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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/28/2023, 07/31/2024, and 04/02/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 16 is objected to because of the following informalities: There is inconsistent use of commas and semicolons in the list of the claim. It is advised that Applicant remove the semicolon and replace it with a comma for consistency. Appropriate correction is required.
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 13 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 13 depends on claim 11 but does not further limit the scope of claim 11. Rather, claim 13 recites an identical limitation as compared to claim 11. Claim 14 depends from claim 13, which depends from claim 11, and claim 14 further limits the scope of the subject matter of claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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 1-20 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 does not distinctly disclose a representative number of embodiments of the nanobodies of the claimed composition. Applicant recites embodiments of the nanobodies engineered to attach to viral targets broadly, including the SARS-CoV-2 virus, influenza, HIV, as well as the ACE2 receptor of the host cell surface, but Applicant does not reduce to practice distinct embodiments of the composition so as to fulfill the requirements of written description. According to Hacisuleyman et al. (Hacisuleyman, Aysima et al. “ModiBodies: A computational method for modifying nanobodies to improve their antigen binding and specificity,” bioRxiv, October 2019), nanobodies, in this case, therapeutic nanobodies, are highly specific and require precise targets to attach to (see Abstract). Here, claim 1 is directed at nanobodies broadly, but Applicant has only recited embodiments of nanobodies engineered to attach to specific viral targets and the host surface, namely the spike protein of SARS-CoV-2 and the ACE2 receptor. Beyond these embodiments the disclosure mentions using the composition to treat other enveloped viral infections, including influenza and HIV, but no specific targets on the host cells or on the viruses themselves are elucidated. As such, Applicant has not fulfilled the requirements of written description with regard to the broad genus of nanobodies, as Applicant has not disclosed any embodiments beyond those discussed above. It is advised that Applicant revise the claims to direct the nanobodies at the well-known spike protein of SARS-CoV-2 and/or the ACE2 receptor, both of which are precise targets that suggest that Applicant would reasonably have possession of them.
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 11, 13, and 14 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.
With regard to claims 11 and 13, the claims are directed at a composition, which is a product. Claims 11 and 13, however, recite active method steps in the form of atomizing and administering to the airways of a subject the compound. Seeing as the claims are clearly drawn to a product and it is not clear how the active method steps would alter the product itself, the active steps render the scope of the claims unclear. In other words, the claims cannot be drawn to both a product and a method, so the claims with active method steps are rejected on account of the unclear scope of the invention.
With regard to claim 14, the claims are directed at a composition, which is a product. Claim 14, however, recites active method steps in the form of administering the composition in two steps. Seeing as the claims are clearly drawn to a product and it is not clear how the active method steps would alter the product itself, the active steps render the scope of the claims unclear. In other words, the claims cannot be drawn to both a product and a method, so the claims with active method steps are rejected on account of the unclear scope of the invention.
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 1-9, 11, 13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20220202933 A1 (filed 2022-03-18 and published 2022-06-30), hereinafter Peyman, as evidenced by Lan et al. (Lan, Jun et al. “Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptor.” Nature vol. 581,7807 (2020): 215-220).
With regard to claim 1, Peyman teach a vaccine cocktail, referred to as a therapeutic vaccine, for treating viral infections (see [0067]). In one embodiment, the therapeutic vaccine is produced with nanobodies capable of binding viral and cellular targets (see [0544]). In one embodiment, cyclodextrin can be used in the composition in combination with antivirals (see [0338]). Peyman provide a motivation for using cyclodextrin in the embodiment because of its role in preventing the viral attachment to cell receptors (see [0340]). In one embodiment, quercetin, a zinc ionophore, is included in a biocompatible drug cocktail in order to treat infections (see [0333]). Peyman provide a clear motivation for the use of quercetin because of its role in reducing excessive glutamate that can cause neuronal death (see [0243]). In one embodiment, the compositions administered to a subject comprise zinc in a saline solution with antiviral medications (see [0103]). Peyman also provide a clear motivation for the use of zinc in the composition on account of its antiviral properties (see [0376]). In one embodiment, a vaccine cocktail is prepared with benzalkonium (see [0067]). Peyman provide a clear motivation for the use of benzalkonium in a vaccine cocktail on account of its ability to produce a strong immune response (see [0192]). Given the clear motivations for the use of cyclodextrin, quercetin, zinc, and benzalkonium discussed above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to combine the aforementioned embodiments of Peyman with the nanobodies in a composition.
With regard to claims 2, 3, and 4, Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). Here, Peyman teach the use of nanobodies to attach to the RBD or ACE2 (see [0544]). In the context of the invention of Peyman, the RBD is the receptor binding domain of the virus that attaches to the ACE2 of the host receptor and causes the binding of the virus to the cell (see [0012], [0013], and [0544]). In the context of this invention, the basis of “the virus” is a coronavirus (see [0012], [0013]). As such, Peyman clearly teach the nanobodies as binding the RBD of the coronavirus, which, according to Lan et al., is the spike protein that mediates binding to the ACE2 of the host cell (see Lan et al. Abstract). Although the nanobody is not explicitly engineered in Peyman, the engineering of the spike protein is a product-by-process claim and is not limiting in the case that the nanobodies of Peyman similarly attach to the viral spike protein.
With regard to claims 5 and 6, Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). The ACE2 receptor is the host cell receptor involved in the binding of the virus.
With regard to claim 7, Peyman teach an embodiment wherein quercetin, a zinc ionophore, is included in a biocompatible drug cocktail in order to treat infections (see [0333]). Peyman provide a clear motivation for the use of quercetin because of its role in reducing excessive glutamate that can cause neuronal death (see [0243]). As such, it would have been obvious to one of ordinary skill prior to the effective filing date of the instant application to use quercetin in a pharmaceutical composition to reduce glutamate.
With regard to claim 9, Peyman teach an embodiment of the composition at physiologic pH adjusted to 7-7.5 pH (see [0233]). Here, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped. As such, the range of 7-7.5 overlaps with the claimed range of 2.5-7.5, and a case of obviousness exists on account of the clearly overlapping ranges.
With regard to claims 11 and 13, Peyman teach that, in one embodiment, the composition is aerosolized or nebulized, a type of atomization, and administered nasally (see [0047]). Peyman also teach that the nasal administration of the nebulized biocompatible drug allows for the drug to reach branches of the trigeminal nerve or the olfactory nerve for delivery to the brain, brain vasculature, and the cerebrospinal fluid, providing a motivation for administration to the airways (see [0045] to [0047]). Regardless, as discussed above, claims 11 and 13 are directed at active method steps that do not necessarily affect the structure of the claimed product.
With regard to claim 16, Peyman teach a method of treating a subject at risk of contracting a viral infection, caused by an enveloped virus, namely coronaviruses (see [0145] to [0148]). The method includes administering to a patient in need thereof a biocompatible drug comprising one or more antiviral medications together with one or more cell pathway inhibitors (see [0145]). As discussed above, embodiments of the composition comprise the following components. In one embodiment, the therapeutic vaccine is produced with nanobodies (see [0544]). In one embodiment, cyclodextrin can be used in the composition in combination with antivirals (see [0338]). Peyman provide a motivation for using cyclodextrin in the embodiment because of its role in preventing the viral attachment to cell receptors (see [0340]). In one embodiment, quercetin, a zinc ionophore, is included in a biocompatible drug cocktail in order to treat infections (see [0333]). Peyman provide a clear motivation for the use of quercetin because of its role in reducing excessive glutamate that can cause neuronal death (see [0243]). In one embodiment, the method comprises the administration of zinc in a saline solution with antiviral medications (see [0103]). Peyman also provide a clear motivation for the use of zinc in the composition on account of its antiviral properties (see [0376]). In one embodiment, a vaccine cocktail is prepared with Benzalkonium (see [0067]). Peyman provide a clear motivation for the use of benzalkonium in a vaccine cocktail on account of its ability to produce a strong immune response (see [0192]). Given the clear motivations for the use of cyclodextrin, quercetin, zinc, and benzalkonium discussed above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to combine the embodiments aforementioned embodiments of Peyman with the nanobodies in a composition to treat or prevent coronavirus infections.
With regard to claims 17, 18, and 19, Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). Here, Peyman teach the use of nanobodies to attach to the RBD or ACE2 (see [0544]). In the context of the invention of Peyman, the RBD is the receptor binding domain of the virus that attaches to the ACE2 of the host receptor and causes the binding of the virus to the cell (see [0012], [0013], and [0544]). In the context of this invention, the basis of “the virus” is a coronavirus (see [0012], [0013]). As such, Peyman clearly teach the nanobodies as binding the RBD of the coronavirus, which is the spike protein, the protein that mediates binding to the host. Although the nanobody is not explicitly engineered in Peyman, the engineering of the spike protein is a product-by-process claim and is not limiting in the case that the antibodies of Peyman similarly attach to the viral spike protein.
With regard to claim 20, Peyman teach an embodiment, wherein quercetin, a zinc ionophore, is included in a biocompatible drug cocktail in order to treat infections (see [0333]). Peyman provide a clear motivation for the use of quercetin because of its role in reducing excessive glutamate that can cause neuronal death (see [0243]). Given this motivation to include quercetin in the composition, it would have been obvious to one of ordinary skill in the art to use quercetin in a composition to treat viral infections.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 20220202933 A1 (filed 2022-03-18 and published 2022-06-30), hereinafter Peyman, as applied to claims 1 and 7 above, in view of Kanda et al. (Kanda, Tatsuo et al. “Additive Effects of Zinc Chloride on the Suppression of Hepatitis A Virus Replication by Interferon in Human Hepatoma Huh7 Cells.” In vivo (Athens, Greece) vol. 34,6 (2020): 3301-3308).
With regard to claim 8, Peyman teach the composition and method discussed and as applied to claims 1 and 7 above. Peyman do not explicitly teach the use of quercetin at a concentration of 8 micrograms mL---1 or that the zinc containing compound is zinc chloride at a concentration of 1 mg mL-1. Although Peyman do not teach that the zinc containing compound is zinc chloride, Peyman do teach that some embodiments can contain zinc in an aqueous form on account of its antiviral properties (see [0376]). Moreover, Kanda et al. teach that zinc chloride specifically has strong antiviral properties that make it desirable over other zinc-containing compounds like zinc sulfate (see Abstract). For example, they found that zinc sulfate tended to enhance while zinc chloride significantly enhanced antiviral properties against the viruses that they studied (see Abstract). Given this motivation to use zinc chloride as opposed to other forms of zinc, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to use zinc chloride in the composition. As discussed above, it would have been obvious to one of ordinary skill in the art to combine the embodiments of Peyman to make and use the composition, but Peyman do not teach the exact concentrations of claim 8. Kanda et al. do, however, teach that zinc chloride can be given at different concentrations to yield different results, indicating that zinc chloride is a result-effective variable in the pharmaceutical composition. Specifically, Kanda et al. teach that zinc concentration in drugs for treating hepatitis can be lowered as compared to traditional formulations in order to achieve a desired result (see page 3306, paragraph 1). Here, zinc chloride is a result-effective variable, and the presence of a known result-effective variable is a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. Although neither reference teach claimed the concentration, given the nature of the zinc chloride as a result-effective variable, it would have been obvious to one having ordinary skill in the art to try to experiment and optimize its concentration to achieve the desired result with a reasonable expectation of arriving at the claimed concentration. Similarly, the motivation for including quercetin is on account of its active role in reducing glutamate that can cause neuronal death and Alzheimer’s disease (see [0243]). Given this biological function, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to try to optimize the concentration of quercetin to affect the results in neuronal death.
Claims 10, 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20220202933 A1 (filed 2022-03-18 and published 2022-06-30), hereinafter Peyman, as applied to claim 1 above, in view of Kanda et al. (Kanda, Tatsuo et al. “Additive Effects of Zinc Chloride on the Suppression of Hepatitis A Virus Replication by Interferon in Human Hepatoma Huh7 Cells.” In vivo (Athens, Greece) vol. 34,6 (2020): 3301-3308), as evidenced by Foo et al. (Foo et al. “Combating Coronavirus: Key Role of Cyclodextrins in Treatment and Prevention,” Roquette, February 2020).
With regard to claim 10, Peyman teach the composition discussed above, which can include a cyclodextrin, but they do not teach that the cyclodextrin is HPßCD at a concentration between 1-10%. Foo et al. teach that the antiviral HPßCD is useful in combating coronaviruses because it has high water solubility and an excellent safety profile (see page 1, paragraph 6). Moreover, as an adjuvant, HPßCD induces helper T-cell response, enhances antigen-specific antibody titers, and maintains longer immune response, while limiting immunoglobulin E production (see page 2, paragraph 3). As such, a person having ordinary skill in the art would have been motivated to use HPßCD in particular when using a cyclodextrin in a pharmaceutical composition, especially one drawn to treating coronaviruses. Further, Foo et al. note that the concentration of HPßCD affects its virucidal function and is relevant to its safety (see page 2, paragraph 1 and page 3, paragraph 2). As such, the concentration of HPßCD in the composition is a result-effective variable, and the presence of a known result-effective variable is a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. Although neither reference teach the concentration at 1-10%, given the nature of the HPßCD as a result-effective variable, it would have been obvious to one having ordinary skill in the art to try to experiment and optimize its concentration to achieve the desired result with a reasonable expectation of arriving at the concentration in claim 10 of the instant application.
With regard to claim 12, Peyman teach the composition and method discussed and as applied above. As discussed above, Peyman teach a vaccine cocktail, referred to as a therapeutic vaccine, for treating viral infections (see [0067]). In one embodiment, the therapeutic vaccine is produced with nanobodies (see [0544]). In one embodiment, cyclodextrin can be used in the composition in combination with antivirals (see [0338]). Peyman provide a motivation for using cyclodextrin in the embodiment because of its role in preventing the viral attachment to cell receptors (see [0340]). In one embodiment, quercetin, a zinc ionophore, is included in a biocompatible drug cocktail in order to treat infections (see [0333]). Peyman provide a clear motivation for the use of quercetin because of its role in reducing excessive glutamate that can cause neuronal death (see [0243]). In one embodiment, the method comprises the administration of zinc in a saline solution with antiviral medications (see [0103]). Peyman also provide a clear motivation for the use of zinc in the composition on account of its antiviral properties (see [0376]). In one embodiment, a vaccine cocktail is prepared with Benzalkonium at 0.01% concentration (see [0067]). Peyman provide a clear motivation for the use of benzalkonium in a vaccine cocktail on account of its ability to produce a strong immune response (see [0192]). Given the clear motivations for the use of cyclodextrin, quercetin, zinc, and benzalkonium discussed above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to combine the embodiments aforementioned embodiments of Peyman with the nanobodies in a composition. Peyman do not explicitly teach the use of quercetin at a concentration of 8 micrograms per mL---1 or that the zinc containing compound is zinc chloride at a concentration of 1 mg mL-1. Although Peyman do not teach that the zinc containing compound is zinc chloride, Peyman do teach that some embodiments can contain zinc in an aqueous form on account of its antiviral properties (see [0376]). Moreover, Kanda et al. teach that zinc chloride specifically has strong antiviral properties that make it desirable over other zinc-containing compounds like zinc sulfate (see Abstract). For example, they found that zinc sulfate tended to enhance while zinc chloride significantly enhanced antiviral properties against the viruses that they studied (see Abstract). Given this motivation to use zinc chloride as opposed to other forms of zinc, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to use zinc chloride in the composition. Although Peyman do not explicitly teach the concentrations of 8 micrograms per mL-1 quercetin or 1 mg per mL-1 zinc chloride, these concentrations are the result of a predictable process of routine optimization or experimentation. As discussed above, it would have been obvious to one of ordinary skill in the art to combine the embodiments of Peyman to make and use the composition, but Peyman do not teach the exact concentrations of claim 8. As discussed above, Kanda et al. do teach that zinc chloride can be given at different concentrations to yield different results, indicating that zinc chloride is a result-effective variable in the pharmaceutical composition. Specifically, Kanda et al. teach that zinc concentration in drugs for treating hepatitis can be lowered as compared to traditional formulations in order to achieve a desired result (see page 3306, paragraph 1). Here, zinc chloride is a result-effective variable, and the presence of a known result-effective variable is a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. Although neither reference teach claimed the concentration, given the nature of the zinc chloride as a result-effective variable, it would have been obvious to one having ordinary skill in the art to experiment and optimize its concentration to achieve the desired result with a reasonable expectation of arriving at the claimed concentration. Similarly, the motivation for including quercetin is on account of its active role in reducing glutamate that can cause neuronal death and Alzheimer’s disease (see [0243]). Given this biological function, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to try to optimize the concentration of quercetin to affect the results in neuronal death with a reasonable expectation of achieving the concentration claimed in the instant application. As discussed above, Peyman teach an embodiment of the composition at physiologic pH adjusted to 7-7.5 pH (see [0233]), as well as a sodium phosphate buffered solution at pH 7.4 (see [0077]). Here, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped. As such, the range of 7-7.5 overlaps with the claimed range of 2.5-7.5, and a case of obviousness exists on account of the clearly overlapping ranges. As discussed above, Peyman do not teach that the cyclodextrin is HPßCD at a concentration of 1-5%, but given the reasoning discussed above, it would have been obvious to use HPßCD and to try to optimize the concentration to reasonably arrive at the claimed concentration of 1-5%.
With regard to claim 14, Peyman teach the composition discussed above, but do not teach that the administration of the composition occurs in two steps, wherein the nanobody and cyclodextrin is first administered and the quercetin and zinc is administered second. As discussed above, the invention is directed at or drawn to a product, a composition. It is unclear whether the active method steps would affect the structure of the product. As such, the composition taught by Peyman and recited above is reasonably capable of being administered according to the active method steps and the prior art need not teach active method steps for a claimed product.
With regard to claim 15, Peyman teach many embodiments wherein the vaccine, antivirals, or vaccine cocktails are in a saline or physiological solution, both of which are inherently aqueous (see [0077], [0170], [0181], [0182], [0192], [0500]). Peyman provide a motivation for using an aqueous solution, specifically a saline solution, because of its usefulness in passing through the stomach to release medication locally and its ability to damage the invading viruses in the mucosa (see [0052], [0053]).
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 1-9, 11, 13-14, and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 7, 9, and 10 of copending Application No. 18/680,557 in view of 20220202933 A1 (filed 2022-03-18 and published 2022-06-30), hereinafter Peyman, as evidenced by Foo et al. (Foo et al. “Combating Coronavirus: Key Role of Cyclodextrins in Treatment and Prevention,” Roquette, February 2020).
This is a provisional nonstatutory double patenting rejection.
With regard to claim 1, Jena (557) claims an aqueous composition comprising: a cyclodextrin; a zinc ionophore; a zinc-containing compound; and, a preservative (see claim 1). Jena (557) does not claim the use of nanobodies. Peyman does, however, teach the use of nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir, etc. and anti-inflammatory pathway inhibitors and Ceapin-A7 and KIRA8 or spermidine to strengthen the immune response (see [0544]). Given this motivation of strengthening immune response in the subject, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of then instant application to combine the references of Jena (557) and Peyman to make a composition containing the components discussed above.
With regard to claims 2, 3, and 4, Jena (557) claim the composition discussed above. Specifically, they claim an aqueous composition comprising a cyclodextrin, a zinc ionophore, a zinc-containing compound, and a benzalkonium preservative (see claims 1, 5). Jena (557) do not claim nanobodies, but, as discussed above, it would have been obvious to use nanobodies in the invention of Jena (557) in light of Peyman. Jena (557) do not teach that the nanobodies are engineered to attach to a viral protein, spike protein, or coronaviral protein. Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). Here, Peyman teach the use of nanobodies to attach to the RBD or ACE2 (see [0544]). In the context of the invention of Peyman, the RBD is the receptor binding domain of the virus that attaches to the ACE2 of the host receptor and causes the binding of the virus to the cell (see [0012], [0013], and [0544]). In the context of this invention, the basis of “the virus” is a coronavirus (see [0012], [0013]). As such, Peyman clearly teach the nanobodies as binding the RBD of the coronavirus, which is the spike protein that mediates binding to the host cell, as discussed above. Although the nanobody is not explicitly engineered in Peyman, the engineering of the spike protein is a product-by-process claim and is not limiting in the case that the antibodies of Peyman similarly attach to the viral spike protein. Based on the reasoning above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to combine the references of Jena (557) and Peyman to include the nanobodies discussed above.
With regard to claims 5 and 6, Jena (557) claim the composition discussed above, but they do not claim the use of nanobodies (see claim 1). Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). The ACE2 receptor is the host cell receptor involved in the binding of the virus. Given the reasoning above, it would have been obvious to combine the references of Peyman and Jena (557) to include the nanobodies discussed above.
With regard to claim 7, Jena (557) claims the composition discussed above wherein the zinc ionophore is quercetin (see claim 4).
With regard to claim 9, Jena (557) claim the use of a phosphate buffer (see claim 9), but they do not explicitly claim that the composition is buffered to pH 2.5-7.5. Peyman et al. do, however, teach an embodiment of the composition at physiologic pH adjusted to 7-7.5 pH (see [0233]). Further, they motivate the use of a pH value in this range, specifically 7.4, because of its ability to contribute to preventing aggregation of viral particles (see [0077]). As such, it would have been obvious to one having ordinary skill prior to the effective filing date of the instant application to combine the references to use the pH ranges motivated by Peyman et al. Here, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped. As such, the range of 7-7.5 overlaps with the claimed range of 2.5-7.5, and a case of obviousness exists on account of the clearly overlapping ranges.
With regard to claim 10, Jena (557) claims this composition wherein the cyclodextrin is at least 1 selected from the group of: hydroxypropyl-β-cyclodextrin, M-βCD, and SBEβCD (see claim 2). Jena (557) does not, however, claim the use of the cyclodextrin at a concentration between 1-10%. Here, as discussed above, Foo et al. note that the concentration of HPßCD affects its virucidal function and is relevant to its safety (see page 2, paragraph 1 and page 3, paragraph 2). As such, the concentration of HPßCD in the composition is a result-effective variable, and the presence of a known result-effective variable is a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. Although neither reference teach the concentration at 1-10%, given the nature of the HPßCD as a result-effective variable, it would have been obvious to one having ordinary skill in the art to experiment and optimize its concentration to achieve the desired result with a reasonable expectation of arriving at the concentration in claim 10 of the instant application.
With regard to claims 11 and 13, Jena (557) claim the composition discussed above, but they do not claim a method of administration (see claim 1). Peyman teach that, in one embodiment, the composition is aerosolized or nebulized, a type of atomization, and administered nasally (see [0047]). Peyman also teach that the nasal administration of the nebulized biocompatible drug allows for the drug to reach branches of the trigeminal nerve or the olfactory nerve for delivery to the brain, brain vasculature, and the cerebrospinal fluid, providing a motivation for administration to the airways (see [0045] to [0047]). Given the reasoning above, it would have been obvious to one of ordinary skill prior to the effective filing date of the instant application to combine the references of Peyman and Jena (557) to administer the composition in a nebulized form in the airways of the subject, particularly nasally in order to increase drug delivery to the brain. Regardless, as discussed above, claims 11 and 13 are directed at active method steps that do not necessarily affect the structure of the claimed product.
With regard to claim 14, as discussed above, the claims are directed at a composition, which is a product. Claim 14, however, recites active method steps in the form of administering the composition in two steps. Seeing as the claims are clearly drawn to a product and it is not clear how the active method steps would alter the product itself, the active steps render the scope of the claims unclear.
With regard to claim 16, Jena (557) claim a method of reducing enveloped virus number comprising administering to a subject in need thereof an aqueous composition comprising a cyclodextrin, a zinc ionophore, a zinc-containing compound, and a benzalkonium preservative (see claims 1, 5, 10). Again, Jena (557) do not claim the use of nanobodies, but Peyman provide a clear motivation for the use of nanobodies. Given the reasoning above, it would have been obvious to combine the references to include nanobodies in the composition of method discussed above.
With regard to claims 17, 18, and 19, Jena (557) claim the method discussed above. Specifically, they claim a method of reducing enveloped virus number comprising administering to a subject in need thereof an aqueous composition comprising a cyclodextrin, a zinc ionophore, a zinc-containing compound, and a benzalkonium preservative (see claims 1, 5, 10). Jena (557) do not claim the use nanobodies, but, as discussed above, it would have been obvious to use nanobodies in the invention of Jena (557) in light of Peyman. Jena (557) do not teach that the nanobodies are engineered to attach to a viral protein, spike protein, or coronaviral protein. Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). Here, Peyman teach the use of nanobodies to attach to the RBD or ACE2 (see [0544]). In the context of the invention of Peyman, the RBD is the receptor binding domain of the virus that attaches to the ACE2 of the host receptor and causes the binding of the virus to the cell (see [0012], [0013], and [0544]). In the context of this invention, the basis of “the virus” is a coronavirus (see [0012], [0013]). As such, Peyman clearly teach the nanobodies as binding the RBD of the coronavirus, which is the spike protein, the protein that mediates binding to the host. Although the nanobody is not explicitly engineered in Peyman, the engineering of the spike protein is a product-by-process claim and is not limiting in the case that the antibodies of Peyman similarly attach to the viral spike protein. Based on the reasoning above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to combine the references of Jena (557) and Peyman to include the nanobodies discussed above.
With regard to claim 20, Jena (557) teach the method discussed above wherein the zinc ionophore is quercetin (see claim 4).
Claims 8, 12, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 7, 9, and 10 of copending Application No. 18/680,557 in view of 20220202933 A1 (filed 2022-03-18 and published 2022-06-30), hereinafter Peyman, and in further view of Kanda et al. (Kanda, Tatsuo et al. “Additive Effects of Zinc Chloride on the Suppression of Hepatitis A Virus Replication by Interferon in Human Hepatoma Huh7 Cells.” In vivo (Athens, Greece) vol. 34,6 (2020): 3301-3308), as evidenced by Foo et al. (Foo et al. “Combating Coronavirus: Key Role of Cyclodextrins in Treatment and Prevention,” Roquette, February 2020).
With regard to claim 8, Jena (557) claims the composition discussed above wherein the zinc-containing compound is zinc chloride (see claim 7). Jena (557) do not, however, teach the specific concentrations of quercetin at 8 micrograms per mL-1 and zinc chloride at 1 mg per mL-1. Kanda et al. teach that zinc chloride specifically has strong antiviral properties that make it desirable over other zinc-containing compounds like zinc sulfate (see Abstract). For example, they found that zinc sulfate tended to enhance while zinc chloride significantly enhanced antiviral properties against the viruses that they studied (see Abstract). Kanda et al. further teach that zinc chloride can be given at different concentrations to yield different results, indicating that zinc chloride is a result-effective variable in the pharmaceutical composition. Specifically, Kanda et al. teach that zinc concentration in drugs for treating hepatitis can be lowered as compared to traditional formulations in order to achieve a desired result (see page 3306, paragraph 1). Here, zinc chloride is a result-effective variable, and the presence of a known result-effective variable is a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. As such, it would have been obvious to one having ordinary skill in the art to try to experiment and optimize its concentration to achieve the desired result with a reasonable expectation of arriving at the claimed concentration. Similarly, as discussed above, Peyman et al. provide the motivation for including quercetin on account of its active role in reducing glutamate that can cause neuronal death and Alzheimer’s disease (see [0243]). Given this biological function, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to try to optimize the concentration of quercetin to affect the results in neuronal death.
With regard to claim 12, Jena (557) claim the composition discussed above, but they do not claim the use of nanobodies or specific concentrations for the HPßCD, quercetin, zinc chloride, benzalkonium, or pH (see claim 1). As discussed above, Peyman teach an embodiment that uses nanobodies capable of attaching to a host cell membrane, and Peyman also provide a clear motivation for using cyclodextrin, quercetin, zinc-containing compounds, benzalkonium, and phosphate buffer. Given the reasoning above and the clear motivation to use these components in a composition, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the instant application to combine the references. Although it would have been obvious to one having ordinary skill in the art to combine the references to make a composition comprising the nanobodies recited Peyman in combination with the quercetin, zinc chloride, benzalkonium, phosphate buffer, and HPßCD as discussed above, neither reference claims the specific concentrations of these components recited in claim 12 of the instant application. Nonetheless, as recited above and in light of Kanda et al., these components are result-effective variables, and the presence of a known result-effective variable is a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In other words, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the instant application to try to optimize the concentrations of the components discussed above.
With regard to claim 15, Jena (557) claim the composition discussed above wherein the composition is in an aqueous solution (see claim 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-17, 20-26, and 29-35 of U.S. Patent No. 12226431, hereinafter Jena (431), in view of 20220202933 A1 (filed 2022-03-18 and published 2022-06-30), hereinafter Peyman.
With regard to claim 1, Jena (431) claims a composition for administration to a subject, for inhibiting viral entry and replication of an enveloped virus in cells of the subject, consisting of: 1-5% cyclodextrin; a zinc ionophore; a zinc-containing compound; a preservative; and, an aqueous buffer where the preservative is 0.01% benzalkonium chloride (see claims 10 and 14). Jena (431) does not claim the use of a nanobody in the composition. Peyman does, however, teach the use of nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir, etc. and anti-inflammatory pathway inhibitors and Ceapin-A7 and KIRA8 or spermidine to strengthen the immune response (see [0544]). Given this motivation of strengthening immune response in the subject, it would have been obvious too one having ordinary skill in the art prior to the effective filing date of then instant application to combine the references of Jena (431) and Peyman to make a composition containing the components discussed above.
With regard to claims 2, 3, and 4, Jena (431) claims the composition discussed above. Specifically, Jena (431) claims a composition comprising 1-5% cyclodextrin, quercetin, zinc chloride, benzalkonium, and an aqueous buffer (see claims 10-12 and 14). As discussed above, Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). Here, Peyman teach the use of nanobodies to attach to the RBD or ACE2 (see [0544]). In the context of the invention of Peyman, the RBD is the receptor binding domain of the virus that attaches to the ACE2 of the host receptor and causes the binding of the virus to the cell (see [0012], [0013], and [0544]). In the context of this invention, the basis of “the virus” is a coronavirus (see [0012], [0013]). As such, it is the position of the examiner that Peyman clearly teach the nanobodies as binding the RBD of the coronavirus, which is the spike protein, the protein that mediates binding to the host. Although the nanobody is not explicitly engineered in Peyman, the engineering of the spike protein is a product-by-process claim and is not limiting in the case that the antibodies of Peyman similarly attach to the viral spike protein.
With regard to claims 5 and 6, Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). The ACE2 receptor is the host cell receptor involved in the binding of the virus.
With regard to claim 7, Jena (431) claims that the zinc ionophore is quercetin (see claim 12).
With regard to claim 8, Jena (431) claims that the quercetin is at a concentration of 8 ug mL-1; and the zinc is zinc chloride and is at a concentration of 1 mg mL-1 (see claim 13).
With regard to claim 9, Jena (431) claims that the composition is citrate buffered at a pH of 2.5 (see claim 15) and that the composition is phosphate buffered at pH 7.5 and the preservative is 0.01% benzalkonium chloride (see claim 16).
With regard to claim 10, Jena (431) claims a composition for administration to a subject, for inhibiting viral entry and replication of an enveloped virus in cells of the subject, consisting of: 2-hydroxypropyl-ßCD; quercetin; a zinc-containing compound; a preservative; and, an aqueous buffer (see claim 35). Jena (431) does not claim the composition wherein the HPßCD at a concentration between 1-10%, but they do claim that the cyclodextrin is at a concentration of 1-5% (see claim 10). Jena (431) do not, in this embodiment, claim the specific concentration of 1-10% 2-hydropropyl-ßCD (cyclodextrin). Nonetheless, given the Jena (431) claim 1-5% cyclodextrin in the other embodiment discussed above, a person having ordinary skill in the art would recognize that, on account of the fact that hydropropyl-ßCD is a cyclodextrin, 1-5% 2-hydroxypropyl-ßCD could be used at a concentration of 1-5% with a reasonable expectation of success. Here, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped. As such, the range of 1-10% and 1-5% clearly overlap, and a case of obviousness exists on account of this overlap.
With regard to claims 11 and 13, Jena (431) claims the composition is administered as an inhalation or an aerosol spray (see claim 17). Given that aerosolization implies atomization, Jena (431) claims the limitation of atomization.
With regard to claim 12, Jena (431) claims the composition discussed above comprising 1-5% cyclodextrin, zinc ionophore, a zinc-containing compound, a preservative, and an aqueous buffer (see claim 10). Here, the zinc-containing compound is zinc chloride at 1 mg per mL-1 (see claims 11 and 13), the zinc ionophore is quercetin at 8 micrograms per mL-1 (see claims 12 and 13), the preservative is 0.01% benzalkonium (see claim 14), and the solution is citrate buffered at a pH of 2.5 or is phosphate buffered at pH 7.5 (see claims 15 and 16). Jena (431) also claims a composition for administration to a subject consisting of 2-hydroxypropyl-ßCD, quercetin, a zinc-containing compound, a preservative, and an aqueous buffer. Jena (431) do not, in this embodiment, claim the specific concentration of 1-5% 2-hydropropyl-ßCD (cyclodextrin). Nonetheless, given the Jena (431) claim 1-5% cyclodextrin in the other embodiment discussed above, a person having ordinary skill in the art would recognize that, on account of the fact that hydropropyl-ßCD is a cyclodextrin, 1-5% 2-hydroxypropyl-ßCD could be used at a concentration of 1-5% with a reasonable expectation of success.
With regard to claim 14, Jena (431) claims a method of treating a subject at risk of contracting a viral infection, caused by an enveloped virus, the method comprising the step of: administering to the subject a first composition consisting of 1-5% cyclodextrin, a preservative, and an aqueous buffer; and, administering separately, or coadministering, a second composition consisting of quercetin, a zinc-containing compound, a preservative, and an aqueous buffer (see claim 29). Regardless, as discussed above, the claims are directed at a composition, which is a product. Claim 14, however, recites active method steps in the form of administering the composition in two steps. Seeing as the claims are clearly drawn to a product and it is not clear how the active method steps would alter the product itself, the active steps render the scope of the claims unclear.
With regard to claim 15, Jena (431) claims a method of treating a subject at risk of contracting a viral infection, caused by an enveloped virus, the method comprising the step of: administering to the subject a first composition consisting of 1-5% cyclodextrin, a preservative, and an aqueous buffer; and, administering separately, or coadministering, a second composition consisting of quercetin, a zinc-containing compound, a preservative, and an aqueous buffer (see claim 29).
With regard to claim 16, Jena (431) claims a method of treating a subject at risk of contracting a viral infection, caused by an enveloped virus, the method comprising the step of: administering to the subject a first composition consisting of 1-5% cyclodextrin, a preservative, and an aqueous buffer; and, administering separately, or coadministering, a second composition consisting of quercetin, a zinc-containing compound, a preservative, and an aqueous buffer (see claim 20).
With regard to claims 17, 18, and 19, Jena (431) claims the method discussed above. Specifically, Jena (431) claims a composition comprising 1-5% cyclodextrin, quercetin, zinc chloride, benzalkonium, and an aqueous buffer (see claims 10-12 and 14). As discussed above, Peyman teach an embodiment of the composition discussed above with or without nanobodies obtained from llamas and alpacas to attach to the RBD-ACE2, or multiple antibodies to spike proteins or the use of ACE2 decoys or administered together with a known antiviral such as remdesivir (see [0544]). Here, Peyman teach the use of nanobodies to attach to the RBD or ACE2 (see [0544]). In the context of the invention of Peyman, the RBD is the receptor binding domain of the virus that attaches to the ACE2 of the host receptor and causes the binding of the virus to the cell (see [0012], [0013], and [0544]). In the context of this invention, the basis of “the virus” is a coronavirus (see [0012], [0013]). As such, it is the position of the examiner that Peyman clearly teach the nanobodies as binding the RBD of the coronavirus, which is the spike protein, the protein that mediates binding to the host. Although the nanobody is not explicitly engineered in Peyman, the engineering of the spike protein is a product-by-process claim and is not limiting in the case that the antibodies of Peyman similarly attach to the viral spike protein.
With regard to claim 20, Jena (431) claims that the zinc ionophore is quercetin (see claim 12).
Summary
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable on the grounds of obviousness. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable. Claims 1-20 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brendan P Oliss whose telephone number is (571)272-6347. The examiner can normally be reached Monday - Thursday 8 am - 6 pm.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRENDAN P. OLISS/Examiner, Art Unit 1658
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654