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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the illustration of the addition of the plurality of microbes to the wastewater-treatment system at a controlled and predetermined dosing rate or microbial source, dosing input, dosing line, or other graphical or labeled representation of the claimed microbial addition must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are further objected to because inaccurate or inconsistent textual matter. In Figure 2, “plague-forming unit” should apparently read “plaque-forming unit”. In Figure 14, “MOISTURE & SOUNDS CONTENT” should apparently read “MOISTURE & SOLIDS CONTENT”; the second occurrence of “N:P Ratio” appears inconsistent with paragraph [0201], which identifies the corresponding values as a P:K ratio; and the units or values reported for Total Kjeldahl Nitrogen and Potassium are internally inconsistent. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. The following matters require correction:
The disclosure is objected to because of the following informalities:
Appropriate correction is required.
1. Paragraph [0016] recites a microbial concentration range of approximately 103 CFU/mL to 1040 CFU/mL. This upper value is inconsistent with paragraphs [0021], [0026] and [0075], which recite an upper value of 1013 CFU/mL. Applicant is required to clarify the intended upper value and amend the specification so that the concentration is stated consistently.
2. Paragraphs [0016], [0021], and [0022] refer to pollutants measured by “DOD and TSS”. The abbreviation “DOD” is not defined in the specification and appears inconsistent with the specification’s repeated use of “BOD” as a wastewater-quality measurement. Applicant is required to define “DOD” or clarify whether “BOD” was intended and make the terminology consistent throughout the disclosure.
3. Paragraphs [0026] and [0075] state that “1 gram dry weight microbe” is equivalent to 10-13 CFU/mL. As written, this statement equates a mass with a number concentration and appears mathematically inconsistent with the surrounding CFU/mL and g/mL ranges. For example, the preceding ranges appear to employ a conversion of approximately 10-13 gram dry weight per CFU, because 102 CFU/mL multiplied by 10-13 g/CFU equals 10-11 g/mL, and 1012 CFU/mL multiplied by 10-13 g/CFU equals 10-1 g/mL. Applicant is required to clarify whether one CFU corresponds to approximately 10-13 gram dry weight, one gram dry weight corresponds to approximately 1013 CFU, or some other relationship was intended, and to correct the exponents and units accordingly.
4. Terminology relating to microbial age and residence time is used inconsistently:
Paragraph [0045] defines “MCRT” as “Mean Cell Residence Time” but expresses it as “mass sludge wasted/mass sludge in system”. As written, this expression does not provide a time value or identify the applicable time basis. Applicant is required to clarify and correct the stated relationship.
Paragraph [0046] introduces “Solids Retention Time” as “STR” although the conventional abbreviation used elsewhere appears to be “SRT”, and includes the grammatically unclear statements “STR, can find two different meanings” and “STR are may also be used”.
Paragraph [0054] refers to MCRT as an “average mean residence time” for wastewater, whereas paragraph [0045] defines MCRT as Mean Cell Residence Time. Applicant is required to clarify whether MCRT, SRT, or HRT is intended and use the terms consistently.
Paragraph [0058] uses the expression “y > 5 days” without defining the symbol “y”.
Paragraph [0062] recites the incomplete range “from about 2 weeks to about days”. Applicant is required to supply or correct the omitted value.
5. The Brief Description of the Drawings is incomplete or inaccurate:
Paragraphs [0029]-[0041] omit any description of Figure 10, although Figure 10 is included in the drawing set.
Paragraph [0041] describes Fig. 14 as a “graph”, whereas Figure 14 is presented as a table.
Paragraph [0030] states that “FIG. 2 is chart” which should be grammatically corrected.
6. The specification further contains numerous typographical and grammatical errors. Representative examples include, but are not limited to:
[0002] and [0042]: ”preforming” should apparently read “performing”
[0008]: “given it broadest” should apparently read “given its broadest”.
[0014]: “forgoing” should apparently read “foregoing”.
[0018]: “girt chamber” and “girt” should apparently read “grit chamber” and “grit”; “where by” should apparently read “whereby”.
[0023]-[0024]: “NPM” should apparently read “MPN”; “Samonella” should apparently read “Salmonella”; and “is obtaining” should apparently read “is obtained”.
[0044]: “on a regular and period basis” should apparently read “on a regular and periodic basis”.
[0059]: “peek” should apparently read “peak”.
[0077]: the phrases “have are added”, “This second doses” and “conventions methods” are grammatically incorrect and require correction.
[0081]: “treatment does” should apparently read “treatment dose”.
[0093]: “dislcosure” should apparently read “disclosure”.
[0112]: “digestor” is used inconsistently with “digester”, and “spreading on a filed” should apparently read “spreading on a field”.
[0114]: “preferrably” should apparently read “preferably”.
The above list is representative and is not intended to identify every typographical or grammatical error present in the specification. Applicant is required to review the entire specification and correct all similar informalities, while ensuring that no new matter is introduced. The replacement continuation paragraph already submitted for paragraph [0001] should be retained as the controlling paragraph. The identified numerical, terminology, drawing-reference, and typographical inconsistencies appear throughout the current specification.
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 and 2 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 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.
Although the specification discusses D50 microbial age and identifies desired D50 age values, the rejection is not based on an absence of the D50 subject matter from the specification. Rather, the specification fails to teach how the D50 age of the relevant microbial population is determined and how the claimed dosing rate is selected or controlled so as to maintain the recited D50 age.
Claim 1 requires, inter alia, adding a plurality of microbes having a D50 age of less than 14 days at a controlled and predetermined dosing rate, wherein the dosing rate maintains the D50 age of the microbes in the wastewater in the wastewater-treatment system at less than 20 days old. Claim 2 depends from claim 1 and further requires that the wastewater-treatment plant have a throughput of about 5MGD to about 40 MGD.
For purpose of this rejection, and without resolving the separate questions of claim interpretation raised under 25 U.S.C. 112(b), “D50 age” is understood as the age at which 50 percent of the cumulative microbial population is at or below that age. The specification similarly states that D50 is the value representing the age of the microbes making up 50 percent of the cumulative population. However, this statement supplies only a statistical definition of D50; it does not teach how the chronological ages necessary to construct the microbial-age distribution are determined in an operating wastewater-treatment system. Figure 1 likewise depicts a generalized age-distribution graph having D10, D50, and D90 values, but does not disclose how the underlying microbial-age data are obtained.
In particular, the specification does not disclose an assay, labeling technique, tracer method, sampling protocol, microscopic method, biochemical marker, mathematical model, or other procedure by which a person skilled in the art could determine the ages if the individual microbes making up the relevant population. The specification also does not explain how the operator is to distinguish or account for: the microbes intentionally added to the treatment system; microbes naturally present in the influent wastewater; microbes already resident in the treatment system; descendants produced by reproduction of the added microbes; viable microbes versus dead of inactive microbes; or the total microbial population versus only the floc-forming microbial population. These distinctions are material because the inclusion or exclusion of any of these groups would alter the resulting microbial age distribution and, consequently, its D50 value. Although paragraph [0052] discusses counting floc-forming populations using culture media, such a count does not determine the chronological ages of the counted microbes or produce the age distribution required to calculate D50.
The specification further fails to provide an enabling procedure for selecting or adjusting the claimed dosing rate so that the D50 age within the wastewater-treatment system remains below 20 days. Paragraph [0044] generally states that microbes should be young when added and should be added on a regular and periodic basis. Paragraphs [0045]-[0048] describe desired relationships between microbial age and mean cell residence time, solids retention time, or hydraulic residence time. These passages identify desired age relationships, but do not disclose how a known MCRT, SRT, or HRT is converted into the claimed microbial D50 age or how a dosing rate is calculated from those parameters. Similarly, paragraph [0054] states that microbes would have to be added “at a rate sufficient” to maintain a youthful population in view of flow, microbial removal, recycle, and wasting. There merely restates the desired result. It does not provide an equation, mass-balance relationship, algorithm, lookup table, experimental protocol, or worked calculation by which the operator can determine the rate sufficient to obtain and maintain the recited D50. Paragraph [0058] states that adding young microbes may shift the average age, D10, or D50 age of a viable population downward, but does not quantify the relationship between the amount or frequency of added microbes and the resulting D50 age.
The disclosure therefore does not teach how to perform either of the two essential D50 operations required by claim 1:
1. verifying that the plurality of microbes before addition has a D50 age of less than 14 days; and
2. determining and controlling the dosing rate that maintains the D50 age of the relevant microbial population in the operating treatment system below 20 days.
The working examples do not remedy these omissions. The examples disclose various plant arrangements, treatment volumes, microbial dosing amounts, holding periods, pollutant measurements, and sludge characteristics, but do not report a measured D50 age for an added treatment batch or for the microbial population within an operating wastewater-treatment system. Nor do the examples identify the method used to measure D50, demonstrate a dosing rate calculation ties to D50, or show feedback adjustments made in response to a measured microbial-age distribution.
The breadth of the claims further supports the conclusion that undue experimentation would be required. Claim 1 is not limited to a particular microbial species, wastewater composition, treatment-device configuration, residence time, recycle rate, wasting rate, temperature, oxygen condition, or microbial growth and death rate. The claimed microbial concentration extends from about 103 CFU/mL to 1013 CFH/mL, and the specification contemplates activated-sludge-systems, fixed-film systems, collection networks, and combinations.
The specification itself recognizes that microbial age depends upon such factors as MCRT, SRT, HRT, wastewater flow, recycle, microbial removal, and microbial reproduction. Nevertheless, no general method is provided for determining the D50 age or controlling it across this broad range of operating conditions. A person of ordinary skill in the art would therefore be required to develop an age-determination methodology, decide which organisms are included in the population, establish a model correlating dosing with the resulting age distribution, calibrate that model for the selected treatment system, and validate that the D50 remains below the claimed threshold. Such experimentation is not merely routine optimization of disclosed operating parameters because the specification does not provide underlying measurement or control methodology from which such optimization could begin.
Claim 2 does not cure the deficiency of claim 1.
Accordingly, claims 1 and 2 consequently fail to comply with the enablement requirement of 35 U.S.C. 112(a).
Claims 1 and 2 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 claim 1, the recitation of “A method of controlling the age of microbial in treating an influent wastewater stream…”, further, the claim requires a plurality of microbes “containing from about 103 cfu/ml to 1013 cfu/ml”, having a D50 age of less than 14 days, a dosing rate that maintains “the D50 age of the microbes in the wastewater in the wastewater treatment system” below 20 days, and an effluent having pollutants “as measured by DOD and TSS reduced by at least about 90%”.
However, there is no mention by which step or by what means the age of microbial in treating an influent wastewater stream has been controlled. Further, “controlling the age of microbial” is indefinite because “microbial” is adjectival and does not identify a noun or population who age is being controlled. This ambiguity is not resolved by the remainder of the claim. The claim later refers both to the initially added “plurality of microbes” and more broadly to “the microbes in the wastewater in the wastewater treatment system”. The specification also uses differing terminology, including “added microbes”, “biomass”, “viable population”, and populations of floc-forming microbes. Accordingly to the extent the preamble is intended to limit the claimed method it does not reasonably identify the subject whose age is controlled and by what means or step this is accomplished.
Additionally, “the plurality of microbes containing from about 103 cfu/ml to 1013 cfu/ml” is indefinite because colony-forming units per milliliter is a concentration expressed relative to a volume of a medium. A “plurality of microbes” does not itself contain a CFU/mL concentration, and the claim does not identify the liquid, suspension, or other sample to which the stated concentration applies.
Regarding the limitation requiring that the plurality of microbes have a D50 age of less than 14 days, but subsequently requires that the dosing rate maintain “the D50 age of the microbes in the wastewater in the wastewater treatment system at less than 20 days old”. The specification defines D50 as the value representing the age of the microbes that make up 50% of the cumulative population. This definition requires identification of the particular population whose cumulative age distribution is being evaluated. Claim 1 does not clearly identify the population used to determine the later system D50. It is unclear whether “the microbes in the wastewater in the wastewater treatment system” includes: only the intentionally added microbes; the added microbes and their descendants; microbes naturally present in the influent; microbes already resident in the treatment system; viable and nonviable microbes; only floc-forming microbes; or all microbial organisms present in the wastewater. It is also unclear if the D50 is calculated collectively for the entire wastewater-treatment system or separately for the first, second, or third treatment device.
Also, the limitation “pollutants as measured by DOD and TSS”, is indefinite because “DOD” is not defined in the claim or specification. The disclosure repeatedly uses “BOD” as a wastewater measurement and reports influent and effluent BOD together with TSS. Although the disclosure suggests that “DOD” may have been intended to read “BOD”, the Office cannot presume or rewrite the intended limitation. As written, it is unclear what property or pollutant measurement “DOD” represents, and therefore it is unclear what must be reduced to satisfy the claim.
Lastly, the phrase “whereby the pollutants in the wastewater are reduced providing an effluent having pollutants as measured by DOD and TSS reduced by at least about 90%.” does not clearly define the required treatment result. First, it is unclear whether DOD and TSS must each individually be reduced by at least about 90%, only one of DOD or TSS must be reduced by that amount, an average or combined value based on DOD and TSS must be reduced by that amount, or the pollutants generally must be reduced by 90%, with DOD and TSS serving only as examples of measurements. Second, the claim does not identify the reference value against which the 90% reduction is determined. It is unclear whether the comparison is made relative to the raw influent entering the wastewater-treatment system, the wastewater immediately before microbial dosing, the wastewater entering one of the individual treatment devices, a predetermined baseline or some other measurement. Third, the claim does not state whether the reduction is based on pollutant concentration, pollutant mass loading, or another metric. This distinction is material because the specification reports both concentration values, such as mg/L, and load values, such as pounds per day, for BOD and TSS.
Regarding claim 2, this claim is further indefinite because it depends from claim 1 and also for recitation of “the wastewater treatment plant has a throughput of about 5 MGD to about 40 MGD”. Claim 1 does not previously introduce “a wastewater treatment plant” and therefore “the wastewater treatment plant” lacks antecedent basis. Although the specification discusses both wastewater treatment systems and wastewater treatment plants the claim language does not establish whether the “plant” is identical to the wastewater treatment system of claim 1, a larger facility containing that system, only the 3 recited devices or a separate structure entirely.
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 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,155,484. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,155,484 recites substantially the same method, including first, second and third treatment devices through which wastewater flows sequentially; adding pollutant-removing microbes at a controlled and predetermined dosing rate; the recited microbial concentration; microbes never having been frozen or freeze dried and having a D50 age of less than 14 days; maintaining the D50 age below 20 days by the dosing rate; and reducing BOD and TSS by at least about 90%.
The differences in wording of present claim 1 do not provide a patentable distinction over the patented claim. In particular, the meaning of “DOD” in present claim 1 is separately addressed under 35 U.S.C. 112(b); to the extent “DOD” was intended to recite “BOD”, the limitation is expressly recited in patented claim 1.
Regarding claim 2, claim 2 of U.S. Patent No. 11,155,484 further recites that the wastewater treatment system has a throughput of about 5 MGD to about 40 MGD, which is the same throughput range recited in present claim 2. Accordingly, claims 1 and 2 are not patentably distinct from claims 1 and 2 of U.S. Patent No. 11,155484.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM ADDISON GEISBERT whose telephone number is (703)756-5497. The examiner can normally be reached Mon-Fri 7:30-5:00 EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby RAMDHANIE can be reached at (571)270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.A.G./ Examiner, Art Unit 1779
/Bobby Ramdhanie/ Supervisory Patent Examiner, Art Unit 1779
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