DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application was filed 08/08/2024 and is a national stage entry of PCT/US2023/062430 with an international filing date: 02/10/2023 and claims priority from provisional application 63267862 , filed 02/11/2022.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63267862 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The application does not appear to teach the SEQ ID NO of the claims. Thus the are being given priority to 2/10/2023
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/17/2025 is being considered by the examiner.
It is noted that the IDS contain office actions related to foreign applications, but do not provide a context or specific claims or references that are discussed in the actions. These have been reviewed for what is provided within them, but the relevant application material such as specification, claims and cited references have not been used for the review.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 9-13, 15-17, 19, 21, 25, 30-31 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.
Independent claim 1 is drawn to method of detecting guanitoxin-producing bacteria in an aqueous liquid, the method comprising detecting one or more guanitoxin biosynthetic genes in the aqueous liquid, wherein the one or more guanitoxin biosynthetic genes are GntA,GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT, or a combination thereof.
Independent claim 17 is drawn kit for detecting guanitoxin-producing bacteria in an aqueous liquid, the kit comprising one or more nucleic acids each at least partially complementary to a portion of one or more guanitoxin biosynthetic genes, wherein the one or more guanitoxin biosynthetic genes are GntA, GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT, or a combination thereof.
Thus the independent claims are drawn to the detection of any guanitoxin-producing bacteria. Thus the applicant is claiming a bacterial genus by the function of being a quanitoxin-producing bacteria. Dependent claims draw the invention to cyanobacteria. This is a genus as Nabout (Biodivers Conserv(2013) teaches, “Although the number of biodiversity studies is increasing, the total number of species in different taxonomic groups remains uncertain. Estimates of the number of described species of Cyanobacteria range from 2,000 to 8,000.” Further dependent claims draw the invention to Sphaerospermopsis torques-reginae, Chrysosporum ovalisporum, Cuspidothrix, Cylindrospermopsis, Cylindrospermum, Dolichospermum, Microcystis, Oscillatoria, Planktothrix, Phormidium, Anabaena flos-aquae, A. lemmermannii Raphidiopsis mediterranea, Tychonema, or Woronichinia. Animesh Sahoo (https://biologylearner.com/oscillatoria-salient-features-occurrence-thallus-structure-reproduction/, 11/12/2022) teaches, “Oscillatoria is a genus of about 76 species in the family Oscillatoriaceae.”
Further Fiore (Harmful Algae 92 (2020) 101737) teaches, “Anatoxin-a(S) is the most potent natural neurotoxin produced by freshwater cyanobacteria. “….”We propose the new name guanitoxin (GNT) to emphasize its distinctive guanidino organophosphate chemical structure.”
Thus the art previously guanitoxin (GNT) was called Anatoxin-a(S).
The specification teaches:
[0124] As used herein, the term "guanitoxin biosynthetic gene" refers to a gene that encodes a protein involved in producing guanitoxin or an intermediate compound in the biosynthesis of guanitoxin. In embodiments, guanitoxin biosynthetic gene is GntA, GntB, GntC, GntD, GntE, GntF, GntG, GntH, Gntl, GntJ, or GntT or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntA or a fragment thereof. In
embodiments, the guanitoxin biosynthetic gene is GntB or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntC or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntD or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntE or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntF or a fragment thereof. In
embodiments, the guanitoxin biosynthetic gene is GntG or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntH or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntI or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntJ or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntT or a fragment thereof.
[0125] The term "GntA gene" or "GntA" as used herein refer to the any of the recombinant or naturally-occurring forms of the GntA gene or variants or homologs thereof. In embodiments, the GntA gene codes for a GntA polypeptide capable of maintaining the activity of the GntA polypeptide (e.g., within at least 50%, 80%, 90%, 95%, 96%, 97%, 98%, 99% or 100% activity compared to GntA polypeptide). In some aspects, the variants or homologs have at least 90%, 95%, 96%, 97%, 98%, 99% or 100% nucleic acid sequence identity across the whole sequence or a portion of the sequence (e.g., a 50, 100, 150 or 200 continuous nucleic acid portion) compared to a naturally occurring GntA gene (e.g. SEQ ID NO:23-27).
Thus in view of the specification the claims encompasses any fragment of any gunaitoxin synthetic genes from any guanitoxin-producing species as determined by any genus. It is further noted the gunaitoxin synthetic genes encompass genes that are part of the a gunaitoxin producing pathway, but can function in other pathways. The specification provides no specific function for any of the enzymes. Thus this is an enormous genus of bacteria, a genus of 200 to 8000 species of cyanobacteria and then 76 species of Oscillatoriaceae for example. Claim 12 provides a list of 14 cyanobacteria species conservative assuming 50 species for each that is
Further the claim encompass the same issue for the 11 genes recited in the independent claim.
Claim 5 broadens the genus by drawing the invention to, “the portion of the one or more guanitoxin biosynthetic genes comprises a coding sequence, a promoter region sequence, a terminator region sequence, or an intergene region sequence.” This provides for thousands of bases which do not specifically encode the genes,
Dependent claims limit the claims to SEQ ID NO 1 and SEQ ID NO 2 or SEQ ID NO 3 and SEQ ID NO 4. However, searching SEQ ID NO 1 provides:
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Only applicants own specification provides genes from bacteria.
Thus the claim lacks adequate written description for the genus of detecting guanitoxin producing bacteria by the detection of guanitoxin synthetic genes. Again it is noted while analysis focused on GntA, review of the additional genes claimed (GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT,) provided the same issues. further increasing the genus encompassed.
Further claim 15 recites, “the aqueous liquid is ingested by, inhaled by, or contacted with a subject.” The recitation of ingested or inhaled appear to encompass performing the method in vivo. The skilled artisan would further have to determine how to assay the presence or absence of guanitoxin synthetic genes in an in vivo system. As the art and instant specification are silent as to how to determine guanitoxin synthetic genes in vivo, the skilled artisan would thus have to determine how to target the specific nucleic acid of interest in vivo. Further the skilled artisan would further have to determine how to assay the nucleic acid sequence of specific cells or groups of cells in vivo , as examining all the cells in vivo would result in considerable heterogeneity, as well as possible issues with nucleic acids of symbiotic bacteria, and nucleic acids present in the digestive tract from food sources. The skilled artisan would further have to determine if the in vivo assay corresponds to in vitro assays. The skilled artisan would also have to determine how amplify the signal for the presence of mutations in single MBL genes in genomic DNA in such away as to be able to predictably determine the presence or absence of variant nucleic acids in a manner which is specifically detectable. This would require undue experimentation, as systems for in vivo nucleic acid mutation detection are not known in the art and the specific guidance required as outlined above has not been provided in the instant specification or prior art.
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 1-7, 9-13, 15-17, 19, 21, 25, 30-31 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.
Independent claim 1 is drawn to method of detecting guanitoxin-producing bacteria in an aqueous liquid, the method comprising detecting one or more guanitoxin biosynthetic genes in the aqueous liquid, wherein the one or more guanitoxin biosynthetic genes are GntA,GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT, or a combination thereof.
Independent claim 17 is drawn kit for detecting guanitoxin-producing bacteria in an aqueous liquid, the kit comprising one or more nucleic acids each at least partially complementary to a portion of one or more guanitoxin biosynthetic genes, wherein the one or more guanitoxin biosynthetic genes are GntA, GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT, or a combination thereof.
Thus the independent claims are drawn to the detection of any guanitoxin-producing bacteria. Thus the applicant is claiming a bacterial genus by the function of being a quanitoxin-producing bacteria. Dependent claims draw the invention to cyanobacteria. Further dependent claims draw the invention to Sphaerospermopsis torques-reginae, Chrysosporum ovalisporum, Cuspidothrix, Cylindrospermopsis, Cylindrospermum, Dolichospermum, Microcystis, Oscillatoria, Planktothrix, Phormidium, Anabaena flos-aquae, A. lemmermannii Raphidiopsis mediterranea, Tychonema, or Woronichinia. Animesh Sahoo (https://biologylearner.com/oscillatoria-salient-features-occurrence-thallus-structure-reproduction/, 11/12/2022) teaches, “Oscillatoria is a genus of about 76 species in the family Oscillatoriaceae.”
Further Fiore teaches, “Anatoxin-a(S) is the most potent natural neurotoxin produced by fresh water cyanobacteria. “….”We propose the new name guanitoxin (GNT) to emphasize its distinctive guanidino organophosphate chemical structure.”
Thus the art previously guanitoxin (GNT) was called Anatoxin-a(S).
The specification teaches:
[0124] As used herein, the term "guanitoxin biosynthetic gene" refers to a gene that encodes a protein involved in producing guanitoxin or an intermediate compound in the biosynthesis of guanitoxin. In embodiments, guanitoxin biosynthetic gene is GntA, GntB, GntC, GntD, GntE, GntF, GntG, GntH, Gntl, GntJ, or GntT or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntA or a fragment thereof. In
embodiments, the guanitoxin biosynthetic gene is GntB or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntC or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntD or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntE or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntF or a fragment thereof. In
embodiments, the guanitoxin biosynthetic gene is GntG or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntH or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntI or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntJ or a fragment thereof. In embodiments, the guanitoxin biosynthetic gene is GntT or a fragment thereof.
[0125] The term "GntA gene" or "GntA" as used herein refer to the any of the recombinant or naturally-occurring forms of the GntA gene or variants or homologs thereof. In embodiments, the GntA gene codes for a GntA polypeptide capable of maintaining the activity of the GntA polypeptide (e.g., within at least 50%, 80%, 90%, 95%, 96%, 97%, 98%, 99% or 100% activity compared to GntA polypeptide). In some aspects, the variants or homologs have at least 90%, 95%, 96%, 97%, 98%, 99% or 100% nucleic acid sequence identity across the whole sequence or a portion of the sequence (e.g., a 50, 100, 150 or 200 continuous nucleic acid portion) compared to a naturally occurring GntA gene (e.g. SEQ ID NO:23-27).
Thus in view of the specification the claims encompasses any fragment of any gunaitoxin synthetic genes from any guanitoxin-producing species as determined by any genus. It is further noted the gunaitoxin synthetic genes encompass genes that are part of the a gunaitoxin producing pathway, but can function in other pathways. The specification provides no specific function for any of the enzymes. Claim 12 provides a list of 14 cyanobacteria species conservative assuming 50 species for each that is
Further the claim encompass the same issue for the 11 genes recited in the independent claim.
Dependent claims limit the claims to SEQ ID NO 1 and SEQ ID NO 2 or SEQ ID NO 3 and SEQ ID NO 4. However, searching SEQ ID NO 1 provides:
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Only applicants own specification provides genes from bacteria.
Thus the metes and bounds of the claims is vague, confusing and unclear what is required by, “detecting one or more guanitoxin biosynthetic genes in the aqueous liquid, wherein the one or more guanitoxin biosynthetic genes are GntA,GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 9-13, 15, 17, 19, 21, 25, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neilan (US 2009/0275018) and Camargo (Revealing the biosynthesis of guanitoxin, a naturally occurring neurotoxic organophosphate. (2020)
With regards to claim 1, 17Neilan discloses a method of detecting neurotoxin-producing bacteria in an aqueous liquid, the method comprising detecting a toxin biosynthetic gene in the aqueous liquid (para [0011]-[0017] - "a method for the detection of toxic cyanobacteria, the method comprising the steps of: (a) obtaining a cyanobacterial sample; and (b) analyzing the sample for the presence of hepatotoxin associated aminotransferase domain sequences, wherein the presence of hepatotoxin-associated aminotransferase domain sequences are indicative of toxic cyanobacteria. The hepatotoxin-associated aminotransferase domain sequences may be derived from the mcyE open reading frame of the microcystin synthetase gene complex ... analysis step (b) may comprise: (i) amplification of DNA from the sample using suitable primers; and (ii) detection of amplified sequences."; para [0020] - "The cyanobacterial sample may comprise one or more isolated or cultured cyanobacterial organisms or may be an environmental sample containing one or more cyanobacterial organisms. The environmental sample may be a water sample or a sample from a blue-green algal bloom."; para [0045] - "the present inventors have developed a molecular tool enabling the successful identification of potentially hepatotoxic cyanobacterial species ... tool resides in a single PCR reaction based on the presence/absence of an aminotransferase (AMT) domain within the hepatoxin synthesis gene cluster."; para [0053] - "the cyanobacteria to which the present invention relates are any potentially hepatotoxic cyanobacteria, typically being those capable of production of microcystin or nodularin ... For example, the cyanobacteria may be selected from the genera Anabaena, Nostoc, Microcystis, Planktothrix, Oscillatoria, Phormidium, and Nodularia."; Note, Anabaena [Dolichospermum], Microcystis, Planktothrix, Oscillatoria, Phormidium are guanitoxin-producing cyanobacteria elected by the instant application, see instant claims 11-12).
Neilan does not specifically disclose detecting a guanitoxin biosynthetic gene in the aqueous liquid, wherein the guanitoxin biosynthetic gene is GntA or wherein the one or more nucleic acids comprises a first nucleic acid comprising a sequence having at least 80% identity to SEQ ID NO:1 and a second nucleic acid comprising a sequence having at least 80% identity to SEQ ID NO:2; or wherein the one or more nucleic acids comprises a first nucleic acid comprising a sequence having at least 80% identity to SEQ ID NO:3 and a second nucleic acid comprising a sequence having at least 80% identity to SEQ ID NO:4.
However, Camargo discloses where guanitoxin is present in Dolichospermum (pg 30, para 3 - pg 31, para 1 - "less attention was given to anatoxina(S) [guanitoxin] for several reasons: fewer validated poisoning events, instability and lack of the purified, standard compound, and the absence of knowledge of its biosynthesis genes .... Up to now it has been found only in freshwater planktonic cyanobacterial strains of the genera Dolichospermum (previously Anabaena) and Sphaerospermopsis"), where detection of GNT biosynthetic genes may be useful for detecting and monitoring of guanitoxin in water samples (pg 37, para 1 - "Toxic freshwater cyanobacterial harmful algae blooms
(CyanoHBs) are a public health concern worldwide. One of the most potent and overlooked cyanotoxins, guanitoxin ... By using genome mining approaches, we found a potential biosynthetic gene cluster (BGC) responsible for GNT production. We then biochemically investigated the GNT production using in vitro and in vivo assays to rigorously validate our proposal... Our GNT biosynthetic proposal may contribute to the development of rapid and sensitive methods of detection and monitoring of this forgotten toxin in freshwaters used for public supply."), where the biosynthetic gene cluster includes GntA (pg 39, para 3-4 - "To identify the biosynthetic gene cluster, we focused on the key intermediate ... a homolog to the PLP dependent oxygenase MppP was found. This enzyme catalyzes the first committed step of known enduracididine biosynthesis ... This gene, gntC, was found in a candidate metabolic gene cluster consisting of 10 co-localized genes (gntA-J) (Fig. 1 C). A closer look at the putative GNT gene cluster revealed that contained genes that could be used to construct a hypothetical biosynthetic pathway.,. the hypothetical GNT pathway also contains another enzyme predicted to use an arginine like substrate, GntA."; pg 42, para 5 - pg 43, para 1 - "Thus, the heme protein N-hydroxylase GntA may be a key enzyme in GNT
biosynthesis and, therefore, a hallmark for environmental detection of this toxin."), and PCR primers for amplifying GNT genes (pg 55, para 1 - "PCR methods. Coexpression of the GntB and GntC into pCOLADuet-1 vector was carried out amplifying codon optimized gene ...For primer set gntB-F/R program used was 98 C for 30 seconds for denaturing conditions ... primer set gntC-F/R program used was 98 C for 30 seconds..
Therefore it would have been prima facie obvious to one of skill in the art prior to the effective filing date of the claims to detect the genes of Camarago in a liquid by the method of Neilan. The artisan would be motivated as Neilan suggests the detection of neuro toxin producing cyanobacteria form freshwater environments. Camargo teaches, “Sphaerospermopsis torques-reginae is a planktonic freshwater cyanobacteria species with broad distribution in several Brazilian aquatic environments. Some strains of this species are known to produce the neurotoxic organophosphate guanitoxin (GNT) as well as spumigin and anabaenopeptin, both protease inhibitors.” The artisan would have a reasonable expectation of success as the artisan is merely detecting known methods.
With regards to claim 2, 19 Camarago teach GntA,GntB, GntC, GntD, GntE, GntF, GntG, GntH, GntI, GntJ, GntT, (table 1, pages 40-41)
With regards to claim 3, Neilan teach PCR amplification and Camarago teaches gntB and GntC primers in supplemental table (page 84).
With regards to claim 4, Neilan teaches, “[0057] Typically, according to methods of the invention the analysis of DNA is carried out by PCR amplification. Amplified products may be further analysed by nucleic acid sequencing. PCR amplification may be conducted on DNA extracted from cyanobacterial isolates or environmental samples as described above, or alternatively sequences may be amplified directly from organisms without the need for prior DNA extraction or purification steps. A variety of methods for direct PCR are known to those skilled in the art.”
With regards to claims 5-6, Camargo teaches, “we found a potential biosynthetic gene cluster (BGC) responsible for GNT production” )[age 37. Abstract).
Claims 7, 9-10 and 21 recites “a sequence having at least 90% identity to” and then recites a SEQ ID NO. The recitation of “a sequence” allows for the interpretation the claim encompasses fragments. Thus the claims encompass any two nucleotides of the recited SEQ ID NO to the full length. and Camarago teaches gntB and GntC primers in supplemental table (page 84), which render obvious the claims in view of the breadth of the claims.
With regards to claim 11, Camargo teaches cyanobacteria (page 9, abstract).
With regards to claim 12, Camargo teaches Sphaerospermopsis torques-reginae(page 9, abstract).
With regards to claim 13, Camargo teaches freshwater and lakes including Lake Erie ((page 9, abstract).
With regards to claim 15, Camargo teaches, “Pharmacological studies have shown that animals exposed to GNT showed characteristic symptoms of excessive cholinergic stimulation such as salivation, tearing, urinary incontinence, muscle fasciculation and respiratory paralysis.” (page 19, 1st paragraph)Thus ingestion, inhalation or contacting are obvious.
With regards to claim 30, Camargo and Neilan teach PCR which provide for dNTP, control, and label (0041 Neilan)
Claim(s) 16 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neilan (US 2009/0275018) and Camargo (Revealing the biosynthesis of guanitoxin, a naturally occurring neurotoxic organophosphate. (2020) as applied to claims 1-7, 9-13, 15, 17, 19, 21, 25, 30 above, and further in view of Fernandes (Extraction, Stability, and Bioavailability of guanitoxin in Sphaerospermopsis torques-reginae cultures analyzed by mass spectroscopy (2020)
The art of Neilan and Camarago suggest the detection of cyanobacteria with produce neurotoxins such guanitoxin by detection of toxin synthesis genes.
While Neilan and Camarago recognize guanitoxin as a neurotoxin they do not specifically teach treatment.
However, Fernandez provides a thesis or dissertation on Extraction, Stability, and Bioavailability of guanitoxin in Sphaerospermopsis torques-reginae. Fernandez teaches treatment with atropine sulfate therapy, activated charcoal, diazepam, propofol and phenobarbital. (1.4.6)
Therefore it would been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to treat animals exposed to guanitoxin with sulfate therapy, activated charcoal, diazepam, propofol or phenobarbital. (1.4.6). The artisan would have a reasonable expectation of success as the artisan is merely using known treatment which have shown efficacy to guanitoxin exposure.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683
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