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 .
Response to Amendment
The amendments filed 27 March 2026 have been entered. Claims 2-3, 5-16, 18, and 21-22 are pending.
It is noted that the preambles of claims 13-14 appear to have been altered from the previously presented versions of 03 October 2025 without any amendment being indicated; these alterations are taken to be unintentional changes arising from formatting errors and the claims are treated as being the same as the previously presented claims.
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 2 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 2is 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 .
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 2-3, 5-9, 16, 18 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over 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, wherein each of the first and second electrode: a. projects in parallel from a distal end of the housing for a projection length (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), b. has a diameter (Paragraph 0030; Figs. 3A, 3C show first and second diameters; see also optimizing shape in last sentence of Paragraph 0033), and c. has a spacing distance between the first and second electrodes (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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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).
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 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).
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 2-3, 5-9, 16, 18 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of DeLuca (US20090036792A1).
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, wherein each of the first and second electrode: a. projects in parallel from a distal end of the housing for a projection length (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), b. has a diameter (Paragraph 0030; Figs. 3A, 3C show first and second diameters; see also optimizing shape in last sentence of Paragraph 0033), and c. has a spacing distance between the first and second electrodes (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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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).
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 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).
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 27 March 2026 regarding the rejections under 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
Applicant argues that the rejection is improper for failure to set forth the specific term or phrase that is indefinite and why the metes and bounds are unclear.
As noted in the previous office action and above, it is thus 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". While the applicant refers to Ex Parte Kimura, which related to the claim language of “normal pumping operation”, this is not relevant to the limitations at hand as an explanation has been provided—it is not just that “about” has not been defined, but that as a result it is unclear what range of each measurement is encompassed by the claim language. The claims of the instant application recite specific ranges of ratios and distances where the ranges themselves are not actually disclosed in either of the claims or specification, where there is no indication of what range is encompassed by adding the word “about”. Furthermore, unlike “normal pumping operation” of Kimura which could have been defined through accepted meaning in the art as known by one having ordinary skill in the art, “about” may be defined by each individual according to any number of reasons such as manufacturing costs or ability, functional limitations, etc. The applicant refers to their own “consistent usage” of the term as informing a person of ordinary skill in the art how the approximation is intended but none of the recited ranges provides any particular intention of the approximation at all. It is not convincing that merely using the undefined term repeatedly would provide any particular meaning or intention to the term. Applicant cites RAI Strategic Holdings Inc v Philip Morris Products as support, but this decision relates to the written description support of a sub-range within a disclosed range, rather than to the definiteness of an undefined term of degree. While the applicant states that the specified ranges in each claim “are not arbitrary numbers” and refers to paragraphs of the instant specification which relate the stated ranges with atraumatic contact with the muscle tissue and ability to measure electrical activity, it has not been made clear whether “about” with the claimed ranges is intended to refer to any dimension which permits the described functions or if it is intended to refer to a dimension some distance from the claimed range which would also permit the described functions.
The claims remain rejected under 35 U.S.C. 112(b).
Applicant's arguments filed 27 March 2026 regarding the failure of the previous office action to properly address Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argues that the response to previous arguments is “legally insufficient because it refers to nothing more than per se rules derivable from cited case law”.
Applicant appears to be referring to the citation of 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) in response to the applicant attacking individual references of the obviousness-type rejections having multiple references. The previous office action noted in each case why a particular reference was utilized in a given combination which resulted in the applicant’s arguments being irrelevant as in each case the individual reference was attacked for features which were not part of the rejections under 35 U.S.C. 103.
Applicant's arguments filed 27 March 2026 regarding the rejection of the claims under 35 U.S.C. 102 have been fully considered and are persuasive.
As a result, the claims are no longer rejected under 35 U.S.C. 102 and the rejections of the claims have been updated to reflect the amendments to the claims.
Applicant's arguments filed 27 March 2026 regarding the rejection of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant refers to the legal standard for obviousness without referring to any rejection or making any argument.
Regarding the rejection of claims 21-22 over Powell alone, the applicant argues that the interpretation of the claims is improper as it is unreasonably broad with regard to a “bipolar sensor”, which should be interpreted according to the specification as “a paired, two-electrode structure with a defined spatial relationship, intended to operate together”. The applicant further argues that the rejection under Powell has improperly interpreted a claim term to encompass a structure that the specification treats as a distinct and separate component, specifically regarding a transoral probe and a rigid probe as described in paragraphs 0065-0076 of the instant specification. The applicant additionally argues that the drawings of Powell have been incorrectly used to infer actual proportions or dimensions without a specific disclosure regarding the limitation of the electrodes projecting in parallel. The applicant additionally argues that the Powell reference has been misread with respect to the electrodes projecting in parallel. The applicant additionally argues that the rejection using Powell constitutes impermissible hindsight reconstruction. The applicant additionally argues that the use of routine optimization to reject the claimed ranges of dimensions is improper and that the description in the office action of a lack of criticality “signals that no amount of evidence of criticality will suffice”.
With respect to the interpretation of a claim term to encompass distinct and separate components, the argument is not convincing. Applicant’s argument seems to rely upon reading definitions of words which have an established meaning into the claims improperly. There is no reason that the probe and electrode pair as claimed should require structure as described in the specification beyond that which is present in the claim language. The claim language in no way requires a rigid probe or precludes a curved probe from serving as a “probe configured to receive EMG signals… wherein a distal end of the probe comprises a bipolar sensor” and including “an electrode pair” along with the remaining structural limitations. In re Smith refers to improperly construing a claim term so broadly as to include other claim terms which were distinct components; applicant appears to be arguing instead that the description of different probe types in the specification, wherein both probe types are described as including either bipolar or multipolar sensors (See paragraph 0067), should be imparted into the claims to preclude a probe with a bipolar sensor from including a curved, transoral probe. Furthermore, as described above, Powell cites the use of electrodes in pairs, including one pair (e.g. a single bipolar sensor) which operate together under a defined spatial relationship (see paragraphs 0027, 0030, 0033, 0077 of Powell which explicitly recites the use of bipolar electrodes and additionally refers to measurements being made based on differences in signals between electrodes working as a pair) such that it discloses a paired, two-electrode structure with a defined spatial relationship, intended to operate together.
While the drawings have been used to demonstrate the projection of the electrodes in parallel, they have not been used to define precise proportions or particular sizes. The arrows of the annotated Fig. 3B demonstrate the outward projection of the electrodes, according to the described and drawn configuration of the electrodes, any pair of two electrodes positioned on opposite sides of a central axis such that they are positioned at the same point along the curve of the probe would necessarily project in parallel which can similarly be demonstrated by the annotation.
While the applicant points to paragraph 0057 and 0078 to state that the Powell reference has been misunderstood, neither of these paragraphs appears to disclaim the electrodes projecting in parallel. The applicant cites the description of the electrodes as “spherical” and “positioned on the surface of the curved probe” along with the configuration of electrodes and curvature of the probe as seen in Figs. 3A and 3C and described in paragraphs 0057 and 0077-0078 as evidence that Powell does not support the projection of the electrodes in parallel. However, as noted above, the figures demonstrate that any pair of two electrodes positioned on opposite sides of a central axis such that they are positioned at the same point along the curve of the probe would necessarily project in parallel as further supported by paragraph 0033 of Powell which describes that the positions of the electrodes may be optimized for each patient as desired and Fig. 3B shows that a routine placement of an array of electrodes would include electrodes which would project in parallel. While it is true that the unknown radius of curvature of Powell would mean that the sensor projects relative to its local surface normal and thus that electrodes along different lengths of the radius of curvature could not project in parallel, it similarly holds true that electrodes at the same point along the radius of curvature may project in the same direction, in parallel.
Regarding impermissible hindsight reconstruction to construct the claimed structure using Powell, Powell itself recites a bipolar sensor and that the electrodes may comprise bipolar electrodes, as described above.
Regarding the routine optimization of dimensions, while the applicant argues that no evidence was provided regarding why it would have been routine optimization to arrive at the claimed limitation, Powell explicitly describes that the dimensions may be altered as a matter of routine optimization to increase a signal-to-noise ratio, which is described in the instant application as a reason for the particular dimensions to be utilized. As a result, the allegation is not seen as unsupported. Regarding the citation of In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) and the discussion of criticality, the so-called “prebuttal” has been provided not to “[foreclose] Applicant from presenting any evidence to overcome the obviousness rejection” but to demonstrate the current understanding of the instant specification, wherein it does not appear to suggest criticality of the claimed ranges.
Claims 21-22 remain rejected in view of Powell.
Regarding the rejection of claims 21-22 over Powell in view of DeLuca, the Applicant ponders the inclusion of two alternative rejections of Powell. As described in both rejections, Powell does not explicitly disclose and anticipate all of the claimed limitations. Powell alone renders obvious the claimed dimensions, as does Powell in view of DeLuca, where both have been provided in order to promote compact prosecution by demonstrating to the applicant that should the rejection in view of Powell alone be overcome regarding the use of routine optimization to determine the range in dimensions, an alternative rejection in view of Powell in view of DeLuca is also applicable and explicitly discloses dimensions within the claimed ranges. While the applicant argues that the office action has not provided a reasoned basis for the modification, Powell explicitly discloses that the dimensions of the electrodes may be optimized for improved SNR. Applicant additionally argues that the electrode arrangement and dimensions of DeLuca are configured for a flat substrate and could not be used to modify the curved, anatomy-conforming probe of Powell. However, DeLuca describes that the substrate is flexible (Paragraph 0021) such that the substrate may take on a curved shape similar to the curved probe shape of Powell specifically to allow conforming to anatomy. Similarly, while the electrodes of DeLuca project from a bottom of the substrate as pins rather than from the top as spherical electrodes as described by Powell, this positioning is not used in modifying Powell as it is not an electrode dimension that would alter the SNR and would similarly function in that the electrodes are placed on a surface according to the muscle which the electrodes are intended to be placed over. The use of the dimensions of the electrodes of DeLuca would not require a device-breaking redesign of Powell as the design itself would not change at all, only the electrode dimensions in the goal of SNR optimization as described by Powell.
Claims 21-22 remain rejected in view of Powell in view of DeLuca.
Regarding the rejection of claims 10-13, while the applicant argues that the office action relies on impermissible picking and choosing from the secondary reference, it remains to be seen how the modification of Powell, which describes an EMG-equipped probe, with Mananas Villanueva, which describes providing feedback during use of an EMG-equipped probe, in order to provide feedback to one using the EMG-equipped probe of Powell, would require impermissible hindsight. The applicant’s arguments appear to suggest that a rejection under 35 U.S.C. 103 as a whole as improper, as it purports that the extraction of “only those teachings of Mananas Villanueva to fill in the gaps for the recited content that is admittedly missing from Powell’s disclosure” is itself improper, even though if Mananas Villanueva or Powell either taught all of the limitations together there would be no need to discuss obviousness at all. Applicant states that Mananas Villanueva is non-analogous while describing that art may be considered analogous to the claimed invention if a reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem) or if the reference is reasonably pertinent to the problem faced by the inventor; as noted, Mananas Villanueva relates to an invention of an EMG electrode-equipped probe for monitoring muscle activity, such that it is clearly in the same field of endeavor even if addressing a different problem (e.g., the use of the invention of Mananas Villanueva to monitor anal or vaginal cavities rather than an oral cavity as described by Powell). While the applicant argues that the probes themselves have different arrangements of the EMG electrodes, it remains that both inventions describe the monitoring of muscle activity through EMG electrodes and that Mananas Villanueva provides an instruction and feedback system for the EMG electrodes to enable more accurate placement and thus more accurate measurement from the electrodes which would similarly improve the accuracy and ease of use of the EMG-equipped device of Powell.
Regarding the rejection of claim 14, the applicant argues that the prior art fails to provide evidence of motivation to modify Powell with Dijkman and that the obviousness rationale is thus improper and justified only by hindsight. While the applicant cites WL Gore & Associates, Inc. v. Garlock, Inc. as similar, the facts of that particular case relate to a limitation which was improperly described as obvious when a modification to teach the limitation would have been contrary to the knowledge of one having ordinary skill in the art and the modification was in fact taught against by various prior art. The instant claims, in contrast, recite a limitation which is known in the prior art and the advantages of such a modification are predictable even if Powell does not explicitly state a need for such changes. As Dijkman describes that an EMG-equipped probe may be hollow to permit the passage of wires therethrough and to support the flexibility of the probe, it may be seen that modification of the EMG-equipped probe of Powell to include a hollow lumen would be technically feasible, having a predictable result, and with a recognized reason for doing so (e.g., to improve flexibility or longevity).
The claim remains rejected under 35 U.S.C. 103.
Regarding the rejection of claim 15, the applicant argues that the combination of Powell with Chung reflects hindsight reconstruction and is thus improper. The applicant additionally argues that Chung summarizes other prior art references within such that Chung is used as a conduit for additional, uncited references. The applicant further argues that the provided motivation is unsupported and improper.
However, Chung itself discloses receiving EMG signal data for motor unit action potential having a rise time of less than about 500 µS. While Applicant refers to Chung as summarizing other prior art references to be used improperly as a conduit for those uncited references, this “summary” of Chung is used merely to support the motivation to combine the references, where Chung itself provides the teaching of limiting the rise time to less than 500 µS and Chung additionally cites further references as a motivation to use that rise time limit, where such motivation would similarly apply to Powell in its detection of muscle activation through EMG sensing. The “uncited references” are not used as a teaching but as support for motivation to combine, where they demonstrate that it is known in the art that applying the limit of Chung would create a predictable result having a predictable effect (data which is relevant to a particular target muscle area).
The claim remains rejected under 35 U.S.C. 103.
Conclusion
THIS ACTION IS MADE FINAL. 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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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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