Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
The original claim set filed 21 Oct 2024 is acknowledged. Claims 1-13 are currently pending. No claims are cancelled. Claims 1-13 will be examined on the merits herein.
In the interest of avoiding future errors, applicant is notified that the original claim set was re-filed as part of the substitute specification’s clean version.
For clarity of the record, references to the specification in this action use paragraph numbers from the specification as filed (17 Aug 2024).
Priority
This application claims priority to the earliest provisional application 60/780,827 (filed 10 March 2026). Therefore, the effective filing date of claims 1-6 is 10 Mar 2006.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. This is only a notice for applicant’s information; it is not a rejection or objection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “a live attenuated Bordetella pertussis-based means for eliciting an anti-Bordetella pertussis immune response” in claim 13. The sufficient structure is “live attenuated Bordetella pertussis” which is sufficient for performing the function of “eliciting an anti-Bordetella pertussis immune response” when used in the step as in the method.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof. Instead, the claims are interpreted as covering any “live attenuated Bordetella pertussis” strain.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claim 1 is objected to because of the following informalities: the abbreviation aPV should be defined at first use; it refers to “acellular vaccines (aPV)” per [0006]. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: typographical error; “wherein live attenuated Bordetella pertussis strain” should read “wherein the live attenuated Bordetella pertussis strain”. Appropriate correction is required.
Applicant is advised that should claim 1 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). Claims 1 and 13 are methods that each have one step: “administering a dose of a vaccine comprising a sufficient number of a live attenuated Bordetella pertussis strain to the respiratory tract of the subject to cause colonization of the subjects lungs” in claim 1, and “colonizing the respiratory tract of the subject with a sufficient amount of a live attenuated Bordetella pertussis -based means for eliciting an anti-Bordetella pertussis immune response”. As noted in the claim interpretation section above, both claims are interpreted as including any live attenuated Bordetella pertussis. In both claims 1 and 13, the administration/colonization step “causes the subject to develop a more Th1-biased immune response against Bordetella pertussis compared to the immune response against Bordetella pertussis that would have been induced in the subject had the subject been vaccinated with an aPV instead of the live attenuated Bordetella pertussis-based vaccine.”
Claim Rejections - 35 USC § 112 2nd
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.
Regarding claims 1-13, claims 1-13 recite a step of “administering a dose of a vaccine comprising a sufficient number of a live attenuated Bordetella pertussis strain to the respiratory tract of the subject” and recite additional functional limitations describing the effects that occur in the body after the administration step. Claims 1 and 13 each recite the in vivo functions of the strain colonizing the subject’s lungs and causing a more Th1-biased immune response compared to if the subject had been immunized with an aPV vaccine instead. Claim 2 recites the subject’s splenocytes secrete a higher ratio of IGNg to IL-5 when compared to if the subject had been immunized with an aPV vaccine instead. Claim 3 recites an increase in the titer of anti-FHA IgG in the subject’s serum compared to if the subject had been immunized with an aPV vaccine instead. Claim 4 recites the serum anti-FHA IgG1/IgG2a ratio induced by the colonization of the subject’s lungs is lower compared to if the subject had been immunized with an aPV vaccine instead. Claim 5 recites administration/colonization induces an immune response in the subject which reduces the amount of inflammatory cell infiltration into the lungs of the subject caused by infection of the subject with a pathogenic strain of Bordetella pertussis compared to if the lungs had not been colonized. Claims 6-8 recite reductions in the number of pathogenic Bordetella pertussis in the lungs. Claims 9-12 recite the same limitations as claim 1, but with somewhat narrower scope of live attenuated Bordetella pertussis strains.
See MPEP 2173.05(g): “ the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938));” The instant claims amount to a description of a problem to be solved- which administration steps and live attenuated bacteria can be used to achieve the in vivo outcomes of claims 1-13?
MPEP 2173.05(g) states “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. … The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise.” MPEP 2173.05(g) states that the ambiguity of a functional limitation is resolved if the “specification provide[s] a formula for calculating a property along with examples that meet the claim limitation and examples that do not" or if “the specification provides a general guideline and examples sufficient to teach a person skilled in the art when the claim limitation was satisfied.”
However, there is no such formula for calculating the effects of administration provided in the specification. Also, the specification does not provide any general guidance on how to determine which administrations and strains have the claimed effects; the general guidance only addresses administrations that could occur but is silent on whether the administration would have the effects (for example, see dosing information at [0083-0084]). The specification only teaches one specific example strain BPZE1 (see Results beginning pg. 17) but this does not provide information about whether other strains and administrations would have the claimed effects. Therefore, the claims are indefinite because the claim only states a result obtained instead of setting forth well-define boundaries and one of ordinary skill in the art would not know from the claim terms, in view of the guidance from the specification, what scope of administration steps and strains that are encompassed by the claim. In the interest of compact prosecution, in this action the claims will be interpreted as encompassing any administration step using any live attenuated B. pertussis, unless there is specific evidence that the claimed function does not occur.
Regarding claim 6, the claim recites the limitation “wherein administering to the subject a single dose of the vaccine comprising the live attenuated Bordetella pertussis strain one week before the subject is infected by the pathogenic strain of Bordetella pertussis reduces the number of pathogenic Bordetella pertussis bacteria in the lungs of the subject seven days after being infected with the pathogenic strain of Bordetella pertussis compared to the number of pathogenic Bordetella pertussis bacteria in the lungs of the subject seven days after being infected with the pathogenic strain of Bordetella pertussis had the subject been vaccinated with a single dose of aPV instead of the single dose of the vaccine comprising the live attenuated Bordetella pertussis strain.” This claim is phrased as if it recites an effect/ intended use that the administration step should be capable of achieving: “wherein administering… reduces the number of pathogenic Bordetella pertussis bacteria”. However, the limitation also includes features that are not present in the parent claim’s administration step: “one week before the subject is infected by the pathogenic strain of Bordetella pertussis”. Due to the phrasing of the claim, one of ordinary skill in the art would not be able to determine whether infection with pathogenic bacteria is a second step that is required by the claimed method, or whether the claim merely requires that the claimed method be capable of achieving the effect if such an infection were to occur. Therefore, the claim is indefinite. In the interest of compact prosecution, the limitation is interpreted as an intended use/effect and is interpreted as not requiring pathogenic bacteria actually be administered.
Regarding claim 7, the claim recites the limitation “wherein administering to the subject a single dose of the vaccine comprising the live attenuated Bordetella pertussis strain one week before the subject is infected by the pathogenic strain of Bordetella pertussis reduces the number of pathogenic Bordetella pertussis bacteria in the lungs of the subject twenty-eight days after being infected with the pathogenic strain of Bordetella pertussis compared to the number of pathogenic Bordetella pertussis bacteria in the lungs of the subject twenty-eight days after being infected with the pathogenic strain of Bordetella pertussis had the subject been vaccinated with a single dose of aPV instead of the single dose of the vaccine comprising the live attenuated Bordetella pertussis strain.” Like in claim 6 above, one of ordinary skill in the art would not be able to determine whether infection with pathogenic bacteria is a second step that is required by the claimed method, or whether the claim merely requires that the claimed method be capable of achieving the effect if such an infection were to occur. Therefore, the claim is indefinite. In the interest of compact prosecution, the limitation is interpreted as an intended use/effect and is interpreted as not requiring pathogenic bacteria actually be administered.
Regarding claim 8, this claim depends from claim 7 and is a limitation discussing “the number of pathogenic Bordetella pertussis bacteria in the lungs of the subject”. Like in claims 6-7 above, one of ordinary skill in the art would not be able to determine whether infection with pathogenic bacteria is a second step that is required by the claimed method, or whether the claim merely requires that the claimed method be capable of achieving the effect if such an infection were to occur. Therefore, the claim is indefinite. In the interest of compact prosecution, the limitation is interpreted as an intended use/effect and is interpreted as not requiring pathogenic bacteria actually be administered.
Claim Rejections - 35 USC § 112 1st
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 1-13 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.
One of ordinary skill in the art would believe that applicants have demonstrated possession of a method that administers strains broadly but does not require functional effects resulting from administration of the broad genus of B. pertussis strains (other than the effects that are known in the art to be present for live attenuated B. pertussis as a genus), or a method that administers the BPZE1 strain in the steps used in the examples in order to achieve the specific functional effects resulting from administration, but would not believe that applicants have demonstrated possession of a method that administers a broad genus of live attenuated B. pertussis strains to achieve specific functional effects.
MPEP 2163 states:
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
Claims 1-8 and 13 recite a step of “administering a dose of a vaccine comprising a sufficient number of a live attenuated Bordetella pertussis strain to the respiratory tract of the subject” and recite additional functional limitations describing the effects that occur in the body after the administration step. Claims 1 and 13 each recite the in vivo functions of the strain colonizing the subject’s lungs and causing a more Th1-biased immune response compared to if the subject had been immunized with an aPV vaccine instead. Claim 2 recites the subject’s splenocytes secrete a higher ratio of IGNg to IL-5 when compared to if the subject had been immunized with an aPV vaccine instead. Claim 3 recites an increase in the titer of anti-FHA IgG in the subject’s serum compared to if the subject had been immunized with an aPV vaccine instead. Claim 4 recites the serum anti-FHA IgG1/IgG2a ratio induced by the colonization of the subject’s lungs is lower compared to if the subject had been immunized with an aPV vaccine instead. Claim 5 recites administration/colonization induces an immune response in the subject which reduces the amount of inflammatory cell infiltration into the lungs of the subject caused by infection of the subject with a pathogenic strain of Bordetella pertussis compared to if the lungs had not been colonized. Claims 6-8 recite reductions in the number of pathogenic Bordetella pertussis in the lungs. Claims 9-12 recite the same limitations as claim 1, but with somewhat narrower scope of live attenuated Bordetella pertussis strains by reciting specific mutations that could be made, but still recites a genus of different strains with different genetics and different properties.
The specification does not provide guidance on how to determine which administrations and strains have the claimed effects, commensurate with the genus that is claimed. The specification discusses formulations and administration protocols that could occur generally (for example, see dosing information at [0083-0084]), but is silent on whether the administration(s) disclosed would have the claimed effects.
The specification only teaches one specific example strain BPZE1 (see Results beginning pg. 17) but this does not provide information about whether other strains and administrations would have the claimed effects. Also, the specification only teaches one specific administrations of BPZE1 that can “cause a more Th1-biased immune response against Bordetella pertussis compared to the immune response against Bordetella pertussis that would have been induced in the subject had the subject been vaccinated with an aPV instead of the live attenuated Bordetella pertussis strain-based vaccine” as required by claim 1, 13, and the dependent claims; specifically, this administration is one nasal dose of BPZE1 in mice [0129-0130] using 4*106 CFU per 20 µL PBS [0112].
Notably, the recitation of functions in dependent claims 2-8 indicates that applicant believes that these functions limit the parent claim and the effects are not shared among all administrations; however, the specification does not describe which administration steps result in the functional limitation so that one of ordinary skill in the art would recognize that the inventors had possession of the functionally claimed invention at the relevant time.
Like the specification, the art teaches that functional limitations are not shared across the full genus of “live attenuated B. pertussis strain” that is claimed structurally. For example, Roberts et al. (1990; PTO-892) teaches administration of live attenuated aroA mutant strains of B. pertussis and found that the administration step protects against virulent B. pertussis colonization but does not lead to colonization of the lungs by the attenuated strain (Abstract), as required by claims 1 and 13. Also, Debrie et al. (WO-03102170-A1; PTO-892) has similar teachings to the specification about what was known in the art at the time of invention. Like the specification, Debrie teaches the use of B. pertussis strains for the preparation of vaccines (Abstract) and teaches intranasally immunizing mice (pg. 19 par. 3) (i.e. administration to the respiratory tract of the subject, see instant claims 1-8 and 13). But Debrie also teaches that the functions of the mutant strains that are generated must be experimentally tested in the Examples and that intranasally immunizing mice allows one to “verify” the ability of BPZE2 strain to colonize the respiratory tract, to induce serum and mucosal responses, and to protect against B. pertussis challenge (pg. 19 par. 3).
In summary, the claims include a sub-genus of steps of administering live attenuated B. pertussis strains, but the sub-genus is defined solely by the functions listed in claims 1-8 and 12. MPEP 2163 states:
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. … For example, in the biotech art, if a strong correlation has been established between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
In this case, the administration steps are described solely based on their function, but neither the specification nor the art has established a strong correlation that would allow one of ordinary skill in the art to predict with a reasonable degree of confidence the method steps fulfilling the claimed invention based on the recitation of the function.
Also, the specification discloses only a single administration protocol that has the functions required by the claims. See MPEP 2163:
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species… A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)”
In this case, the art shows that the one protocol and strain tested are not representative of the entire genus because other live attenuated B. pertussis strains have different properties and those of ordinary skill believe that verification of a strain’s properties is required rather than being predictable from the known strains.
Therefore, when evaluating the specification in the context of the prior art at the time of invention, one having ordinary skill in the art at the time of invention would have concluded that the specification demonstrated possession of a method that administers strains broadly but does not require functional effects resulting from administration of the broad genus of B. pertussis strains (other than the effects that are known in the art to be present for live attenuated B. pertussis as a genus), or a method that administers the BPZE1 strain in the steps used in the examples in order to achieve the specific functional effects resulting from administration, but would not believe that applicants have demonstrated possession of a method that administers a broad genus of live attenuated B. pertussis strains to achieve specific functional effects. Therefore, claims 1-13 are rejected for failing to demonstrate possession of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Citations refer to the machine-translated English translation of the reference, which is attached with this action.
Debrie teaches the use of B. pertussis strains for the preparation of vaccines (Abstract) and teaches intranasally immunizing mice (pg. 19 par. 3) (i.e. administration to the respiratory tract of the subject, see instant claims 1-8 and 13). In particular, Debrie teaches live strains or Bordetella that are deficient in producing pertussis toxin (PTX), dermonecrotic toxin (DNT), and in the release of tracheal cytotoxin (TCT) by means of genetic attenuation (Abstract). Debrie teaches that these strains are “genetically attenuated” (pg. 2 par. 4) (i.e. live attenuated B. pertussis or B. pertussis-based means, see instant claims 1-8 and 13). First, Debrie teaches the BPREDN mutant (Example 4 pg. 16), which is “deficient in the production of the toxin DNT and expressing a toxin PTX made enzymatically inactive by mutation (hereinafter called toxin PTRE)” (pg. 16 par. 3), and the strain lacks the enzymatically active PTX gene because the parent mutant strain BPRADN was PTX- (pg. 16 par. 4). The PTRE variant has only point mutations in two amino acids and the rest of the protein is intact, so it is immunogenic (pg. 6 par. 3). In other words, the BPREDN mutant has an immunogenic but not enzymatically inactive ptx gene, lacks an enzymatically active ptx gene, and has a deleted dnt gene (see instant claims 9 and 11-12), but it has a native ampG gene. Second, Debrie also teaches generating a variant of the B. pertussis ampG gene, called ampG2, in which the “variant codes for the AmpG protein of B. pertussis to which the 13 N-terminal amino acids of the AmpG protein of E. coli have been added” (pg. 18, par. 3). In other words, the ampG2 gene is a heterologous ampG gene because it encodes a non-native fusion protein. Finally, Debrie teaches “constructs containing the native or mutated [i.e. heterologous] ampG gene under the control of the porous promoter Ppor [were] inserted by double homologous recombination at the chromosomal locus of ampG” (pg. 19 par. 1) and that this recombination occurred in the BPREDN strain to produce the isolate BPZE2 (pg. 19 par. 2). Therefore, the BPZE2 isolate has a mutated ptx gene (PTRE), a deleted dnt gene, and the heterologous ampG2 gene replacing the Bordetella ampG gene (see instant claims 9-12).
Claims 1-8 and 13 recite functional limitations describing the effects that occur in the body after the administration step. The ability to perform these limitations is something that is inherent to the administration step, and the specification is silent on structural characteristics of the claimed bacteria/administrations that render them capable of performing or not performing the claimed functions. Therefore, these functional characteristics are considered to be inherent properties of all administrations of all live attenuated B. pertussis strains, absent evidence to the contrary. See MPEP 2112 for a discussion of rejections based on inherency. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
In the instant case, Debrie teaches a bacterial strain according to the claims, and also teaches its intranasal administration, which is a situation in which the functional effects of claims 1-8 and 13 would occur. Debrie teaches the live attenuated B. pertussis strain BPSMDN strain can colonize the respiratory tract and protect against B. pertussis infection (Example 2, and particularly pg. 14 par. 4 and pg. 15 par. 1), teaches the live attenuated B. pertussis strains BPRA and BPRADN can also can colonize the respiratory tract and protect against B. pertussis infection (Example 3, particularly pg. 15 par. 4-5 and par. bridging pg. 15-16), and teaches specific protocols for intranasally immunizing mice in order to “verify” the ability of BPZE2 strain to colonize the respiratory tract, to induce serum and mucosal responses, and to protect against B. pertussis challenge (pg. 19 par. 3). Therefore, in this case, Debrie teaches several bacterial strains that meet all the structural limitations required by the claim (BPZE2, BPREDN, etc.) and a method of using the bacteria such that the inherent properties of the bacterial strain would be revealed. The “advance” claimed in the instant application is a demonstration of the previously untested properties of the live attenuated mutants, which does not render the old composition patentably new to the discoverer.
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 1-8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-8 of U.S. Patent No. US 6660261 B1. Although the claims at issue are not identical, they are not patentably distinct from each other.
‘261 claim 2 (and dependent claims) recites a pharmaceutical composition containing a pharmacologically efficient quantity of a Bordetella strain deficient in the production of pertussis toxin (i.e. a live attenuated B. pertussis), wherein said deficient Bordetella strain induces a higher production of antibodies against said filamentous hemagglutinin than the wild-type parent Bordetella pertussis strain; and wherein said deficient Bordetella strain colonizes lungs of an animal to which said pharmaceutical composition is administered.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘261 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition so the Bordetella strain colonizes the lungs (i.e. administering to the respiratory tract of a subject), so the method is anticipated because its only step is the disclosed use of the product. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 8986709 B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892).
The ‘709 claims recite a method of administering a live B. pertussis strain that is deficient in TCT, PTX, and DNT to a subject. Instant claims 11-12 teach that the strain with deficient DNT is attenuated. The ‘709 claims recite that the method has effects in the airway (i.e. bacteria are administered to the respiratory tract of the subject). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Instant claims 1-8 and 13 are anticipated by ‘709 alone.
The ‘709 claims do not teach the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9, or comprises a heterologous ampG gene replacing the Bordetella ampG gene, as in instant claim 10.
Debrie teaches the use of B. pertussis strains for the preparation of vaccines (Abstract) and teaches intranasally immunizing mice (pg. 19 par. 3) (i.e. administration to the respiratory tract of the subject, see instant claims 1-8 and 13). In particular, Debrie teaches live strains or Bordetella that are deficient in producing pertussis toxin (PTX), dermonecrotic toxin (DNT), and in the release of tracheal cytotoxin (TCT) by means of genetic attenuation (Abstract). Debrie teaches that these strains are “genetically attenuated” (pg. 2 par. 4) (i.e. live attenuated B. pertussis or B. pertussis-based means, see instant claims 1-8 and 13). First, Debrie teaches the BPREDN mutant (Example 4 pg. 16), which is “deficient in the production of the toxin DNT and expressing a toxin PTX made enzymatically inactive by mutation (hereinafter called toxin PTRE)” (pg. 16 par. 3), and the strain lacks the enzymatically active PTX gene because the parent mutant strain BPRADN was PTX- (pg. 16 par. 4). The PTRE variant has only point mutations in two amino acids and the rest of the protein is intact, so it is immunogenic (pg. 6 par. 3). In other words, the BPREDN mutant has an immunogenic but not enzymatically inactive ptx gene, lacks an enzymatically active ptx gene, and has a deleted dnt gene (see instant claims 9 and 11-12), but it has a native ampG gene. Second, Debrie also teaches generating a variant of the B. pertussis ampG gene, called ampG2, in which the “variant codes for the AmpG protein of B. pertussis to which the 13 N-terminal amino acids of the AmpG protein of E. coli have been added” (pg. 18, par. 3). In other words, the ampG2 gene is a heterologous ampG gene because it encodes a non-native fusion protein. Finally, Debrie teaches “constructs containing the native or mutated [i.e. heterologous] ampG gene under the control of the porous promoter Ppor [were] inserted by double homologous recombination at the chromosomal locus of ampG” (pg. 19 par. 1) and that this recombination occurred in the BPREDN strain to produce the isolate BPZE2 (pg. 19 par. 2). Therefore, the BPZE2 isolate has a mutated ptx gene (PTRE), a deleted dnt gene, and the heterologous ampG2 gene replacing the Bordetella ampG gene (see instant claims 9-12).
One of ordinary skill in the art at the time of invention would consider it prima facie obvious to improve the method of the claims of ‘709 by choosing the BPZE2 strain of Debrie as the strain that is deficient in TCT, PTX, and DNT rather than some generic other strain that is deficient in TCT, PTX, and DNT, thereby arriving at the claimed invention, because using an art-known strain is desirable because it reduces the time and expense compared to generating a new strain and increases reproducibility of the results by allowing comparison with others in the field. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification could be performed with a reasonable expectation of success because ‘709 teaches that there is a reasonable expectation of success at administering all bacteria in the genus and because Debrie’s BPZE2 bacteria falls within the genus disclosed in the ‘709 claims.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the claims of ‘709) teaches a method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the live B. pertussis strain that is deficient in TCT, PTX, and DNT used); the substituted element (i.e. the BPZE2 strain) was already known and already shown to function as a live B. pertussis strain that is deficient in TCT, PTX, and DNT, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one strain for another within the genus with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 9180178 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘178 claims teach a method “comprising administering to the subject in need of such treatment a live attenuated Bordetella pertussis strain comprising at least a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene replacing the Bordetella ampG gene, wherein the strain is able to colonize and induce protective immunity in the subject” (claim 1), “ wherein the live attenuated Bordetella strain is administered intranasally” (claim 4).
Also, claim 6 teaches “the live attenuated Bordetella strain is a BPZE1 strain deposited with the Collection Nationale de Culture Microorganismes as accession number I-3585.” The ‘178 specification teaches this strain has ptx genes deleted and replaced with a mutated ptx encoding inactive enzyme (Example 2). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘178 specification is being used to understand the meaning of the strain name in the claims. The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US-9415077-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘077 claims teach a method “comprising: colonizing the respiratory tract of the mammal by intranasally administering a live mutated Bordetella pertussis strain to the mammal, wherein the strain is mutated to reduce its production of functional pertussis toxin, dermonecrotic toxin, and tracheal cytotoxin” (i.e. a live attenuated strain, claim 1) and further teaching that “the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 2) “the mutation of the ptx gene comprises the substitution of an amino acid involved in substrate binding and/or an amino acid involved in catalysis” (claim 5) and “the substitution of the amino acid involved in substrate binding comprises R9K and the substitution of the amino acid involved in catalysis comprises E129G” (claim 6) (i.e. the PTX gene is enzymatically inactive but immunogenic because the rest of the protein is intact). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US-9526778-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘778 claims teach a method “comprising the step of administering to the subject a sufficient amount of a live attenuated, mutated Bordetella pertussis strain, wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene,” (claim 1) “wherein the strain is administered intranasally” (claim 2) (i.e. to the respiratory tract). Also, claim 5 teaches “the live attenuated, mutated Bordetella pertussis strain is BPZE1” and the ‘778 specification teaches this strain produces inactivated ptx (“Materials and Methods – Bacterial strains and Growth Conditions”). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘778 specification is being used to understand the meaning of the strain name in the claims. The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. US-9528086-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of ‘086 teach a method “comprising administering to a subject the live attenuated Bordetella pertussis strain comprising a mutated pertussis toxin (ptx)gene, a deleted dermonecrotic toxin (dm) gene, a heterologous ampG gene” (claim 10) and that “the mutated ptx gene [can comprise] at least one mutation leading to an enzymatically inactive protein that retains immunogenic properties” (claims 1 and dependent claims). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
The ‘086 claims do not teach administration is to the respiratory tract of the subject, as in instant claim 1. The teachings of Debrie were laid out above in the rejection of US 8986709 B2, and include intranasal administration of a B. pertussis strain with a mutated ptx gene (PTRE), a deleted dnt gene, and the heterologous ampG2 gene replacing the Bordetella ampG gene.
One of ordinary skill in the art at the time of invention would consider it prima facie obvious to improve the method of the claims of ‘086 by choosing the intranasal administration of Debrie as the administration protocol for the strain rather than some generic other administration, thereby arriving at the claimed invention, because using an art-known administration protocol is desirable because it reduces the time and expense compared to generating a new administration protocol and increases reproducibility of the results by allowing comparison with others in the field. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification could be performed with a reasonable expectation of success because ‘709 teaches that there is a reasonable expectation of success at all administration steps and because Debrie’s intranasal administration protocol falls within the genus disclosed in the ‘086 claims.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the claims of ‘086) teaches a method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the administration protocol used); the substituted element (i.e. the intranasal administration) was already known and already shown to function as an administration protocol for a live B. pertussis strain that is deficient in PTX, and DNT and with a heterologous ampG gene, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one administration protocol for another within the genus with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US-9119804-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other. A divisional was filed after this the application that this patent is based from (12/224,895). However, it does not protect from this double patenting rejection because, see MPEP 804.01: (B) the claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made because none of the claims in the set filed 9 Sep 2008 that was restricted reference the effect of inducing a more Th1-biased immune response like the claimed invention; and (E) the instant application is a continuation rather than a divisional application, and “Note that a restriction requirement in an earlier-filed application does not carry over to claims of a continuation application in which the examiner does not reinstate or refer to the restriction requirement in the parent application”.
The claims of ‘804 teach a live attenuated B. pertussis strain and an immunogenic composition, vaccine, and/or kit comprising it, wherein the strain is BPZE1. The specification of ‘804 teaches that BPZE1 was constructed by replacing the B. pertussis ampG gene with the E. coli gene, deleting the ptx genes and replacing with inactive ptx, and deleting the dnt gene (Example 2). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘804 specification is being used to understand the meaning of the strain name in the claims. ‘804 claims 8-9 also teach a vaccine comprising a strain with these same mutations, wherein the strain is able to colonize and induce protective immunity in a subject.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘804 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
As in the rejection of US-9528086-B2 above, the ‘804 claims do not teach administration is to the respiratory tract of the subject, as in instant claim 1. The teachings of Debrie and the reason for combining is the same as laid out in the ‘086 rejection above.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US-9655959-B2 as evidenced by Locht et al. (WO2007104451A1; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘959 claim 1 (and dependent claims) teach a vaccine comprising a pharmaceutically acceptable carrier and a live attenuated Bordetella strain that has been rendered deficient in functional adenylate cyclase toxin (CyaA), functional pertussis toxin (PTX), functional dermonecrotic toxin (DNT), and functional tracheal cytotoxin (TCT), but retains the ability to colonize a mammalian subject's lungs and induce a protective immune response against Bordetella infection, wherein the genes encoding CyaA, PTX, and AmpG have been deleted, mutated or replaced. ‘959 claim 5 teaches the strain lacks a functional wild-type ampG gene and ‘959 claim 6 teaches the strain comprises a heterologous ampG gene. ‘959 claims 8 and 10 teaches the strain is BPAL10. The ‘959 specification teaches that “BPAL10 was derived from B. pertussis BPZE1, a BPSM derivative strain producing inactivated pertussis toxin (PTX), no dermonecrotic toxin (DNT) and background levels of tracheal cytotoxin (TCT)” (Examples – Methods – Bacterial growth conditions). Specifically, Locht teaches that BPZE1 has B. pertussis ampG gene was replaced by Escherichia coli ampG (i.e. heterologous ampG), the ptx gene deleted and replaced with inactive PTX, and the dnt gene deleted (“Example 2 - Construction of B. pertussis BPZE1”). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” See MPEP 2131.01: “Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991)”. In this case, the ‘959 specification and the Locht reference are being used to understand the meaning of the strain name in the claims.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘959 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition so the Bordetella strain colonizes the lungs (i.e. administering to the respiratory tract of a subject), so the method is anticipated because its only step is the disclosed use of the product. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US-9730995-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘995 claims teach a live attenuated B. pertussis strain and an immunogenic composition comprising it, wherein the strain comprises at least a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic toxin (dnt) gene, and a heterologous ampG gene replacing the Bordetella ampG gene, wherein the strain is able to colonize and induce protective immunity against Bordetella pertussis infection in a subject when administered to the subject. ‘995 claim 6 teaches that the composition can be in the form of a nasal inhaler.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘995 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition nasally (i.e. administering to the respiratory tract of a subject), so the method is anticipated because its only step is the disclosed use of the product. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Instant claims 1-8 and 13 are anticipated by ‘995 alone.
The claims of ‘995 do not teach that strain with mutated PTX is a strain where the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9. What is not taught a subset of what is not taught in the rejection of US 8986709 B2 above. The teachings of Debrie and the motivation to combine is the same as in the rejection of ‘709 above.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US-9839683-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘683 claims teach a method “ comprising the step of infecting the subject's respiratory tract with a live Bordetella pertussis strain which is deficient for tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT)” (claim 1), “wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 2) “the mutation of the ptx gene comprises the substitution of an amino acid involved in substrate binding and/or an amino acid involved in catalysis” (claim 5) and “the substitution of the amino acid involved in substrate binding comprises R9K and the substitution of the amino acid involved in catalysis comprises E129G” (claim 6) (i.e. the PTX gene is enzymatically inactive but immunogenic because the rest of the protein is intact). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US-10046044-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘044 claims teach a method “comprising the step of colonizing the respiratory tract of a mammalian subject with a vaccine comprising a sufficient amount of a live attenuated Bordetella pertussis strain that has been rendered deficient in functional pertussis toxin (PTX), functional dermonecrotic toxin (DNT), and functional tracheal cytotoxin (TCT)” (claim 1) “wherein the strain comprises a heterologous ampG gene” (claim 6). Also, ‘044 claim 8 teaches “the strain is BPAL10” and the ‘044 specification teaches that this strain produces inactivated ptx (“Methods- Bacterial growth conditions”). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘044 specification is being used to understand the meaning of the strain name in the claims. The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US-10258681-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other. A divisional was filed after this the application that this patent is based from (15/626,331). However, it does not protect from this double patenting rejection because, see MPEP 804.01: (B) the claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made because the restricted inventions are a product and a method of making it, while the claimed invention is a method of using an invention; and (E) the instant application is a continuation rather than a divisional application, and “Note that a restriction requirement in an earlier-filed application does not carry over to claims of a continuation application in which the examiner does not reinstate or refer to the restriction requirement in the parent application”.
The claims of ‘681 teach an immunogenic composition comprising a dose of a live attenuated Bordetella pertussis strain which is able to colonize a subject when administered to the subject, wherein the live attenuated Bordetella pertussis strain has its native Bordetella pertussis ampG gene replaced with a heterologous ampG gene.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘681 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
As in the rejection of US-9528086-B2 above, the ‘681 claims do not teach administration is to the respiratory tract of the subject, as in instant claim 1. Like in the rejection of U.S. Patent No. US 8986709 B2 above, the ‘681 claims do not teach the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9. Also, the ‘681 claims do not teach the live attenuated strain comprises a deleted or mutated DNT gene, as in instant claims 10-11. The teachings of Debrie and the reason for combining is the same as laid out in the ‘086 and ‘709 rejections above. It is noted that the Debrie strain also comprises the DNT mutation.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US-10369207-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘207 claims teach a vaccine comprising a pharmaceutically acceptable carrier and a live attenuated Bordetella strain that has been rendered deficient in functional adenylate cyclase toxin (CyaA) and functional pertussis toxin (PTX), but retains the ability to colonize a mammalian subject's lungs and induce a protective immune response against Bordetella infection, wherein the genes encoding CyaA, and PTX have been deleted, mutated or replaced. ‘207 claim 4 teaches the strain lacks a gene encoding functional DNT, ‘207 claim 5 teaches the strain lacks a functional wild-type ampG gene and ‘207 claim 6 teaches the strain comprises a heterologous ampG gene.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘207 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition so the Bordetella strain colonizes the lungs (i.e. administering to the respiratory tract of a subject), so the method is anticipated because its only step is the disclosed use of the product. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Instant claims 1-8 and 13 are anticipated by ‘207 alone.
The claims of ‘207 do not teach that strain with deficient PTX is a strain where the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9, and do not teach that the strain lacking a functional wild-type ampG and comprising a heterologous ampG is a strain where the heterologous gene replaces the wild-type gene, as in instant claim 10. What is not taught is the same as in the rejection of US 8986709 B2 above. The teachings of Debrie and the motivation to combine is the same as in the rejection of ‘709 above.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US-10420827-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘827 claims teach a method “comprising infecting the antigen-sensitized subject's respiratory tract with a live Bordetella pertussis strain which is deficient for tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT)” (claim 1) “wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 2), “wherein the mutation of the ptx gene comprises a substitution of an amino acid involved in substrate binding and/or an amino acid involved in catalysis” (claim 4) and “wherein the substitution of the amino acid involved in substrate binding comprises R9K and the substitution of the amino acid involved in catalysis comprises E129G” (claim 5) (i.e. the PTX gene is enzymatically inactive but immunogenic because the rest of the protein is intact). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US-10610580-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of ‘580 teach an immunogenic composition comprising a dose of a live attenuated Bordetella strain which is able to colonize a subject when administered to the subject, wherein the strain comprises at least a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic toxin (dnt) gene, and a heterologous ampG gene replacing the Bordetella ampG gene. ‘580 claim 8 teaches the bacteria is B. pertussis.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘580 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
As in the rejection of US-9528086-B2 above, the ‘580 claims do not teach administration is to the respiratory tract of the subject, as in instant claim 1. Like in the rejection of U.S. Patent No. US 8986709 B2 above, the ‘580 claims do not teach the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9. The teachings of Debrie and the reason for combining is the same as laid out in the ‘086 and ‘709 rejections above.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US-10653765-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘765 claims teach a method “comprising the step of infecting the subject with a live Bordetella pertussis strain which is deficient for tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT)” (claim 1) “wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 2), “wherein the mutation of the ptx gene comprises a substitution of an amino acid involved in substrate binding and/or an amino acid involved in catalysis” (claim 4) and “wherein the substitution of the amino acid involved in substrate binding comprises R9K and the substitution of the amino acid involved in catalysis comprises E129G” (claim 5) (i.e. the PTX gene is enzymatically inactive but immunogenic because the rest of the protein is intact). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
As in the rejection of US-9528086-B2 above, the ‘765 claims do not teach administration is to the respiratory tract of the subject, as in instant claim 1. The teachings of Debrie and the reason for combining is the same as laid out in the ‘086 rejection above.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. US-10682377-B2 as evidenced by Locht et al. (WO2007104451A1; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘377 claims teach a method “comprising the step of administering to the respiratory tract of the subject an amount of a composition comprising a pharmaceutically acceptable carrier and live attenuated Bordetella pertussis wherein the live attenuated Bordetella pertussis are deficient in pertactin, tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT)” (claim 1) and that “the live attenuated Bordetella pertussis [can be] the BPZE1P strain deposited with the Collection Nationale de Cultures de Microorganismes under the accession number CNCM-I-5150” (claim 6). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
The ‘377 specification teaches that BPZE1P is a mutant derived from the BPZE1 strain (col. 2 ln. 11) and the BPZE1 strain is defined in WO2007104451A1 (col. 1 ln. 48). ‘451 teaches that BPZE1 has B. pertussis ampG gene was replaced by Escherichia coli ampG (i.e. heterologous ampG), the ptx gene deleted and replaced with inactive PTX, and the dnt gene deleted (“Example 2 - Construction of B. pertussis BPZE1”). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” See MPEP 2131.01: “Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991)”. In this case, the ‘377 specification and the ’451 reference are being used to understand the meaning of the strain name in the claims.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US-11065276-B2 as evidenced by Locht et al. (WO2007104451A1; PTO-892) in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘276 claim 1 teaches a composition comprising live attenuated pertactin-deficient Bordetella bacteria, wherein the live attenuated pertactin-deficient Bordetella bacteria are the BPZE1P strain of Bordetella pertussis deposited with the Collection Nationale de Cultures de Microorganismes under accession number CNCM-I-5150. The ‘276 specification teaches that BPZE1P is a mutant derived from the BPZE1 strain (col. 2 ln. 11) and the BPZE1 strain is defined in WO2007104451A1 (col. 1 ln. 48). ‘451 teaches that BPZE1 has B. pertussis ampG gene was replaced by Escherichia coli ampG (i.e. heterologous ampG), the ptx gene deleted and replaced with inactive PTX, and the dnt gene deleted (“Example 2 - Construction of B. pertussis BPZE1”). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” See MPEP 2131.01: “Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991)”. In this case, the ‘276 specification and the ’451 reference are being used to understand the meaning of the strain name in the claims.
As in the rejection of US-9528086-B2 above, the ‘276 claims do not teach administration is to the respiratory tract of the subject, as in instant claim 1. The teachings of Debrie and the reason for combining is the same as laid out in the ‘086 rejection above. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US-11110161-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘161 claims teach a method “comprising the step of infecting the subject's respiratory tract with a live attenuated Bordetella pertussis strain which is deficient in tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT)” (claim 1) “wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 2), “wherein the mutation of the ptx gene comprises a substitution of an amino acid involved in substrate binding and/or an amino acid involved in catalysis” (claim 4) and “wherein the substitution of the amino acid involved in substrate binding comprises R9K and the substitution of the amino acid involved in catalysis comprises E129G” (claim 5) (i.e. the PTX gene is enzymatically inactive but immunogenic because the rest of the protein is intact). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US-11285201-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘201 claims teach a vaccine comprising live Bordetella strain where the ptx gene has been mutated, the dnt gene has been deleted or mutated, and the Bordetella ampG gene is replaced with a heterologous ampG gene, wherein the resulting live mutated Bordetella strain is able to colonize the respiratory tract of a subject and induce protective immunity in the subject. See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘201 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition so the Bordetella strain colonizes the respiratory tract (i.e. administering to the respiratory tract of a subject), so the method is anticipated because its only step is the disclosed use of the product. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Instant claims 1-8 and 13 are anticipated by ‘201 alone.
The claims of ‘201 do not teach that strain with mutated PTX is a strain where the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9. What is not taught is a subset of what is not taught in the rejection of US 8986709 B2 above. The teachings of Debrie and the motivation to combine is the same as in the rejection of ‘709 above.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US-11446372-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘372 claims teach a method “comprising the step of administering to the mammalian subject a vaccine comprising a pharmaceutically acceptable carrier and a live attenuated Bordetella strain, wherein the live attenuated Bordetella strain retains the ability to colonize the mammalian subject's lungs” (i.e. administered to the respiratory tract) (claim 1), and “wherein the strain is BPZE1f3 deposited with the Collection Nationale de Cultures de Microorganismes (CNCM) under Registration No. CNCM I-5247” (claim 9). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
The ‘372 specification teaches that BPZE1f3 is a mutant derived from the BPZE1 strain (col. 9 ln. 41-42) and “BPZE1, lacks the gene coding for dermonecrotic toxin, produces genetically detoxified pertussis toxin and is deficient for tracheal cytotoxin production by the replacement of the B. pertussis ampG gene with the Escherichia coli ampG gene” (col. 2 ln. 5-8). See MPEP 804: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘372 specification is being used to understand the meaning of the strain name in the claims.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US-11819545-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘545 claims teach a method “comprising the step of administering to the subject's respiratory tract a live attenuated Bordetella pertussis strain” (claim 1) “wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 3), “wherein the mutation of the ptx gene comprises a substitution of an amino acid involved in substrate binding and/or an amino acid involved in catalysis” (claim 5) and “wherein the substitution of the amino acid involved in substrate binding comprises R9K and the substitution of the amino acid involved in catalysis comprises E129G” (claim 6) (i.e. the PTX gene is enzymatically inactive but immunogenic because the rest of the protein is intact). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US-12403188-B2 in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘188 claim 1 (and dependent claims) teach a vaccine comprising a pharmaceutically acceptable carrier and a live attenuated Bordetella pertussis strain engineered to stably produce Fim3, wherein the live attenuated Bordetella pertussis strain retains the ability to colonize a mammalian subject's lungs and induce a protective immune response against Bordetella infection by Bordetella pertussis or Bordetella parapertussis. ‘188 claim 4 teaches the live attenuated Bordetella pertussis strain has been rendered deficient in a PTX, a functional DNT (i.e. deleted or mutated dnt gene), and a functional TCT.
See MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” The claims of ‘188 teaches a prior art device/composition and teaches that it’s normal operation involves administering the composition so the Bordetella strain colonizes the subject’s lungs (i.e. administering to the respiratory tract of a subject), so the method is anticipated because its only step is the disclosed use of the product. The in vivo functions of instant claims 1-8 and 13 are presumed to occur upon administration absent evidence to the contrary.
Instant claims 1-8 and 13 are anticipated by ‘188 alone.
The claims of ‘188 do not teach that strain with mutated PTX is a strain where the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9, and do not teach that the strain lacking a TCT is a strain where the heterologous ampG gene replaces the wild-type gene, as in instant claim 10. What is not taught is the same as in the rejection of US 8986709 B2 above. The teachings of Debrie and the motivation to combine is the same as in the rejection of ‘709 above.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/338,314 (reference application, claims filed 27 May 2025) in view of Debrie et al. (WO-03102170-A1; hereafter Debrie; PTO-892). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The ‘314 claims teach a method “comprising the step of administering to the respiratory tract of the subject an amount of a composition comprising a pharmaceutically acceptable carrier and live attenuated pertactin-deficient Bordetella pertussis bacteria” (claim 1) “wherein the live attenuated pertactin- deficient Bordetella pertussis bacteria are deficient in Bordetella pertussis tracheal cytotoxin (TCT), functional pertussis toxin (PTX), and Bordetella pertussis dermonecrotic toxin (DNT)” (claim 4). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
Instant claims 1-8 and 13 are anticipated by ‘314 alone.
Like in the rejection of U.S. Patent No. US 8986709 B2 above, the ‘314 claims do not teach the live attenuated Bordetella pertussis strain produces an immunogenic but enzymatically inactive pertussis toxin (PTX) but not an enzymatically active PTX, as in instant claim 9, or comprises a heterologous ampG gene replacing the Bordetella ampG gene, as in instant claim 10. The teachings of Debrie and the reason to combine are the same as laid out in the rejection above.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/028,179 (reference application, claims filed 17 March 2025) as evidenced by U.S. Patent No. US 9180178 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The ‘179 claims teach a method “comprising administering a therapeutically effective amount of a mutated Bordetella strain, wherein the strain comprises a mutated pertussis toxin (ptx) gene, a deleted or mutated dermonecrotic (dnt) gene, and a heterologous ampG gene” (claim 1), “wherein the mutated Bordetella strain is administered to the patient by nasal administration” (claim 12), “wherein the mutated Bordetella strain is attenuated” (claim 10), “wherein the mutated Bordetella strain is administered to the patient as live vaccine” (claim 11), and “wherein the mutated strain is BPZE1 strain that is identified by the accession number CNCM I-3585” (claim 7). The in vivo functions of instant claims 1-8 and 13 are presumed to occur absent evidence to the contrary.
As discussed above in the rejection over ‘178, the BPZE1 strain with this deposit number has a deleted or mutated dermonecrotic (dnt) gene, a heterologous ampG gene replacing the Bordetella ampG gene, and ptx genes deleted and replaced with a mutated ptx encoding inactive enzyme. ”). See MPEP 2131.01: “Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991)”. In this case, the ’178 reference is being used to understand the meaning of the strain name in the claims.
Conclusion
No claims are allowed.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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