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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on May 15, 2024. Claims 1-13 are pending and are currently examined.
Claim Rejections - 35 USC § 112 (b)
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 1-13 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.
The base claim 1 recites a phrase “a formulation base prepared by adding polyethylene glycol to crosslinked polyacrylic acid” render the claims indefinite. It is not clear if the formulation base comprises the polyethylene glycol and crosslinked polyacrylic acid” or not.
The above rejection is also extent to claims 4 for “…the formulation base is prepared by thickening …” and claim 11 at “…which is prepared by adding…”.
In addition, these phrases, “a formulation base prepared by adding polyethylene glycol to crosslinked polyacrylic acid”, “…the formulation base is prepared by thickening …” and “…which is prepared by adding…”, are product-by-process claims. See MPEP § 2113.
Regarding claim 13, it is directed to the formulation of claim 1, which is used to be intranasally administered at one-shot volume of 250 - 750 µl per nose to target both of nasal mucosa and nasopharynx simultaneously. Here the formulation is considered as a product, while a “intranasally administered at one-shot volume of 250 - 750 µl per nose” is considered as a process/method of administering the formulation to a subject. It is not clear how a product can comprise a process/method.
This claim recites product and process in the same claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05 (p).
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-6, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid)
The base claim 1 is directed to a formulation for spraying nasal vaccine, comprising an antigen and a formulation base prepared by adding polyethylene glycol to crosslinked polyacrylic acid.
Taizo teaches an invention providing a gel type mucoadhesive preparation for nasal spray, which comprises a gel preparation containing a pharmaceutically active substance in a gel base containing a mucoadhesive agent, for nasal spray (See [0020]), and the particle size of the formulation sprayed by the nasal spray device is also one of the factors to be considered in order to improve the clearance of the drug (See [0011]). Taizo also discloses that at present, intranasal administration type preparations have been designed and developed as vaccine administration routes for influenza vaccines, diphtheria vaccines, and the like against viruses that cause airborne infection, utilizing the high immune responsiveness of the nose. Thus, great expectations are placed on the development of intranasal administration type preparations that take advantage of the anatomical and physiological features of the nasal cavity (See [0006]. Here the description teaches a formulation and device for the nasal spray and teaches the importance of the vaccine administration by nasal spray.
For the claimed antigen in the formation, although Taizo does not specifically use the term “antigen”, Taizo teaches deliver the Influenza HA vaccine by nasal spray (See [0006]), where the influenza HA vaccine contains the HA protein as antigen. This can be evidenced by Dunkle. Dunkle teaches that the first and only recombinant hemagglutination inhibition (HAI) (rHA) protein influenza vaccine (RIV, Flublok®) is a purified solution of rHA proteins produced in a proprietary strain of Lepidopteran cells (expresSF+). The trivalent recombinant vaccine contains rHA antigens that are exact genetic matches of the strains selected for the vaccine, but at a higher dose of rHA than conventional vaccines (See page 957, left column). Accordingly, Taizo indicates the formula of influenza HA vaccine contains HA antigen.
As for the formulation base prepared by adding polyethylene glycol to crosslinked polyacrylic acid, Taizo teaches that when the active drug in a dissolved state is better for absorption by the affected part to be treated (nasal mucosa in the case of nasal drops), it is preferable to use a solubilizer or to dissolve the active drug in a water-soluble organic solvent in advance to prepare a formulation. Examples of such water-soluble organic solvents include lower alcohols such as ethanol and isopropanol, and glycols such as propylene glycol, 1,3-butylene glycol, and polyethylene glycol (See [0042], which indicates that the formulation contains the polyethylene glycol as claimed.
Although Taizo does not use the term of crosslinked polyacrylic acid, Taizo teaches that the carboxyvinyl polymer to be used as the adhesive polymer in the present invention is a hydrophilic polymer obtained by polymerizing acrylic acid as a main component, and an ordinary polymer, for example, Carbopol (registered trademark) commercially available from Noveon Inc., USA, can be used (See [0039]), where the carboxyvinyl polymer is a crosslinked agent and the polymerizing acrylic acid creates the polymer polyacrylic acid. This can be evidenced by ScienceDirect and Panzade’s study. ScienceDirect teaches that polyacrylic acid (PAA) is a polymer formed by the polymerization of the monomer acrylic acid (See page 2). Panzade teaches that Carbopol polymers are polymers of acrylic acid cross-linked with polyalkenyl ethers or divinyl glycol. The Carbopol polymer family is based on cross linked acrylic acid chemistry (See Abstract), and depending upon the degree of cross-linking and manufacturing conditions, various grades of Carbopol are available. Carbopol 971 P has slightly lower level of cross-linking agent than Carbopol 974 P (See page 672, right column, paragraph 2). Thus, Taizo teaches the crosslinked polyacrylic acid.
In addition, the claim for the formulation base is a product-by-process claim. The method steps recited to prepare the formulation base are not considered when determining patentability of the product (MPEP § 2113). In In re Thorpe, the court stated, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). (Emphasis added).
Based on the description above, Taizo as evidenced by Dunkle, ScienceDirect and Panzade teaches a formulation for nasal spray that can be used for vaccine administration including viral antigen (such as influenza HA) and a polyethylene glycol and hydrophilic polymer obtained by polymerizing acrylic acid and a crosslinked agent, Carbopol polymers/ carboxyvinyl polymer.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 4, Taizo teaches that the dripping into the lower nasal passage can be improved to some extent by adding an adhesive polymer to be described later as a formulation base (See 0010]), and the formulation base is thickened with the thickening agent of a carboxyvinyl polymer selected from neutral or basic water-soluble amino acids (See claim 11, page 4). Taizo also teaches by applying the shearing force from the outside, the spray density biased to the outer periphery in the case of adjusting only the viscosity modifier is uniformly sprayed (See [0023]).
Finally, Taizo teaches the “adding polyethylene glycol to the obtained one, and said formulation base” as claimed by stating that it is preferable to use a solubilizer or to dissolve the active drug in a water-soluble organic solvent in advance to prepare a formulation. Examples of such water-soluble organic solvents include polyethylene glycol (See [0042]). Taizo also teaches the water-soluble polymer compound can be used to nasal mucosa (See [0042]) and nasopharynx (See [0011]). Taizo discloses that it is preferable to use a carboxyvinyl polymer or gellan gum, or a gel base using a carboxyvinyl polymer and gellan gum at the same time, as the adhesive polymer, in order to simultaneously satisfy the requirements of having skin / mucosa adhesiveness, having little change in the viscosity of the preparation by a spraying operation, reaching the affected area to be treated (in the nasal cavity in the case of nasal drops) while maintaining a high viscosity (See [0037]). Because the epithelial layer of the nasal mucosa has better permeability and is the route of absorption of water-soluble macromolecular drugs (See [0005]), it is obvious that one of skilled in the art can allow the formulation base to target both of the nasal mucosa and nasopharynx simultaneously as claimed.
Nevertheless, based on the description above, the claim for the formulation base in claim 4 is a product-by-process claim. The method steps recited to prepare the formulation base are not considered when determining patentability of the product (MPEP § 2113).
Regarding claim 5, Taizo teaches that specific examples thereof include inorganic bases such as sodium hydroxide and potassium hydroxide, and the basic amino acid is arginine, lysine, and ornithine (See 0040), and the viscosity modifier is selected from the group consisting of sodium chloride, potassium chloride and calcium chloride (See claim 10).
Regarding claim 6, Taizo teaches the influenza HA vaccine (See e.g., [0041]) that is evidenced by Dunkle’s study. Dunkle teaches the influenza vaccine contain HA antigen and is from an inactivated influenza vaccine (IIV) (See page 957, left column).
Regarding claim 8, Taizo teaches the influenza vaccine (See e.g., [0006]) that also can be evidenced by Dunkle’s study. Dunkle teaches that the influenza vaccine can contain the whole antigen of influence virus as being produced by inactivation of whole pathogens (See page 962, right column, paragraph 3).
Regarding claim 11, based on the description above, Taizo teaches that the intranasal formulations are widely available (See claim 18, [0002]) and can be used as vaccine administration (See [0006]). At the same time, Taizo teaches the crosslinked polyacrylic acid by stating that a hydrophilic polymer obtained by polymerizing acrylic acid (See 0039]) and teaches adding the polyethylene glycol with a molecular weight of 300 to 500 to the formulation base (See [0042]).
Nevertheless, based on the description above, the claim for the formulation base in claim 11 is a product-by-process claim. The method steps recited to prepare the formulation base are not considered when determining patentability of the product (MPEP § 2113).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid) as applied to claims 1, 4-6, 8 and 11 above, and in view of Kamishita et al. (US5158761, patented on Oct. 27, 1992).
Claim 2 requires the polyethylene glycol is macrogol 400 and/or macrogol 4000, and the content ratio of the polyethylene glycol is 0.1 - 10.0 w/w % of the formulation base.
Taizo teaches the polyethylene glycol having a molecular weight of 300 to 500 is added to the water-insoluble formulation (See [0042]), which contain the molecular weight of macrogol as claimed, however, it does not explicitly point the macrogol 400 and/or macrogol 4000, and the content ratio of the polyethylene glycol is 0.1 - 10.0 w/w % of the formulation base.
Kamishita teaches a spray base gel having an excellent spread-stick prop erty, which is prepared by thickening a 0.2-1.5% by weight aqueous solution of carboxyvinyl polymer with a water-soluble basic substance, followed by adjusting the viscosity thereof with a viscosity adjustor within the range of 500-5,000 centipoise so that the particle size distribution of spray after spraying is over 80% in the area of 20-100 run and a spray gel preparation having an excellent spread-stick property, which is prepared by mixing an active medicament with said spray gel base (See Abstract), here the spray base gel contain 3% polyethylene glycol by weight (See Example 6 and below), which is within the claimed range.
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the content ratio of the polyethylene glycol of Kamishita into Taizo’s study to arrive at an invention as claimed. One of skill in the art would have been motivated to do so to apply the 3% of polyethylene glycol 400 into the formulation base to develop an excellent spread-stick property as taught by Kamishita, and there would be a reasonable expectation of success to develop such formulation as claimed.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid) as applied to claims 1, 4-6, 8 and 11 above, and in view of Youne et al. (EFSA J. 2021 Aug 11;19(8):e06693.).
Claim 3 requires that the crosslink location and crosslink density in the crosslinked polyacrylic acid are adjusted so that the carboxyl content in the crosslinked polyacrylic acid is 60.0 - 62.0 w/w %, and the crosslinked polyacrylic acid is carboxy vinyl polymer with a high crosslink density to the extent that is does not cause spinnability.
Taizo teaches the carboxyvinyl polymer to be used as the adhesive polymer in the present invention is a hydrophilic polymer obtained by polymerizing acrylic acid as a main component, and Carbopol is used as crosslinked agent (See [0039]). However, Taizo does not explicitly point the carboxyl content in the crosslinked polyacrylic acid.
Younes describes the safety evaluation of crosslinked polyacrylic acid polymers (carbomer) as a new food additive and teaches that Carbomers, defined as high molecular mass polymers of acrylic acid cross-linked with polyalkenyl ethers of sugars or polyalcohols with 56–68% of carboxylic acid groups (for the dried substance), are used in pharmaceutical products and recognized as excipients in the European Pharmacopoeia (European Pharmacopoeia 10.5, 2021) (See page 6, paragraph 1.2 and Table 2 below ), where the 56–68% of carboxylic acid groups is comparable with the carboxyl content in the crosslinked polyacrylic acid as claimed. Younes also teaches that two different grades of carbomer can be manufactured by varying the amount of the crosslinker used in the polymerisation reaction (i.e. sold under the trade names Carbopol® 974P NF Polymer, defined as ‘highly crosslinked’ (See page 3, paragraph 4), where the ‘highly crosslinked’ carbomer is a crosslinked polyacrylic acid polymer (See page 3, paragraph 1), which has the same polymer structure as claimed and should has the same features for not causing the spinnability.
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the carboxyl content of Younes into Taizo’s study to arrive at an invention as claimed. One of skill in the art would have been motivated to do so because the 56–68% of carboxylic acid content of the carbomers can be used in pharmaceutical products, and there would be a reasonable expectation of success to develop such formulation as claimed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid) as applied to claims 1, 4-6, 8 and 11 above, and further evidenced by WHO-2012 (https://cdn.who.int/media/docs/default-source/pvg/global-vaccine-safety/pneumococcal-vaccine-rates-information-sheet.pdf).
Claim 7 requires the specific strains of virus and bacteria in the formulation of claim 6.
Taizo teaches a nasal spraying formulation for influenza HA vaccine, pneumococcal vaccine, and recombinant Adsorbed Hepatitis B Vaccine (See [0041]). Based on the description above, the influenza HA used in the influenza vaccine is from the influenza virus as claimed. Here the pneumococcal vaccine contains antigen from Streptococcus pneumoniae as claimed. This can be evidenced by WHO’s information sheet. WHO teaches that Pneumococcal vaccines are characterized by the number of Streptococcus pneumoniae serotype antigens that they contain and whether or not these antigens are conjugated to a protein carrier. The older pneumococcal vaccines are unconjugated (also called polysaccharide vaccines - PPSV) whilst the newer vaccines are conjugated (also called conjugated vaccines - PCV) (See page 1). Thus, Taizo’s pneumococcal vaccine teaches claim 7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid) as applied to claims 1, 4-6, 8 and 11 above, and in view of Chavda et al. (Drug Discov Today. 2021 Nov;26(11):2619-2636).
Claim 9 requires the antigen is inactivated whole COVID-19 antigen, recombinant protein antigen thereof, or various viral vectors incorporating genes encoding the antigen proteins.
Taizo teaches a formulation for spraying nasal vaccine comprising an antigen from viruses such as influenza virus. However, it is silent on the antigen is from Covid-19 as claimed.
Chavda reviews the intranasal vaccines forSARS-CoV-2 and teaches that unlike conventional Coronavirus2019 (COVID-19) vaccines, intranasal vaccines display a superior advantage because the nasal mucosa is often the initial site of infection (See Title and Abstract). Chavda also discloses the nasal vaccine development for SARS-COV-2 (See Figure 6 and below) that include Adenovirus vector-based SARS-COV-2 vaccines expressing the S protein.
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the Adenovirus vector-based SRAS-COV-2 vaccines of Chavda into Taizo’s study to arrive at an invention as claimed. One of skill in the art would have been motivated to do so because intranasal vaccine displays a superior advantage than the conventional COVID-19 vaccine, and there would be a reasonable expectation of success to develop such formulation for targeting SARS-COV-2 based on the teachings of Taizo and Chavda.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid) as applied to claims 1, 4-6, 8 and 11 above, and further evidenced by GSK (https://www.fda.gov/media/119403/download).
Claim 10 requires the antigen is hepatitis B surface antigen (HBs antigen) and/or hepatitis B nucleocapsid antigen (HBc antigen).
Taizo teaches a nasal spraying formulation for influenza HA vaccine, pneumococcal vaccine, and recombinant Adsorbed Hepatitis B Vaccine (See [0041]). Here the recombinant Adsorbed Hepatitis B Vaccine contains the hepatitis B surface antigen as claimed. This can be evidenced by GSK’s prescribing information. GSK teaches that ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide (See page 9, item 11). Thus, Taizo’s Adsorbed Hepatitis B Vaccine teaches claim 10.
Claims 12-13 is rejected under 35 U.S.C. 103 as being unpatentable Joge Taizo (JP-2013064022-A, published on April 11, 2013, hereinafter, “Taizo”) as evidenced by Dunkle et al. (Expert Rev Vaccines. 2016 Aug;15(8):957-66), Panzade et al. (Research J. Pharm. and Tech.3 (3): July-Sept. 2010; Page 672-675) and ScienceDirect (https://www.sciencedirect.com/topics/medicine-and-dentistry/polyacrylic-acid) as applied to claims 1, 4-6, 8 and 11 above, and in view of Kamishita et al. (EP3162378 A1, published on Mar. 05, 2017).
Regarding claim 12, it is directed to a rhinovaccination system of vaccine comprising a spray device in which the nozzle contacts the periphery of the external nostril to fix the direction of spraying, which is filled with the formulation of claim 1.
Taizo teaches the spray device nozzle and the periphery of the outside nostril (See e.g., [0038] and [0011])), however, it is silent on the rhinovaccination system.
Kamishita teaches a rhinovaccination system to administer an influenza vaccine composition to nasal mucosa, which is used in combination with a medical syringe (See [0001]). Kamishita also teaches that the rhinovaccination system of influenza vaccine is equipped with a rhinal spray nozzle comprising a hollow nozzle body having a tip portion defining a nozzle orifice (See page 3, lines 18-26), and an inactivated whole influenza virion, can enhance the immune induction in human beings without an adjuvant; and further have made an administration system by setting the combination into a metered-dose syringe-based squirt having an optimized shape/configuration of the nozzle (See [0012]), which teaches the nozzle and indicates the direction can be fixed. Kamishita also teaches that the rhinovaccination system is performed with a syringe-based squirt, in an amount of 0.25 mL for one nostril (See 0067]), and the rhinovaccination system can be completed softly and in a short time without stressing the inactivated whole antigen of virus (See [0049]).
Regarding claim 13, it requires that the formulation is used to be intranasally administered at one-shot volume of 250 - 750 μL per nose to target both of nasal mucosa and nasopharynx simultaneously.
Taizo teaches an intranasal formulation for vaccine administration to the nasal mucosa of the nasal cavity and surrounding tissues from nostril to the nasopharynx (See [0006] and [0011]). However, it does not point out the one-shot volume per nose.
Kamishita teaches a method to evaluate and analyze the immune responses of the influenza vaccine by stating that each group were vaccinated by nasal spray-administration with an appropriate disposable device, in an amount of 0.25 mL for one nostril (equivalent of 45 mg HA for both nostrils), twice at an interval of 3 weeks (See 0059]), which indicates a one-shot volume within the claimed range.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the rhinovaccination system of vaccine and the intranasal administration volume of Kamishita into Taizo’s study to arrive at an invention as claimed. One of skill in the art would have been motivated to do because the rhinovaccination system of vaccine can make the spreading of an inactivated whole influenza virion in nasal mucosa in a wide spread and in a long time to enhance the immunogenicity of an antigen (See [0019]), and there would be a reasonable expectation of success to develop such a formulation based on the teachings from Taizo and Kamishita.
Conclusion
No claims are allowed.
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/RUIXUE WANG/ Examiner, Art Unit 1672
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