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 .
Priority
Priority to US 63/276,931, filed 11/8/2021, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 8/1/2024, before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Regarding claims 3 and 7, these claims recite the phrase “…has the amino acid sequence…”. This phrase is interpreted to mean “comprises” in this context because claim 1 invokes “comprises” and the specification recites both: “In certain embodiments, the peptide comprises or consists of the amino acid sequence of VGRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGSG (SEQ ID NO: 1), fragments, or variants thereof. In certain embodiments, the peptide comprises or consists of the amino acid sequence of GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGCG (SEQ ID NO: 2), fragments, or variants thereof.” (Specification, page 2, line 8).
Consequently, this is the broadest reasonable interpretation.
Claims 8-10, and 13 also use the phrase “has” or “having”. These claims are similarity interpreted to recite “comprising” or “comprises”.
Regarding claims 14 and 15, for the sake of compact prosecution, these claims will be examined as if they depended from claim 13. Claim 13 actually recites a vector.
Claim Objections
Claim 16 objected to because of the following informalities. For grammatical purposes, the article “a” should be between “and” and “pharmaceutically acceptable excipient”. Appropriate correction is required.
Claim 17 is objected to as being dependent upon an objected to base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 18 objected to because of the following informalities. For grammatical purposes, the term “tablets” should be singular “tablet”. Appropriate correction is required.
Furthermore, claim 18 is objected to as being dependent upon an objected to base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 19 is objected to as being dependent upon an objected to base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
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 1-6, 14, and 15 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.
Regarding claim 1, claim 1 recites: “A method of treating or preventing a viral infection comprising administering an effective amount of a peptide, or a vector encoding a peptide, comprising the amino acid sequence VGRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGSG (SEQ ID NO: 1) or a variant thereof.”
It is not clear which peptide comprises SEQ ID NO: 1 or whether both comprise SEQ ID NO: 1. However, a vector may not comprise amino acids. Clarification is requested.
Claim 1 is rejected.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, claim 2 does not resolve the indefiniteness of claim 1.
Claim 2 is rejected.
Regarding claim 3, claim 3 does not resolve the indefiniteness of claim 1.
Claim 3 is rejected.
Regarding claim 4, the phrase “…wherein the peptide, or vector encoding a peptide,…” makes it not clear as to which peptide is being encoding by the claimed vector. It could be “the peptide” or any other peptide. Clarification is requested.
Furthermore, claim 4 does not resolve the indefiniteness of claim 1.
Claim 4 is rejected.
Regarding claim 5, claim 5 recites the limitation "the subject" in line 1. There is insufficient antecedent basis for this limitation in the claim. “Subject” is not recited by claim 1.
Furthermore, claim 5 does not resolve the indefiniteness of claim 1.
Claim 5 is rejected.
Regarding claim 6, claim 6 recites the limitation "the subject" in line 1. There is insufficient antecedent basis for this limitation in the claim. “Subject” is not recited by claim 1.
Furthermore, claim 6 does not resolve the indefiniteness of claim 1.
Claim 6 is rejected.
Regarding claim 14, claim 14 recites the limitation "a recombinant vector" in line 1. There is insufficient antecedent basis for this limitation in the claim. “Recombinant vector” is not recited by claim 7.
Furthermore, even if claim 7 did contain a “recombinant vector”, this should be referred to as “…the recombinant vector of…” in claim 14.
Claim 14 is rejected.
Regarding claim 15, claim 15 recites the limitation "a recombinant vector" in line 1. There is insufficient antecedent basis for this limitation in the claim. “Recombinant vector” is not recited by claim 7.
Furthermore, even if claim 7 did contain a “recombinant vector”, this should be referred to as “…the recombinant vector of…” in claim 15.
Claim 15 is rejected.
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 1-2 and 4-6 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.
Regarding claim 1, the specification recites: “A "variant" refers to a chemically similar sequence because of amino acid changes or chemical derivative thereof. In certain embodiments, a variant contains one or two, or more amino acid deletions or substitutions. In certain embodiments, the substitutions are conserved substitutions. In certain embodiments, a variant contains one, two, or ten or more, or ten or less amino acid additions. In certain embodiments, the additions may be to the N-terminus or the C- terminus. The variant may be substituted with one or more chemical substituents.” (Specification, page 5, line 29).
This definition means that there is no limit to number of substitutions and deletions which in turns results in a nearly unlimited sequence space.
At the time the invention was made, the level of skill for preparing peptides with desired functional properties was high. However, even if a synthesis and selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identify peptides that yield polypeptides with the recited properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); see also Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1876 (Fed. Cir. 2011) (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”) Absent the conserved structure (length) provided by the provided species, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what peptide with a particular set of properties would look like structurally.
Since only a limited number of species of peptides are taught within the claimed genus above, the instant claim above fails the written description requirement. A representative number of species has not been taught to describe this genus.
Specifically, Applicant discloses only two specific embodiments that only differ by a single residue.
In the general case, a single point mutation can change the biophysical properties of a peptide: “In summary, we have shown that the structural changes in the fibrillar state of the Aβ42 peptide that are observed to occur upon introduction of single point mutations can be accompanied by changes in the dominance of the microscopic processes by which these aggregates are themselves formed.” (Bolognesi et al. ACS Chem Bio 9:2 (2013) page 381 col. 2 para. 3) and “In summary, while ovispirin-1 and novispirin G-10 both had solution structures that were helical and amphipathic in the presence of TFE, a relatively simple change in their primary structure (a single glycine–isoleucine exchange) had profound effects on their respective toxicities for human erythrocytes and epithelial cells.” (Sawai et al. Protein Eng. 15:3 (2002) page 232 col. 1 para. 3).
Furthermore, many sequences allowed by the current scope of the claims, result in non-functional aggregates. Wang (Wang, et al. MAbs. Vol. 1. No. 3. Taylor & Francis, (2009)) discloses a variety of aggregation prone motifs that occur in commercial antibodies (Wang, page 262, Table 2). The scope of the claims currently may incorporate such motifs and result in non-functional aggregates.
Finally, Zhou et al. (Zhou, et al. Biochimica et Biophysica Acta (BBA)-Biomembranes 1858.8: 1914-1925 (2016)) discloses that peptides are also subject to significant activity changes from a single mutation: “In our study, we constructed two anticancer peptides with only one difference in residue, but they showed dissimilar modes of action. One could penetrate into cells, target on mitochondria, and induce cell apoptosis, while the other could cause cell membrane lysis. This finding provides us a good example to study the structure-function relationship of ACPs as important drugs.” (Zhou et al., Abstract).
Given the mutation analysis in the Specification at page 24, it is reasonable to conclude that a large swathes of the claimed genus would include residues that interferes with the claimed binding activity. Therefore, the provided examples are not representative of the enormous claimed genus.
Given the issue of sequence space encompassed by the claimed genus, the skilled artisan would not have been in possession of the substantial repertoire of peptide species encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of every polynucleotide molecule recited by claim 1.
Consequently, claim 1 is rejected.
Regarding claim 2, claim 1 is rejected as described above. Claim 2 fails to reduce the claimed genus size of peptides. One of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of every polynucleotide molecule recited by claim 2.
Consequently, claim 2 is rejected.
Regarding claims 4-6, claim 1 is rejected as described above. Claims 4-6 fail to reduce the claimed genus size of peptides. One of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of every polynucleotide molecule recited by claims 4-6.
Consequently, claims 4-6 are rejected.
Examiner note: Claim 3 is not rejected because it claims only a single species which is supported by the specification.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SARS-CoV-2 inhibition, does not reasonably provide enablement for inhibition of all possible viral infections, nor the prevention of viral infections in general. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
The breadth of the claims;
The scope of the claim is very broad because it encompasses any possible viral infection as well as prevention of said infections.
The nature of the invention;
The invention in question is a method of treating or preventing viral infections by administering a peptide or a vector encoding a peptide comprising SEQ ID NO: 1 or a variant thereof.
This is a treatment claim that encompasses administering a therapeutic peptide or a nucleic acid that would result in the expression of said peptide.
The state of the prior art;
Viruses vary in phenotype and therefore strategies for viral treatment vary tremendously.
For example, Kausar et al. (Kausar, et al. International journal of immunopathology and pharmacology 35: 20587384211002621 (2021)) discloses various treatment strategies as well as the fact that some viruses have no treatment currently:
“Antiviral drugs are a class of medicines particularly used for the treatment of viral infections. Drugs that combat viral infections are called antiviral drugs. Viruses are among the major pathogenic agents that cause number of serious diseases in humans, animals and plants. Viruses cause many diseases in humans, from self-resolving diseases to acute fatal diseases. Developing strategies for the antiviral drugs are focused on two different approaches: Targeting the viruses themselves or the host cell factors. Antiviral drugs that directly target the viruses include the inhibitors of virus attachment, inhibitors of virus entry, uncoating inhibitors, polymerase inhibitors, protease inhibitors, inhibitors of nucleoside and nucleotide reverse transcriptase and the inhibitors of integrase. The inhibitors of protease (ritonavir, atazanavir and darunavir), viral DNA polymerase (acyclovir, tenofovir, valganciclovir and valacyclovir) and of integrase (raltegravir) are listed among the Top 200 Drugs by sales during 2010s. Still no effective antiviral drugs are available for many viral infections. Though, there are a couple of drugs for herpesviruses, many for influenza and some new antiviral drugs for treating hepatitis C infection and HIV. Action mechanism of antiviral drugs consists of its transformation to triphosphate following the viral DNA synthesis inhibition. An analysis of the action mechanism of known antiviral drugs concluded that they can increase the cell’s resistance to a virus (interferons), suppress the virus adsorption in the cell or its diffusion into the cell and its deproteinisation process in the cell (amantadine) along with antimetabolites that causes the inhibition of nucleic acids synthesis.” (Kausar et al., Abstract).
Pronin et al. discloses that viral treatment involves multiple mechanisms and that viral targets themselves are a constantly moving target:
“Unfortunately, as antiviral drugs are used, resistance begins to develop against them. One way to reduce the rate of appearance of the resistant pathogens is the use of various combinations of antiviral agents, and the trend towards the use of combination therapy has intensified in recent years (Chaudhuri et al. 2018). With this aim, a constant search of new targets is carried to inhibit the reproduction of viruses (or to affect the life cycle of the virus). Of the antiviral agents that exist today, 38% act on the polymerase, 24%–on viral proteases, 8%–on non-structural HCV protein 5A, in the treatment of which outstanding results have been achieved in recent years, 4% are aimed against integrase, while 14% have the M2 ion channel, neuraminidase, hemagglutinin and influenza nucleoprotein as their targets. The remaining 12% of the drugs affect the host, not the viruses. This group includes mainly interferons (IFNs) and their inducers (Chaudhuri et al. 2018; Ershov and Narovlyansky 2015; Kanda et al. 2017). This review focuses on the group of preventive and therapeutic medicines, the main active substance of which are polyprenols.” (Pronin et al., page 1, col. 2, para. 2).
Ison et al. (Ison, Michael G. Clinics in chest medicine 38.1: 139. (2016)) discloses that multiple strategies are employed for a single virus class like influenza:
“A wide range of viruses can affect the respiratory tract; in general, these can be divided into viruses for which the primary site of infection is the respiratory tract (classic respiratory viruses, including influenza, respiratory syncytial virus [RSV], human metapneumovirus [hMPV], parainfluenza virus [PIV], rhinovirus, and adenovirus) and viruses that can affect the respiratory tract opportunistically (ie, herpes simplex [HSV], cytomegalovirus [CMV], and measles). The focus of this article is antivirals directed at classic respiratory viruses; excellent reviews of agents for the treatment of HSV and CMV infections can be found elsewhere.1, 2, 3 However, there is significant effort being invested in novel antivirals for respiratory viruses often directed at novel targets, combinations designed to increase potency and reduce resistance emergence, therapeutic antibodies, and immunomodulatory agents selected to mitigate immunopathologic host responses; agents in advanced clinical development are reviewed briefly here, whereas more detailed reviews may be found elsewhere.4, 5, 6 Few antiviral drugs are currently approved for treating respiratory virus infections and most of these are specific inhibitors of influenza viruses. The emergence of new pathogens like Middle East respiratory syndrome coronavirus has also led to screening efforts to identify new therapeutics.7, 8.” (Ison et al., Introduction).
Ison also summarizes many classes of agents used to treat influenza in Table 1:
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807
439
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(Ison, et al., page 142, Table 1).
(D) The level of one of ordinary skill;
A person of ordinary skill in the art in the field of fusion proteins is usually at least a Master’s level education.
(E) The level of predictability in the art;
As described above, the predictability of this art is very poor. Viruses mutate with high frequency and different viruses respond in unpredictable ways to the treatment strategies listed above.
(F) The amount of direction provided by the inventor and the existence of working examples and the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant provides data for treatment of SARS-CoV-2 and no other virus families. Furthermore, no evidence of prevention of viral infection was provided.
Regarding claim 1, this claims encompasses all possible viral infections as well as prevention of viral infections. It would require undue experimentation to test the claimed peptides against all viral infections and furthermore for the ability to prevent any virus, including SARS-CoV-2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Consequently, claim 1 is rejected.
Regarding claim 2, claim 1 is rejected as described above. This claim reduces the range of viral infections to SARS-CoV-2. Therefore, this claim address the rejection partially. However, no evidence of prevention of SARS-CoV-2 is provided. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Consequently, claim 2 is rejected.
Regarding claims 3-6, claim 1 is rejected as described above. These claims do not reduce the amount of experimentation needed to show enablement. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Consequently, claims 3-6 are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bancel et al. US20150141499, published 5/21/2015.
Regarding claim 1, Bancel discloses SEQ ID NO: 174, aligned against Applicant SEQ ID NO: 1 below:
SQ Sequence 36 AA;
Query Match 95.3%; Score 181; Length 36;
Best Local Similarity 97.2%;
Matches 35; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 2 GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGSG 37
|||||||||||||||||||||||||||||||||| |
Db 1 GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGCG 36
Because the peptide of Bancel only differs by a single residue, this is fairly considered a variant of Applicant SEQ ID NO: 1.
Furthermore, Bancel discloses the usage of this polypeptide for the purpose of treating a viral infection in claims 13 and 15:
“13. The pharmaceutical composition of claim 1, wherein the anti-viral polypeptide is selected from the group consisting of SEQ ID NOs: 1-1762.
15. A method to treat a viral infection, comprising administering to a subject the pharmaceutical composition of claim 1.”
Consequently, claim 1 is anticipated by Bancel et al. and rejected.
Regarding claim 3, Bancel discloses SEQ ID NO: 174, aligned against Applicant SEQ ID NO: 3 below:
SQ Sequence 36 AA;
Query Match 100.0%; Score 191; Length 36;
Best Local Similarity 100.0%;
Matches 36; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGCG 36
||||||||||||||||||||||||||||||||||||
Db 1 GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGCG 36
Furthermore, Bancel discloses the usage of this polypeptide for the purpose of treating a viral infection in claims 13 and 15:
“13. The pharmaceutical composition of claim 1, wherein the anti-viral polypeptide is selected from the group consisting of SEQ ID NOs: 1-1762.
15. A method to treat a viral infection, comprising administering to a subject the pharmaceutical composition of claim 1.”
Consequently, claim 3 is anticipated by Bancel et al. and rejected.
Regarding claim 4, claim 1 is anticipated as described above. Claim 4 further recites the case wherein the peptide, or vector encoding a peptide, is administered in combination with another antiviral agent.
Bancel discloses in para. [0020]: “In certain embodiments, the method further comprises the step of administering an effective amount of an anti- viral agent, e.g., an anti -viral agent described herein, to the subject at the same time or at a different time from the administering the composition, e.g., before or after the administering the composition. In some embodiments, the anti- viral agent is an anti- viral polypeptide, e.g., an anti- viral polypeptide described herein. In some embodiments, the anti-viral agent is a small molecule anti-microbial agent, e.g., a small molecule anti-viral agent described herein.”
Consequently, claim 4 is anticipated by Bancel et al. and rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over by Bancel et al. US20150141499, published 5/21/2015, in view of Watson, et al. Therapeutic advances in respiratory disease 15:1753466621995050 (2021).
Regarding claim 5, claim 1 is anticipated as described above.
Bancel does not disclose treating subjects 55 years of age or older.
However, Watson discloses that respiratory infections is an increasing problem in the elderly population:
“With the United Nations (UN) predicting a doubling of the number of over 60-year-olds worldwide from 901 million in 2015 to 2.1 billion in 2050, ensuring overall quality of life in our aging population is now a major global public health challenge. Problems arise not only in dealing with an aging immune system and complex multi morbidities, but also in knowing how to identify, distinguish, prevent and treat the infectious diseases that often exacerbate morbidity in the elderly.
The burden of respiratory viral infections in the elderly has been highlighted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which has infected millions of people worldwide and had unprecedented impacts on healthcare systems and society as a whole. Age has been found to be the biggest risk factor for the development of severe COVID-19. Furthermore, a large United Kingdom (UK) prospectives observation study demonstrated that COVID-19 mortality was over 11 times higher in >80-year-olds than in <50-year-olds.
Other respiratory viruses, including influenza and respiratory syncytial virus (RSV) however also lead to substantial morbidity and mortality, particularly in the elderly. Similarly, there is an increasing understanding of the burden of human metapneumovirus (HMPV), human rhinovirus (HRV) and human parainfluenza virus (HPIV). Respiratory viral infections inhibit the ability of the elderly to function and carry out their everyday life tasks. Thus, having a substantial impact on the elderly individuals and their families. Furthermore, respiratory viruses are key contributors to exacerbation of chronic diseases.” (Watson et al., page 1, col. 1, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the peptide of Bancel to treat elderly subjects greater than 55 years old because Watson outlines the need to treat such subjects in the event of viral outbreaks, including acute viral infections such as SARS-CoV-2.
A person of ordinary skill in the art would be motivated to use an anti-viral peptide to treat an elderly subject in order to reduce the severity of symptoms and would have a reasonable expectation of success because Bancel characterizes SEQ ID NO: 174 as an anti-viral peptide.
Consequently, claim 5 is obvious over Bancel et al. in view of Watson et al. and rejected.
Regarding claim 6, claim 1 is anticipated as described above. Bancel does not disclose treating subjects diagnosed with a severe acute infection requiring intensive care.
Watson discloses the treatment the need to treat acute infections:
“With the United Nations (UN) predicting a doubling of the number of over 60-year-olds worldwide from 901 million in 2015 to 2.1 billion in 2050, ensuring overall quality of life in our aging population is now a major global public health challenge. Problems arise not only in dealing with an aging immune system and complex multi morbidities, but also in knowing how to identify, distinguish, prevent and treat the infectious diseases that often exacerbate morbidity in the elderly.
The burden of respiratory viral infections in the elderly has been highlighted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which has infected millions of people worldwide and had unprecedented impacts on healthcare systems and society as a whole. Age has been found to be the biggest risk factor for the development of severe COVID-19. Furthermore, a large United Kingdom (UK) prospectives observation study demonstrated that COVID-19 mortality was over 11 times higher in >80-year-olds than in <50-year-olds.
Other respiratory viruses, including influenza and respiratory syncytial virus (RSV) however also lead to substantial morbidity and mortality, particularly in the elderly. Similarly, there is an increasing understanding of the burden of human metapneumovirus (HMPV), human rhinovirus (HRV) and human parainfluenza virus (HPIV). Respiratory viral infections inhibit the ability of the elderly to function and carry out their everyday life tasks. Thus, having a substantial impact on the elderly individuals and their families. Furthermore, respiratory viruses are key contributors to exacerbation of chronic diseases.” (Watson et al., page 1, col. 1, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the peptide of Bancel to treat acute viral infections such as SARS-CoV-2 because Watson discloses that such infections lead to increased morbidity rates in the elderly population.
A person of ordinary skill in the art would be motivated to use an anti-viral peptide to treat an acute infection in order to reduce the severity of symptoms and would have a reasonable expectation of success because Bancel characterizes SEQ ID NO: 174 as an anti-viral peptide.
Consequently, claim 6 is obvious over Bancel et al. in view of Watson et al. and rejected.
Free of the Prior Art
Regarding claim 2, Bancel discloses SEQ ID NO: 174, aligned against Applicant SEQ ID NO: 1 below:
SQ Sequence 36 AA;
Query Match 95.3%; Score 181; Length 36;
Best Local Similarity 97.2%;
Matches 35; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 2 GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGSG 37
|||||||||||||||||||||||||||||||||| |
Db 1 GRFRRLRKKTRKRLKKIGKVLKWIPPIVGSIPLGCG 36
Because the peptide of Bancel only differs by a single residue, this is fairly considered a variant of Applicant SEQ ID NO: 1.
However, neither Bancel teaches or suggests usage of SEQ ID NO: 174 against SARS-CoV-2 or any other coronavirus. Other prior art sources, such as Eckert et al. WO2010080819, published 7/15/2010, disclose that this peptide as primarily known as an anti-bacterial peptide, not an anti-viral peptide. Because Bancel does not disclose usage against SARS-CoV-2 or any other coronavirus, a person of ordinary skill in the art would lack motivation to use this peptide against such viruses and not have a reasonable expectation of success.
Regarding claim 7, this claim has been interpreted to have a transitional phrase of “comprising”. The prior art fails to disclose this sequence as required by claim 7. The prior art fails to teach or suggest the cysteine to serine mutation. The criticality, or lack thereof, is not taught or suggested in the prior art. Even disregarding the functional differences between cysteine and serine, a person of ordinary skill in the art would have no reasonable way to choose that particular cysteine for mutation without the data provided by the present application.
Consequently, claim 7 is free of the prior art.
Claims 8-12 are all dependent upon claim 7 and therefore also free of the prior art.
Regarding claim 13, claim 13 is free of the prior art because the peptide being encoded by said nucleic acid is novel and nonobvious.
Regarding claims 14 and 15, these claims have been interpreted to depend from claim 13, but either way, these claims would be free of the prior art.
Regarding claim 16, claim 16 is free of the prior art because the is novel and nonobvious.
Claims 17-19 are all dependent upon claim 16 and therefore also free of the prior art.
Conclusion
Claims 1-6, 14, and 15 are rejected.
Claims 16-19 are objected to.
Claims 7-13 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/JEANETTE M LIEB/ Primary Examiner, Art Unit 1654
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