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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 7, 2026 has been entered.
Status of the Claims
Claims 1-20 were originally filed December 6, 2024.
The amendment received April 18, 2025 added status identifiers only.
The amendment received October 7, 2025 amended claims 1, 3, 14, and 16 and canceled claims 2, 15, and 20.
The amendment received April 7, 2026 amended claims 1, 7, and 14.
Claims 1, 3-14, 16-19 are currently pending.
Claims 1, 3, 5, 7, 14, 16, and 18 are currently under consideration.
Election/Restrictions
Applicant elected, without traverse, Group I (claims 1-3, 5-10, 12-16, and 18-20) in the reply filed on April 18, 2025. Claims 4, 11, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicant elected, without traverse, preventing viral infection of a cell, LIN28B or fragments thereof, LIN28B binds to Alu retrotransposons, parenteral, and viral infections as the species in the reply filed on April 18, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 6, 8-10, 12, 13, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Please note: preventing viral infection of a cell is a subgenus, LIN28B or fragments thereof is not a single specific species, parenteral is a subgenus, and viral infections is a subgenus. In order to advance prosecution, the elections have been accepted. However, this does not preclude a future species requirement particularly if the claims are amended or if new claims are added. For search purposes, subgenuses were searched since only subgenuses were elected.
Please note: “viral infections” was deleted from dependent claim 7. This should cause the withdrawal of the claim due to a nonelected species. However, the claim is still under consideration since viral infections fall under “microbial infections”.
Priority
The present application is a 371 (National Stage) of PCT/US2023/024552 filed June 6, 2023 which claims the benefit of 63/349,623 filed June 7, 2022.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Oath/Declaration
The Declaration under 37 CFR 1.132 filed April 7, 2026 is insufficient to overcome any rejections of record. Please refer to the various “Arguments and Response” sections below.
New Rejections
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 5, 7, 14, 16, and 18 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. This is a new matter rejection.
While the originally filed specification teaches the genus of Alu-mediated interferon production in a viral infection, the originally filed specification does not specify that VSV, zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, and hepatitis B virus have Alu-mediated interferon production.
Applicants pointed to page 5, lines 9-16; page 8, lines 36-37; page 9, lines 5-18; and page 10, lines 27-29 to support the amendments. The portions from the originally filed specification are provided below.
Page 5, lines 9-16: The Alu-mediated interferon related pathology may be selected from the group consisting of viral infections, bacterial infections, microbial infections, fungal infections, yeast infections, parasitic infections, cancers, autoimmune diseases, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's disease. neurodegenerative disorders, neurological disorders, inflammatory disorders, age-related macular degeneration, Geographic atrophy, depression, Parkinson's disease, Alzheimer disease, metabolic
disorders, pregnancy complications, and blood disorders. In some embodiments, the Alu- mediated interferon related pathology is a viral infection.
Page 8, lines 36-37 and page 9, lines 5-18: "Prevention" or "preventing" as used herein refers to any of: halting the effects of an Alu- mediated interferon related pathology, reducing the effects of an Alu-mediated interferon related pathology, reducing the incidence of an Alu-mediated interferon related pathology, reducing the development of an Alu-mediated interferon related pathology, delaying the onset of symptoms of an Alu-mediated interferon related pathology, increasing the time to onset of symptoms of an Alu-mediated interferon related pathology, and reducing the risk of development of an Alu-mediated interferon related pathology. "Active agent" as used herein is defined as a substance, component or agent that has
measurable specified or selective physiological activity when administered to an individual in a therapeutically effective amount. Examples of active agents as used in the present invention include substances which are capable of preventing Alu-mediated interferon related pathologies. At least one active agent is used in the compositions of the present invention. In some embodiments, the active agent is LIN28B protein. In some embodiments, the active
agent is LIN28A or a combination of LIN28A and LIN28B. In other embodiments, the active agent is a fragment of LIN28B, LIN28A or a combination of fragments thereof. The fragments
may comprise the RNA binding sites thereof.
Page 10, lines 27-29 (page 10, lines 30-37 and page 11, lines 5-6 included to provide the entire paragraph): The term "Alu-mediated interferon (IFN) related pathologies" as used herein refers to a disease or disorder in which excessive Alu-mediated IFN production is present leading to an excessive inflammatory response. Examples of Alu-mediated IFN related pathologies
includes, but is not limited to, viral infections, bacterial infections, microbial infections, fungal
infections, yeast infections. parasitic infections, cancers such as breast and gastric cancers, autoimmune diseases such as multiple sclerosis, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's disease, neurodegenerative disorders such as Alzheimer's disease and Parkinson's disease, neurological disorders, Geographic atrophy,
depression, Alstrom syndrome, pulmonary arterial hypertension, peeling skin disease, Alport
syndrome, Fanconi anemia, Gaucher disease, Pomp disease, Fabry disease, Charcot-Marie Tooth disease, Waardenburg syndrome type 4, hereditary spastic paraplegia, spastic paraplegias, and Peutz-Jeghers syndrome, age-related macular degeneration, metabolic disorders, pregnancy complications, and blood disorders.
The above citations make clear that only the genus of viral infections was indicated in the originally filed specification as having Alu-mediated IFN production.
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.
Claims 1, 3, 5, 7, 14, 16, and 18 are 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how “Alu-mediated interferon production” alters the claims. Is another method step required (i.e. determining that IFN production is Alu-mediated, determining if IFN production is altered, etc.)? Does “Alu-mediated interferon production” alter VSV, zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, and hepatitis B virus (e.g. only some types of the recited viral infections are prevented)? Do all VSV, zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, and hepatitis B virus infections have Alu-mediated IFN production?
Claims 1, 3, 5, 7, 14, 16, and 18 are 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the RNA binding sites that will prevent viral infections of VSV, zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, and hepatitis B virus are. Are the RNA binding sites from LIN28B or LIN28A or something else?
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 depends on independent claim 1. Independent claim 1 requires a subject with a viral infection wherein the viral infection is VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus. Dependent claim 7 broadens the scope of the Alu-mediated interferon-related pathology to include any bacterial infections, microbial infections, fungal infections, yeast infections, etc. Thus, claim 7 fails to further limit the scope of independent claim 1. 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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(d) as failing to further limit for claim 7 were considered but are not persuasive for the following reasons.
Applicants contend that deletion of viral infections from the Markush group negates the rejection.
Applicants’ arguments are not convincing since deletion of viral infections did not negate the rejection.
Independent claim 1 requires a subject with a viral infection wherein the viral infection is VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus.
Dependent claim 7 contains a Markush group well outside the requirements of independent claim 1 (i.e. VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus). The Markush group of claim 7 broadens the scope of independent claim 1 by including bacterial infections, microbial infections, fungal infections, yeast infections, parasitic infections, cancers, autoimmune diseases, IBD, systemic lupus erythematosus, rheumatoid arthritis, Sjogren’s disease, neurodegenerative disorders, neurological disorders, geographic atrophy, depression, inflammatory disorders, age-related macular degeneration, metabolic disorders, pregnancy complications, and blood disorders.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 5, 7, 14, 16, and 18 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. This is a written description rejection.
Independent claim 1 is drawn to a method for preventing an Alu-mediated response in Alu-mediated interferon related pathologies in a subject comprising administering to the subject a therapeutically effective amount of a composition comprising LIN28A, LIN28B, RNA binding sites thereof, or a combination thereof wherein the Alu-mediated interferon related pathologies are viral infections comprising VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus. Independent claim 14 is drawn to a method for preventing an Alu-mediated response to a viral infection caused by upregulation of Alu retrotransposons (RTs) in a subject comprising administering to the subject a therapeutically effective amount of a composition comprising LIN28A, LIN28B, a RNA binding site thereof, or a combination thereof wherein the viral infection is VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus.
The Figures and Examples are silent with regard to a single example of the presently claimed methods. The Figures show LIN28B expression in human placenta, transfected JEG3 cells, and transfected HTR8/SVneo cells. The Figures also show LIN28B increases TNF expression in transfected JEG3 cells but decreases TNF expression in transfected HTR8/SVneo cells. The Figures also show that IFNL3 expression is increased in transfected 293T cells and LIN28B binds Alu. The Figures are silent with regard to any in vitro model or in vivo animal model for any viral infections. Examples 1 and 2 refer to the methods for obtaining the results shown in the Figures. Example 3 is “prophetic” and provides no real information or data. The Figures and Examples are silent with regard to LIN28A or any RNA binding sites. Therefore, one skilled in the relevant art would not reasonably conclude that the Applicants had possession of the invention as claimed since there is not a single example of any in vitro or in vivo animal model of any viral infection utilizing LIN28A, LIN28B, or RNA binding sites thereof.
Please also note that present claim 7 is broader in scope than the viral infections of present independent claim 1 from which claim 7 depends.
See Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See page 1116.).
The skilled artisan cannot envision the method of independent claims 1 or 14. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class wherein the specification provided only the bovine sequence.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(a) (written description) for claims 1, 3, 5, 7, 14, 16, and 18 were considered but are not persuasive for the following reasons.
Applicants contend that the in vitro data for LIN28B regarding altering IFN production negates the rejection. Applicants point to the Declaration filed April 7, 2026. The Declaration points to Wickramage et al. (see the IDS received April 7, 2026) and Figure 5 regarding viral infection.
Applicants’ arguments are not convincing since the present specification lacks written description regarding the presently claimed methods.
The Figures show LIN28B expression in human placenta, transfected JEG3 cells, and transfected HTR8/SVneo cells. The Figures also show LIN28B increases TNF expression in transfected JEG3 cells but decreases TNF expression in transfected HTR8/SVneo cells. The Figures also show that IFNL3 expression is increased in transfected 293T cells and LIN28B binds Alu. The Figures are silent with regard to any in vitro model or in vivo animal model for any viral infections. Examples 1 and 2 refer to the methods for obtaining the results shown in the Figures. Example 3 is “prophetic” and provides no real information or data. The Figures and Examples are silent with regard to LIN28A or any RNA binding sites. In addition, it is unclear what the “RNA binding sites” are which would prevent viral infection of VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus.
Again, all evidence should be submitted as an Exhibit and not in the IDS. See MPEP § 42.63 and 41.154.
Wickramage et al. shows that viral RNA in 293T cells and DICER-KO cells infected with VSV, ZIKV, or RSV is downregulated with the transfection of 759-SAM (see Figure 3). However, the paper does not indicate what 759-SAM is. Figure 5 of the Declaration shows that 759-SAM decrease viral RNA in 293T cells and DICER-KO cells infected with VSV, ZIKV, or RSV. However, Figure 5 and the Declaration do not indicate what 759-SAM is. In addition, the present claims are broader in scope than what is provided in Wickramage et al. or Figure 5. Most importantly, applicants cannot show written description via an NPL or later filed data. Written description must be present at the time of filing. The originally filed specification does not even clarify what 759-SAM is. One of skill in the art would assume the RNA binding sites in the claims would be from LIN28B or LIN28A, however, Wickramage et al. suggests that 759-SAM may be RNA binding sites from C19MC.
Claims 1, 3, 5, 7, 14, 16, and 18 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a scope of enablement rejection.
There are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is “undue”. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5. The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation necessary needed to make or use the invention based on the disclosure.
See In re Wands USPQ 2d 1400 (CAFC 1988):
The breadth of the claims and the nature of the invention:
Independent claim 1 is drawn to a method for preventing an Alu-mediated response in Alu-mediated interferon related pathologies in a subject comprising administering to the subject a therapeutically effective amount of a composition comprising LIN28A, LIN28B, RNA binding sites thereof, or a combination thereof wherein the Alu-mediated interferon related pathologies are viral infections comprising VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus. Independent claim 14 is drawn to a method for preventing an Alu-mediated response to a viral infection caused by upregulation of Alu retrotransposons (RTs) in a subject comprising administering to the subject a therapeutically effective amount of a composition comprising LIN28A, LIN28B, a RNA binding site thereof, or a combination thereof wherein the viral infection is VSV, Zika virus, RSV, SARS-CoV-2, vaccinia virus, HSV, Epstein-Barr virus, CMV, or hepatitis B virus. Accordingly, the claim scope is unduly broad with respect to the encompassed viral infections and the mechanism of action. Please note: present claim 7 broadens the scope of the pathologies recited in present independent claim 1 from which claim 7 depends.
The state of the prior art and the level of predictability in the art:
While there is some correlation between Alu and pathologies including viral infections in the prior art, the prior art is silent with regard to the association of LIN28 to preventing all the presently claimed viral infections. See, for example, Jang et al., 1989, HSV infection induces increased transcription of Alu repeated sequences by RNA polymerase III, FEBS Letters, 258(2): 255-258; Crooke et al., 2021, Reduced A-to-I editing of endogenous Alu RNAs in severe COVID-19 disease, J Immunol, 206(8): 1691-1696; Aune et al., 2022, Alu RNA Structural Features Modulate Immune Cell Activation and A-to-I Editing of Alu RNAs Is Diminished in Human Inflammatory Bowel Disease, Frontiers in Immunology, 13: 818023 (13 pages); Cantarella et al., 2024, Adenovirus small E1A directs activation of Alu transcription at YAP/TEAD- and AP-1-bound enhancers through interactions with the EP400 chromatin remodler, Nucleic Acids Research, 52: 9481-9500; Crooke et al., 2021, Reduced A-to-I editing of endogenous Alu RNAs in lung after SARS-CoV-2 infection, Current Research in Immunology, 2: 52-59; and Li et al., 2021, Alu retrotransposons and COVID-19 susceptibility and morbidity, Human Genomics, 15(2): 11 pages. Lin28 is known to bind Alu (see Elbarbary et al., 2014, Dodging two bullets with one dsRNA-binding protein, Cell Cycle, 13(3): 345-346 and Elbarbary et al., 2013, STAU1 binding 3’ UTR IRAlus complements nuclear retention to protect cells from PKR-mediated translational shutdown, Genes & Development, 27: 1495-1510). However, LIN28 is associated with causing cancer. Therefore, administration of LIN28 must be closely monitored to ensure that cancer is not a side effect of treatment. In addition, in applicant’s own specification, LIN28B had the opposite effect on TNF expression in different cell lines. Thus, it is not clear if LIN28B would have the same effects on different viral infections due, at least in part, to the viral infections occurring in different cell types. In addition, in some viral infections, LIN28 expression is upregulated. Therefore, it would be presumed that the addition of LIN28 would not lead to treatment. See Wu et al., 2015, Lin28B over-expression mediates the repression of let-7 by hepatitis B virus X protein in hepatoma cells, Int J Clin Exp Med, 8(9): 15108-15116; You et al., 2014, Hepatitis B virus X protein upregulates LIN28A/LIN28B through Sp-1/c-Myc to enhance the proliferation of hepatoma cells, Oncogene, 33: 449-460; Han et al., 2020, Association of LIN28B polymorphisms with chronic hepatitis B virus infection, Virology Journal, 17: 81 (9 pages); and McDaniel et al., 2016, Lin28 and let-7: roles and regulation in liver disease, Am J Physiol Gastrointest Liver Physiol, 310: G757-G765. Therefore, the level of predictability in the art is dependent on many factors. While finding treatments for viral infections is important, the state of the art requires vast amounts of data, including in vitro models; in vivo animal models; phase 0-IV clinical trials; etc.
The level of skill in the art:
The level of skill would be high, most likely at the Ph.D. and/or MD level.
The amount of direction provided by the inventor and the existence of working examples:
There are no specific examples directed to the presently claimed invention; nor is there any guidance as to how to specifically utilize LIN28A, LIN28B, or RNA binding sites thereof to treat any viral infection claimed in independent claims 1 and 14 or the broadening claim of dependent claim 7 which is within the scope of the presently claimed invention. The general teachings in the specification regarding LIN28B altering TNF expression, altering IFNL3 expression, and binding to Alu do not provide any guidance with regard to treating viral infections. Furthermore, no direction is provided on how to avoid cancer when administering a known oncogene.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In light of the unpredictability surrounding the claimed subject matter, the undue breadth of the claimed invention’s intended use, and the lack of adequate guidance, one wishing to practice the presently claimed invention would be unable to do so without engaging in undue experimentation. One wishing to practice the presently claimed invention would have to produce additional experiments and data including in vitro models of every pathology and viral infection; in vivo animal models of every pathology and viral infection; and phase 0-IV clinical trials for each pathology and viral infection.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(a) (scope of enablement) for claims 1, 3, 5, 7, 14, 16, and 18 were considered but are not persuasive for the following reasons.
Applicants contend that the in vitro data for LIN28B regarding altering IFN production negates the rejection. Applicants point to the Declaration filed April 7, 2026. The Declaration points to Wickramage et al. (see the IDS received April 7, 2026) and Figure 5 regarding viral infection.
Applicants’ arguments are not convincing since the present specification lacks scope of enablement regarding the presently claimed methods.
The Figures show LIN28B expression in human placenta, transfected JEG3 cells, and transfected HTR8/SVneo cells. The Figures also show LIN28B increases TNF expression in transfected JEG3 cells but decreases TNF expression in transfected HTR8/SVneo cells. The Figures also show that IFNL3 expression is increased in transfected 293T cells and LIN28B binds Alu. The Figures are silent with regard to any in vitro model or in vivo animal model for any viral infections. Examples 1 and 2 refer to the methods for obtaining the results shown in the Figures. Example 3 is “prophetic” and provides no real information or data. The Figures and Examples are silent with regard to LIN28A or any RNA binding sites.
Again, all evidence should be submitted as an Exhibit and not in the IDS. See MPEP § 42.63 and 41.154.
Wickramage et al. shows that viral RNA in 293T cells and DICER-KO cells infected with VSV, ZIKV, or RSV is downregulated with the transfection of 759-SAM (see Figure 3). However, the paper does not indicate what 759-SAM is. Figure 5 of the Declaration shows that 759-SAM decrease viral RNA in 293T cells and DICER-KO cells infected with VSV, ZIKV, or RSV. However, Figure 5 and the Declaration do not indicate what 759-SAM is. In addition, the present claims are broader in scope than what is provided in Wickramage et al. or Figure 5. The originally filed specification does not even clarify what 759-SAM is. One of skill in the art would assume the RNA binding sites in the claims would be from LIN28B or LIN28A, however, Wickramage et al. suggests that 759-SAM may be RNA binding sites from C19MC.
Claim Rejections - 35 USC § 102
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, 3, 5, 7, 14, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burns et al. WO 2020/077295 published April 16, 2020.
For present claims 1, 3, 5, 7, 14, 16, and 18, Burns et al. teach methods of administering LIN28 to subjects to treat viral infections including SARS-CoV-2 wherein administration is intravenous (please refer to the entire specification particularly sections E48, E120, E286; pages 5, 9, 18, 73, 74; claims).
Therefore, the teachings of Burns et al. anticipate the presently claimed method.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Burns et al. for claims 1, 3, 5, 7, 14, 16, and 18 were considered but are not persuasive for the following reasons.
Applicants contend that Burns et al. does not teach an Alu-mediated response in Alu-mediated interferon-related pathologies or a viral infection caused by upregulation of Alu RTs. Applicants contend that Burns et al. does not teach administering LIN28B, LIN28A, RNA binding sites thereof, or combinations thereof.
Applicants’ arguments are not convincing since the teachings of Burns et al. anticipate the methods of the instant claims. Burns et al. teach administration of the same product to the same subject population as presently claimed. Therefore, Burns et al. anticipates the presently claimed single step method of administration.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
A discovery of a mechanism of action is not necessarily inventive.
Claims 1, 3, 5, 7, 14, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angel et al. WO 2021/222389 published November 4, 2021.
For present claims 1, 3, 5, 7, 14, 16, and 18, Angel et al. teach methods of administering LIN28 to subjects to treat viral infections including SARS-CoV-2 wherein administration is intravenous (please refer to the entire specification particularly pages 4, 5, 22, 23, 25, 32, 39, 41-43, 47, 49; claims).
Therefore, the teachings of Angel et al. anticipate the presently claimed method.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102(a)(1) as being anticipated by Angel et al. for claims 1, 3, 5, 7, 14, 16, and 18 were considered but are not persuasive for the following reasons.
Applicants contend that Angel et al. do not teach a method of preventing an Alu-mediated response to a viral infection caused by upregulation of Alu retrotransposons (RTs) in a subject via administering LIN28B subjects with viral infecitons.
Applicants’ arguments are not convincing since the teachings of Angel et al. anticipate the methods of the instant claims. Angel et al. teach administration of the same product to the same subject population as presently claimed. Therefore, Angel et al. anticipates the presently claimed single step method of administration.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
A discovery of a mechanism of action is not necessarily inventive.
New Rejections
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, 3, 5, 7, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,331,362 in view of Bayer et al., 2018, Chromosome 19 microRNAs exert antiviral activity independent from type III interferon signaling, Placenta, 61: 33-38.
U.S. Patent 12,331,362 claims methods of administering C19MC miRNA inhibitors to treat infantile hepatic hemangioma, infantile brain tumor, other infantile tumors, preeclampsia, intrauterine growth restriction, or preterm birth.
Bayer et al. teach that C19MC miRNA can be utilized as an antiviral for zika virus or VSV (please refer to the entire reference particularly the abstract).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one complication that can be treated with C19MC miRNA) for another (i.e. viral infections that can be treated with C19MC miRNA) would have yielded predictable results (i.e. treatment) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing C19MC miRNA as an antiviral) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 3, 5, 7, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,435,757 in view of Bayer et al., 2018, Chromosome 19 microRNAs exert antiviral activity independent from type III interferon signaling, Placenta, 61: 33-38.
U.S. Patent 10,435,757 claims methods of administering C19MC miRNA inhibitors to treat infantile hemangioma, infantile hepatic hemangioma, infantile brain tumor, choriocarcinoma, preeclampsia, or intrauterine growth restriction.
Bayer et al. teach that C19MC miRNA can be utilized as an antiviral for zika virus or VSV (please refer to the entire reference particularly the abstract).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one complication that can be treated with C19MC miRNA) for another (i.e. viral infections that can be treated with C19MC miRNA) would have yielded predictable results (i.e. treatment) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing C19MC miRNA as an antiviral) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 3, 5, 7, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,155,880 in view of Bayer et al., 2018, Chromosome 19 microRNAs exert antiviral activity independent from type III interferon signaling, Placenta, 61: 33-38.
U.S. Patent 11,155,880 claims methods of administering C19MC miRNA inhibitors to treat infantile hemangioma, infantile hepatic hemangioma, infantile brain tumor, choriocarcinoma, preeclampsia, or intrauterine growth restriction.
Bayer et al. teach that C19MC miRNA can be utilized as an antiviral for zika virus or VSV (please refer to the entire reference particularly the abstract).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one complication that can be treated with C19MC miRNA) for another (i.e. viral infections that can be treated with C19MC miRNA) would have yielded predictable results (i.e. treatment) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing C19MC miRNA as an antiviral) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 3, 5, 7, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,844,809 in view of Li et al., 2021, Alu retrotransposons and COVID-19 susceptibility and morbidity, Human Genomics, 15(2): 11 pages.
U.S. Patent 11,844,809 claims a vaccine comprising SINE Alu repeats.
Li et al. teach that Alu can be a therapeutic target for SARS-CoV-2 infection (please refer to the entire reference particularly the abstract, Discussion, Conclusion).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. Alu vaccine) for another (i.e. method of utilizing Alu to treat viral infections) would have yielded predictable results (i.e. treatment) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing an Alu vaccine as an antiviral) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 3, 5, 7, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,357,789. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,357,789 are drawn to methods of treating viral infections via utilizing Alu SINEs.
Claims 1, 3, 5, 7, 14, 16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/868690 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/868690 (reference application) are drawn to methods of treating VSV, RSV, SARS-CoV2, or zika virus in a subject via administering Alu RNA.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 7, 14, 16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-22 of copending Application No. 18/512,489 in view of Li et al., 2021, Alu retrotransposons and COVID-19 susceptibility and morbidity, Human Genomics, 15(2): 11 pages.
Copending Application No. 18/512,489 claims vaccines comprising Alu SINEs.
Li et al. teach that Alu can be a therapeutic target for SARS-CoV-2 infection (please refer to the entire reference particularly the abstract, Discussion, Conclusion).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. Alu vaccine) for another (i.e. method of utilizing Alu to treat viral infections) would have yielded predictable results (i.e. treatment) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing an Alu vaccine as an antiviral) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 5, 7, 14, 16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10 and 21-30 of copending Application No. 19/221,228 in view of Bayer et al., 2018, Chromosome 19 microRNAs exert antiviral activity independent from type III interferon signaling, Placenta, 61: 33-38.
Copending Application No. 19/221,228 claims methods of treating IH, infantile hepatic hemangioma, infantile brain tumor, or other infantile tumor via administering a C19MC miRNA inhibitor.
Bayer et al. teach that C19MC miRNA can be utilized as an antiviral for zika virus or VSV (please refer to the entire reference particularly the abstract).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one complication that can be treated with C19MC miRNA) for another (i.e. viral infections that can be treated with C19MC miRNA) would have yielded predictable results (i.e. treatment) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing C19MC miRNA as an antiviral) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 5, 7, 14, 16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7-11, 14, 20-22, and 24-29 of copending Application No. 19/161,289 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 19/161,289 (reference application) are drawn to methods of treating viral infection via administering Alu SINES.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 7, 14, 16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 9-12, 14, 16, 18, 22, 24-26, 29-31, 34, 35, and 37 of copending Application No. 19/161,132 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 19/161,132 (reference application) are drawn to methods of treating viral infection via administering Alu SINES.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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