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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 7/2/2026 wherein claims 1, 4-8, and 10 were amended; claims 2 and 3 were canceled; and claims 11-17 were added.
Note(s): Claims 1 and 4-10 are pending.
Priority
This application is a 371 of PCT/CN2019/096303 filed 7/17/2019.
Note(s): The earliest effective filing date is 7/17/2019.
Claim Interpretation
Independent claim 1 is directed to a method of preventing and/or treating an infectious disease and/or an infection associated disease and/or syndrome comprising administering a prophylactically and/or therapeutically effective amount of a heterogeneous nuclear ribonucleoprotein A2B1 (hnRNPA2B1), a nucleic acid molecule encoding the protein, and a promoter or inhibitor to a subject as set forth in detail in therein.
Independent claim 8 is directed to a pharmaceutical composition or kit comprising a prophylactically or therapeutically effective amount of a heterogeneous nuclear ribonucleoprotein A2B1 (hnRNPA2B1), a nucleic acid molecule encoding the protein, a promoter or inhibitor, and a pharmaceutically or immunologically acceptable carrier or excipient as set forth therein.
Independent claim 9 is directed to a method of screening a drug for anti-infection as set forth therein.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1, 4-7, and 11-16) filed 4/21/2025 and 9/17/2025 is acknowledged. The restriction requirement was deemed proper and made FINAL.
In the response filed 9/17/2025, Applicant elected the following species: hnRNPA2B1 polypeptide (SEQ ID No: 2), nucleic acid molecule (SEQ ID No: 1), promoter (pcDNA3.1 eukaryotic expression vector), and infectious disease (Herpes Simplex Virus (HSV) infection).
Initially, the elected species was examined. However, since no prior art was found which could be used to reject the claims, the search was extended to the prior art cited below. The search was not further extended because art was found which could be used to reject the claims.
Withdrawn Claims
Claims 8-10 and 17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 7/2/2026 to the rejection of claims 1-7 made by the Examiner under 35 USC 102, 103, and/or 112 have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Written Description Rejection
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, 4-7, and 11-16 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.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to the prevention of infectious diseases, the prevention of infection associated diseases, and the prevention of infection associated diseases and syndromes. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
APPLICANT’S ASSERTIONS
In summary, it is asserted that the invention provides support for ‘prevention’ of infection diseases, infection associated diseases, and infection associated diseases and syndromes for the following reasons. The examples clearly and powerfully demonstrated the role of hnRNPA2B1 in prevention infection and related diseases because (1) Example 1 recognizes that hnRNPA2B1 binds to virus DNA after and infection. (2) Example 4 significantly lower serum interferon beta levels after HV-1 infection. (3) Example 6 shows that hnRNPA2B1 is critical for preventing death caused by viral infection. It is asserted that the results overall specification demonstrate that hnRNPA2B1 is the first line of defense in the innate immune system against viral invasion.
EXAMINER’S RESPONSE
All of Applicant’s arguments were considered but deemed non-persuasive for the following reasons. While the disclosure supports that hnRNPA2B1 is a part of the body’s line of defense, the evidence of record does not support the ‘prevention’ of infections and related diseases and syndrome thereof. The disclosure clearly supports a reduction in possibly getting such infections and treatment of infections, but it does not support a subject not experiencing, getting, or having an infection or symptom resulting from an infection or related condition.
The term ‘prevent’ according to any standard dictionary (e.g., Merriam-Webster’s Dictionary) is defined to keep from happening or existing’. Example 4, according to page 8 paragraphs [0120] and [0121] of Applicant’s published application (US 2022/0257710) disclosed that the results obtained were lower than those of will type mice (paragraph [0120]). In paragraph [0121], Applicant discloses that the results indicate that “hnRNPA2B1 may play an important role in anti-infection” which is not an indication of total inhibition, prevention, or definitive that an action does not happen or exists. Similarly, the conclusion from Example 5 (page 8, paragraphs [0122]-[0125]), Example 6 (page 8, paragraphs [0126]-[0128]), and Example 7 (page 8, paragraph [0129] – page 9, paragraph [0132]) are consistent and used the same ‘may play’ terminology found in Example 4. Hence, based on the record, it appears that the disclosure clearly supports treatment and reduction of infectious diseases and/or an infection associated with disease/syndrome. Thus, the rejection is still deemed proper.
112 Second Paragraph Rejections
All outstanding rejections, except those below, are withdrawn because the claims were amended to overcome the 112 second paragraph rejections. The remaining rejections were modified to address the pending claims. For example, some of the 112 rejections made previously over claims 2 and 3 are now over claim 1 because the limitations of claims 2 and 3 were incorporated into independent claim 1.
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, 4-7, and 11-16 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.
Claims 1, 4-7, and 11-16: Amended independent claim 1 ambiguous for reasons of record and those set forth below. (1) It is unclear what promoters Applicant is referencing that are compatible with the invention (see claim 1, lines 25-30). In the amended claim it is set forth that the promoters are (a) agents that increase the protein level of hnRNPA2B1 or promote the function of hnRNPA2B1 and (b) agents from an overexpression vector of hnRNPA2BI or hnRNPA2B1 coding sequence a precursor proteins, conjugates, or complexes that can be transformed into hnRNPA2B1 in vivo. The text incorporated ((a) and (b)) do not clarify the claimed invention as it is unclear what the metes and bounds of what Applicant believes to be agents that that increase the protein level of hnRNPA2B1 or promote the function of hnRNPA2B1. In addition, there are no listed specific agents resulting from an overexpression vector of hnRNPA2B1 or agents from hnRNPA2B1 coding sequence a precursor proteins, conjugates, or complexes that can be transformed into hnRNPA2B1.
In summary, the claim is ambiguous because it is unclear what agents are being referenced that increase the protein level of hnRNPA2B1 or promote the function of hnRNPA2B1 and because it is unclear what precursor proteins, conjugates, or complexes can be transformed into hnRNPA2B1 in vivo.
(2) Amended independent claim 1 is ambiguous because it is unclear what are the actual species resulting from “a molecule that hybridizes with the nucleotide sequence defined in (i) under a strict condition, wherein the striction condition is selected from a condition that hybridization and elution at 0.2 x SSC, 0.1% SDS, 60 degrees C or addition of denaturant during hybridization wherein the denaturant comprises 50% (v/v) formamide, 0.1% fetal bovine serum, 0.1% Ficoll, 42 degrees C, or hybridization that occurs only when the identity between the two sequences is more that 80%”. It is unclear what two sequences Applicant is referencing that are being prepared. It is also unclear what the actual products (molecules) are that are being generated and claimed.
(3) Newly added section (iii) of the claim (lines 21-24) is also vague and indefinite. Specifically, the first portion of the text of (iii) indicates that the molecule has more than 80% homology or identity to that of SEQ ID Nos. 1 or 3. However, ambiguity enters the claim when one incorporates the phase, ‘and encodes a protein or peptide that is active in treating an infectious disease and/or an infection associated disease and/or symptom’. It is unclear what ‘symptom(s)’ Applicant is referencing as in line 2 of the claim, reference is made to ‘syndrome’, not ‘symptom’. Also, the phrase indicates that even if 80% homology or identity to SEQ ID Nos. 1 or 3 is present, the molecule still does not necessarily encode a protein or peptide that is active in treating an infectious disease and/or an infection associated with a disease.
(4) In amended claim 1, lines 34-38 which are directed to the infection associated with disease and/or symptom is one selected from insufficient or overproduction of cytokines’ is confusing. Specifically, the terms “insufficient” and “excessive” in claim 1, lines 34-35, are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Since claims 4-7, and 11-16 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
APPLICANT’S ASSERTIONS
In summary, it is asserted that the claims were amended and that the Examiner’s rejections in the office action mailed 1/2/2026 are moot.
EXAMINER’S RESPONSE
Applicant’s arguments were considered but deemed non-persuasive for reasons of record and those set forth supra. In particular, it is noted that Applicant did not respond or address the rejections of record (for example those of claims 2 and 3) but canceled some of the claims and incorporated the same or a variation of rejected language from the canceled claims.
102/103 Rejection
Note(s): The 103 rejection has been modified to be consistent with the pending claims which were amended. However, the rejection is the same a presented in the office action mailed1/2/2026. Also, since some of the claim were ambiguous as set forth in the 112 second paragraph rejections, it was difficult to ascertain the metes and bounds of the some of the claims.
Furthermore, it should be noted that both Hu et al (Scientific Reports, 2017, Vol. 7, No. 9094, pages 1-9) and Tortelli et al (Frontiers in Neurology, 2020, Vol. 11, Article 552295, pages 1-9) are both being made of record as evidentiary references to illustrate that what Applicant asserts o be lacking in the cited prior art is a well-known characteristics in the art.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-7, and 11-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Martinez et al (Neuron, 2016, Vol. 92, No. 4, 32 pages) as evidenced by Hu et al (Scientific Reports, 2017, Vol. 7, No. 9094, pages 1-9) and Tortelli et al (Frontiers in Neurology, 2020, Vol. 11, Article 552295, pages 1-9).
Independent claim 1 is directed to a method of preventing and/or treating an infectious disease and/or and infection associated disease and/or syndrome comprising administering a prophylactically and/or therapeutically effective amount of a heterogeneous nuclear ribonucleoprotein A2B1 (hnRNPA2B1), a nucleic acid molecule encoding the protein, and a promoter or inhibitor to a subject as set forth therein.
Claim 4 is directed to wherein the infection is a DNA viral infection, bacterial infection, fungal infection or a combination thereof.
Claim 5 is directed to the method of claim 1 wherein the insufficient or excessive production of cytokines is interferon after infection.
Claim 6 is directed to the method of claim 1 wherein the product is a pharmaceutical composition or kit.
Claim 7 is directed to the method of claim 1 wherein the product also contains other agents for prevention and/or treatment of an infectious disease and/or an infection associated disease and/or symptom selected from clinically common antibiotics, clinically common antiviral drugs, and clinically common immunosuppressants.
Claim 11 is directed to a method of claim 1 wherein the infection is caused by a DNA virus infection.
Claim 12 is directed to the method of claim 1 wherein the infection is caused by one or more viruses selected from herpes simplex virus, hepatitis B virus, adenovirus, poxvirus, small DNA virus, and adeno-associated virus.
Claim 13 is directed to the method of claim 1 wherein the autoimmune disease is as listed therein.
Claim 14 is directed to the method of claim 1 wherein the pharmaceutical composition or kit is in the various forms as set forth therein.
Claim 15 is directed to the method of claim 14 wherein the injection is from directed naked DAN or protein injection, and liposome encapsulated DNA or protein injection.
Claim 16 is directed to the method of claim 7 wherein the clinically common antibiotics, antiviral drugs, and immunosuppressants are as set forth therein.
Martinez et al is directed to protein-RNA networks that are regulated my normal and ALS associated mutant (hnRNPA2B1) in the nervous system. HnRNPA2B1 encodes an RNA binding protein associated with neurodegeneration. Transcriptome-wide crosslinking and immunoprecipitation resulted in knowledge about UAGG motifs enriched within approximately 2,500 hnRNPA2B1 binding sites (see entire document, especially, page 2, abstract; page 3, second complete paragraph). UV-crosslinked protein-RNA complexes were generated (page 3, second complete paragraph; page 18, Figure 1A). HnRNPA2B1 binds UAGG motifs within RNA resulting in a complex comprising hnRNPA2B1, a nucleic acid molecule (RNA), and a UAGG. 3’UTR binding in the myelin basic protein (Mbp) gene, a known hnRNPA2B1 substrate (this is the promoter component) (page 3, third complete paragraph, page 18, Figure 1E). Also, Martinize disclose other promoters including neurofilament heavy chain gene (Nefh, page 18, Figure 1F), Kenj10 (page 18, Figure 1G), Slca2, Ubln2, and Sfpq (page 18, Figure 1I) on pages 3-4, bridging paragraph. Thus, a promoter component is present.
Altered levels or mutations in RNA binding proteins are associated with neurological diseases including spinal muscular atrophy, fragile X syndrome, amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration (FTLD), and Alzheimer’s disease (page 2, ‘Introduction’, first paragraph). In addition, as set forth in Martinez et al, the focus of the document is ALS (page 2, abstract). Hence, the disease is ALS.
Alternatively, while it may be asserted that infectious diseases, infectious associated diseases, and infectious associates disease syndromes exclude neurodegenerative disease, DeChiara et al (Mol. Neurobiol., 2012, Vol. 46, pages 614-638) is made of record as an evidentiary reference. DeChiara et al is made of record for its teachings that infectious agents are related to neurodegeneration. In particular, DeChiara et al set forth that a growing body of epidemiologic and experimental data points to chronic bacterial and viral infections as possible risk factors for neurodegenerative diseases (e.g., Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis).
Still, DeChiara et al disclose that infections of the central nervous system especially those characterized by a chronic progressive course, may produce multiple damage in infected and neighboring cells. The activation of inflammatory processes and host immune responses cause chronic damage resulting in alterations of neuronal function and viability. The different pathogens may also directly trigger neurotoxic pathways. Also, DeChiara et al disclose that viral and microbial agents are reported to produce molecular hallmarks of neurodegeneration. Furthermore, DeChiara et al disclose that their review focus on the contributions of neurodegeneration by herpes simplex type-1 human immunodeficiency, influenza virus, and Chlamydia pneumoniae (see entire document, especially, page 614, abstract). Thus, it would have been obvious to a skilled artisan using the teachings of DeChiara et al that the diseases therein are encompassed within the scope of Applicant’s “infectious diseases, infectious associated diseases, and infectious associated disease syndromes”. Hence, the limitations of claims are met.
APPLICANT’S ASSERTIONS
In summary, it is asserted that independent claim 1 is directed to an infection associated disease and/or symptom that involves insufficient or excessive production of cytokines, endotoxic shock or death, inflammatory injury of organs, and autoimmune diseases. In addition, it is asserted that neurodegenerative diseases and infection have fundamental differences in etiology as detailed therein. Thus, it is summarized that the neurodegenerative diseases and syndromes taught and suggested by Martinez et al and DeChiara et al are different and not within the scope of an infectious disease and/or an infection associated disease and/or syndrome defined in the claims.
EXAMINER’S RESPONSE
All of Applicant’s arguments were considered but deemed non-persuasive for reason of record and those set forth below. Martinez et al is directed to ALS associated mutant hnRNPA2B1 in the nervous system. Hu et al (Scientific Reports, 2017, Vol. 7, No. 9094, pages 1-9) is made of record as an evidentiary reference because it discloses that increased blood inflammatory cytokine levels in the bases of amyotrophic lateral sclerosis (ALS) (see entire document, especially, abstract; page 1, first paragraph; page 3, second paragraph; page 4, Table 1; page 5, Figure 3; page 6, Figure 4). Thus, Hu et al confirms that the teachings of Martinez et al are applicable to the pending invention.
Tortelli et al (Frontiers in Neurology, 2020, Vol. 11, Article 552295, pages 1-9) is also made of record as an evidentiary reference because it discloses that plasma inflammatory cytokines are elevated in amyotrophic lateral sclerosis (ALS) subjects (see entire document, especially, abstract; page 1, ‘Introduction’; page 4, Table 1; page 4, Table 2 and , left column, first and second complete paragraphs; page 6, Figures 1 and 2). Thus, Tortelli et al confirms that the teachings of Martinez et al are applicable to the pending invention
NEW GROUNDS OF REJECTIONS
112 Second Paragraph Rejections
Claims 5, 7, and 11-16 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.
Claims 1, 4-7, and 11-16: According to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite under, in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention. The pending claims (see claims 1, 4, 6, 7, 11, and 12, for example) are directed to preventing infectious diseases, infection associated disease and syndrome wherein hnRNPA2B1 comes from a multitude of known and unknown sources selected from:
(a) a polypeptide having the amino acid sequence set forth in SEQ ID NO: 2 or SEQ ID NO: 4; or
(b) a protein or polypeptide that has a homology or sequence identity (for example, a homology of more than 80% or a sequence identity of more than 80%, such as 80%, 85%,90%, 95%, 98%, 99%) with the amino acid sequence set forth in SEQ ID NO: 2 or SEQ ID NO: 4 wherein the designated protein/polypeptide also has an infection inhibitory activity; or
(c) a nucleic acid molecule having the nucleotide sequence set forth in SEQ ID NO: 1or SEQ ID NO: 3; or
(d) a molecule that hybridizes with the nucleotide sequence defined in (i) under various conditions in lines 15-20 of claim 1; or
(e) a nucleic acid molecule, which has a homology or sequence identity (e.g. a homology of more than 80% homology or a sequence identity of more than 80%, such as 80%, 85%, 90%, 95%, 98%, and 99%) with the nucleotide sequences set forth in SEQ ID NO:1 or SEQ ID NO:3, and also encodes a protein or peptide that is active in preventing and/or treating an infectious disease and/or an infection associated disease and/or symptom;
(f) species wherein the promoter is selected from: agents that increase the protein level of hnRNPA2B 1 or agents that promote the function of hnRNPA2B 1, as such agents result in an overexpression vector of hnRNPA2B 1 or hnRNPA2B 1 coding sequence; a liposome encapsulated DNA of hnRNPA2B 1 coding sequence; or an hnRNPA2B 1 precursor protein or conjugate or complex that can be transformed into hnRNPA2B 1 in vivo; and
(g) the inhibitor utilized is selected from: any antibody against hnRNPA2B 1 or any nucleic acid molecule encoding the protein, any siRNA, any miRNA, any antisense oligonucleotide, any antagonist, and any blocker.
Thus, the claims encompasses a species defined by multiple Markush groups and subgroups thereof. As a result, the pending claim encompasses a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claim. Hence, due to an inability to envision the metes and bounds of the compounds and diseases defined by the Markush groups, the claims are deemed to be vague and indefinite.
Claim 5: The amended claim is directed to insufficient or excessive production of cytokines and specifically interferon. The terms “insufficient” and “excessive” in claim 5, lines 3 and 4, are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 6 and 7: The amended claim is ambiguous for the following reasons. It is unclear what is the actual product (final substance(s)) from hnRNPA2B1, the nucleic acid molecule ending the protein, the promoter, and the inhibitor that is present in the product and being claimed. Even if the product is a pharmaceutical composition, what is the composition being claimed? In addition, it is unclear what other agents for the prevention and/or treatment of an infectious disease and/or an infection associated disease and/or symptom Applicant is claiming. What specific clinically common antibiotics, antiviral drugs, and immunosuppressants as what one person deems as being common varies from person to person.
Claims 11 and 12: The claims are ambiguous because it is unclear what specific diseases Applicant is referring to that are caused by a DNA virus infection, herpes simplex virus, hepatitis B virus, adenovirus, poxvirus, small DNA virus, and adeno-associated virus and compatible with the pending invention.
Claims 14-16: The claim are ambiguous for the following reasons. Claims 14-16 depend upon claims 6 or 7. The actual product being claimed is not specified. Thus, while the product may be in a particular for or administered in a designated manner, the claims are ambiguous because it is unclear what the product is being claimed.
Additional Evidentiary References
The following documents were previously made of record as evidentiary references of known promoters.
Lin et al, FEBS, J Author manuscript, available in PMC, 2022, pages 1-33 (see entire document, especially, abstract; page 16, second complete paragraph);
Jia et al, Frontiers in Cellular Neuroscience, 2017, Vol. 1, pages 1-13 (see entire document, especially, abstract);
Millington-Ward et al, Scientific Reports, 2020, Vol 10, No. 16515, 12 pages (see entire document, especially, abstract); and
Miyao et al, Jpn. J. Cancer Res., 1997, Vol. 88, pages 678-686 (see entire document, especially, abstract).
Comments/Notes
Once again, Applicant is respectfully requested to thoroughly review the claims for clarity in order that one may ascertain the metes and bounds of the claimed invention.
Martinez et al (Neuron, 2016, Vol. 92, No. 4, 32 pages) which is cited supra is not being mailed with this office action. The document was included in the office action mailed 2/20/2025.
Conclusion
Claims 1, 4-7, and 11-16 are rejected. Claims 8-10 and 17 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Correspondences
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 30, 2026
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