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 .
DETAILED ACTION
Claims 1-2 and 4-13 are pending and under examination on their merits. Claim 3 is cancelled.
The scope of enablement rejection under 35 U.S.C. 112(a) is withdrawn in view of the amendment.
The provisional nonstatutory double patenting rejections over claims 1, 4, and 6-10 of copending Application No. 18/577,882 are withdrawn in view of the approved terminal disclaimer filed on 11/21/2025.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant argues against the rejection of claims under 35 U.S.C. 101 on the grounds that the present application is not an abstract concept but rather a concrete and tangible method requiring: 1) cultivating a customized biofilm, 2) utilizing the biological function of the biofilm for detection, and 3) measuring physical parameters and correlating them (Arguments, bottom paragraph on page 9 through paragraphs 1-2 on page 10). Applicant argues that calculating the ΔDO and fitting formulas are necessary mathematical steps to associate physical measurement values with the concentration of the target chemical substance and that these mathematical steps are integrated into a specific practical application for detecting ammonia nitrogen (Arguments, bottom paragraph on page 10).
In response, these arguments are unpersuasive because the mathematical steps are not integrated into the practical application. First, “detecting ammonia nitrogen” itself is not a practical application but merely a measurement. For example, the claims do not recite any specific action taken in response to the ammonia nitrogen (e.g. changing specific operating parameters of a sewage treatment plant from which the environmental water sample originated in response to specific values of ammonia nitrogen detected). Furthermore, each of the additional elements of the claims has been considered and found to be well-understood, routine, and conventional. Therefore, the claim as a whole does not amount to significantly more than the judicial exception of an abstract idea. See the rejection under 35 U.S.C. 101 below.
Applicant argues against the rejection of claims under 35 U.S.C. 103 on the grounds that the present application differs from Tanaka because: (i) Tanaka has a fundamentally different purpose, (ii) Tanaka’s biofilm is in a different state, (iii) Tanaka is based on different technical principles, and (iv) Tanaka uses different methods of controlling biofilm activity (Arguments, paragraph 3 on page 11 through top paragraph on page 12).
In response, regarding (i), Tanaka detects ammonia nitrogen ([0054], [0062], and Fig. 3), which is recited in the instant claim 1 preamble, so Tanaka does not have a fundamentally different purpose. Regarding (ii), Tanaka is not relied on to teach a biofilm, rather Liu is relied on to teach forming a biofilm. Regarding (iii), Tanaka’s method is a respirometric method (i.e. measures the consumption of oxygen by living microorganisms) just like the presently claimed method, so Tanaka is not based on different technical principles. Regarding (iv), the presently claimed invention, like Tanaka, also controls temperature (see step S1 of claim 1, in which the temperature is controlled and [004] and [0033] of Tanaka), so Tanaka does not use different methods of controlling biofilm activity. Therefore, none of points (i)-(iv) are persuasive.
Applicant argues further against the rejection of claims under 35 U.S.C. 103 on the grounds that (i) Liu has different targets and principles, (ii) Liu uses different types of microorganisms, (iii) Liu’s nutrient solutions have different roles, and (iv) Liu employs heterotrophic bacteria that are sensitive to organic matter and are not suitable for detecting inorganic substances like ammonia nitrogen (Arguments, paragraph 3 on page 12 through paragraph 2 on page 13).
In response, regarding (i), Liu’s method is also a respirometric method (i.e. measures the consumption of oxygen by living microorganisms), so the principle of the method is the same. Although Liu has a different target (BOD rather than ammonia nitrogen), Liu is not relied on to teach the target. Rather, Tanaka is relied on to teach the linear dependence of ammonia on the oxygen demand (as measured by current: see Fig. 3, [0046], and [0054] of Tanaka). Regarding (ii), Liu’s method is generic to any microorganism that consumes oxygen (see Liu claim 1) and furthermore, Liu is not relied on to teach the nitrifying bacteria. Regarding (iii), Liu is not relied on to teach the nutrient solutions. Rather, Chen is relied on to teach the nutrient solutions. Regarding (iv), Liu is not relied on to teach the nitrifying bacteria. Tanaka is relied on to teach these bacteria ([032]).
Applicant argues further against the rejection of claims under 35 U.S.C. 103 on the grounds that (i) Chen has a different purpose because Chen is focused on fundamental research/enrichment culture rather than analytical detection (Arguments bottom paragraph on page 13), (ii) Chen operates on a larger scale (Arguments, paragraph 1 on page 14), and (iii) Chen’s teachings are not applied to a practical application (Arguments, paragraph 2 on page 14).
Regarding (i)-(iii), Chen is analogous art because Chen grows nitrifying bacteria, so the reference is reasonably pertinent to the problem faced by the inventor, which is how to grow nitrifying bacteria to detect ammonia nitrogen (see MPEP 2141.01(a)(I): A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).
Applicant argues further against the rejection of claims under 35 U.S.C. 103 on the grounds that (i) Emerson is in a different technical field (Arguments, paragraph 4 on page 14), (ii) Emerson uses a different technical approach (Arguments, paragraph 5 on page 14), and (iii) Emerson is not focused on real-time, online water quality monitoring (Arguments, bottom paragraph on page 14).
Regarding these points, Emerson is purely relied on as evidence that ammonia and ammonium are present in equilibrium in water (Emerson page 2379, left column, bottom paragraph including formula). Therefore, Applicant’s arguments are not pertinent to the rejection under 35 U.S.C. 103.
Applicant argues further against the rejection of claims under 35 U.S.C. 103 on the grounds that those skilled in the art would have no motivation to introduce Liu’s technology, which is aimed at a different pollutant, to improve the toxicity sensor in Tanaka because this modification would compromise the functionality and stability of toxicity detection (Arguments, paragraph 2 on page 15). Applicant argues that the person of ordinary skill in the art would not have had a reasonable expectation of success in applying the cultivation conditions from Chen to Tanaka’s sensor for detecting trace ammonia because the ammonia nitrogen concentration in Chen’s system is very high (Arguments, paragraph spanning pages 15-16).
In response, these arguments are not persuasive because Applicant has not provided any objective evidence that the modification of Tanaka by Chen would compromise the functionality and stability of toxicity detection. With respect to the ammonia concentration, Chen’s modification is to teach the enrichment conditions for step S1 of the claimed method (culture and acclimation of nitrification biofilm). Chen is not relied on to teach any feature of step S2, in which ammonia detection occurs. Therefore, Chen’s higher ammonia nitrogen concentration would not interfere with ammonia detection.
Lastly, Applicant argues that there are significant synergistic effects among the various technical features of the present invention (Arguments, paragraphs 4-6 on page 16).
In response, “synergistic effects” are not a secondary consideration against obviousness. Rather, unexpected results are a secondary consideration against obviousness. See MPEP 716.02(a): Evidence must show unexpected results. Furthermore, the burden is on applicant to establish results are unexpected and significant (MPEP 716.02(b)(I)). Here, Applicant has not explained whether these synergistic results are unexpected or significant.
Applicant argues against the nonstatutory double patenting rejection over claims 1 and 6 of U.S. Patent No. 9,423,373 on the grounds that the assignee is different than the present application (Arguments, paragraph 1 on page 19).
In response, this argument is unpersuasive because U.S. Patent No. 9,423,373 shares an inventor with the present application (Changyu Liu). See MPEP 804: “Some commonality of inventorship or (deemed) ownership must exist between two or more patents or applications before consideration can be given to the issue of double patenting.” Here, although the ownership is different, there is commonality of inventorship.
Specification
The amendment filed 11/21/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: although replacement of microorganism membrane with biofilm is permissible for most cases, in the context of “microorganism membrane reactor” the amendment introduces new matter. For example, in the amended specification at least [0062]-[0067] replace “microorganism membrane reactor” with biofilm reactor. The person of ordinary skill in the art would understand a biofilm reactor as encompassing any type of reactor where a biofilm grows on a solid surface (e.g. moving bed biofilm reactor, rotating biological contactor, membrane biofilm reactor). The specification as filed discloses specifically a “microorganism membrane reactor,” shown as 6 in Fig. 1 of the as-filed specification, This reactor is described in ([0054]). It would be permissible to replace “microorganism membrane reactor” with just “reactor” or in some cases to replace “microorganism membrane reactor” with “biofilm” (e.g. [0050] and [0060]).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 1-2 and 4-13 are objected to because of the following informalities:
In claim 1, “A method for detecting ammonia nitrogen content in an ammonia-containing water sample to be detected.” The phrase “to be detected” is redundant and should be removed.
Similarly, claims 2 and 4-13 all recite both “for detecting” and “to be detected.” The phrase “to be detected” is redundant and should be removed.
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.
Claims 1-2 and 4-13 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.
Claim 1 recites “the environmental water sample comprises an actual water sample containing environmental microorganisms.” It is unclear how “actual” is further modifying environmental water sample. Furthermore, there is a discrepancy between the method preamble, which recites “an ammonia-containing water sample” and the first method step (S1), which recites “the environmental water sample,” which creates confusion as to whether the environmental water sample is the ammonia-containing water sample.
Claim 1 step S2(b) recites the limitation "the two water samples" in line 5 of step S2(b). There is insufficient antecedent basis for this limitation in the claim. The prior step recites an ammonia-free water sample and an ammonia containing standard water sample and step S2(b) recites both an ammonia-free water sample and an ammonia-containing water sample to be detected, so it is unclear which are the two water samples.
In addition, claim 1 step S2(b) refers to step S21 rather than a step S2(a) so the claim is further indefinite because there is no step S21.
Claims 2 and 4-13 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Modified Rejection Necessitated by Amendment) Claims 1-2 and 4-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea without significantly more.
The rationale for this determination is explained below.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 1 recites a method for detecting ammonia nitrogen content by a nitrification biological reaction comprising the steps S1, S2, S2(a), and S2(b). Claim 1 is drawn to a process, which is one of the four statutory categories of invention (Step 1: Yes). Claim 1 recites the judicial exception of an abstract idea (Step 2A Prong One: Yes) because steps S2(a) and S2(b) both recite “calculating a difference value of a dissolved oxygen concentration” and step S2(a) also recites “obtaining a fitting formula according to the ΔDO and an ammonia nitrogen concentration of the ammonia-containing standard water sample.” Calculating a difference value and obtaining a fitting formula are both processes that can be performed in the human mind. Step S2(b) also recites substituting this difference value into the fitting formula to calculate an ammonia nitrogen concentration, which is another process that can be performed in the human mind.
The judicial exception is not integrated into a practical application (Step 2A Prong Two: No) because the claim is drawn purely to the detection of ammonia nitrogen content in an environmental water sample with no action taken based on the detected ammonia nitrogen content.
The additional elements recited in the claim are well-understood, routine, and conventional (Step 2B: No). Claim 1 step S1, which recites “Culture and acclimation of nitrification biofilm comprising continuously conveying an environmental water sample with a temperature of 10-45°C and a nitrification nutrient solution to a surface of a substrate until a nitrification biofilm is formed on the surface of the substrate,” is well-understood, routine, and conventional. See Chen et al. (Process Biochemistry 43 (2008) 33-41; Abstract and page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph). Furthermore, the growth of biofilms of nitrifying microorganisms is also well-understood, routine, and conventional (see Abstract of Raud et al., Biotechnology and bioprocess engineering 18.5 (2013): 1016-1021), as well as page 61, paragraph 1 of Bollmann et al. (Methods in enzymology. Vol. 486. Academic Press, 2011. 55-88, page 58, 2.1. Batch and continuous culture cultivation, paragraphs 3-4).
Regarding dependent claims 2 and 4-13, the same analysis applies as above (Step 1: Yes, Step 2A Prong One: Yes, Step 2A Prong Two: No). With respect to step 2B, enrichment of a microorganism (“continuously conveying an environmental water sample with a temperature of 10-45ºC and a nitrification nutrient solution to a surface of a substrate until a nitrification biofilm is formed on the surface of the substrate“) by optimizing culture conditions such as substrate (dependent claims 4-5), aeration (dependent claim 6), temperature (dependent claim 7), and flow rate (dependent claims 9-13) are all well-understood, routine and conventional. See Abstract and paragraph 1, page 113959 of Yao et al. (Rsc Advances 6.115 (2016): 113959-113966) for the discussion of optimizing temperature and ammonia feeding conditions. See Bollmann et al. (FEMS microbiology ecology 37.3 (2001): 211-221) for the optimization of ammonium concentration and oxygen partial pressure (page 212, right column, 2.4. Continuous culture experiments as well as Table 1). See the discussion of dilution rate (flow rate) in Bollmann et al. (Methods in enzymology. Vol. 486. Academic Press, 2011. 55-88, page 58, 2.1. Batch and continuous culture cultivation, paragraphs 3-4). Furthermore, the growth of biofilms of nitrifying microorganisms is also well-understood, routine, and conventional (see Abstract of Raud et al., Biotechnology and bioprocess engineering 18.5 (2013): 1016-1021), as well as page 61, paragraph 1 of Bollmann et al. (Methods in enzymology. Vol. 486. Academic Press, 2011. 55-88, page 58, 2.1. Batch and continuous culture cultivation, paragraphs 3-4).
Regarding dependent claims 8-9, ammonium chloride is a known standard for calibration in ammonia-sensing instruments. For example, Chen teaches that ammonium chloride is a standard in the Nessler method (page 34, right column, 2.2. Analytical methods, paragraph 1). Therefore, claims 8-9 do not recite additional elements that amount to significantly more than the judicial exception of an abstract idea.
Therefore, none of the claims are eligible under 35 U.S.C. 101.
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 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.
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.
The following rejections are necessitated by the amendment.
Claims 1-2 and 4-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (JP 2005091091 A) in view of Liu (US 9,423,373 B2) and Chen et al. (Process Biochemistry 43 (2008) 33-41) as evidenced by Emerson et al. (1975. Aqueous ammonia equilibrium calculations: Effect of pH and temperature. Journal of the Fisheries Research Board of Canada 32, 2379-2383).
“Ammonia nitrogen content” is given its broadest reasonable interpretation as ammonia present in the form of NH3 or NH4+. There is no special definition provided for “ammonia nitrogen content” within the specification, but dependent claim 8 recites “wherein the ammonia-containing standard water sample in step S2 is an ammonium chloride solution,” so the person of ordinary skill in the art would have understood that ammonia and ammonium are used interchangeably since they are present in equilibrium in aqueous solutions.
“Acclimation” is interpreted according to its plain meaning as becoming accustomed to a new conditions.
Tanaka teaches a sensor comprising a membrane immobilized with an ammonia oxidizing bacteria ([[032]). Ammonia-oxidizing bacteria are a type of nitrifying bacteria ([0026]). Tanaka immobilizes nitrite-forming (nitrifying) bacteria in a microbial membrane and continuously passes a mixture of a buffer solution containing ammonium nitrogen and sample water through the sensor ([0006]). Tanaka measures the dissolved oxygen concentration via an electrode attached to one side of the membrane ([0025] and Fig. 1).
Tanaka’s sample water is polluted river water ([0058]) or sewage mixed with river water ([0007]).
Tanaka teaches the optimum growth temperature of 28 to 30 °C for ammonia-oxidizing bacteria ([0033]), which is within the claimed range of 10-45 °C.
Tanaka calibrates the sensor with calibration solutions having at least two or more different substrate concentrations (usually, at least one or more ammonia nitrogen concentrations of 0 to 10 mg/L and at least one or more ammonia nitrogen concentrations of 10 mg/L or more) ([0032]). To summarize, Tanaka teaches an ammonia-free water sample and an ammonia-containing standard water sample: the calibration solutions having at least two or more different substrate concentrations of 0 to 10 mg/L and 10 mg/L or more.
Tanaka teaches obtaining a fitting formula: Tanaka obtains the slope of a straight line by plotting the differences in sensor outputs with respect to the respective substrate concentrations ([0029] and [0032]).
Although Tanaka teaches calibrating the sensor with an ammonia-free water sample ([0032]), Tanaka does not explicitly teach subtracting the sensor output for the ammonia-free water sample from the sensor output for the sample water or from the sensor output for the calibration solution (i.e. ΔDO in steps S2(a) and S2(b)).
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to subtract the sensor output (dissolved oxygen concentration) for the ammonia-free water sample from both the dissolved oxygen concentration for the water sample as well as the calibration solution. The person of ordinary skill in the art would have been motivated to reduce the measurement noise from the sensor and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Tanaka does not teach calculating an ammonia nitrogen concentration of the ammonia-containing water sample by substituting a difference value into the fitting formula . Rather, Tanaka calculates the inhibition percentage ([0055]). Tanaka teaches that ammonia is a harmful substance contained in river water in which sewage water is mixed ([0007]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tanaka to calculate ammonia nitrogen concentration of the ammonia-containing water sample rather than inhibition percentage. The person of ordinary skill in the art would have been motivated to assess the quality of the water sample by determining the amount of ammonia in the sample. The person of ordinary skill in the art would have recognized based on Tanaka’s teaching that the sensor output difference is linearly dependent on the amount of ammonia in the water sample within a certain range of ammonia concentrations (see Fig. 3 and [0054]). Therefore, the person of ordinary skill in the art would have understood that by substituting the dissolved oxygen difference of the sample into Tanaka’s linear relationship, the concentration of the substrate (ammonia) is determined. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications to the method of Tanaka.
Tanaka teaches that the sample water is in contact with the membrane ([0025] and Fig. 1, 20a is the flow path, 25 is the membrane, and the dissolved oxygen electrode is 21) but Tanaka does not teach that the sample water continuously flows through the membrane. However, Tanaka’s dissolved oxygen measurements are of effluent water because the sensor is on the other side of the membrane (Fig. 1).
Tanaka does not teach continuously conveying an environmental water sample and a nitrification nutrient solution to the surface of the substrate until a nitrification biofilm is formed on the surface of the substrate. Rather, Tanaka teaches suspending nitrifying bacteria in an aqueous solution of sodium alginate and dropping the suspension on a porous cellulose membrane, sandwiching the membrane with another cellulose membrane, and gelling the sodium alginate with an aqueous solution of calcium chloride to immobilize the cells ([0027]).
Tanaka’s nitrification nutrient solution contains inorganic nitrogen in the form of ammonia ([0033]) but Tanaka does not specify that the solution also contains carbon. However, Tanaka teaches that the buffer solution contains trace nutrient components necessary for growth ([0004]).
Liu teaches a process for determining biological oxygen demand of a water sample (Abstract). Liu teaches physically adsorbing microorganisms on the surface of a cellulose membrane or dialysis membrane to produce a biological membrane (biofilm) (column 1, lines 44-46). Liu teaches that the flow rate of the microorganism-containing water sample flowing through the microbial carrier is 0.5 mL/min-10.0 mL/min (column 10, lines 27-30). Liu cultures the bacteria to create a biofilm (i.e. acclimates the bacteria) prior to measuring biological oxygen demand (steps a)-e) of column 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tanaka by applying Liu’s technique of physically adsorbing the nitrifying microorganisms on the membrane rather than chemically immobilizing the bacteria, which is a multi-step process (see [0027] of Tanaka). It would have been further obvious to adopt Liu’s configuration of continuously flowing (implied by the disclosed flow rate) the sample through the membrane rather than past the membrane in order to maximize contact between the membrane and the sample for colonization by bacteria. The person of ordinary skill in the art would have had a reasonable expectation of success in growing a biofilm of nitrifying microorganisms on the membrane given that Liu’s technique is not limited to any particular species of bacteria. Furthermore, Liu’s technique is reasonably pertinent to the problem of Tanaka because both Liu and Tanaka teach respirometric methods that require measuring the consumption of oxygen by living microorganisms.
Tanaka and Liu do not teach the cultivation conditions for growing nitrifying microorganisms on a membrane.
Chen teaches enriching for nitrifying bacteria using a membrane-coupled bioreactor (Abstract). Chen feeds the reactor a medium containing sodium bicarbonate (“inorganic carbon source”) and ammonia (“inorganic nitrogen source”) (page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph). The nitrifying bacteria are enriched in batch culture from activated sludge in an aeration tank at a wastewater treatment plant and then transferred to the membrane bioreactor (page 34, paragraph bridging left and right columns).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Chen’s enrichment conditions to the method of Tanaka modified by Liu in order to tailor the cultivation conditions to specifically cultivate nitrifying bacteria on the membrane. Although Chen’s membrane bioreactor differs from the reactors of both Tanaka and Liu in that the reactor has a recycle loop (page 34, left column, 2.1 Membrane-coupled bioreactors), the person of ordinary skill in the art would have turned to Chen for the nutrient requirements for the enrichment of nitrifying bacteria. The person of ordinary skill in the art would have been motivated to introduce additional nutrients in the form of a medium comprising the sodium carbonate and ammonia taught by Chen in order to favor the growth of nitrifying bacteria on the membrane. The person of ordinary skill in the art would have had a reasonable expectation of success given that Tanaka’s sample is sewage (Tanaka [0001]), which the person of ordinary skill in the art would have expected to contain nitrifying bacteria, just like Chen’s activated sludge in an aeration tank at a wastewater treatment plant.
Regarding claim 2, Tanaka does not teach forming a biofilm on the membrane (“surface of a substrate”) by simultaneously and continuously conveying both the water sample and growth medium through the membrane.
Chen teaches continuously flowing water containing microorganisms and nutrients through a membrane (Chen page 34, left column, 2.1 Membrane-coupled bioreactors, paragraphs 1-2) and Liu teaches physically adsorbing microorganisms on the surface of a cellulose membrane or dialysis membrane to produce a biological membrane (biofilm) (column 1, lines 44-46).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to grow Tanaka’s nitrifying microorganisms into a biofilm on a membrane by continuously flowing the water sample and nutrients through the membrane based on the combined teachings of Chen and Liu. The person of ordinary skill in the art would have had a reasonable expectation of success in the growth of a biofilm of nitrifying microorganisms on the membrane.
Regarding claim 4, Chen’s medium contains both carbonate and ammonium ions (page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph). Although Chen explicitly teaches ammonia in the medium, ammonium is necessarily present because ammonia and ammonium are present in equilibrium in water as evidenced by Emerson (page 2379, left column, bottom paragraph including formula).
Regarding claim 5, Chen also teaches a nitrifying bacteria growth medium comprising carbonate and nitrogen in the form of nitrite (page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph).
Regarding claim 6, all of Tanaka’s test water is aerated (Fig. 1, air pump 12, [0041]).
Regarding claim 7, Tanaka teaches the optimum growth temperature of 28 to 30°C for ammonia-oxidizing bacteria ([0033]), which overlaps with the claimed range of 25-37ºC.
Regarding claim 8, Tanaka does not teach that the ammonia-containing standard water sample in step S2 is ammonium chloride solution.
However, Chen teaches that ammonium chloride is a standard in the Nessler method for the detection of ammonia (page 34, right column, 2.2. Analytical methods, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use ammonium chloride as the standard in the method of Tanaka given that it was the standard used in conventional ammonia-detection methods such as the Nessler method. The person of ordinary skill in the art would have had a reasonable expectation of success in using ammonium chloride as the standard in the method of Tanaka modified by Liu and Chen.
Regarding claim 9, Tanaka teaches calibration solutions having at least two or more different substrate concentrations (usually, at least one or more ammonia nitrogen concentrations of 0 to 10 mg/L and at least one or more ammonia nitrogen concentrations of 10 mg/L or more) ([0032]).
Tanaka does not teach that the ammonia nitrogen concentration of the ammonia chloride solution is 0-40 mg/L.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use at least 10 mg/L of ammonium chloride as the standard, given that Tanaka teaches this amount of ammonia nitrogen as the standard and Chen teaches ammonium chloride as the standard. The range of at least 10 mg/L overlaps with the claimed range of 0-40 mg/L. The person of ordinary skill in the art would have had a reasonable expectation of success in using at least 10 mg/L of ammonium chloride as the standard, which is necessarily in equilibrium with ammonia.
Regarding claim 10, Tanaka does not teach that the flow rates of the environmental water sample and the nitrification nutrient solution are independently 0.1-10 mL/min. However, Liu teaches that the flow rate of the microorganism-containing water sample flowing through the microbial carrier is 0.5 mL/min-10.0 mL/min (column 10, lines 27-30), which overlaps with the claimed range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the nitrification nutrient solution in the method of Tanaka modified by Liu and Chen. The person of ordinary skill in the art would have had a reasonable expectation of success in using a similar flow rate to that of Liu’s microorganism-containing water sample.
Regarding claim 11, Tanaka does not teach that the flow rate of each of the water samples in step S2 is 0.1-10 mL/min.
Liu teaches a flow rate of a blank sample through the biofilm of 1.0 mL/min-3.0 mL/min (column 10, lines 57-60).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the water samples in the method of Tanaka modified by Liu and Chen using Liu’s flow rate as a starting point. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the flow rates.
Regarding claim 12, Tanaka does not teach that the flow rates of the environmental water sample and the nitrification nutrient solution in step S1 are independently 2-3 mL/min. However, Liu teaches that the flow rate of the microorganism-containing water sample flowing through the microbial carrier is 0.5 mL/min-10.0 mL/min (column 10, lines 27-30), which overlaps with the claimed range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the nitrification nutrient solution in the method of Tanaka modified by Liu and Chen. The person of ordinary skill in the art would have had a reasonable expectation of success in using a similar flow rate to that of Liu’s microorganism-containing water sample.
Regarding claim 13, Tanaka does not teach that the flow rate of each water sample flowing through the nitrification biofilm in step S2 is independently 2-3 mL/min.
Liu teaches a flow rate of a blank sample of through the biofilm of 1.0 mL/min-3.0 mL/min (column 10, lines 57-60).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention routinely optimize the flow rate of the water samples in the method of Tanaka modified by Liu and Chen using Liu’s flow rate as a starting point. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the flow rates.
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.
The following rejections are necessitated by the amendment.
Claims 1-2 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 9,423,373 (‘373) in view of Tanaka (JP 2005091091 A) and Chen (Process Biochemistry 43 (2008) 33-41) as evidenced by Emerson (1975. Aqueous ammonia equilibrium calculations: Effect of pH and temperature. Journal of the Fisheries Research Board of Canada 32, 2379-2383).
Claim 1 of ‘373 recites a method for detecting biochemical oxygen demand comprising: a) subjecting an air-saturated microorganism-containing water sample to microorganism cultivation to obtain a biofilm; b) allowing an air-saturated blank water sample to pass through the biofilm obtained in said step a), and determining a dissolved oxygen (DO) reduction current of said blank water sample; c) allowing an air-saturated target water sample to pass through the biofilm having been subjected to said step b), and determining a DO reduction current of said target water sample; d) calculating the difference between the DO reduction current of said blank water sample and the DO reduction current of said target water sample according to the DO reduction current of the blank water sample obtained in said step b) and the DO reduction current of the target water sample obtained in said step c); and e) determining BOD of the target water sample according to the difference obtained in said step d) and a predetermined standard curve; wherein said microorganism-containing water sample is activated sludge, surface water, domestic sewage or microorganism-containing industrial wastewater; and said blank water sample is one or more selected from tap water, well water, rain water and groundwater.
Claim 6 of ‘373 depends from claim 1. Claim 6 of ‘373 further recites determining the differences between the DO reduction current of the blank water sample and the DO reduction currents of the standard solutions and determining a standard curve according to the differences and the BOD concentration of the standard solutions.
Claims 1 and 6 of ‘373 are drawn to the detection of biochemical oxygen demand (BOD) rather than ammonia nitrogen. Claims 1 and 6 of ‘373 do not recite that the biofilm comprises nitrification microorganisms.
Tanaka teaches a sensor comprising a membrane immobilized with an ammonia oxidizing bacteria ([[032]). Ammonia-oxidizing bacteria are a type of nitrifying bacteria ([0026]). Tanaka immobilizes nitrite-forming (nitrifying bacteria) in a microbial membrane and continuously passes a mixture of a buffer solution containing ammonium nitrogen and sample water through the sensor ([0006]). Tanaka measures the dissolved oxygen concentration as current via an electrode attached to one side of the membrane ([0025] and Fig. 1).
Tanaka teaches the optimum growth temperature of 28 to 30 °C for ammonia-oxidizing bacteria ([0033]), which is within the claimed range of 10-45 °C.
Tanaka calibrates the sensor with calibration solutions having at least two or more different substrate concentrations (usually, at least one or more ammonia nitrogen concentrations of 0 to 10 mg/L and at least one or more ammonia nitrogen concentrations of 10 mg/L or more) ([0032]). To summarize, Tanaka teaches an ammonia-free water sample and an ammonia-containing standard water sample: the calibration solutions having at least two or more different substrate concentrations of 0 to 10 mg/L and 10 mg/L or more.
Tanaka teaches obtaining a fitting formula: Tanaka obtains the slope of a straight line by plotting the differences in sensor outputs with respect to the respective substrate concentrations ([0029] and [0032]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claims 1 and 6 of ‘373 by growing nitrification microorganisms in the biofilm in order to detect ammonia nitrogen concentration of the ammonia-containing water sample rather than biochemical oxygen demand. The person of ordinary skill in the art would have been motivated to assess the quality of the water sample by determining the amount of ammonia in the sample. The person of ordinary skill in the art would have recognized based on Tanaka’s teaching that the dissolved oxygen concentration is linearly dependent on the amount of ammonia in the water sample within a certain range of ammonia concentrations (see Fig. 3 and [0054]), thus a measurement of dissolved oxygen is easily converted into a measurement for ammonia.
Tanaka does not teach calculating an ammonia nitrogen concentration of the ammonia-containing water sample by substituting a difference value into the fitting formula.
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to calculate the ammonia concentration by substituting the dissolved oxygen difference of the sample into Tanaka’s linear relationship. The person of ordinary skill in the art would have recognized based on Tanaka’s teaching that the dissolved oxygen concentration is linearly dependent on the amount of ammonia in the water sample within a certain range of ammonia concentrations (see Fig. 3 and [0054]). Therefore, the person of ordinary skill in the art would have understood that by substituting the dissolved oxygen difference of the sample into Tanaka’s linear relationship, the concentration of the substrate (ammonia) is determined. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications to the method of claims 1 and 6 of ‘373.
Although Tanaka teaches calibrating the sensor with an ammonia-free water sample ([0032]), Tanaka does not explicitly teach subtracting the sensor output for the ammonia-free water sample from the sensor output for the sample water or from the sensor output for the calibration solution (i.e. ΔDO in steps S2(a) and S2(b)).
Regarding ΔDO in steps S2(a)1 and S2(b), claim 6 of ‘373 recites calculating the difference between the DO reduction current of a target water sample and blank water sample (see step d of claim 1) as well as the difference in the DO reduction current of the standard water samples and the blank water sample (claim 6 of ‘373).
Claim 6 of ‘373 does not recite subtracting the DO concentration for an ammonia-free water sample from that of an ammonia-containing water sample or from that of an ammonia-containing standard water sample.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to subtract the dissolved oxygen concentration (measured as current by an electrode) for the ammonia-free water sample from both the dissolved oxygen concentration for the water sample as well as the calibration solution. The person of ordinary skill in the art would have been motivated to reduce the measurement noise from the sensor and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Claims 1 and 6 of ‘373 do not recite the cultivation conditions for growing nitrifying microorganisms in a biofilm. Claims 1 and 6 of ‘373 also do not recite that the biofilm grows on the surface of a substrate.
Tanaka’s nitrification nutrient solution contains inorganic nitrogen in the form of ammonia ([0033]) but Tanaka does not specify that the solution also contains carbon. However, Tanaka teaches that the buffer solution contains trace nutrient components necessary for growth ([0004]).
Chen teaches enriching for nitrifying bacteria using a membrane-coupled bioreactor (Abstract). Chen feeds the reactor a medium containing sodium bicarbonate (inorganic carbon source) and ammonia (inorganic nitrogen source) (page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph). The nitrifying bacteria are enriched in batch culture from activated sludge in an aeration tank at a wastewater treatment plant and then transferred to the membrane bioreactor (page 34, paragraph bridging left and right columns). Chen teaches using a polysulfone membrane to separate bacteria during the recycle step (page 34, left column, 2.1 Membrane-coupled bioreactors, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Chen’s enrichment conditions to the method of claims 1 and 6 of ‘373 modified by Tanaka in order to tailor the cultivation conditions to specifically cultivate nitrifying bacteria. Although Chen’s membrane bioreactor differs from the reactors of both claims 1 and 6 of ‘373 and Tanaka in that the reactor has a recycle loop (page 34, left column, 2.1 Membrane-coupled bioreactors), the person of ordinary skill in the art would have turned to Chen for the nutrient requirements for the enrichment of nitrifying bacteria. The person of ordinary skill in the art would have been motivated to introduce additional nutrients in the form of a medium comprising the sodium carbonate and ammonia taught by Chen in order to favor the growth of nitrifying bacteria in a biofilm. The person of ordinary skill in the art would have had a reasonable expectation of success given that the sample of claims 1 and 6 of ‘373 includes activated sludge, which the person of ordinary skill in the art would have expected to contain nitrifying bacteria, just like Chen’s activated sludge in an aeration tank at a wastewater treatment plant.
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a substrate for the biofilm to grow on, such as Chen’s membrane. The person of ordinary skill in the art would have had a reasonable expectation of success in the growth of nitrifying microorganisms on a membrane.
Regarding claim 2, claims 1 and 6 of ‘373 do not recite simultaneously and continuously conveying the water sample and nitrification nutrients to the surface of a substrate in order to grow a biofilm of nitrifying microorganisms.
Chen teaches continuously flowing water containing microorganisms and nutrients through a membrane (Chen page 34, left column, 2.1 Membrane-coupled bioreactors, paragraphs 1-2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to grow Tanaka’s nitrifying microorganisms into a biofilm on a membrane by continuously flowing the water sample and nutrients through the membrane based on Chen’s teaching. The person of ordinary skill in the art would have had a reasonable expectation of success in the growth of a biofilm of nitrifying microorganisms on the membrane.
Regarding claim 4, Chen’s medium contains both carbonate and ammonium ions (page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph). Although Chen explicitly teaches ammonia in the medium, ammonium is necessarily present because ammonia and ammonium are present in equilibrium in water as evidenced by Emerson (page 2379, left column, bottom paragraph including formula).
Regarding claim 5, Chen also teaches a nitrifying bacteria growth medium comprising carbonate and nitrogen in the form of nitrite (page 34, left column, 2.1 Membrane-coupled bioreactors, top paragraph).
Regarding claim 6, claim 1 of ‘373 recites that the samples are aerated.
Regarding claim 7, claims 1 and 6 of ‘373 do not recite the cultivation growth temperature.
Tanaka teaches the optimum growth temperature of 28 to 30°C for ammonia-oxidizing bacteria ([0033]), which overlaps with the claimed range of 25-37ºC.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Tanaka’s optimum growth temperature for nitrifying bacteria to the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen. The person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Regarding claim 8, Tanaka does not teach that the ammonia-containing standard water sample in step S2 is ammonium chloride solution.
However, Chen teaches that ammonium chloride is a standard in the Nessler method for the detection of ammonia (page 34, right column, 2.2. Analytical methods, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use ammonium chloride as the standard in the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen given that it was the standard used in conventional ammonia-detection methods such as the Nessler method. The person of ordinary skill in the art would have had a reasonable expectation of success in using ammonium chloride as the standard in the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen.
Regarding claim 9, Tanaka teaches calibration solutions having at least two or more different substrate concentrations (usually, at least one or more ammonia nitrogen concentrations of 0 to 10 mg/L and at least one or more ammonia nitrogen concentrations of 10 mg/L or more) ([0032]).
Tanaka does not teach that the ammonia nitrogen concentration of the ammonia chloride solution is 0-40 mg/L.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use at least 10 mg/L of ammonium chloride as the standard, given that Tanaka teaches this amount of ammonia nitrogen as the standard and Chen teaches ammonium chloride as the form of the standard. The range of at least 10 mg/L overlaps with the claimed range of 0-40 mg/L. The person of ordinary skill in the art would have had a reasonable expectation of success in using at least 10 mg/L of ammonium chloride as the standard, which is necessarily in equilibrium with ammonia.
Claims 10-13 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 9,423,373 (‘373) in view of Tanaka (JP 2005091091 A) and Chen (Process Biochemistry 43 (2008) 33-41) as evidenced by Emerson (1975. Aqueous ammonia equilibrium calculations: Effect of pH and temperature. Journal of the Fisheries Research Board of Canada 32, 2379-2383), as applied to claims 1-2 and 4-9 above, further in view of Liu PGPub (US20140326617A1).
See discussion of claims 1 and 6 of ‘373, Tanaka, and Chen above, which is incorporated into this rejection as well.
Regarding claim 10, claims 1 and 6 of ‘373 do not recite and Tanaka does not teach that the flow rates of the environmental water sample and the nitrification nutrient solution are independently 0.1-10 mL/min.
Liu PGPub teaches a biochemical oxygen sensor comprising a biofilm and an electrode ([0093]-[0094]). Liu PGPub teaches that the flow rate of the microorganism-containing water sample flowing through the microbial carrier is 0.5 mL/min-10.0 mL/min ([0073]), which overlaps with the claimed range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the environmental water sample and the nitrification nutrient solution in the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen based on the suggested flow rates of Liu PGPub. The person of ordinary skill in the art would have had a reasonable expectation of success in using a similar flow rate to that of Liu PGPub’s microorganism-containing water sample.
Regarding claim 11, Tanaka does not teach that the flow rate of each of the water samples in step S2 is 0.1-10 mL/min.
Liu PGPub teaches a flow rate of a blank sample through the biofilm of 1.0 mL/min-3.0 mL/min ([0074]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the water samples in the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen using Liu’ PGPub’s flow rate as a starting point. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the flow rates.
Regarding claim 12, claims 1 and 6 of ‘373 do not recite and Tanaka does not teach that the flow rates of the environmental water sample and the nitrification nutrient solution in step S1 are independently 2-3 mL/min. However, Liu PGPub teaches that the flow rate of the microorganism-containing water sample flowing through the microbial carrier is 0.5 mL/min-10.0 mL/min ([0073]), which overlaps with the claimed range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the environmental water sample and the nitrification nutrient solution in the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen based upon Liu PGPub’s flow rate. The person of ordinary skill in the art would have had a reasonable expectation of success in using a similar flow rate to that of Liu PGPub’s microorganism-containing water sample.
Regarding claim 13, claims 1 and 6 of ‘373 do not recite and Tanaka does not teach that the flow rate of each water sample flowing through the nitrification biofilm in step S2 is independently 2-3 mL/min.
Liu PGPub teaches a flow rate of a blank sample of through the biofilm of 1.0 mL/min-3.0 mL/min ([0074].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to routinely optimize the flow rate of the water samples in the method of claims 1 and 6 of ‘373 modified by Tanaka and Chen using Liu PGPub’s flow rate as a starting point. The person of ordinary skill in the art would have had a reasonable expectation of success in the routine optimization of the flow rates.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657