DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-12 and 14-20 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.
With regards to claim 1, in line 1, the limitation “dielectric property “ is set forth and in line 18, the limitation --- said dielectric related property --- is set forth. It appears that the terms refer to the same element yet are labeled differently, thus rendering the scope indefinite. For examination purposes, Examiner assumes that the limitation in line 1 should be changed to --- dielectric related property ---.
With regards to claim 4, it is unclear as to whether the “a dielectric related property” in lines 2-3 is referring to the same “dielectric related property” set forth in line 18 of claim 1, or referring to a different dielectric related property. For examination purposes, Examiner assumes the former. Note that if the former, claim 4 appears to be redundant as claim 1 has been amended to set forth that identification of a change is based on said dielectric related property, etc..
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 (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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-4, 8-12, 14-17 and 19-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bouton et al. (US Pub No. 2003/0036713) in view of Arad (US Pub No. 2005/0107719).
With regards to claim 1, Bouton et al. disclose a wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user, comprising:
at least one transducer having at least one antenna configured for at least one of delivering radio frequency -radiation having a plurality of different frequencies between 900 MHz and 2.5 GHz to the internal tissue and intercepting said radio frequency radiation from said internal tissue, in a plurality of transmission sessions during a period of at least 24 hours (paragraphs [0020], [0080] referring to applying electromagnetic energy in the range of 300 MHz to 30 GHz, wherein the claimed range falls within the disclosed range; paragraphs [0027]-[0028], [0031], [0034], [0081], referring to the electromagnetic energy being transmitted with an antenna and a receiver (i.e. antenna) measuring a returned signal; note that the transducer is capable of delivering radiofrequency radiation over a period of time, including a period of at least 24 hours);
a memory storing code (paragraph [0031], referring to the memory) ;
a data interface (50) coupled to a display (i.e. monitor) (paragraph [0082], referring to the user interface (50) which can be for a monitor); and
at least one processor (40, “computer”) operatively coupled to the memory for executing the code (paragraphs [0031], [0082], referring to the data processing and control unit (40)) comprising instructions for;
analyzing said intercepted radio frequency radiation to determine a dielectric[-related] property of said internal tissue (paragraphs [0021]-[0021]; [0024]-[0025], [0031], [0087]-[0090], referring to comparing the returned signal to the reference signal, wherein the reference signal can be “one or more other signal measurements…of one or more other signal measurements resulting from application of electromagnetic energy to the first volume a predetermined amount of time earlier”; further, in paragraphs [0087]-[0089], wherein it is disclosed that “received signals(s)” (i.e. plurality of signals of the intercepted radio frequency radiation) are compared to reference signals, wherein a deviation/change/difference (i.e. differential signal) in the signals is identified via being measured and the differential signal is used to determine if an abnormal (for example elevated) level of fluid is present in the area of tissue being monitored, wherein, as is set forth in paragraph [0026], the measured signal is altered by changes in the bulk value or specific makeup of dielectric properties, wherein dielectric properties of tissue can change measurably in the case that fluid levels become elevated within the tissue and sub-regions of fluid that are introduced or removed can cause movement of boundaries where differing dielectric properties meet in the region or volume-being monitored and change the path and nature of the received signal, and therefore the change in the signals correspond to a “dielectric-related” property of said internal tissue);
identifying a change in the at least one biological parameter (i.e. fluid levels in tissue/edema) by said dielectric related property determined from said intercepted radio frequency radiation (paragraph [0019], referring to the device/methods being used for detecting elevated or otherwise abnormal levels of fluids in living tissue, for example, as a result of edema, etc.; paragraph [0020], referring to detecting a change in the level of fluid in tissue by applying the electromagnetic energy and measuring a resultant or returned signal and comparing the signal to a reference signal to determine if the fluid level in the tissue has changed; paragraphs [0087]-[0089], wherein it is disclosed that “received signals(s)” (i.e. plurality of signals of the intercepted radio frequency radiation) are compared to reference signals, wherein a deviation/change/difference (i.e. differential signal) in the signals is identified via being measured and the differential signal is used to determine if an abnormal (for example elevated) level of fluid is present in the area of tissue being monitored, wherein, as is set forth in paragraph [0026], the measured signal is altered by changes in the bulk value or specific makeup of dielectric properties, wherein dielectric properties of tissue can change measurably in the case that fluid levels become elevated within the tissue and sub-regions of fluid that are introduced or removed can cause movement of boundaries where differing dielectric properties meet in the region or volume-being monitored and change the path and nature of the received signal, and therefore the change in the signals correspond to a “dielectric-related” property of said internal tissue) and
sending said change to the data interface for presentation on the display (paragraphs [0031], [0081]-[0082], referring to the signal processor (70) comparing the returned signal to the reference signal to determine if the level of fluid in the tissue of the body has changed, wherein the signal processor (70) is in communication with the data processing and control unit (40), which is in communication with the user interface (50), such as a monitor/display, and an alarm (60); paragraph [0087], referring to, if the measured signal deviates from the reference signal by a predetermined amount or in a predetermined manner, alarm (60) can be activated; Figure 1).
However, Bouton et al. do not specifically disclose that the apparatus further comprises a non radio frequency radiation sensor configured for evaluating an indicator of a physical condition of said user, wherein the at least one processor further comprises instructions for analyzing said indicator from said non-radio frequency radiation sensor and wherein the change in the at least one biological parameter is identified by a combination of said dielectric related property and said indicator from said non-radiofrequency radiation sensor, thereby improving accuracy of said monitoring compared to use of said intercepted radio frequency radiation alone.
Arad discloses using an electrocardiograph (i.e. non-radio frequency radiation sensor) to measure the depth, frequency and/or timing of the breathing cycle (i.e. pattern of physiological activity), in order to be able to correct for the effect of breathing on the chest impedance, which would otherwise mask the effects of pulmonary edema and other symptoms of congestive heart failure on the chest impedance (paragraph [0009]). The ECG data is used together with impedance imaging (i.e. data inherently associated with dielectric properties) to evaluate the condition of congestive heart failure and used to measure the breathing cycle to correct the impedance imaging (paragraphs [0011]-[0012]). Change in the impedance of the lungs associated with a pulmonary edema is correlated with the cardiac cycle, and images taken at one phase in the cardiac cycle may be subtracted from images taken 180 degrees apart in the cardiac cycle, wherein such a procedure may emphasize pulmonary edemas in the resulting canonical image (paragraph [0138]).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the apparatus of the Bouton et al. further comprise a non-radiofrequency radiation sensor (i.e. ECG which detects a pattern of physiological activity) configured for evaluating an indicator of a physical condition of said user and further have the at least one processor of Bouton et al. further comprise instructions for analyzing said indicator from said non-radio frequency radiation sensor and wherein the change in the at least one biological parameter is identified by a combination of said dielectric related property and said indicator from said non-radiofrequency radiation sensor, thereby improving accuracy of said monitoring compared to use of said intercepted radio frequency radiation alone, as taught by Arad, in order to avoid masking the effects of pulmonary edema and other symptoms of congestive heart failure and instead accurately emphasize pulmonary edemas/fluid level changes (paragraphs [0009], [0011]-[0012], [0138]).
With regards to claim 3, Bouton et al. disclose that said processing unit is configured for identifying said change by detecting at least one of a trend, a biological process, and a pattern according to said intercepted radio frequency radiation of said plurality of transmission sessions (paragraphs [0031], [0082], [0090]).
With regards to claim 4, Bouton et al. disclose that said processing unit is configured for evaluating a property change in a dielectric related property of the internal tissue in at least one of said plurality of transmission sessions and performing said identification according to said property change (paragraph [0026]).
With regards to claim 8, Bouton et al. disclose that said reporting unit is configured for generating said report in real time (paragraph [0087], note that alarm is generated in real time).
With regards to claim 9, Bouton et al. disclose that said at least one biological parameter is indicative of a fluid content in the internal tissue during said period (Abstract; paragraph [0087]).
With regards to claims 10 and 16-17, Bouton et al. disclose that said processing unit is configured for detecting a pattern of at least one physiological activity (i.e. and thus detect a physiological activity) of the user, said processing unit being configured for calculating a clinical state of said user (i.e. performing said analyzing) with respect to said fluid content and to said pattern, wherein said at least one intercepted radio frequency radiation is being changed as an outcome of at least one thoracic movement during said period (paragraphs [0020], [0024], [0077], [0082], [0087]; Figure 1, note that fluid level changes and edema, hematomas, etc. are associated with patterns of at least one physiological activity of the user).
With regards to claim 11, Bouton et al. disclose that said at least one biological parameter is indicative of a member of a group consisting of a trauma, etc. (paragraphs [0003]-[0007], [0015], [0077]).
With regards to claim 12, Bouton et al. disclose that their apparatus further comprises a repository configured for storing information pertaining to said user, said processing unit being configured for performing said analyzing with respect to said information, wherein said information comprises at least one of physiological, anatomical, and clinical data related to said user (paragraphs [0020], [0024]-[0025], [0087], referring to the measured signal).
With regards to claim 14, Arad discloses that said non EM radiation sensor being a member of a group consisting of ECG, etc. (paragraphs [0011]-[0012]).
With regards to claim 15, Arad discloses that said non EM radiation sensor is configured for detecting a pattern of a physiological activity (i.e. breathing cycle) of the user, said processor executes a code for performing said analyzing said indicator with respect to said pattern (paragraphs [0009], [0011]-[0012]).
With regards to claims 19 and 20, Bouton et al. disclose that said at least one biological parameter is indicative of a concentration of a solute (i.e. salt) in the internal tissue (paragraph [0031], referring to detecting changes in fluid levels, wherein changes in fluid content in tissue inherently results in changes in solute, such as inherently present salt, concentration as well).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bouton et al. in view of Arad as applied to claim 1 above, and further in view of Mawhinney (US Patent No. 4,991,585).
With regards to claim 2, as discussed above, the above combined references meet the limitations of claim 1. However, they do not disclose that said processing unit further comprises a communication module for communicating with a remote processing unit thereby allowing performing of at least one of said analyzing and said identifying by said remote processing unit.
Mawhinney disclose a system for determining whether or not an abnormal condition exists by using a non-invasive monitor that makes use of the interferometric effects on a phase-modulated carrier signal caused by movement within certain tissue of an individual, such as the thorax of the patient (Abstract; column 1, lines 47-62). An antenna and processing means for analyzing a signal, such as an envelope detector (218) may be situated within the same housing (i.e. and thus disposed on the body as the housing of the monitor is placed adjacent the body), or the envelope detector (218) may be situated with and be considered as part of a remove alarm-control means (column 5, lines 9-38; Figure 2). Mawhinney discloses a communication module for communicating with a remote processing unit thereby allowing performing of at least one of said analyzing and said identifying by said remote processing unit (column 5, lines 25-38).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the processing unit of the above combined references comprise a communication module for communicating with a remote processing unit thereby allowing performing of at least one of said analyzing and said identifying by said remote processing unit, as taught by Mawhinney, as performing signal analysis either at the body of the user or remotely are known effective alternative techniques for analyzing signals (column 5, lines 25-38).
Claims 5-7 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bouton et al. in view of Arad, as applied to claim 1 above, and further in view of Hatlestad (US Pub No. 2004/0073093).
With regards to claims 5 and 18, as discussed above, the above combined references meet the limitations of claim 1. However, they do not specifically disclose that said plurality of transmission sessions are performed in an adaptive rate or are intermittent. Further, they do not specifically disclose that the processing unit is configured for performing at least the step of identifying a period suitable for performing a data acquisition session. Additionally, the above combined references do not specifically disclose that their apparatus further comprises a posture detection unit configured for detecting a posture of the user, said processing unit being configured for analyzing said intercepted radio frequency radiation with respect to said posture.
Hatlestad discloses detecting a context when monitoring a physiological condition of a patient, wherein the context may be used to control when the measurement of physiological conditions occurs (pg. 1, paragraph [0007]; pg. 2, paragraphs [0022-[0023]; pgs. 2-3, paragraphs [0026]-[0029]). By taking physiological measurements with regards to context, the measurements may be made with a high degree of certainty when assessing the health of a patient (pg. 1, paragraphs [0004]-[0005]). Hatlestad further discloses that their apparatus further comprises a posture detection unit configured for detecting a posture of the user (i.e. a change of posture movement), said adaptive rate being determined according to said posture, which can be used to control a particular mode of therapy (pgs. 2-3, paragraphs [0026]-[0029]; pg. 3, paragraph [0033]).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the plurality of transmission sessions of the above combined references be performed in an adaptive rate and further include identifying a period suitable for performing a data acquisition session, and further have the apparatus of the above combined references further comprise a posture detection unit configured for detecting a posture of the user, said processing unit being configured for analyzing said intercepted radio frequency radiation with respect to said posture, as taught by Hatlestad, in order to obtain measurements with a high degree of certainty (pg. 1, paragraphs [0004]-[0005]) and control a particular mode of therapy (paragraphs [0026]-[0029], [0033]).
With regards to claim 6, Bouton et al. disclose that said processing unit is configured for calculating a clinical state according to at least one output of a non radio frequency radiation sensor and said intercepted radio frequency radiation (paragraph [0087], referring to determine an abnormal clinical state). Further, Hatlestad discloses that said adaptive rate is determined according to a clinical state of the user (pg. 1, paragraph [0007]; pg. 2, paragraphs [0022-[0023]; pgs. 2-3, paragraphs [0026]-[0029]).
With regards to claim 7, Hatlestad discloses that their apparatus further comprises a posture detection unit configured for detecting a posture of the user (i.e. a change of posture movement), said adaptive rate being determined according to said posture (pgs. 2-3, paragraphs [0026]-[0029]; pg. 3, paragraph [0033]).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,758,150. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claims 1 and 13 of the Patent. That is, claims 1 and 13 of the Patent falls entirely within the scope of instant claim 1, or in other words, instant claim 1 is anticipated by claims 1 and 13 of the Patent. Specifically, because claim 1 of the Patent claims the same structure (i.e. at least one transducer having at least one antenna configured for at least one of delivering radio frequency radiation having a plurality of different frequencies between 900 MHz and 2.5GHz, a processing unit (i.e. at least one processor) configured for analyzing said intercepted radio frequency and identifying a change (i.e. code instructions for computing a differential signal and identifying a change (i.e. change) from a plurality of signals of hte intercepted radio frequency radiation), a reporting unit (i.e. at least one processor with code instructions for generating an output), wherein said at least one antenna is configured for being disposed on the body, etc.) and a non-radiofrequency radiation sensor configured for evaluating an indicator of a physical condition, etc. [claim 13], as claimed in instant claim 1, the system of instant claim 1 is anticipated by claim 1 of the Patent.
With regards to claim 2, claim 2 of the Patent sets forth the same limitations.
With regards to claim 3, claim 3 of the Patent sets forth the same limitations.
With regards to claim 4, claim 4 of the Patent sets forth the same limitations.
With regards to claim 5, claim 5 of the Patent sets forth the same limitations.
With regards to claim 6, claim 6 of the Patent sets forth the same limitations.
With regards to claim 7, claim 7 of the Patent sets forth the same limitations.
With regards to claim 8, claim 8 of the Patent sets forth the same limitations.
With regards to claim 9, claim 9 of the Patent sets forth the same limitations.
With regards to claim 10, claim 10 of the Patent sets forth the same limitations.
With regards to claim 11, claim 11 of the Patent sets forth the same limitations.
With regards to claim 12, claim 12 of the Patent sets forth the same limitations.
With regards to claim 13, claim 13 of the Patent sets forth the same limitations.
With regards to claim 14, claim 14 of the Patent sets forth the same limitations.
With regards to claim 15, claims 1 (wherein the differential signal represents a pattern of physiological activity) and 14 of the Patent sets forth the same limitations.
With regards to claim 16, claim 1 (wherein the differential signal represents a pattern of physiological activity) of the Patent sets forth the same limitations.
With regards to claim 17, claim 15 of the Patent sets forth the same limitations.
With regards to claim 18, claim 16 of the Patent sets forth the same limitations.
With regards to claim 19, claim 17 of the Patent sets forth the same limitations.
With regards to claim 20, claim 18 of the Patent sets forth the same limitations.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,059,238.
Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claims 1 and 13 of the Patent. That is, claims 1 and 13 of the Patent falls entirely within the scope of instant claim 1, or in other words, instant claim 1 is anticipated by claim 1 of the Patent. Specifically, because claims 1 and 13 of the Patent claims the same structure (i.e. at least one transducer having at least one antenna configured for at least one of delivering radio frequency radiation having a plurality of different frequencies between 900 MHz and 2.5GHz, a processing unit (i.e. at least one processor) configured for analyzing said intercepted radio frequency and identifying a change (i.e. code instructions for computing a differential signal and identifying a change (i.e. change) from a plurality of signals of the intercepted radio frequency radiation), a reporting unit (i.e. at least one processor with code instructions for generating an output), wherein said at least one antenna is configured for being disposed on the body and thus at least temporary fixed to a location on the body, etc. and further a non radio frequency radiation sensor configured for evaluating an indicator, etc. [claim 13]), as claimed in instant claim 1, the system of instant claim 1 is anticipated by claim 1 of the Patent.
With regards to claim 2, claim 2 of the Patent sets forth the same limitations.
With regards to claim 3, claim 3 of the Patent sets forth the same limitations.
With regards to claim 4, claim 4 of the Patent sets forth the same limitations.
With regards to claim 5, claim 5 of the Patent sets forth the same limitations.
With regards to claim 6, claim 6 of the Patent sets forth the same limitations.
With regards to claim 7, claim 7 of the Patent sets forth the same limitations.
With regards to claim 8, claim 8 of the Patent sets forth the same limitations.
With regards to claim 9, claim 9 of the Patent sets forth the same limitations.
With regards to claim 10, claim 10 of the Patent sets forth the same limitations.
With regards to claim 11, claim 11 of the Patent sets forth the same limitations.
With regards to claim 12, claim 12 of the Patent sets forth the same limitations.
With regards to claim 13, claim 13 of the Patent sets forth the same limitations.
With regards to claim 14, claim 14 of the Patent sets forth the same limitations.
With regards to claim 15, claims 1 (wherein the differential signal represents a pattern of physiological activity) and 14 of the Patent sets forth the same limitations.
With regards to claim 16, claim 1 (wherein the differential signal represents a pattern of physiological activity) of the Patent sets forth the same limitations.
With regards to claim 17, claim 15 of the Patent sets forth the same limitations.
With regards to claim 18, claim 16 of the Patent sets forth the same limitations.
With regards to claim 19, claim 17 of the Patent sets forth the same limitations.
With regards to claim 20, claim 18 of the Patent sets forth the same limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 and 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Bouton and Arad have been introduced to teach the amended limitations.
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.
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/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798