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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2024 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Claim Status
Claims 1-20 are currently pending and have been examined on their merits.
Claim Objections
Claim 17 is objected to because although it is apparent that applicant intends to require the sample to further comprise one or more of the recited polycyclic aromatic hydrocarbons (PAHs), because coronene (required by claim 1) is also a PAH (specification, p. 2, lines 20-22), the claim should be amended to require one or more additional polycyclic aromatic hydrocarbons.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112:
(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.
(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.
Claims 2-3 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
The claims contain 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 specification lacks complete deposit information for the deposit of Halomonas caseinilytica 10SCRN4D. Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of this specific strain, a suitable deposit for patent purposes is required.
It is not clear whether a deposit has been made.
If the deposit has been made under the provisions of the Budapest Treaty, the deposit requirement may be fulfilled by filing an affidavit or declaration by applicants or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number averring that:
the deposit was made under the Budapest treaty and “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent”.
This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring that:
“during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request”;
“all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application”;
“the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest”; and
“the deposits will be replaced if they should become non-viable or non-replicable”.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR § 1.801-1.809 for further information concerning deposit practice.
Claims 18-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 18-20 depend from claim 17 which requires the sample to “further comprise one or more polycyclic aromatic hydrocarbons selected from the group consisting of benzo[a]pyrene, pyrene, and phenanthrene” (emphasis added). These claims recite various degradation percentages for each of these PAHs. The claims lack clarity because claim 1 already requires a polycyclic aromatic hydrocarbon (coronene) and the claims are therefore indefinite because they refer to an amount of “the polycyclic aromatic hydrocarbon” but the claims effectively require two polycyclic aromatic hydrocarbons (coronene and one of the PAHs recited in claim 17).
In the interest of compact prosecution, these claims have been interpreted as follows:
Claim 18 is interpreted to refer to degradation of 20 to 65 percent of benzo[a]pyrene based on an initial amount of the benzo[a]pyrene.
Claim 19 is interpreted to refer to degradation of 35 to 70 percent of pyrene based on an initial amount of the pyrene.
Claim 20 is interpreted to refer degradation of 20 to 60 percent of phenanthrene based on an initial amount of the phenanthrene.
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 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okeyode et al. (Archives of Environmental Protection, 2023, Vol. 49, No. 3, pages 78-86).
The applied reference has at least one common co-author with the designated co-inventors of the instant application. Based upon the earlier publication date of the Okeyode et al. non-patent literature reference, it constitutes prior art under 35 U.S.C. 102(a)(1).
To exempt this reference as prior art under 35 U.S.C. § 102(a)(1), applicant may invoke the 35 U.S.C. § 102(b)(1)(A) exception if it can be shown that: (i) the disclosure was made publicly available 1 year or less before the effective filing date of the claimed invention and (ii) the prior art subject matter originated solely from one or more members of the present application’s inventive entity. The office acknowledges that the cited prior art was electronically published on September 2023, which is within 1 year of the effective filing date of the instant application and, therefore, the exception may be invoked by applicant if the above requirements are met.
The Okeyode et al. reference lists co-authors which are not designated as co-inventors in this application. Thus, it is not readily apparent that at least one of the co-inventors designated in the present application are the sole originators of the claimed methods. To invoke the 35 U.S.C. § 102(b)(1)(A) exception and disqualify Okeyode et al. as prior art, an affidavit or declaration of attribution under 37 CFR § 1.130(a) must be filed with the office. The “Declaration of Attribution” should disqualify the disclosure as prior art by attributing the conception of the invention to at least one of the co-inventors by providing: (i) a statement from at least one co-inventor stating that they invented the potential prior art subject matter and (ii) a reasonable explanation as to why the non-inventive contributors (co-authors Basheer Chanbasha, Emmanuel Afuecheta, and Shahad Algarni) are listed as additional authors in the prior art publication. See MPEP § 2155.01. Because applicant has not filed such affidavit or declaration, Okeyode et al. has been applied as prior art under 35 U.S.C. § 102(a)(1) for the reasons discussed below.
Regarding claim 1, Okeyode teaches an experiment wherein Halomonas caseinilytica 10SCRN4D was grown in the presence of coronene at three different concentrations (16.6 µM, 33 µM, and 166.5 µM)(p. 81, left col., par. 1).
As discussed above, the sample comprises coronene at a first concentration.
As discussed above, the bacterial strain is Halomonas caseinilytica.
Okeyode assessed the concentration of coronene after 20 days and found that H. caseinilytica degraded 48%, 38%, and 25% of the coronene at 16.6 µM, 33 µM, and 166.5 µM, respectively (p. 82, left col., par. 1; Fig. 2).
Accordingly, the sample was contacted with a bacterial strain for a time sufficient to degrade at least one polycyclic aromatic hydrocarbon and the product collected contained coronene at a second concentration lower than the first concentration.
Regarding claim 2, as discussed above, Okeyode teaches that the strain is Halomonas caseinilytica 10SCRN4D.
Regarding claim 3, as discussed above, Okeyode teaches the same strain. Accordingly, it must have the same properties (morphology, average length, average width). Nonetheless, it is noted that Okeyode teaches that the strain is rod-shaped with an average length of 2.1 µm and average width of 0.5 µm. Both of these values fall within the claimed range.
Regarding claim 4, as discussed above, Okeyode teaches assessment of coronene concentration at 20 days (a value falling within the claimed range of from 1 to 100 days). Additionally, Okeyode teaches that growth was monitored over 30 days (p. 81, left col., par. 1-2; p. 84, left col., par. 2). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 5, as discussed above, Okeyode teaches contacting 16.6 µM, 33 µM, and 166.5 µM. Each of these values fall entirely within the claimed range of from 10 to 200 micromolar. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 6, as discussed above, Okeyode assessed the concentration of coronene after 20 days and found that H. caseinilytica degraded 48%, 38%, and 25% of the coronene at 16.6 µM, 33 µM, and 166.5 µM, respectively (p. 82, left col., par. 1; Fig. 2). Thus, Okeyode teaches the method wherein the second concentration is from 20 to 75 percent lower than the first concentration based on the total weight of the sample and the total weight of the coronene before and after the degrading.
Regarding claim 7, Okeyode teaches that the salinity was 10% NaCl. As such, Okeyode teaches the method wherein a salinity of the sample is from 0.1 to 25 percent weight sodium chloride by volume based on a total volume of the sample. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 8, Okeyode teaches that the temperature was 37°C (a value falling in the range of from 25 to 50 °C). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 9, Okeyode teaches that the pH was 7 (a value falling in the range of 4 to 9). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 10, Okeyode teaches that degradation can occur over as long as 80 days (a value falling within 78 to 82 days) and at the end of 80 days, 76% was degraded (giving rise to a rate of 0.116 µM coronene per day; a value falling in the range of 0.100 to 0.130 µM per day)(p. 84, left col., par. 2). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 11, Okeyode teaches that the doubling time was 8.78, 11.13, and 15.71 hours for 16.6, 33.3, and 166.5 µM, respectively. Accordingly, Okeyode teaches three doubling times falling within the range of 8 to 16 hours. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 12, as discussed above, Okeyode teaches a first concentration of 16.6 µM (falling in the range of 15 to 20 µM), pH 7 (falling in the range of 6.8 to 7.2), a temperature of 37°C (falling in the range of 35 to 40 °C), salinity of 10% (falling in the range of 8 to 12 percent weight sodium chloride by volume based on a total volume of the sample), contacting for 20 days (falling in the range of 18 to 22 days), resulting in a degradation of 48% (falling in the range of 45 to 50 percent based on an initial concentration of the coronene). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 13, Okeyode teaches that the starting aliquot was around 5 x 105 CFU/ml (a value falling in the range of 4.5 x 105 to 5.5 x 105 CFUs per milliliter). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 14, Okeyode teaches that the maximum concentration for the 16.6 µM coronene sample was around 7 x 1011 CFU/ml (a value falling in the range of 6 x 1011 to 8 x 1011 CFU/mL). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023)(MPEP § 2131.03(I)).
Regarding claim 16, Okeyode also tested the effect of temperature on coronene degradation (p. 82, right col., par. 2 through p. 83, left col., par. 3). Specifically, Okeyode tested a sample containing 16.6 µM (falling in the range of 15 to 20 µM) of coronene at a temperature of 30°C (falling in the range of 28 to 32°C), at a pH of 7 (falling within the range of 6.8 to 7.2), with a salinity of 10% (falling in the range of 8 to 12 percent weight sodium chloride by volume based on a total volume of the sample), resulting in a biodegradation of approximately 50% (falling in the range of 40 to 60 percent based on an initial concentration of the coronene).
Regarding claim 17, Okeyode teaches that the biodegradation effect was also tested with samples comprising benzo[a]pyrene, pyrene, and phenanthrene (p. 84, right col., par. 1).
Regarding claim 18, Okeyode teaches that 10SCRN4D degraded 43.68% ± 19.36% of benzo[a]pyrene (a range falling entirely within the claimed range of 20 to 65 percent of the polycyclic aromatic hydrocarbon is degraded based on an initial amount of the benzo[a]pyrene)(p. 84, right col., par. 1).
Regarding claim 19, Okeyode teaches that 10SCRN4D degraded 51.75% ± 13.67% pyrene (a range falling entirely within the claimed range of 35 to 70 percent of the polycyclic aromatic hydrocarbon is degraded based on an initial amount of the pyrene)(p. 84, right col., par. 1).
Regarding claim 20, Okeyode teaches that the 10SCRN4D degraded 41.83% ± 16.24% of phenanthrene (a range falling entirely within the claimed range of 20 to 65 percent of the polycyclic aromatic hydrocarbon is degraded based on an initial amount of the phenanthrene).
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Okeyode et al. (Archives of Environmental Protection, 2023, Vol. 49, No. 3, pages 78-86).
The teachings of Okeyode are set forth above and applied herein.
Regarding claim 15, Okeyode also tested the effect of salinity on the coronene degradation (p. 83, right col., par. 3 through p. 84, left col., par. 1). Specifically, Okeyode tested a sample containing 16.6 µM (falling in the range of 15 to 20 µM) of coronene at a salinity of 0.5% (a value falling in the range of 0.2 to 0.8 percent weight sodium chloride by volume based on a total volume of the sample), a temperature of 37°C (falling in the range of 35 to 40 °C), resulting in biodegradation of 57% (a value falling in the range of 55 to 60 percent based on an initial concentration of the coronene).
Although Okeyode does not specifically teach that the pH in this example was in the range of 6.8 to 7.2, it is reasonable to conclude that the pH was in this range because Okeyode teaches that generally the optimum pH range for PAH degradation falls between pH 6 and 8, with the neutral pH being the most commonly reported (p. 83, left col., par. 3).
Alternatively, because Okeyode teaches that neutral pH is the most commonly reported pH range and is in the optimum pH range for PAH degradation, it would have been obvious to have modified Okeyode’s method such that the pH falls is within the range of 6.8 to 7.2.
Accordingly, claim 15 is anticipated by, or obvious over Okeyode.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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, Melenie Gordon can be reached at (571) 272-8037. 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.
/GRANT C CURRENS/Examiner, Art Unit 1651
Prosecution Insights