragraph 0229).
Regarding claim 21, Pyle et al. teach the tumor surprises cancer selected from hairy cell leukemia, chronic myelogenous leukemia, cutaneous T-cell leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, multiple myeloma, follicular lymphoma, malignant melanoma, squamous cell carcinoma, renal cell carcinoma, prostate carcinoma, bladder cell carcinoma, breast carcinoma, ovarian carcinoma, non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, basaliom, colon carcinoma, cervical dysplasia, and Kaposi's sarcoma (AIDS-related and non-AIDS related) (page 19, paragraph 0230).
Regarding claim 23, Pyle et al. teach the nucleic acid molecule comprises a single strand nucleic acid molecule which forms a hairpin structure comprising the double-stranded section and a loop. Pyle et al. teach the nucleic acid molecule comprises a double stranded nucleic acid molecule and two blunt ends. Pyle et al. teach the nucleic acid molecule comprises at least one of the group consisting of a 5' triphosphate and a 5' diphosphate (page 2, paragraph 0012). With respect to phosphorothioate linkages that serve to increase protection against RNase activity, the nucleic acid molecule can include a phosphorothioate at least the first, second, or third internucleotide linkage at the 5' or 3' end of the nucleotide sequence. Pyle et al. teach the 2' modifications can be used in combination with one or more phosphate linker modifications (page 11, paragraph 0122). Pyle et al. teach A first region of a nucleic acid is complementary to a second region of the same or a different nucleic acid if, when the two regions are arranged in an antiparallel fashion, at least one nucleotide residue of the first region is capable of base pairing with a residue of the second region (page 6, paragraph 0046). Pyle et al. teach the nucleic acid of the invention comprises intramolecular nucleotide base pairing, a hairpin. Pyle teaches the nucleic acid molecule of the invention is sometimes referred herein as a short hairpin nucleic acid molecule (page 9, paragraph 0093).
Regarding claim 24, Pyle et al. teach the hairpin nucleic acid molecule forms a blunt end, an RNA duplex where the intramolecular structure produces a 3' overhang (page 10, paragraph 0100).
Regarding claim 35, Pyle et al. teach the nucleic acid molecule can include a phosphorothioate at least the first, second, or third internucleotide linkage at the 5' or 3' end of the nucleotide sequence (page 11, paragraph 0122). Pyle et al. teach The composition of claim 7, wherein the 2'-modified nucleotide comprises a modification selected from the group consisting of: 2'-deoxy, 2'-deoxy-2'-fluoro, 2'-0-methyl, 2'-0-methoxyethyl (2'-0-MOE), 2'-0-aminopropyl (2'-0- AP), 2'-0-dimethylaminoethyl (2'-0 DMAOE), 2'-0-dimethylaminopropyl (2'-0-DMAP), 2'-0-dimethylaminoethyloxyethyl (2'-0-DMAEOE), and 2'-0-N-methylacetamido (2'-0-NMA) (page 38, claim 8).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pyle et al. (US 2016/0046943 Al) as applied to claim 1 above, and further in view of Kabi et al. (Journal of Advances in Medicine and Medical Research, 2020).
Pyle et al. teach a method a disease or disorder in a subject in need thereof by inducing type I interferon production in a cell of the subject (page 2, paragraph 0013). Pyle et al. teach the method comprises contacting the cell with a nucleic acid molecule, wherein the molecule comprises a double-stranded section of less than 19 base pairs and at least one blunt end (page 2, paragraph 0013).
Regarding claim 19, Pyle et al. teach Infections include, but are not limited to, viral infections, bacterial infections, anthrax, parasitic infections, fungal infections and prion infection. Pyle et al. teach viral infections include, but are not limited to, infections by hepatitis C, hepatitis B, influenza virus, herpes simplex virus (HSY), human immunodeficiency virus (HIV), respiratory syncytial virus (RSV), vesicular stomatitis virus (VSV), cytomegalovirus (CMV), poliovirus, encephalomyocarditis virus (EMCV), human papillomavirus (HPV) and smallpox virus. Pyle et al. teach the infection is an upper respiratory tract infection caused by viruses and/or bacteria (page 19, paragraphs 0224-0225).
Pyle et al. do not specifically teach coronavirus or long covid.
Kabi et al. teach Post-COVID-19 syndrome patients can be divided into acute, those who may have serious sequelae such as thromboembolic complications and chronic, those with a non-specific clinical picture, often dominated by fatigue and breathlessness. Kabi teaches the lungs of people who died from COVID-19 showed distinctive vascular features, consisting of severe endothelitis, associated with the presence of intracellular virus and disrupted cell membranes. Kabi et al. teach the pulmonary vessels showed widespread thrombosis with microangiopathy and intussusceptive angiogenesis. Kabi et al. teach the concomitant and inflammatory release of autoantigens from dying neutrophils is increasingly a hallmark of autoimmune processes. Kabi et al. teach COVID-19 patients suffer from ARDS, diffuse alveolar damage, edema, hemorrhage, and intraalveolar fibrin deposition (pages 290-291, pathophysiology). Kabi et al. teach treatment is mainly focused on reassurance, self-care and symptomatic control. Kabi et al. teach there are currently no FDA-approved treatments specifically for this condition (page 293, conclusion).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Pyle et al. for a method of treating a disease or disorder with the teachings of Kabi et al. for “Post Covid-19 Syndrome” Long Covid. Kabi et al. provide motivation by teaching that teach treatment is mainly focused on reassurance, self-care and symptomatic control. Kabi et al. teach there are currently no FDA-approved treatments specifically for this condition (page 293, conclusion). One of skill in the art would have had a reasonable expectation of success at combining Pyle et al. and Kabi et al. because Pyle teaches treatment of various diseases and syndromes including patients with ARDS.
Conclusion
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
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