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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 October 2025 has been entered.
Response to Amendment
The amendments filed 03 October 2025 have been entered. Claims 2-3, 5-16, 18, and 20-22 are pending.
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 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
The term “about” in claim 20 and 21 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is thus not clear what lengths are encompassed by the claimed "about 0.5mm and about 3mm", "about 0.1mm and about 1.0mm", and "about 0.60mm and about 1.5mm", nor is it clear what ratios are encompassed by "about 0.075:1 and about 1.5".
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.
Claims 2-3, 5-9, 16, 18 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160150993 A1 to Powell (cited by Applicant).
Regarding claim 22, Powell discloses a method of generating electromyography (EMG) data derived from one or more muscle or muscle groups located in an upper airway cavity of a patient (Paragraph 0009-0011):
a. providing a system comprising:
i. a probe (probe in Fig. 3D) configured to receive EMG signals from one or more muscle groups located in an upper airway cavity of a patient (See Figs. 1-3B), wherein the probe comprises a bipolar sensor (“Probe 30” of Fig. 3A which encompasses the “electrodes 34” and “curved end 32”; Paragraph 0009-0011—the at least one sensor can be a bipolar surface electrode) configured with each of:
1. a housing (Fig. 3A—"curved end 32” including the printed circuit board which appears to correspond to “11” in the figures; paragraph 0077); and
2. an electrode pair (“Electrodes 34” of Fig. 3A; Fig. 3D having two electrodes; electrodes 12 are shown in pairs; paragraph 0009-0011—“ at least one sensor can be a bipolar surface electrode” and “a plurality of bipolar surface electrodes” such that there may be a pair of electrodes) comprising a first and second electrode each having a diameter (Paragraph 0030; Figs. 3A, 3C show first and second diameters; see also optimizing shape in last sentence of Paragraph 0033); and
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Any two electrodes may serve as the electrode pair, where the first and second diameter may be indicated by any two arrows, annotated Fig. 3C at left
wherein each of the first and second electrodes
(a) are separated from each other by a spacing distance (Paragraph 0011, 0067-- sensors/electrodes being provided (in embodiments providing a plurality thereof), are spaced apart from an adjacent electrode by about 5 mm (for example); Figs. 3A and 3C illustrate spaced separation of the electrodes; see also optimizing locations in the last sentence of Paragraph 0033); and
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See spacing distances indicated by arrows in annotated Fig. 3C, left
(b) project in parallel (when interpreted in light of the specification at Paragraph 0009, Paragraph 0010, Paragraph 0036, the electrodes extend from the surface of the probe in parallel; Figs. 3A, 3B illustrate electrodes that extend from the surface of the probe in parallel) from a distal end of the housing for a projection length;
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See electrodes which project for a projection length indicated by arrows, where the arrows and thus the projection are in parallel, annotated Fig. 3B at left
wherein the bipolar sensor is configured to obtain electrical signal data generated from muscle or muscle group activity associated with a target tissue when the bipolar sensor is positioned by an operator to contact a membranous area overlying the target tissue in the upper airway cavity of the patient during an EMG data collection operation (Paragraph 0009-0011-- arranging a plurality of bipolar surface electrodes on the surface of mucosal tissue of a patient each at a predetermined location on tissue, each predetermined location plurality of locations, each location corresponding to a specific muscle and/or muscle layer, wherein each electrode configured to produce first signals responsive to spontaneous EMG activity or abnormal MUP's of the specific muscle/layer; Fig. 3A);
ii. a controller (Paragraph 0009, 0080-0082, 0085—at least one controller/processor; processor 20) comprising:
1. a memory (Paragraph 0080-0082, Paragraph 0085—memory…); and
2. a processor (Processor 20) configured to:
a. incorporate data received from each of the memory and one or more operator inputs, wherein each of the memory and operator inputs are configured to operate the probe during the EMG data collection operation (Paragraph 0009-0011, 0080-0082, 0085-- The processor may include computer instructions operating thereon for accomplishing any and all of the methods and processes disclosed in the present disclosure…); and
b. execute a set of instructions associated with the generation of EMG signal data obtained when the bipolar sensor is in contact with the membranous area overlaying the muscle or muscle group during the EMG data collection operation (Paragraph 0009, Paragraph 0080-0082, 0085-- The processor may include computer instructions operating thereon for accomplishing any and all of the methods and processes disclosed in the present disclosure…);
3. an amplifier configured to amplify electrical activity signal data received from the bipolar sensor during the EMG data collection operation (Paragraph 0034-0037-- With respect to amplification, differential amplifiers may be used to amplify the voltage difference between, for example, the input terminals (two) connected to the recording electrode, as opposed to between input terminals and the ground); and
4. a communications interface comprising:
a. network interface (Paragraph 0083-0085—a communication network…); and
b. a user interface (Paragraph 0082-0083, 0085-- To provide for interaction with a user, the subject matter described herein may be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor and the like) for displaying information to the user and a keyboard and/or a pointing device (e.g., a mouse or a trackball) by which the user may provide input to the computer);
b. inserting the probe through the patient’s mouth and into the upper airway cavity (Paragraph 0047, 0058, 0078-- may comprise an elongated member configured with a size and shape for insertion into the mouth of a patient);
c. identifying a target tissue in the patient’s upper airway cavity (Paragraph 0009-0012, 0048-0049, 0068-0070-- arranging a plurality of bipolar surface electrodes on the surface of mucosal tissue of a patient each at a predetermined location on tissue, each predetermined location plurality of locations, each location corresponding to a specific muscle and/or muscle layer…);
d. contacting the membranous material overlying the target tissue with the distal end of the probe to generate contact between the bipolar sensor and the membranous area overlaying the target tissue during the EMG data collection operation, wherein neither the probe nor the bipolar sensor penetrates or pierces the target tissue (abstract, Paragraph 0012);
e. receiving electrical signal data from muscle or muscle group activity generated during the EMG data collection operation (Abstract; paragraphs 0009-0011, 0013, 0020, 0041, 0049, 0055-0061);
f. processing the electrical signal data to generate EMG data for the target muscle (Abstract; paragraph 0057-0061, 0076, 0079-0082-- where the probe device is connected to a measuring device to process signals (e.g., information) generated from sensors (e.g., electrodes, and/or thermal) provided with the probe… a probe may be connected to a processor 20 which may include computer instructions operating thereon to, for example, digitally process at least one of EMG/thermal signals); and
g. evaluating the EMG data (Paragraph 0009, 0055-0061, 0079-0082-- the sensor may register from a muscle an EMG activity that deviates from a benchmark activity (e.g., expected results) indicating the occurrence of some type of abnormality with the muscle…the processor 20 may be connected to a database 30 which includes information on normal EMG activities of the muscle being sensed (e.g., comparison with EMG activities of non-apnea patients allows for determination of occurrence of apnea in the patient under monitoring). For example, instructions operating on the processor 20 can be provide which enables comparison of the EMG activity (for example) with that of EMG activity of a non-apnea patient); and
h. generating diagnostic data for the patient associated with a presence of a neuromuscular condition associated with the target tissue (Paragraph 0020, 0041, 0056-- In some embodiments, the collected EMG and thermal data may be analyzed to assess and diagnose the quality and condition of the muscle, nerve and tissue dynamics, and may also be used to diagnose OSA).
Regarding claim 2, Powell discloses the method of claim 22, wherein during the EMG data collection operation the distal end of the probe is positioned by the operator to elastically deform the target tissue (“made flexible” ¶Paragraph 0045, Paragraph 0057, Paragraph 0141).
Regarding claim 3, Powell discloses the of claim 22, wherein the target tissue comprises one or more of the patient’s soft palate, pharyngeal wall, or tongue (Abstract; paragraph 0011-0013, 0017, 0041, 0044, 0047-0048, 0056).
Regarding claim 5, Powell discloses the method of claim 22, wherein when the bipolar sensor is in contact with the membranous material overlying the target tissue, a portion of the muscle or muscle group is positioned within the spacing distance (Abstract, Paragraph 0022, 0050-- the contraction and relaxation of muscles in other parts of the body located in close proximity to membranous tissue generate electrical activity that may be detected and assessed according to some of the embodiments of the present disclosure).
Regarding claim 6, Powell discloses the method of claim 5, wherein when the bipolar sensor is in contact with the membranous material overlying the target tissue a potential difference is measured for the muscle or muscle group positioned within the spacing distance (Paragraph 0022- 0024, 0027, 0050-- Excitability of tissues, whether nerves or muscles, is reflected in the magnitude of the transmembrane potential in a steady state… At rest, a pair of electrodes placed on the surface of a muscle registers no potential difference between them. Thus, EMG recording of a normal muscle at rest is silent. During muscle activation, as the propagating action potential reaches the near electrode (G1), then G1 becomes negative relative to the distant electrode G2 resulting in an upward deflection of the tracing, followed by neutral deflection (or baseline), followed by downward deflection, and finally neutral deflection (or baseline)).
Regarding claim 7, Powell discloses the method of claim 22, wherein the user interface includes a device configured to allow the operator to view one or more of signal data, EMG data, optical data, or image data generated or derived from the EMG data collection operation (Paragraph 0082, 0085-- To provide for interaction with a user, the subject matter described herein may be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor and the like) for displaying information to the user).
Regarding claim 8, Powell discloses the method of claim 7, wherein the operator repositions the probe in response to information generated by the user interface during the EMG data collection operation (Paragraph 0037, 0056-0057-- impedances may be assessed in each patient for each electrode in each position to achieve less than 5 kOhms (for example), according to some embodiments NOTE: In this case, the probe must clearly be repositioned if each electrode does not achieve less than 5kOhms in order to meet the desired effect).
Regarding claim 9, Powell discloses the method of claim 22, wherein the network interface is operational with one or more of a network, remote server, or a database configured for remote data storage or cloud data storage (Paragraph 0083- 0084-- The computing system according to some such embodiments described above may include clients and servers. A client and server are generally remote from each other and typically interact through a communication network).
Regarding claim 16, Powell discloses the method of claim 22, wherein the generated EMG data is stored in the memory locally or on a second device, or over a network (Paragraph 0081, 0085- 0086-- he processor communicates with at least one database, which may store data related to patients without OSA, as well as collected data from use with other patients… Moreover, in some embodiments, the processor and at least the database can be contained in a personal computer or client computer which may operate and/or collect data from the detecting device).
Regarding claim 18, Powell discloses the method of claim 22, wherein step f) is configured to evaluate neuromuscular function of the target tissue (Paragraph 0020, 0049-- In such embodiments, the quality and/or status of the neuromuscular and tissue dynamics may be determined, which can aid in the diagnosis and/or treatment of conditions associated with said tissues and/or organs…If spontaneous EMG activity occurs or abnormal MUP's are present in the EMG tracing, a neuromuscular pathology may exist).
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.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Powell.
Regarding claim 20, Powell does not explicitly teach wherein first and second electrodes project from the distal end of the housing for a length of between about 0.5 mm and about 3 mm, a diameter of the first and second electrodes is between about 0.1 mm and about 1.0 mm, and the spacing distance between the first and second electrodes is between about 0.60 mm and about 1.5 mm. Powell teaches dimensions (Paragraph 0078) and optimization (last sentence of Paragraph 0033). It would have been obvious to one of ordinary skill in the art at the time of the invention that with routine experimentation, the dimensions would be optimized “for each patient to increase the signal-to-noise ratio (SNR).” Powell, Paragraph 0033. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . .. In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933).
The claimed dimensions do not appear critical to achieve unexpected results. Nothing in the Specification suggests to one of ordinary skill in the art that the claimed range is somehow critical or leads to unexpected results.
The numerous examples of dimensions disclosed in the Specification—and the lack of any accompanying description explaining the criticality of these—are relevant, as they discredit criticality. See, e.g., Ex parte Shastry et al., No. 2017-003614 , 2017 WL 6817003 , at *7 (PTAB Dec. 11, 2017) ("Appellants do not establish criticality or unexpected results for the narrow range of peroxide amount claimed, in view of the broader range disclosed in the Specification ¶ 13.").
Regarding claim 21, Powell does not explicitly teach wherein a first ratio of the spacing distance to the projection length is between about 0.075:1 and about 1.5. Powell teaches dimensions (Paragraph 0078) and optimization (last sentence of Paragraph 0033). It would have been obvious to one of ordinary skill in the art at the time of the invention that with routine experimentation, the dimensions would be optimized “for each patient to increase the signal-to-noise ratio (SNR).” Powell, Paragraph 0033. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . .. In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933).
The claimed dimensions do not appear critical to achieve unexpected results. Nothing in the Specification suggests to one of ordinary skill in the art that the claimed range is somehow critical or leads to unexpected results.
The numerous examples of dimensions disclosed in the Specification—and the lack of any accompanying description explaining the criticality of these—are relevant, as they discredit criticality. See, e.g., Ex parte Shastry et al., No. 2017-003614 , 2017 WL 6817003 , at *7 (PTAB Dec. 11, 2017) ("Appellants do not establish criticality or unexpected results for the narrow range of peroxide amount claimed, in view of the broader range disclosed in the Specification ¶ 13.").
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of DeLuca (US20090036792A1).
Regarding claim 20, Powell teaches the method of claim 22. Powell additionally teaches dimensions (Paragraph 0078) and optimization (last sentence of Paragraph 0033). However, Powell does not explicitly teach wherein first and second electrodes project from the distal end of the housing for a length of between about 0.5 mm and about 3 mm, a diameter of the first and second electrodes is between about 0.1 mm and about 1.0 mm, and the spacing distance between the first and second electrodes is between about 0.60 mm and about 1.5 mm.
DeLuca, in the same field of endeavor of a method of using a probe for measuring EMG signals of a patient’s muscles (Abstract), discloses a probe (11) includes a bipolar sensor (Electrode section 12) having a housing (substrate 16) which includes first and second electrodes (C1 and D1) which project in parallel from the housing (See Fig. 3, C1 and D1 projecting in parallel), wherein first and second electrodes project from the distal end of the housing for a length of between about 0.5 mm and about 3 mm (Paragraph 0021, 0033—a projection length of approximately 2mm), a diameter of the first and second electrodes is between about 0.1 mm and about 1.0 mm (Paragraph 0021, 0033—a uniform diameter in the range between 0.3 mm and 1 mm), and the spacing distance between the first and second electrodes is between about 0.60 mm and about 1.5 mm (Paragraph 0033—a uniform spacing of between 1.5 mm and 5 mm).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dimensions of Powell to utilize those of DeLuca as with routine experimentation, the dimensions would be optimized “for each patient to increase the signal-to-noise ratio (SNR).” (Motivated by Powell, Paragraph 0033).
Furthermore, it is noted that "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . .. In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933).
The claimed dimensions do not appear critical to achieve unexpected results. Nothing in the Specification suggests to one of ordinary skill in the art that the claimed range is somehow critical or leads to unexpected results. The numerous examples of dimensions disclosed in the Specification—and the lack of any accompanying description explaining the criticality of these—are relevant, as they discredit criticality. See, e.g., Ex parte Shastry et al., No. 2017-003614 , 2017 WL 6817003 , at *7 (PTAB Dec. 11, 2017) ("Appellants do not establish criticality or unexpected results for the narrow range of peroxide amount claimed, in view of the broader range disclosed in the Specification ¶ 13.").
Regarding claim 21, Powell teaches the method of claim 22. Powell additionally teaches dimensions (Paragraph 0078) and optimization (last sentence of Paragraph 0033). However, Powell does not explicitly teach wherein a first ratio of the spacing distance to the projection length is between about 0.075:1 and about 1.5. DeLuca, in the same field of endeavor of a method of using a probe for measuring EMG signals of a patient’s muscles (Abstract), discloses a probe (11) includes a bipolar sensor (Electrode section 12) having a housing (substrate 16) which includes first and second electrodes (C1 and D1) which project in parallel from the housing (See Fig. 3, C1 and D1 projecting in parallel), wherein first and second electrodes project from the distal end of the housing for a length of between about 0.5 mm and about 3 mm (Paragraph 0021, 0033—a projection length of approximately 2mm) and the spacing distance between the first and second electrodes is between about 0.60 mm and about 1.5 mm (Paragraph 0033—a uniform spacing of between 1.5 mm and 5 mm), such that DeLuca discloses a ratio of the spacing distance to the projection length is between about 0.075:1 and about 1.5.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dimensions of Powell to utilize those of DeLuca as with routine experimentation, the dimensions would be optimized “for each patient to increase the signal-to-noise ratio (SNR).” (Motivated by Powell, Paragraph 0033).
Furthermore, it is noted that "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . .. In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933).
The claimed dimensions do not appear critical to achieve unexpected results. Nothing in the Specification suggests to one of ordinary skill in the art that the claimed range is somehow critical or leads to unexpected results. The numerous examples of dimensions disclosed in the Specification—and the lack of any accompanying description explaining the criticality of these—are relevant, as they discredit criticality. See, e.g., Ex parte Shastry et al., No. 2017-003614 , 2017 WL 6817003 , at *7 (PTAB Dec. 11, 2017) ("Appellants do not establish criticality or unexpected results for the narrow range of peroxide amount claimed, in view of the broader range disclosed in the Specification ¶ 13.").
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of US 20150182161 A1 to Mananas Villanueva (cited by Applicant).
Regarding claim 10, Powell discloses the method of claim 22. Powell additionally discloses a display device for displaying information and feedback to the user during use of the probe (Paragraph 0082). Powell does not teach providing instructions to the operator for obtaining electrical signal data during the EMG data collection operation. Mananas Villanueva, in the same field of endeavor of a method of measuring EMG signals of a patient’s muscle activity using a probe (Abstract), teaches providing instructions to the operator for obtaining electrical signal data during the EMG data collection operation (Abstract; claims 7 and 8-- verifying the correct placement of said at least two sensors (11) comprises measuring the captured EMG signal and comparing it with threshold values sufficient for assessing a baseline muscle tone measurement, in response to a relaxation exercise, derived from said sensors, and emitting a visual and/or acoustic confirmation or repositioning request signal after measuring and evaluating the captured signal relating to abdominal activity… said repositioning information is carried out with the aid of visual means showing an image of the abdominal area on which the areas where the mentioned sensors (11) must be placed are graphically illustrate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Powell with the displaying of instructions to the operator of Mananas Villanueva in order to predictably improve the ability of the user to perform safe and accurate data collection by ensuring proper placement of the probe.
Regarding claim 11, the combination of Powell and Mananas Villanueva make obvious the method of claim 10. Mananas Villanueva further teaches wherein the instructions are configured to provide the operator with generated EMG data in real time during the EMG data collection operation (Paragraph 0030—signals being recorded with the system at that time can be captured in real time; claims 7-8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Powell with the displaying of instructions to the operator of Mananas Villanueva in order to predictably improve the ability of the user to perform safe and accurate data collection in real time to enable a user to modify their use of the probe as a measurement collection is underway.
Regarding claim 12, the combination of Powell and Mananas Villanueva make obvious the method of claim 11. Powell additionally teaches wherein the instructions are configured to provide the operator with information associated with a need to reposition the probe during the EMG data collection operation (Paragraph 0037, 0056-0057-- impedances may be assessed in each patient for each electrode in each position to achieve less than 5 kOhms (for example), according to some embodiments NOTE: In this case, the probe must clearly be repositioned if each electrode does not achieve less than 5kOhms in order to meet the desired effect). Mananas Villanueva further teaches wherein the operator repositions the distal end of the probe in response to the generated EMG data (claims 7 and 8--verifying the correct placement of said at least two sensors (11) comprises measuring the captured EMG signal and comparing it with threshold values sufficient for assessing a baseline muscle tone measurement, in response to a relaxation exercise, derived from said sensors, and emitting a visual and/or acoustic confirmation or repositioning request signal after measuring and evaluating the captured signal relating to abdominal activity… said repositioning information is carried out with the aid of visual means showing an image of the abdominal area on which the areas where the mentioned sensors (11) must be placed are graphically illustrate). It would have been obvious to one having ordinary skill in the art before the effective filing date to teach wherein the operator repositions the distal end of the probe in response to generated EMG data to predictably improve accuracy and completeness of the generated EMG data by moving the probe when data is indicated to be inaccurate or when data has been sufficiently gathered for a particular area.
Regarding claim 13, the combination of Powell and Mananas Villanueva make obvious the method of claim 11. Powell additionally teaches to provide the operator with information associated with a need to reposition the probe during the EMG data collection operation (Paragraph 0037, 0056-0057-- impedances may be assessed in each patient for each electrode in each position to achieve less than 5 kOhms (for example), according to some embodiments NOTE: In this case, the probe must clearly be repositioned if each electrode does not achieve less than 5kOhms in order to meet the desired effect). Mananas Villanueva further teaches wherein the instructions are configured to provide the operator with information associated with a need to reposition the probe during the EMG data collection operation (claims 7 and 8--verifying the correct placement of said at least two sensors (11) comprises measuring the captured EMG signal and comparing it with threshold values sufficient for assessing a baseline muscle tone measurement, in response to a relaxation exercise, derived from said sensors, and emitting a visual and/or acoustic confirmation or repositioning request signal after measuring and evaluating the captured signal relating to abdominal activity… said repositioning information is carried out with the aid of visual means showing an image of the abdominal area on which the areas where the mentioned sensors (11) must be placed are graphically illustrate). It would have been obvious to one having ordinary skill in the art before the effective filing date to provide instructions configured to provide the operator with information associated with a need to reposition the probe during the EMG data collection operation to predictably improve accuracy and completeness of the generated EMG data by moving the probe when data is indicated to be inaccurate or when data has been sufficiently gathered for a particular area.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of US 20040054392 A1 to Dijkman (cited by Applicant).
Regarding claim 14, Powell discloses the method of claim 22. Powell additionally teaches wherein the probe comprises a distal portion, an intermediate portion, and a proximal portion (see annotated Fig. 3D, below, where C is the distal portion, B is the intermediate portion, and A is the proximal portion of the probe), where at least the proximal portion is configured to allow lead wires to be incorporated (see Fig. 3D, connected to proximal portion).
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However, Powell does not explicitly teach wherein the proximal and intermediate portions are configured as hollow lumens, thereby allowing lead wires or wireless communication transmitter associated with the bipolar sensor to be incorporated in an interior of the probe. Dijkman, in the same field of endeavor of a method for monitoring EMG signals of a patient using a probe (Abstract), teaches wherein the probe comprises the distal portion (Portion indicated by “3” and “5”), an intermediate portion (Portion indicated by “2” which is not covered by the electrodes “5” and including rod “7”), and a proximal portion (Portion indicated by “4”), and wherein the proximal and intermediate portions are configured as hollow lumens (Fig. 2, paragraph 0020, 0023), thereby allowing lead wires (Cores 8 of cable 6, Fig. 2, connect the electrodes 5 to all electrical equipment; Paragraph 0020, 0023) or wireless communication transmitter associated with the bipolar sensor to be incorporated in an interior of the probe (Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the proximal and intermediate portions of the probe hollow to allow lead wires to connect to the electrodes internally in the probe, as taught by Dijkman, to predictably improve flexibility and longevity of the device by avoiding exposure of the lead wires to biological material.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of Chung (“Effect of Sustained Contraction on Motor Unit Action Potentials and EMG Power Spectrum of Human Masticatory Muscles”).
Regarding claim 15, Powell discloses the method claim 22. Powell additionally discloses wherein the probe is in contact with the surface of the membranous area overlying the target tissue (Paragraph 0009-0011-- arranging a plurality of bipolar surface electrodes on the surface of mucosal tissue of a patient each at a predetermined location on tissue, each predetermined location plurality of locations, each location corresponding to a specific muscle and/or muscle layer, wherein each electrode configured to produce first signals responsive to spontaneous EMG activity or abnormal MUP's of the specific muscle/layer; Fig. 3A). However, Powell does not teach the probe is operational to receive EMG signal data for motor unit action potential having a rise time of less than about 500 µS. Chung, in the same field of endeavor of a method for measuring EMG activity of a patient’s muscles (Page 646--we recorded 4 parameters of motor unit action potential before and after a sustained clench, and surface EMG power spectra during the clench), teaches wherein when the probe is in contact with the surface of the membranous area overlying the target tissue, the probe is operational to receive EMG signal data for motor unit action potential having a rise time of less than about 500 µS (Page 647--The motor unit
action potentials selected for assessment required a rise-time less than 0.5 ms. A short motor unit action potential rise-time indicates that the recording electrode is very close to at least one muscle fiber of the motor unit, which ensures that the recording electrode is within the motor unit territory (Kimura, 1989; Stålberg et al., 1996)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Powell to provide a probe which receives EMG signal data when a motor unit action potential has a rise time of less than 500 µS as disclosed by Chung in order to predictably improve the accuracy of the EMG measurements by only measuring action potentials from muscle fibers close to the sensor rather than accounting for action potentials which may be more distal to the sensors and thus not relevant for the target area.
Response to Arguments
Applicant's arguments filed October 03, 2025 have been fully considered but they are not persuasive.
Regarding Powell, the rejection has been updated to reflect the newly amended limitations. Namely, as the art has been interpreted such that the overall device of Powell constitutes a probe and the “curved section 32” constitutes a bipolar sensor including a housing from which electrodes project, Powell may be seen to sufficiently disclose the features noted on Page 10 of applicant’s arguments. While applicant argues that Powell fails to disclose a pair of electrodes in a single sensor, Powell generally discloses “at least one” or “a plurality” of electrodes which may thus encompass a pair of electrodes, and where the section of the probe including these electrodes may serve as the sensor and sensor housing which houses all of the plurality of electrodes.
Applicant additionally argues that Powell cannot be motivated by routine optimization for minimizing an SNR to disclose the claimed limitations of claims 20-21 because “Powell does not disclose a sensor containing more than one electrode”; however, as noted above, the teachings of Powell may be interpreted to have a single sensor which contains multiple electrodes and thus includes spacing which may be accordingly optimized. Furthermore, DeLuca has additionally been cited to disclose the limitations of claims 20-21 in combination with Powell.
Regarding Mananas Villanueva, the reference was cited for the teaching of instructions. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, the rejections have been updated to demonstrate a reasoned explanation to support an obviousness of the combination, wherein Mananas Villanueva has been relied upon to disclose a method of providing feedback regarding a placement of an EMG probe via a display to prompt a user to move the probe when necessary, such that the disclosure of a particular placement in the airway cavity is provided by Powell and is not necessary for Mananas Villanueva to provide to sufficiently teach all of the claimed elements.
Regarding Dijkman, the reference was cited for the teaching of hollow lumens. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As stated in the first office action, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the proximal and intermediate portions of the probe hollow, as taught, by Dijkman, to provide flexibility and avoid exposure of the lead wires to biological material. The rejection has additionally been updated to more clearly define the portions of both Powell and Dijkman. Applicant’s argument that “an electrode pair that projects from the distal end of the housing” “would be unsafe and undermine the benefits associated with Dijkman’s probe” is irrelevant as Dijkman has been relied upon merely to demonstrate that the probe of Powell could be modified to be hollow and to thus include a communications interface in its interior to prevent unnecessary contact of additional elements with biological materials.
Applicant’s arguments with respect to claim(s) 15 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.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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