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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-7) in the reply filed on 4/27/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 8-12 are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 1, it appears that “by” should be –in--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a culture tank for culturing cells, in claim 1, line 2;
an information processing system that processes various pieces of information on the culture of the cells in the culture tank, in claim 1, lines 3-4;
a controller that controls a culture step by the culture tank, in claim 1, line 5;
an in-line sensor that measures a state of a culture fluid in the culture tank, in claim 2, line 2; and
an analyzer that measures the culture fluid sampled from the culture tank offline, in claim 3, line 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A culture tank for culturing cells (as recited in claim 1, line 2) is interpreted to be encompassing a culture tank as disclosed by Applicant such as in paragraph 0033 in Applicant’s specification in the Pre-Grant Publication US 20240067915, and its equivalents.
An information processing system that processes various pieces of information on the culture of the cells in the culture tank (as recited in claim 1, lines 3-4) is interpreted to be encompassing an information processing system as disclosed by Applicant in paragraphs 0031-0032, 0034, 0039 and 0048 of Applicant’s specification, and its equivalents.
A controller that controls a culture step by the culture tank (as recited in claim 1, line 5) is interpreted to be encompassing a controller as disclosed by Applicant in paragraphs 0031, 0032, 0034, 0037-0039, 0042, 0043 and 0046 of Applicant’s specification, and its equivalents.
An in-line sensor that measures a state of a culture fluid in the culture tank (as recited in claim 2, line 2) is interpreted to be encompassing an in-line sensor as disclosed by Applicant in paragraphs 0032, 0042, 0043, 0046, 0056, 0057, 0058, 0060, 0061, 0065, 0066 of Applicant’s specification, and its equivalents.
An analyzer that measures the culture fluid sampled from the culture tank offline (as recited in claim 3, line 2) is interpreted to be encompassing an analyzer that measures culture fluid sampled from the culture tank offline as disclosed by Applicant in paragraphs 0041, 0057, 0061 and 0063, and its equivalents.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4 and 6 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20130115588 (hereinafter “Davis”).
Applicant’s claim 1 recites the following:
a cell culture system comprising:
a culture tank for culturing cells;
an information processing system that processes various pieces of information on the culture of the cells in the culture tank;
and a controller that controls a culture step by the culture tank, wherein the information processing system being operative to store an operation condition in each of a plurality of steps constituting the culture step of the cells and store a step transition condition for transition to a next step, and set an operation condition for the next step when the step transition condition is satisfied during performing one step.
The following disclosures by Davis are relevant to Applicant’s claim, as discussed further below.
Davis discloses systems for culturing and separating of cells or microbial organisms. The invention enables the preparation of target substances generated by cells or microorganisms. Para. 0011.
The system provides for an integrated system comprising a bioreactor vessel in fluid communication with at least one separation unit and under the control of a Human-Machine Interphase (HMI) for controlling processes during the culturing of cells or microorganisms in a culture medium and separating any target substance from such culture medium. The separation unit may include a filtration system, chromatography unit or a combination thereof. Para. 0012.
[Examiner notes that the bioreactor vessel is equivalent to Applicant’s culture tank in claim 1. The Human-Machine Interphase (HMI) for controlling processes is equivalent to Applicant’s information processing system that processes various pieces of information on the culture of the cells in the culture tank, recited in claim 1.]
The HMI includes integrated software to control the bioreactor and filtration and/or chromatography units to permit the user to observe and control all components from a single source spot. Further the software provides for the adding additional components with automatic recognition allowing for expansion of the system under a single controller. Para. 0013.
[Examiner notes that the single controller is equivalent to Applicant’s controller in claim 1.]
The invention provides for a bioreactor comprising a frame structure holding a disposable container for culturing microorganisms or cells. Para. 0014.
The invention provides for a culturing and separating system comprising: a disposable culturing container for housing biomaterials for processing, wherein the disposable culturing container comprises at least one input port, at least one exhaust port, at least one harvest port, a structure for supporting the disposable container, one or more sensors for sensing one or more parameters of the biomaterials in the container; a separating unit in fluid communication with the disposable culturing container, wherein the separating unit comprises at least one disposable filtration unit; and a monitoring means for operating and controlling conditions in the disposable culturing container and separation unit. Paras. 0019-0022.
[Examiner notes that the sensor or monitoring means are equivalent to Applicant’s sensor in claim 2.]
The system can further comprise sensors for monitor conditions within the system, wherein the sensors are connected to the bioreactor and/or the separating device and send signals to the HMI and can include, but not limited to, temperature, dissolved oxygen, pH, tank level, agitation speed, need for addition of substrate or nutrients, flow rate of gas or fluids including recirculation flow rate, inlet and outlet pressure, conductivity, turbidity, UV radiation, etc. Para. 0023.
[Examiner notes that the sensors here can alternatively be considered equivalent to Applicant’s in-line sensor in claim 2.]
The invention provides for a method of producing and separating a target substance comprising the steps of: introducing into a bioreactor a cell or micro-organism culture and culture medium fluid; maintaining the bioreactor and cells or microorganism under conditions to assure the expression of the target substance; moving a portion of the fluid, including cells or microorganisms and the target substance, through a separation device positioned in fluid communication with the bioreactor and separating therein at least some of the target substance from the fluid while allowing the remaining moving fluid and cells to pass through the separation device for return to the bioreactor; wherein the target substance separated from the fluid is removed to a collection vessel; and operating and controlling the system and processes therein with a single computer having the ability to control and adjust parameters within all the components of the system. Paras. 0024-0028.
[Examiner notes that the computer is part of the system that is equivalent to Applicant’s information processing system, recited in claim 1.]
Preferably, the bioreactor comprises a structural frame for holding a disposable container and the separation device is a disposable cross-flow filtration filter. In such a disposable system, other disposable units can include the following but not limited to pump head, flow meter, pressure transducer, process lines and connectors between the bioreactor and separation unit. Para. 0029.
"Cell-culturing," refers to culturing cells by a method which includes controlling the cell density of a cell culture, controlling the cell activity of a cell culture, or controlling both the cell density of a cell culture and the cell activity of the cell culture. "Cell activity," as that term is used herein, means production rate by cells of cell products such as, for example, viruses, proteins expressed by recombinant DNA molecules within the cells, natural proteins, nucleic acids, etc. Para. 0055.
The invention comprises a culturing system in which a desired product may be grown to high concentrations in an open or closed system using a bioreactor and separation module. Para. 0056.
After the appropriate number of target substance has been produced, the target substance is separated from the host cells, growth medium constituents and unwanted growth products for subsequent concentration and/or removal from the system. Para. 0057.
At least one variable speed pump is connected to the bioreactor or disposable bioreactor unit for moving fluids into and out of the vessel and for moving fluid to and from the separation unit…The control of the pumps is monitored by controlling systems within the computer module 16. Para. 0059.
The bioreactor vessel 12 or disposable bioreactor unit 21 may be equipped with stirring or agitation means to promote uniform distribution of medium components. Para. 0060.
In the alternative, the bioreactor vessel can be disposed on a magnetic stirrer device which provides agitation of the contents within the vessel. The magnetic stirrer may suitably be of a type having a variable speed, to provide a varying level of agitation in the vessel depending on the density and suspension characteristics of the nutrient medium contained therein. Para. 0061.
The bioreactor or disposable bioreactor unit may also be provided with a medium pH monitoring and adjustment means or other means for adjustment of medium components or conditions of incubation according to means and devices known in the art. Para. 0062.
[Examiner notes that the steps performed by the adjustment means or other means for adjustment of medium components or incubation are equivalent to the steps constituting culture steps, with operation condition, as recited by Applicant in claim 1. Examiner also notes that the Human-Machine Interphase (HMI) for controlling processes , or computer, controls these steps, as discussed earlier above, and in order to adjust the conditions, it is understood that it also stores operation condition, (thus meeting Applicant’s claim 1). See also paragraphs 0063, 0068, 0069, 0070, 0073, 0079, 0081, 0084, 0108 below, which also discloses steps and implies stored operation conditions, in order to perform such steps.]
The bioreactor or disposable bioreactor unit may be associated with a temperature control unit, may be placed in a controlled temperature environment or may be left at ambient temperature and varied depending on the desired cell growth conditions. Para. 0063.
To assist in monitoring the reaction activity and/or components within the bioreactor vessel, the vessel is communicatively connected to instrumentation that monitors temperature, oxygen contents, pH, tank level, any agitation speed, need for additional substrates or nutrients, gas flow rate, etc. Further flow meters, with control valves, may be in communication with the bioreactor vessel and computer module to monitor the input of gases, such as air, oxygen, carbon dioxide, nitrogen or any other gas necessary for culturing of cells or microorganisms. Feedback control of such components is linked to the computer module 16. Para. 0068.
The instrumentation is monitored by the computer and adjustments can be made to the system when needed. Components that can be monitored during the culturing and separation process include filter inlet and outlet pressure, flow from the bioreactor to the filter system, circulation of the retentate to and from the filter system, speed of the circulation pump, activation of valves, among other parameters to ensure optimal separation of a target substance. Para. 0069
A proportional-integral-derivative controller (PID controller) may be used as part of the control system. The PID controller has the ability to control recirculation rate, pressure, tank level, temperature, oxygen content, agitation speed, pH, amount of additives, gas flow rates and other necessary parameters. The PID controller calculations use an algorithm performed by the computer system and involve three separate parameters, and is accordingly sometimes called three-term control: the proportional value determines the reaction to the current error, the integral value determines the reaction based on the sum of recent errors, and the derivative value determines the reaction based on the rate at which the error has been changing. The weighted sum of these three actions is used to adjust the process via a control element such as the position of a control valve or the power supply of a heating element. By tuning the three constants in the PID controller algorithm, the controller can provide control action designed for specific process requirements. Para. 0070.
The source liquid is incubated with the chromatography resin for a sufficient contact time to lead to binding of a desirably high percentage of the target substance to the chromatography resin, and to form resulting resin-target complexes. A simple method of incubation may entail stirring or shaking the separation device containing the slurry. The preferred contact (incubation) time in the separation device depends on the particular chromatography resin employed and its concentration of binding sites for the target substance, as well as the relative concentration of beads and target substance. The reaction time of the chemistry will vary from ligand to ligand, but the higher the concentration of available binding sites compared to the target substance, the shorter the preferred incubation time. Temperature may be controlled during the incubation step by the thermal jacket (or other heat transfer means) to provide the liquid and resin mixture with a suitable temperature to preserve the target substance's activity. Suitable temperatures for such purpose may be readily determined within the skill of the art and without undue experimentation. Para. 0079.
There can be several clarification steps to remove from the source liquid particulate contaminants prior to sending the source liquid into the separation unit for concentration of the target substance to avoid contaminating the purified target substance. The clarification step can be accomplished by methods well-known in the purification art, for example, centrifugation, gravity separation, precipitation, flocculation-assisted sedimentation, decanting, normal filtration, sieving, absorption, adsorption and tangential flow filtration. Para. 0081.
Multiple add-on units can be included in the system. For example source fluid leaving the bioreactor vessel or fermentor can be initially purified through a clarification step and such clarified solution can be introduced into an ultrafiltration unit and multiple other units in a step-by-step fashion for production of the final product. Importantly as each additional unit is added to the overall system, the present integrated system can be customized for the specific process of interest and the HMI easily recognizes each new unit with immediate control of the movement of fluids from one unit to the next unit. Para. 0084.
All of the steps for culturing cells or microorganisms, between the initial inoculation of the bioreactor and the removal of the target substance from the separation device are preferably completed under conditions where all control and monitoring is completed by a single monitoring system and accessed through the computer port…. All sampling, monitoring, and medium adjustments may be performed automatically and aseptically. When the appropriate amount of time has elapsed to yield the desired target concentration, the system may be automatically changed from the cell growth to the product harvest phase by appropriate valve means adjustments, activated and implemented by the software within the single source computer. Para. 0108.
Regarding claim 1, as mentioned above, the bioreactor vessel is equivalent to Applicant’s culture tank in claim 1. The Human-Machine Interphase (HMI) for controlling processes is equivalent to Applicant’s information processing system that processes various pieces of information on the culture of the cells in the culture tank, as recited in claim 1. The single controller (para. 0013) is equivalent to Applicant’s controller in claim 1. The computer (paras. 0024-0028 is part of the system that is equivalent to Applicant’s information processing system, recited in claim 1.
The steps performed by the adjustment means or other means for adjustment of medium components or incubation (para. 0062) are equivalent to the steps constituting culture steps, with operation condition, as recited by Applicant in claim 1. Examiner also notes that the Human-Machine Interphase (HMI) for controlling processes , or computer, controls these steps, and in order to adjust and control the conditions as disclosed, it is understood that it also stores operation condition, store step transition condition for transition to a next step, and set an operation condition for the next step when the step transition condition is satisfied during performing one step, (and thus meets Applicant’s claim 1). See also paragraphs 0063, 0068, 0069, 0070, 0079, 0081, 0084, 0108 which also discloses steps and implies stored operation conditions and setting an operation condition, etc., in order to perform such steps.
As to claim 2, see paragraphs 0019-0023 wherein the sensor or monitoring means are equivalent to Applicant’s in-line sensor in claim 2.]
Claim 4 recites the system of claim 2, wherein the step transition is a condition regarding a relationship between a measurement value or an output value of the in-line sensor and a set value.
See paragraph 0023 disclosing sensors for monitor condition such as temperature, dissolved oxygen, pH, tank level, agitation speed, need for addition of substrate or nutrients, flow rate of gas or fluids including recirculation flow rate, inlet and outlet pressure, conductivity, turbidity, UV radiation, etc. Para. 0023. These monitoring imply storing conditions in relationship to each other, for example, in order to determine a “need for addition of substrate or nutrients”.
See also paragraphs 0024-0028 disclosing “operating and controlling the system and processes therein with a single computer having the ability to control and adjust parameters within all the components of the system.” Controlling and adjusting parameters here imply storing conditions in relationship to each other.
See also for example paragraph 0070 of Davis, wherein detecting changes or adjusting parameters implies storing a condition regarding a relationship [e.g., change] in a measurement.
Claim 6 recites the system of claim 1, wherein when a waiting time to satisfy the step transition condition has elapsed, the controller performs a control to halt a step regarding the step transition condition. Adjusting a parameter (see discussion of claim 4 above) implies halting a step as recited in claim 6, in order to adjust to a new parameter (i.e., new step). See for example paragraph 0079 and 0108.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130115588 (hereinafter “Davis”).
Claim 7 recites the system of claim 6, wherein after performing the control to halt the step, the controller selects cancel of the step or return to the step in accordance with a manual operation by an operator.
Davis is silent as to this step. However, it would have been obvious to one skilled in the art that the adjustments disclosed by Davis can include returning to a previous parameter (i.e., return to a previous step) as may be desirable for performing a process or for optimizing the process (e.g., cell culturing). Canceling a step would also have been obvious to one skilled in the art, in order to end the process, or to adjust the parameter (adjust a step). These steps result in predictable outcomes and require no more than ordinary skills in the art, in the use of the system in the manner disclosed by Davis.
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130115588 (hereinafter “Davis”) in view of US 20150185173 (hereinafter “Potyrailo”).
As to claim 3, Davis, discussed above, is silent as to an analyzer that measures the culture fluid sampled from the culture tank offline,
wherein the information processing system compares a measurement value of the in-line sensor with an offline analysis value of the analyzer and calibrates the in-line sensor in accordance with a result of the comparison.
However Potyrailo discloses an analyzer and the recited steps to be known in the art, for purposes of calibration. More specifically, Potyrailo discloses the following.
FIG. 11 depicts results of the off-line analysis of growth of cells in a typical cell culture run. The off-line analysis was performed using a NucleoCounter NC-100 and it served as a reference data for the evaluation of the developed in-line sensor. Off-line analysis was performed by periodic sampling of the cell culture and performing measurements of the concentration of viable cells, the concentration of nonviable cells, total number of cells (as the sum of viable and nonviable cells), and percent viability of cells (as the ratio of viable to total number of cells multiplied by 100%). A resonant sensor was also positioned directly in this cell culture and in-line measurements were performed with this sensor. FIG. 12 depicts results of the in-line analysis of growth of cells as collected with the resonant sensor. Quantitation of the concentration of viable cells, the concentration of nonviable cells, total number of cells, and percent viability of cells was performed using a well-known partial least squares (PLS) technique of analysis of spectra. The PLS determines correlations between the independent variables and the instrument response by finding the direction in the multidimensional space of the instrument response that explains the maximum variance for the independent variables. A comparison of off-line measurement (FIG. 11) and in-line measurement (FIG. 12) results illustrates a desired correlation between measurements done by off-line and in-line instruments such as measurements of the concentration of viable cells, the concentration of nonviable cells, total number of cells, and percent viability of cells. Para. 0085.
The resonant sensor 14 may be calibrated based on the analysis of off-line parameters or exposure to bioreactors 12 with known percentages of viable cells, upon exposure to a cell culture medium without cells, and upon exposure to a cell culture medium with a known concentration of viable cells. The response of the one or more sensors 14 is measured and an analytical relationship between the environmental parameter and the sensor response is established. The analytical fit coefficients may be calculated using multivariate calibration. In multivariate calibration, more than one property of the sensor response is related to the value of the environmental parameter of interest. Multivariate calibration utilizes the full impedance spectra for calibration, or at least two of individually measured parameters (Zp, Fp, Fz, F1, F2, Z1, Z2), or at least two of any other parameters that can be extracted from the response of the resonance circuit of the sensor 14. Nonlimiting examples of these additional parameters are quality factor of resonance, phase angle, and magnitude of impedance of the resonance circuit response sensor 14. Nonlimiting examples of multivariate analysis tools are canonical correlation analysis, regression analysis, nonlinear regression analysis, principal components analysis, discriminate function analysis, multidimensional scaling, linear discriminate analysis, logistic regression, pattern matching, and/or neural network analysis. Multivariate calibration can be performed using spectra from conventional impedance measurements, using spectra from resonance impedance measurements, and/or their combinations. Spectra from resonance impedance measurements can include all utilized resonator responses or only a subset of these responses. Para. 0087.
Thus Potyrailo discloses an analyzer that measures the culture fluid sampled from the culture tank offline, wherein the information processing system compares a measurement value of the in-line sensor with an offline analysis value of the analyzer and calibrates the in-line sensor in accordance with a result of the comparison. One skilled in the art would have recognized the benefit of calibration for accuracy, and thus it would have been obvious to one skilled in the art to incorporate s teachings of Potyrailo in the Davis invention for calibration.
As to the limitations of claim 5, see discussion of claim 4 above, which pertain to the same limitations recited in claim 5 (which will not be repeated for purposes of brevity).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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