DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
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: “breathing pattern monitoring part”, “inspiratory effort point detection part”, “expiratory effort point detect part”, and “supply flow control part” used in claims 1-14.
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.
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 § 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 1-4, 7, 9, 11, and 13-14, and thus their dependent claims, 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.
Claims 1, 7 and 11 all recite the limitation of “a breathing pattern monitoring part, which monitors flow rate and pressure changes of a mixed gas supplied to a patient and collects the patient's breathing pattern information”, while also reciting the limitations of “an inspiratory effort point detection part, which detects an inspiratory effort point” and “an expiratory effort point detection part, which detects a expiratory effort point” – therefore as the “breathing pattern monitoring part” is described as being configured to collect the patient’s breathing pattern information (including both inspiration and expiration), it is unclear how this part differs from the “inspiratory effort point detection part” and the “expiratory effort point detection part”. For the purpose of examination, the examiner will consider such limitations to be met as long as the prior art teaches sensors/structure configured to detect both inspiration and expiration of a user.
Furthermore, claims 7 and 14 recite the limitation of “reduces the flow rate of mixed gas by an minus auxiliary exhalation flow rate (relief flow)” – however it is unclear what is meant by the term “minus auxiliary exhalation flow rate”, as the specification does not provide any further description or value for this term. For the purpose of examination, the Examiner will interpret this limitation to mean the flow of gas is reduced by any amount suitable.
Claim 2, from which is dependent upon claim 1, recites the limitations of “a breathing synchronization unit, which includes a breathing pattern monitoring part, an inspiratory effort point detection part, and an expiratory effort point detection part”, however all of these terms have already been introduced by claim 1. Therefore, it is unclear if such terms are meant to be different and/or additional structural components than that of claim 1, or if they are referring to the same components as claim 1. For the purpose of examination, the Examiner has taken these limitations to be the same components as described in claim 1, from which claim 2 depends upon.
Claims 3 and 13 recite terms such as “basic flow (bias flow)” and “plus auxiliary flow (assist flow)”– however it is unclear what is meant by such terms, as the specification does not provide any further description or any specific flow rate value(s) for this term. For the purpose of examination, the Examiner will interpret the “basic flow (bias flow)” as any flow rate capable of ventilating a patient, and the “plus auxiliary flow (assist flow)” as any increase in the nominally flow rate supplied to the user.
Regarding claim 4, claim 4 recites the limitation of “wherein the patient's maximum inhalation flow is calculated to be three to four times the patient's respiration rate per minute” – however a patient’s maximum inhalation flow and respiration rate per minute is highly subjective and dependent on the user’s physical capabilities and fitness. Therefore, this claim is indefinite.
Regarding claim 9, claim 9 recites the limitation of “wherein the patient's maximum inhalation flow is calculated to be three to four times the patient's respiration rate per minute” – however a patient’s maximum inhalation flow and respiration rate per minute is highly subjective and dependent on the user’s physical capabilities and fitness. Therefore, this claim is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rapport et al. (US 2019/0255272 A1).
Regarding claim 1, Rapport discloses a high flow respiratory therapy device (respiratory therapy device comprising a blower unit 6, humidifier 4, conduit 2, patient interface 5, configured to deliver nasal high flow therapy to a user, Paragraph 0127 and Figure 1) through breath synchronization (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087) comprising: a breathing pattern monitoring part, which monitors flow rate and pressure changes of a mixed gas supplied to a patient (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user) and collects the patient's breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration, and the onset, duration and/or end of expiration of the user, Paragraph 0036, Figure 2A); an inspiratory effort point detection part which detects an inspiratory effort point, at which the patient tries to start inhalation, from the patient's breathing pattern information; (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration Paragraph 0036; the Examiner notes the 112b rejection presented above), an expiratory effort point detection part, which detects a expiratory effort point, at which the patient tries to start exhalation, from the patient's breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration, Paragraph 0036, Figure 2A); and a supply flow control part (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127), which increases the flow of the mixed gas when the patient's respiration becomes the inspiratory effort point (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6) and decreases the flow of the mixed gas when the patient's respiration becomes the expiratory effort point (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, Paragraph 0025 and Figure 6).
Regarding claim 2, Rapport further discloses a breathing synchronization unit (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087; the Examiner notes the 112b rejection presented above with specific regard to claim 2), which includes a breathing pattern monitoring part (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user), an inspiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration Paragraph 0036; the Examiner notes the 112b rejection presented above), and an expiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036; the Examiner notes the 112b rejection presented above), and synchronizes the extracted inspiratory effort point and the expiratory effort point with the patient's breathing pattern information (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087 and Figure 2A), wherein the supply flow control part synchronizes the flow control of the mixed gas with respect to the inspiratory effort point and expiratory effort point synchronized in the breathing synchronization unit (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller configured to adjust flow rate/pressure supplied to the user synchronously with the user’s breathing, Paragraph 0087).
Regarding claim 3, Rapport further discloses wherein the supply flow control part sets a basic flow (bias flow) (the controller 9 configured to adjust flow rate/pressure supplied to the user as desired, therefore fully capable of setting a basic flow to the user, Paragraph 0127), which includes a flow level capable of ventilating the patient's nasal cavity with fresh air and the patient's maximum inhalation flow (nasal high flow therapy provided to the user, Paragraph 0127 and Figure 1), and supplies the mixed gas of the bias flow when the patient's respiration starts (the controller configured to ramp the therapy pressure and flow being supplied to the user such that the ramp cycle begins in synchrony with the start of inspiration portion of a breath, Paragraph 0160), increases and supplies the flow rate by adding an plus auxiliary flow (assist flow) to the bias flow at the inspiratory effort point (ramp cycle then continues to increase, Paragraph 0159-0160), and reduces the flow rate to the bias flow at the expiratory effort point (ramp cycle ends during the expiration portion of a breath, Paragraph 0160). The Examiner also notes the 112b rejection presented above for this particular claim.
Regarding claim 4, Rapport further discloses wherein the patient's maximum inhalation flow is calculated to be three to four times the patient's respiration rate per minute (the Examiner notes the 112b rejection presented above for this particular clam – Rapport’s device is fully capable of calculating various inhalation flow rate values, therefore meets the claim).
Regarding claim 5, Rapport further discloses wherein the inspiratory effort point detection part extracts a maximum inspiratory effort point (the one or more sensors configuration to detect the onset, duration, and/or end of inspiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036), at which the change in inhalation flow rate is maximized (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6; see also Figure 2B and Paragraphs 0139-0141 showing/describing the maximum inhalation flow rate), and an expiratory effort end point which respiration temporarily stops before inhaling again after exhaling, from the patient's breathing pattern information, (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036; see also Figure 2B and Paragraphs 0139-0141 showing/describing the transition point between the end of the user’s exhalation), and detects an inspiratory effort point at which the patient starts an inspiratory effort between the extracted expiratory effort end point and the maximum inspiratory effort point referring to the extracted expiratory effort endpoint and the maximum inspiratory effort point (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036; see also Figure 2B and Paragraphs 0139-0141 showing/describing the maximum inspiration effort point).
Regarding claim 6, Rapport further discloses wherein the expiratory effort point detection part extracts a maximum expiratory effort point (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036), at which the change in the patient's exhalation flow rate is maximized (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during exhalation, Paragraph 0025 and Figure 6; see also Figure 2B and Paragraphs 0139-0141 showing/describing the maximum exhalation flow rate), and an expiratory effort end point, at which respiration temporarily stops before inhaling again after exhaling, from the patient's breathing pattern information (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036; see also Figure 2B and Paragraphs 0139-0141 showing/describing the expiratory effort end point), and detects an inspiratory effort point at which the patient starts an inspiratory effort between the extracted maximum expiratory effort point and the expiratory effort end point referring to the extracted maximum expiratory effort point and the expiratory effort end point (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036).
Regarding claim 7, Rapport discloses a high flow respiratory therapy device (respiratory therapy device comprising a blower unit 6, humidifier 4, conduit 2, patient interface 5, configured to deliver nasal high flow therapy to a user, Paragraph 0127 and Figure 1) through breathing synchronization comprising: a breathing pattern monitoring part, which monitors one or more of flow and pressure changes of a mixed gas supplied to a patient (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user) and collects patient's breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration, and the onset, duration and/or end of expiration of the user, Paragraph 0036, Figure 2A); an expiratory effort point detection part, which detects an expiratory effort point at which the patient tries to start exhalation from the collected breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration, Paragraph 0036, Figure 2A); and a supply flow control part (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127), which supplies the mixed gas of a set basic flow when the patient's respiration starts (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6), and reduces the flow rate of the mixed gas by an minus auxiliary exhalation flow rate (relief flow) at the expiratory effort point to reduce the patient's expiratory effort (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, fully capable of reducing the flow rate of the supplied gas by any degree desired, Paragraph 0025 and Figure 6; the Examiner notes the 112b rejection presented above regarding this particular limitation).
Regarding claim 8, Rapport further discloses a breathing synchronization unit (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087; the Examiner notes the 112b rejection presented above with specific regard to claim 2), which includes a breathing pattern monitoring part (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user), an expiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036), and an expiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036; the Examiner notes the 112b rejection presented above), and synchronizes the extracted expiratory effort point with the patient's breathing pattern information () and synchronizes the extracted inspiratory effort point and the expiratory effort point with the patient's breathing pattern information (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087 and Figure 2A), wherein the supply flow control part synchronizes the flow control of the mixed gas with respect to the inspiratory effort point and expiratory effort point synchronized in the breathing synchronization unit (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller configured to adjust flow rate/pressure supplied to the user synchronously with the user’s breathing, Paragraph 0087).
Regarding claim 9, Rapport further discloses wherein the supply flow control part is set to include a flow level capable of ventilating the patient's nasal cavity with fresh air and the patient's maximum inhalation flow (the controller 9 configured to adjust flow rate/pressure supplied to the user as desired, therefore fully capable of setting a basic flow to the user, Paragraph 0127; nasal high flow therapy provided to the user, Paragraph 0127 and Figure 1), and wherein the patient's maximum inhalation flow is calculated to be three to four times the patient's respiration rate per minute (the Examiner notes the 112b rejection presented above for this particular claim; Rapport’s device is fully capable of calculating various inhalation flow rate values, therefore meets the claim).
Regarding claim 10, Rapport further discloses wherein the expiratory effort point detection part extracts a maximum expiratory effort point (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036), at which the change in the patient's exhalation flow rate is maximized (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during exhalation, Paragraph 0025 and Figure 6), and an expiratory effort end point, at which respiration temporarily stops before inhaling again after exhaling, from the patient's breathing pattern information (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036), and detects an inspiratory effort point at which the patient starts an inspiratory effort between the extracted maximum expiratory effort point and the expiratory effort end point referring to the extracted maximum expiratory effort point and the expiratory effort end point (the one or more sensors configuration to detect the onset, duration, and/or end of expiration of the user, therefore fully capable of extracting a maximum inspiratory effort, Paragraph 0036).
Regarding claim 11, Rapport discloses a therapy method in a high flow respiratory therapy device (respiratory therapy device comprising a blower unit 6, humidifier 4, conduit 2, patient interface 5, configured to deliver nasal high flow therapy to a user, Paragraph 0127 and Figure 1; the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087), comprising: a step in which a breathing pattern monitoring part monitors flow rate and pressure changes of a mixed gas supplied to a patient (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user) and collects the patient's breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration, and the onset, duration and/or end of expiration of the user, Paragraph 0036, Figure 2A); a step in which a detection part of a control part detects an inspiratory effort point, at which the patient tries to start inhalation (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration Paragraph 0036; the Examiner notes the 112b rejection presented above), and an expiratory effort point, at which the patient tries to start exhalation, from the patient's breathing pattern information, or detects only the expiratory effort point (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration, Paragraph 0036, Figure 2A); and a step in which a supply flow control part of the control part actively controls the flow rate of the mixed gas in response to the inspiratory effort point or the expiratory effort point (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, and decrease the pressure/flow of gases supplied to the user during exhalation, Paragraph 0025 and Figure 6).
Regarding claim 12, Rapport further discloses after the step of detecting, a step in which the breathing synchronization part of the control part synchronizes the detected inspiratory effort point or the expiratory effort point with the patient's breathing pattern information (the controller is configured to supply the flow of mixed gases synchronously with the breathing of the user, Paragraph 0087), and wherein in the step of controlling the flow of the mixed gas, the supply flow control part of the control part synchronizes the flow control of the mixed gas in response to the inspiratory effort point and expiratory effort point synchronized in the breathing synchronization part (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, and decrease the pressure/flow of gases supplied to the user during exhalation, Paragraph 0025 and Figure 6).
Regarding claim 13, Rapport further discloses wherein in the step of detecting, in a case in which the inspiratory effort point and the expiratory effort point are detected, in the step of controlling the flow of the mixed gas, the supply flow control part supplies the mixed gas of the bias flow when the patient's respiration starts (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6), increases and supplies the flow rate by adding an plus auxiliary flow (assist flow) to the bias flow at the inspiratory effort point (ramp cycle then continues to increase, Paragraph 0159-0160), and reduces and supplies the flow rate to the bias flow at the expiratory effort point (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, fully capable of reducing the flow rate of the supplied gas by any degree desired, Paragraph 0025 and Figure 6; the Examiner notes the 112b rejection presented above regarding this particular limitation).
Regarding claim 14, Rapport further discloses wherein in a case in which only the expiratory effort point is detected in the step of detecting (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036), in the step of controlling the flow rate of the mixed gas, the supply flow control part supplies the mixed gas of a set basic flow when the patient's respiration starts (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6), and reduces the flow rate of the mixed gas by an minus auxiliary exhalation flow rate (relief flow) at the expiratory effort point (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, fully capable of reducing the flow rate of the supplied gas by any degree desired, Paragraph 0025 and Figure 6; the Examiner notes the 112b rejection presented above regarding this particular limitation), and then, increases the flow rate to the basic flow in proportion to the decrease in expiratory effort, thereby reducing the patient's expiratory effort (process may be repeated overall a number of breaths, therefore repeated, Paragraph 0023).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Huby et al. (US 2020/0405984 A1) and Martin et al. (US 8,844,527 B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785