DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending and examined on the merits.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Claims 1, 19, and 20 are objected to because they recite “19 July 2023.” The recitation should be amended to recite “July 19, 2023.” Since claim 1 is objected to, then its dependent claims, claims 2-18, are objected to.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is 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.
Claim 7 is rendered indefinite by the recitation “the method can detect.” In using the word “can,” then it is unclear whether the detection limitation of claim 7 (detect the fluorine-containing material in the sample at a concentration of 50 micrograms per liter) is required or optional.
Claim 7 recites the limitation "the fluorine-containing material" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not recite a fluorine-containing material in the sample. A fluorine-containing material has a broader scope than the “perfluoroalkyl material” in the sample of parent claim 1.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The microorganism, a strain of Pseudomonas sp. bacterium deposited with a deposit number of NRRL B-68295, is recited in the claims, and thus is essential to the claimed invention. Since the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the microorganism, and it is not apparent if the biological material is readily available to the public.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sunantha (Science of the Total Environment. 2021. 759: 143544. 8 pages) is relevant to the claimed invention in that Sunantha discloses using a bacterium, specifically a genetically engineered bacterial biosensor system, for analysis of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) compounds, allowing for their detection in water samples (page 7, left column, last paragraph; abstract). PFOA and PFOS compounds are directed to perfluoroalkyl material, specifically the perfluoroalkyl materials of instant claims 2 and 3. The biosensor was exposed to PFOA and PFOS compounds and the gfp (green fluorescent protein gene) expression was analyzed by fluorescence microscope (page 5, left column, last paragraph). The results of the exposure demonstrate that the biosensor cells show a good fluorescence upon exposure to PFOA and/or PFOS compounds (page 5, right column, first paragraph). Therefore, Sunantha meets limitations of the claimed invention by disclosing a method of detecting a perfluoroalkyl material, the method comprising contacting a strain of bacterium (their genetically bacterial biosensor system) with a sample (the MSM with PFOA and/or PFOS substrates as taught on page 5, left column, last paragraph) to form a mixture; and observing the mixture to detect fluorescence thereof, wherein such fluorescence indicates the presence of the perfluoroalkyl material in the sample.
Sunantha differs from the claimed invention in that Sunantha does not disclose that the bacterium is a strain of Pseudomonas sp. bacterium deposited with a deposit number of NRRL B-68295. In particular, Sunantha discloses transforming a BL21 expression host with a 4.4 kb construct in order to construct a genetically modified biosensor (page 3, right column, first full paragraph). A BL21 expression host is a E. coli BL21 strain (see page 5, left column, last paragraph). The 4.4 kb construct comprises a regulatory gene (defluorinase gene) and a reporter gene (green fluorescence protein gene) (abstract; page 3, right column, first full paragraph). Though the 4.4 kb construct comprises a regulatory gene (defluorinase gene) from Pseudomonas aeruginosa (PAO1) strain (abstract; page 3, right column, first full paragraph), the genetically modified biosensor itself is not a strain of Pseudomonas sp. bacterium, thus differing from the claimed invention. Though the PAO1 strain is a strain of Pseudomonas sp. bacterium, the PAO1 strain is not the claimed strain since it does not exhibit fluorescence when in the presence of PFOA or PFOS. The fluorescence of the biosensor (an E. coli) of Sunantha is due to the expression of the green fluorescence protein gene.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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