DETAILED ACTION
Claims 21-38 are pending.
Claim Objections
Claims 21, 23 and 32 are objected to because of the following informalities: the name Bordetella bronchispetia is misspelled as “Bordetella bronchioseptica’ is recited in the claims the full spelling (non-abbreviated) name should be used. Appropriate correction is required.
Claim Rejections - 35 USC § 112-2nd paragraph
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 22, 23, 29 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 22 and 29 are indefinite because it is unclear what 6.4 log10 DICC50 per dose" refers to because the term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the interest of compact prosecution, because it appears to refer to a dose of the virus, any effective amount will be interpreted to meet the limitation. Nevertheless, clarification is required to ascertain the metes and bounds of these claims. Further, acronyms and abbreviations must be spelled out and/or defined upon first use in order to be understood without requiring reference to the specification. The Dependent claims do not clarify the issue identified above. Applicants are cautioned against the introduction of new matter.
Claims 23 and 31 are vague and indefinite because of the use of “, inclusive” at the end of the claims. Inclusive of what? It is unclear what is intended by this language. The metes and bounds of the term are not readily understood. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Enablement
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 21-38 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:
An oral vaccine capable of eliciting an immune response in an animal when administered, wherein said vaccine comprises a genetically modified AroA Bordetella bronchiseptica, where the AroA gene is either completely or partially deleted.
, does not reasonably provide enablement for an oral vaccine capable of eliciting an immune response in an animal when administered orally, comprising a whole live canine parainfluenza (CPI) virus and [any] attenuated live Bordetella bronchiseptica (B. bronchiseptica) bacterium; and a method for eliciting a protective immune response against canine parainfluenza virus in an animal, comprising orally administering to the animal the oral vaccine.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The specification is squarely directed to a genetically modified AroA Bordetella bronchiseptica, where the AroA gene is either completely or partially deleted. In fact, AroA deletion is mentioned more than 175 times in the specification. The specification explicitly teaches on page 12, that: "The present disclosure provides aroA mutant Bordetella bronchiseptica bacteria. The aroA mutant Bordetella bronchiseptica bacteria have a genetic alteration in their aroA gene, the genetic alteration being relative to the parent strain aroA gene (e.g. a virulent wild-type parent strain's aroA gene which exhibits normal aroA gene function). Nowhere does the specification teach a non-AroA mutant (i.e., where the AroA activity is fully functional or intact). See also, pages 12-13. As such, the specification makes clear that AroA Bordetella bronchiseptica was preferred over a non-AroA mutant.
Moreover, the specification explicitly teaches that an oral vaccine comprising avirulent non-modified Bordetella bronchiseptica for canines was undesirable, stating: "Systemic administration of live B. bronchiseptica vaccines has not been regarded as a safe option since it is known that the systemic administration of live B. bronchiseptica, even when attenuated, can lead to serious abscess formation [see e.g., Toshach et al., J Am Anim Hosp Assoc 33 126-128 (1997)]. Likewise, studies have demonstrated that intranasal vaccination was far superior to oral vaccination (Ellis J.A., et al. "Comparative efficacy of intranasal and oral vaccines against Bordetella bronchiseptica in dogs." The Veterinary Journal, vol. 212, 2016, pp. 71-77)". (emphasis added in bold and italics) See page 2, lines 14-21, Furthermore, the specification highlights the challenges in combining B. bronchiseptica strains with other antigens in multivalent formulations: "Efforts to provide multivalent vaccines using existing B. bronchiseptica strains combined with other bacterial and viral strains have had limited success." See p. 3, lines 20-25. So not only does the specification repeatedly emphasize the preferred use of intranasal administration for Bb to achieve protection and reports inferior outcomes for oral routes, it also documents challenges in combination vaccines, including antigenic interference and reduced responses when combining live components. The specification fails to teach or suggest use of a non-modified Bordetella bronchiseptica in an oral vaccine, it also expressly teaches away from oral delivery of attenuated live B. bronchiseptica in an oral vaccine, alone or in combination with CPI. 2.
In summary, the entirety of the specification describes only one strain of B. bronchiseptica - which is an attenuated AroA mutant Bordetella bronchiseptica which has been genetically modified such that the AroA gene is either completely or partially deleted. Strain-specific differences can have significant consequences for antigenicity, stability, and immunogenic performance. In fact, on page 2, the specification acknowledges: "B. bronchiseptica is well known for high frequency phase variation and antigenic modulation (Monack, D. M., et al., 'Phase Variants of Bordetella bronchiseptica Arise by Spontaneous Deletions in the Vir Locus,' Molecular Microbiology, vol. 3, no. 12, 1989, pp. 1719-1728). Therefore, from one strain to another, and depending on culture conditions, the expression level of antigenic determinants can vary and impact the immunogenicity of inactivated vaccine preparations" (emphasis added). See p. 2, lines 1-6. Moreover, the specification demonstrates in Example 5, Table 13 and Figure 13, that different levels of protection against B. bronchiseptica challenge was achieved in dogs vaccinated with the oral monovalent vaccine, where the B. bronchiseptica AroA was cultured using two different medias (CW or TSB). Thus, the that even using the same B. bronchiseptica strain cultured in two different medias, results in significantly different protective effects. Specifically, Table 13 shows that Group A (grown in Cohen-Wheeler (CW) medium) was not protective against B. bronchiseptica challenge and 100% of the dogs in Group A had disease, which was comparable to the control Group C (negative - no vaccination control - SCC Table 11). This shows that, even when the strain remains constant, orally administered vaccines comprising a AroA B. bronchiseptica when cultured in different conditions can significantly alter vaccine performance. This highlights the unpredictability of clinical protection against B. bronchiseptica infection by orally administered vaccines comprising B. bronchiseptica and is expressly pointed out in the specification at page 35 (lines 15-18), stating: "Group A produced in a CW medium was not protective, showing that it is unpredictable whether a selected production medium will preserve the ability of the vaccine to protect against a B. bronchiseptica challenge."
It is also noted that the claims use a whole live canine CPI virus which has not been attenuated or rendered non-pathogenic. Results for using a live, unmodified CPI virus are not shown. Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 24, 25, 26, 27, 30, 33, 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hess et al (J. Appl. Res. Vet. Med. January 2011. 9(3): 300-305); provided by Applicants on PTO-1449.
Hess et al disclosed that orally administered vaccines containing live avirulent Bordetella bronchiseptica have excellent efficacy. See abstract. Hess teaches that the USDA-licensed B. bronchiseptica vaccines were previously labeled for either injectable or intranasal administration. Hess provide a study where 8-week-old puppies free of B. bronchiseptica were orally immunized with a dose of live avirulent B. bronchiseptica vaccine and then challenged five weeks later with virulent B. bronchiseptica. None of the immunized puppies were shown to have tracheobronchitis, while all but one of the placebo groups of puppies did. The study demonstrated the efficacy for prevention of disease caused by B. bronchiseptica from oral administration of avirulent (attenuated) live B. bronchiseptica. Page 301, column 1, also teaches that B. bronchiseptica is known to cause disease in felines as well. The study also provided a multivalent vaccine administered orally that included modified live canine parainfluenza virus (CPI) and modified live canine adenovirus type 2 (CAV2) in combination with the attenuated live B. bronchiseptica vaccine; e,g., comprising one or more antigens from further pathogenic organisms. The puppies immunized with the multivalent vaccine also were successfully protected against tracheobronchitis, 95%, and demonstrated that the other vaccine fractions/antigens did not interfere with the B. bronchiseptica protection efficacy. See results on page 303 and Discussion on page 304. It is taught that oral immunization can induce an important secretory antibody response in other mucosal sites. Hess also teaches that oral immunization will prove useful in aggressive and frightened dogs that are difficult to handle during administration of parenteral and intranasal vaccines.
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.
Claim(s) 28-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al (J. Appl. Res. Vet. Med. January 2011. 9(3): 300-305) in view of Wasomen et al (US 20150306209).
Hess et al disclosed that orally administered vaccines containing live avirulent Bordetella bronchiseptica have excellent efficacy. See abstract. Hess teaches that the USDA-licensed B. bronchiseptica vaccines were previously labeled for either injectable or intranasal administration. Hess provide a study where 8-week-old puppies free of B. bronchiseptica were orally immunized with a dose of live avirulent B. bronchiseptica vaccine and then challenged five weeks later with virulent B. bronchiseptica. None of the immunized puppies were shown to have tracheobronchitis, while all but one of the placebo groups of puppies did. The study demonstrated the efficacy for prevention of disease caused by B. bronchiseptica from oral administration of avirulent (attenuated) live B. bronchiseptica. Page 301, column 1, also teaches that B. bronchiseptica is known to cause disease in felines as well. The study also provided a multivalent vaccine administered orally that included modified live canine parainfluenza virus (CPI) and modified live canine adenovirus type 2 (CAV2) in combination with the attenuated live B. bronchiseptica vaccine; e,g., comprising one or more antigens from further pathogenic organisms. The puppies immunized with the multivalent vaccine also were successfully protected against tracheobronchitis, 95%, and demonstrated that the other vaccine fractions/antigens did not interfere with the B. bronchiseptica protection efficacy. See results on page 303 and Discussion on page 304. It is taught that oral immunization can induce an important secretory antibody response in other mucosal sites. Hess also teaches that oral immunization will prove useful in aggressive and frightened dogs that are difficult to handle during administration of parenteral and intranasal vaccines. However, Hess does not specifically recite the identical dosage amounts or specifically recite the method is to protect against canine parainfluenza.
Wasomen et al teach vaccines comprising attenuated canine parvovirus and attenuated Bordetella bronchiseptica for protecting against canine parainfluenza virus. See paragraph [0019] and [0022], e.g., a live attenuated (or killed) CPV-2c isolate of the present invention can be combined in a multivalent vaccine with one or more live attenuated or killed feline antigens including one or more of the following antigens: feline herpesvirus (FHV), feline calicivirus antigen (FCV), feline parvovirus (FPV), feline leukemia virus (FeLV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus (FIV), borna disease virus (BDV), rabies virus, feline influenza virus, feline pneumovirus, Chlamydophila felis, Bordetella bronchiseptica, and Bartonella spp. (e.g., B. henselae).. Paragraph [0070] teaches the vaccines may be used with or without adjuvants. Paragraphs [0070]. [0125]-[0129] teaches does within the range of the claims. The reference teaches methods for eliciting a protective immune response again canine parainfluenza virus.
Additionally, the route of administration of the vaccine and the particular dosage are result effective variables. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since the immunization methods often vary according to the subject being treated and different administration routes and particular doses appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage for an animal by normal optimization procedures known in the art and to choose the acceptable route of administration in the instant circumstance. The prior art teaches that oral, injectable and intranasal all appear to provide adequate protection, and Hess provides explicit teaching of the advantage of oral immunization of dogs.
Pertinent Art, not presently relied upon:
Lafleur et al (US Patent No. 12,648,991 B2; Patent date 6/9/2026. priority date 12/18/19; after Applicant’s priority filing date; not prior art)
Patented claim 1: An oral bivalent vaccine for providing effective protection to a canine from upper respiratory diseases and infectious tracheobronchitis, the oral bivalent vaccine consisting essentially of a modified live canine parainfluenza (CPI) virus and an avirulent live Bordetella bronchiseptica (B. bronchiseptica) and optionally an adjuvant, and wherein the oral bivalent vaccine is formulated for oral administration.
Teaches:
(2) Canine parainfluenza (CPI) virus is a highly contagious virus that causes respiratory illnesses contributing to the contraction of upper respiratory diseases and infectious tracheobronchitis, also known as kennel cough. Although the respiratory signs may resemble those of canine influenza, they are unrelated viruses and require different vaccines for protection. CPI virus is excreted from the respiratory tract of infected animals for up to two weeks after infection and is usually transmitted through the air. CPI virus spreads rapidly in kennels or shelters, where large numbers of dogs are kept together. Clinical signs include either dry or moist coughing, low grade fever, nasal discharge, lack of energy, and loss of appetite.
(3) Currently, there are several commercial canine vaccines that can be administered either subcutaneously or intramuscularly that comprise a live modified CPI virus including Nobivac® Canine 1-DAPPv, which is a modified live virus vaccine for the vaccination of healthy dogs as an aid in the prevention of disease caused by canine parainfluenza virus, canine distemper virus, canine adenovirus, and canine parvovirus. In addition, there are commercial intranasal vaccines, such as Nobivac® Intra-Trac.sub.3, that provides triple protection against agents implicated in the cause of tracheobronchitis, including canine parainfluenza virus, canine adenovirus type 2, and Bordetella bronchiseptica (B. bonchiseptica).
(4) However, despite the advantages of oral vaccination, such as ease of use and lack of animal discomfort during and following vaccination, to date there have been no commercially available oral vaccines containing CPI virus. Therefore, there remains the longstanding need for oral vaccines for canine parainfluenza virus that will aid in the protection of dogs from upper respiratory diseases and/or infectious tracheobronchitis.
Example 3
Immunogenicity Study in Dogs to Demonstrate Efficacy of the Cpi Fraction of an Oral Canine Parainfluenza and Bordetella Bronchiseptica Combination Vaccine
An oral bivalent vaccine for providing effective protection to a canine from upper respiratory diseases and infectious tracheobronchitis, the oral bivalent vaccine consisting essentially of a modified live canine parainfluenza (CPI) virus and an avirulent live Bordetella bronchiseptica (B. bronchiseptica) and optionally an adjuvant, and wherein the oral bivalent vaccine is formulated for oral administration.
Zhang et al (Res. Vet. Sci. 2013. 94: 55-61); provided by Applicants on PTO-1449.
Zhang et al disclose the construction of an aroA deleted Bordetella bronchiseptica attenuated strain. The strain is used to provide full protection against challenge in piglets when injected intranasally. See abstract. A booster dose of the vaccine was administered 3 weeks after the initial immunization. Although Zhang et al do not specifically show the strain administered orally or the response, the strain taught by Zhang is the same as recited in the instant claims, e.g., an attenuated aroA deleted Bordetella bronchiseptica strain. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the structure claimed is the same, it would inherently possess the same function when administered orally. A pharmaceutically acceptable carrier or excipient or vehicle reads on water and therefore would be inherent in the preparation of the mutant strains.
Kim et al (Vet. Microbio. 2009. 138: 318-324); provided by Applicants on PTO-1449.
Kim et al teach a heterologous PCV2 major capsid protein (MCP) was expressed in the Bordetella bronchiseptica aroA mutant strain (BBS-MCP) and used as a live vaccine vehicle. Mice and pigs were immunized with live BBS-MCP via the intranasal route. The antibodies against MCP were induced successfully in the serum as determined by ELISA. In the PCV2 challenge experiment, viral DNA was removed successfully from the lymph nodes of pigs vaccinated with live BBS-MCP. The B. bronchiseptica aroA mutant was constructed by homologous recombination. See abstract. Mice were vaccinated three times on days 1, 14 and 28 (booster vaccines). Although Kim et al do not specifically show the strain administered orally or the response, the strain taught by Kim is the same as recited in the instant claims, e.g., an attenuated aroA deleted Bordetella bronchiseptica strain. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the structure claimed is the same, it would inherently possess the same function when administered orally. A pharmaceutically acceptable carrier or excipient or vehicle reads on water and therefore would be inherent in the preparation of the mutant strains.
Stevenson et al (Vaccine. 2002. 20:2325-2335); provided by Applicants on PTO-1449.
Stevenson teaches that the best studied B. bronchiseptica vaccine strains with defined mutations have a disruption in aroA, a gene which encodes a synthase crucial to the production of aromatic amino acids. Stevenson et al teach that inactivation of the aroA gene highly attenuates B. bronchiseptica, severely impairing its ability to colonize and survive in the respiratory tract. The B. bronchiseptica aroA mutant was investigated as a live vaccine and vector for heterologous antigens. The B. bronchiseptica aroA mutant expressing the non-toxic fragment C (FrgC) of tetanus toxin (strain GVB120) was used to immunize mice intranasally. Immunized mice produced a strong serum and mucosal antibody response to B. bronchiseptica and serum anti-FrgC antibodies. Upon challenge with wild type B. bronchiseptica, immunized mice rapidly reduced the numbers of B. bronchiseptica in their respiratory tract, although clearance was more pronounced in the lower than in the upper respiratory tract. Immunization with GVB120 protected ∼40% of mice from tetanus toxin challenge. A B. bronchiseptica aroA mutant was constructed by allelic exchange. The suicide vector pBPTaroA55 has been described previously, and contains a copy of the B. pertussis aroA gene inactivated by insertion of a kanamycin-resistance cassette. Two groups of mice were dosed intranasally, the group receiving wild type B. bronchiseptica BBC17 received ∼3×104 CFU per mouse while the group receiving the aroA mutant BBC18 received ∼5×107 CFU per mouse. To investigate if the B. bronchiseptica aroA mutant has utility as a live mucosal vaccine against B. bronchiseptica infection and as a live vector for delivering heterologous antigens, adult female BALB/c mice were immunized intranasally with the B. bronchiseptica aroA mutant expressing FrgC (GVB120). For primary immunization, mice received either a single dose (1× prime group; day 0 ∼6.6×107 CFU per mouse) or three doses (3× prime group; days 0, 4 and 8 ∼3.25×107 CFU, 6.63×107 CFU per mouse) of GVB120. All groups received a booster dose of GVB120 (∼6×107 CFU per mouse) 36 days later. Immunization with either the 1× prime or 3× prime regime greatly enhanced the ability of mice to control infection with wild type B. bronchiseptica.
Tucker et al. 2019 (AU 2019204604 A1; published July 11, 2019).
Tucker teaches oral vaccines comprising effective doses of one or more of canine distemper (CD) virus, canine adenovirus type 2 (CAV-2), canine parainfluenza (CPI) virus, canine parvovirus (CPV), and canine coronavirus (CCV), and Bordetella bronchiseptica and any combination thereof (e.g. see [0006, 0049]; meeting limitations found in instant claims 23, 24, 29, 36, and 37). Tucker teaches compositions with and without adjuvants (e.g. [0019, 0054]; meeting limitations in instant claims 39 and 40). Tucker teaches therapeutic doses of the virus include 10² to 10¹⁰ and for the Bordetella from 10⁶ to 10¹⁰ (e.g. see [0049-0050]; meeting broadest reasonable interpretation of limitations found in instant claims 23, 25, and 29, with sufficient specificity). Tucker teaches the vaccines are formulated in volumes of 0.1 to 5 ml (e.g. [0056]; meeting limitations found in instant claim 41).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 8/17/26
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