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 .
Applicant's election without traverse of Group I (Invention I) in the reply filed on 03/18/2026 is acknowledged. Claims 15-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 8, 9, 12 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 pre-AIA the applicant regards as the invention.
Claim 6 recites the phrase “wherein the PAH-utilizing microorganisms comprise Pseudomonas sp. URS-5, Pseudomonas sp. URS-6, Pseudomonas sp. URS-8, and/or Rhodococcus sp. URS-10” which renders the claim vague and indefinite since the specific biological and biochemical properties of the microorganisms are not known and not recited in the claims. For examination purposes the claims will not be limited to specific species of Pseudomonas and Rhodococcu.
Claims 8, 9, 12, recite the phrase “such as” which renders the claim vague and indefinite since it is unclear if the claims are limited to the subject matter stated after the phrase “such as”. Appropriate correction is required. For examination purposes the claims will not be limited to the subject matter stated after the phrase “such as” .
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 6 is 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.
It is apparent that the recited Pseudomonas sp. URS-5, Pseudomonas sp. URS-6, Pseudomonas sp. URS-8, and Rhodococcus sp. URS-10 are required to practice the claimed invention. As such the strain must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC § 112, first paragraph, may be satisfied by a deposit of the microorganisms.
The process disclosed in the specification to make and/or obtain the microorganisms do not appear to be repeatable. It is noted that the claim references MZ144068.1, MZ144069.1, MZ144070.1 and MZ959374. However, it is not apparent if the source materials to make the microorganisms are both known and readily available to the public. Thus, all of the conditions of 37 CFR 1.801-1.809 have not been met since there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicant, or a statement by an attorney of record over his/her signature and registration number, stating that the specific microorganism has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of the 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 and MPEP 2402-2411.05, the applicant may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his/her signature and registration number, showing that:
(1) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(2) all restriction upon availability to the public will be irrevocably removed upon granting of the patent;
(3) the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
(4) the deposit will be replaced if it should ever become inviable.
Claims 1-14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of polyaromatic hydrocarbon (PAH)-degrading enzyme mixture obtained from a culture of a genus of PAH-utilizing microorganisms having been grown in presence of one or more enzyme inducers where the enzymes in the recited mixture have any activity and any amino acid sequence and structure. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The specification as originally filed does not disclose a representative number of species of enzymes and PAH-utilizing microorganisms as encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures correlate with the genus of enzymes that can degrade any polyaromatic hydrocarbon and has enzymatic activity at the recited temperatures ranges and pH ranges.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed a broad and widely varying genus of polyaromatic hydrocarbon (PAH)-degrading enzyme mixture obtained from a culture of a genus of PAH-utilizing microorganisms having been grown in presence of one or more enzyme inducers where the enzymes in the recited mixture have any activity and any amino acid sequence and structure.
The specification teaches Pseudomonas sp. URS-5, Pseudomonas sp. URS-6, Pseudomonas sp. URS-8, and Rhodococcus sp. URS-10 have been deposited in the NCBI Genbank database and were assigned the accession of MZ144068.1, MZ144069.1, MZ144070.1 and MZ959374, respectively. An enabling deposit of these strains and amending the claims to recite these strains would aid in overcoming the rejection.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicant, or a statement by an attorney of record over his/her signature and registration number, stating that the specific microorganism has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of the 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 and MPEP 2402-2411.05, the applicant may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his/her signature and registration number, showing that:
(1) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(2) all restriction upon availability to the public will be irrevocably removed upon granting of the patent;
(3) the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
(4) the deposit will be replaced if it should ever become inviable.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over US20200102236 (04/02/2020; PTO 892) in view of US20070249035 (10/25/2007; PTO 892), WO1991002055A1 (02/21/1991; PTO 892), US20110306569 (2011-12-15; PTO 892).
US20200102236 teaches a process for treatment of hydrocarbon refinery wastewater producing a low bio-sludge, the process including utilizing microbial consortia comprising at least one species of Pseudomonas and at least one species of Bacillus in a ratio of 10:1 to 1:10 where the species of Pseudomonas and species of Bacillus have constitutive expression of at least one hydrocarbon degrading gene including catechol 1, 2 dioxygenase (cata), catechol dioxygenase (c12o, c23o), naphthalene dioxygenase (nahH, nahI) for degrading the poly aromatics/phenolics/heterocyclics (see entire publication and claims especially paragraphs [0013]- [0071]). US20200102236 teaches that the microbial consortia are grown and used in hydrocarbon refinery wastewater containing petroleum hydrocarbons, armomatics, and phenolics. US20200102236 teaches in paragraph [0034]:
“The main object of the present invention is to develop a high cell density novel formulation of microbial consortium having following characteristics like, degradation of aromatics, polyaromatics, hetrocyclic polyaromatics, aliphatics, benzene, toluene, ethylbenzene and xylene (BTEX), paraffin, phenolics, sulfides, production of biosurfactants, reduction of toxic metals like hexavalent chromium to non-toxic states, tolerance to hydrocarbon loads. Beside that each microbes should be catalase positive, lipase positive and indole positive.”
US20200102236 teaches the following in the claims:
1. A process for hydrocarbon refinery wastewater treatment producing low bio-sludge, the process comprises utilizing a microbial consortia comprising at least one species of Pseudomonas and at least one species of Bacillus in a ratio of 10:1 to 1:10,
wherein species of Pseudomonas and species of Bacillus have constitutive expression of at least one hydrocarbon degrading gene,
wherein the species of Pseudomonas are selected from the group consisting of Pseudomonas stutzeri (MTCC 25027), Pseudomonas aeruginosa (MTCC 5389), Pseudomonas aeruginosa strain IOC DHT (MTCC, 5385), Pseudomonas putida IOCR1 (MTCC 5387), Pseudomonas putida IOC5a1 (MTCC 5388) and a mutant thereof,
wherein the species of Bacillus are selected from the group consisting of Bacillus subtilis (MTCC 25026), Bacillus substilis (MTCC 5386), Bacillus thermoleovorans (MTCC 25023), Bacillus stearothermophilus (MTCC 25030), Lysinibacillus sp. (MTCC 25029), Lysinibacillus sp. (MTCC 5666) and a mutant thereof, and
wherein the microbial consortia is used in concentration of at least 102 cfu/ml.
2. The process as claimed in claim 1, wherein the microbes of the consortia works at low mixed liquor suspended solids (MLSS) condition ranging from 700-1300 ppm.
3. The process as claimed in claim 1, wherein the microbe of the consortia has the ability to produce surface active molecules.
4. The process as claimed in claim 1, wherein the microbes of the consortia are grown at a temperature ranging from 5° C. to 50° C.
5. The process as claimed in claim 1, wherein the microbes of the consortia are grown at a pH ranging from 4.0 to 9.0.
6. The process as claimed in claim 1, wherein hydrocarbon degrading gene is selected from the group consisting of: Phosphopantetheinyl transferase (sfp, sfp0), Surfactin synthetase complex (srfAD), Rhamnosyltransferase subunit A (rh1A), Rhamnosyltransferase subunit B (rh1B), Lichenan-specific enzyme IIA component (licA), Lichenan-specific enzyme IIB component (licB), Lichenan-specific enzyme IIC component (licC), Catechol 1, 2 dioxygenase (CatA), Catechol dioxygenase (C12O, C23O), Catechol 2, 3 dioxygenase (xy1E), Naphthalene dioxygenase (nahH, nah1), Aromatic-ring hydroxylating dioxygenase (RHDα), Alkane monooxygenase (AlkB, AlkB1), Alkane dioxygenase (nahAc), n-alkane monooxygenase (CYP153), Long chain alkane monooxygenase (ladA), Flavin-binding monooxygenase (almA), Sulfide: quinone oxidoreductase (sqr), Persulfide dioxygenase (pdo), Chromate Reductase (ChrR) or a combination thereof.
The teachings of the reference differ from the claims in that the reference does not teach the claimed polyaromatic hydrocarbon (PAH)-degrading enzyme mixture obtained from a culture of PAH-utilizing microorganisms having been grown in presence of one or more enzyme inducers.
US20070249035 teach novel strains of isolated and purified bacteria have been identified which have the ability to degrade petroleum hydrocarbons including a variety of PAHs where several isolates also exhibit the ability to produce a biosurfactant (see entire publication and claims especially paragraphs[0009]- [0035]). US20070249035 teach that the combination of the biosurfactant-producing ability along with the ability to degrade PAHs enhances the efficiency with which PAHs may be degraded; and additionally, the biosurfactant also provides an additional ability to bind heavy metal ions for removal from a soil or aquatic environment. US20070249035 teaches in paragraph [0027] in Table 1, three bacterial species designated CZORL1B, BP20, and CZORL1Bsm, and which correspond to isolates 1 through 3 in Table 2, were observed to produce a surfactant when grown in a minimal medium containing naphthalene, phenanthrene, or fluoranthene. US20070249035 teaches in paragraph [0032] the isolates 1-3, ATCC PTA-5580(Alcaligenes-piechaudii SRS); ATCC PTA-5579, (Ralstonia pickettii SRS); and ATCC PTA-5581(Psuedomonas-putida Biotype B SRS) identified above, all demonstrate the ability to produce a biosurfactant, the formation of which was noted during culturing conditions.
WO1991002055A1 teaches a process for the enhancement of naphthalene dioxygenase activity in organisms that have been transformed with DNA encoding the expression of a multiple component naphthalene dioxygenase enzyme where cells including Pseudomonas putida containing the naphthalene dioxygenase enzyme are capable of producing indigo when cultured in the presence of indole. WO1991002055A1 teaches growing Pseudomonas putida and recombinant strains on naphthalene and related aromatic inducers, disrupting cells by French press, centrifuged to obtain crude cell free extracts and supernatants containing naphthalene dioxygenase system which are used for enhanced aromatic oxidation. See entire publication and claims especially Abstract, SUMMARY OF THE INVENTION section, and Examples 1-3. WO1991002055A1 teaches the following in the claims:
1. A process for enhancing naphthalene dioxygenase activity in an organism comprising the step of: transforming an organism with a DNA sequence encoding at least two ferredoxin polypeptides for each reductase polypeptide and iron-sulfur polypeptide, wherein said organism has DNA sequences that express a naphthalene dioxygenase enzyme which comprises reductase, ferredoxin and iron-sulfur polypeptides.
2. The process as recited in claim 1 further comprising the step of: growing said transformed organism in a culture broth containing an amount of iron effective to enhance said naphthalene dioxygenase activity.
3. The process as recited in claim 1 further comprising the step of: transforming said organism with a DNA sequence encoding a ferredoxin analog.
4. The process as recited in claim 3 further comprising the step of: growing said organism in a culture broth containing an amount of iron effective to enhance said naphthalene dioxygenase activity.
5. A process for enhancing naphthalene dioxygenase activity in an organism comprising the step of: growing an organism in a culture broth containing an amount of iron effective to enhance said naphthalene dioxygenase activity, wherein said organism has DNA sequences that express a naphthalene dioxygenase enzyme which comprises reductase, ferredoxin and iron-sulfur polypeptides.
7. A process for enhancing naphthalene dioxygenase activity in an organism comprising the step of: transforming an organism with a DNA sequence encoding a ferredoxin analog, wherein said organism has DNA sequences that express a naphthalene dioxygenase enzyme which comprises reductase, ferredoxin and iron-sulfur polypeptides.
8. The process as recited in claim 7 wherein said DNA sequence encodes Cys at position 47, He at position 52 and Arg at position 67 in said ferredoxin analog.
US20110306569 teach isolated strain of P. aeruginosa, designated strain NY3 which produces biosurfactant substances including rhamnolipids which have biological activities of commercial interest (see entire publication and claims especially paragraphs [0006]-[0011]). US20110306569 the following in paragraph [0023]:
“In an example, there is provided an isolate of P. aeruginosa strain NY3, which produces novel rhamnolipids. These rhamnolipids, or compositions including one or more of said rhamnolipids, can be used to decontaminate soil or water samples (for example to facilitate removal of PAHs, petroleum hydrocarbons, heavy metals, pesticides, or other environmental contaminants), and possess antimicrobial activities against organisms such as bacteria, fungi, and viruses. These substances can also be used as emulsifying, dispersing, foaming, wetting, and/or anti-adhesive agents in a variety of applications, including pharmaceutical formulations, detergents, cosmetics, and food processing.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by culturing and growing the microbial consortia of Pseudomonas and Bacillus taught by US20200102236 in the presence of inducers including naphthalene, phenanthrene, or fluoranthene taught by US20070249035 and PAH as only source of carbon; isolating the enzymes including catechol 1, 2 dioxygenase, catechol dioxygenase, naphthalene dioxygenase for degrading the poly aromatics/phenolics/heterocyclics from the microbial consortia of Pseudomonas and Bacillus as taught and/or suggested by WO1991002055A1; and formulating a mixture comprising the enzymes with the recited optimum pH and temperature activity, recited amount of salt, and biosurfactant including rhamnolipid as taught by US20110306569 and other species of PAH-utilizing organisms of US20070249035. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain an enzyme mixture that can be used for to degrade petroleum hydrocarbons as taught by US20070249035. It would have been obvious to adsorb the enzymes on soil particles as routine optimization and/or as desired which can be used in processes for degrading petroleum hydrocarbons. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because obtaining enzymes from PAH degrading microorganisms are known in the art as shown by the reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408)918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652