DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-2, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hazelwood et al (US20190142337A1; hereinafter, “Hazelwood”), in view of Alam (US20180085573A1).
Regarding claim 1, Hazelwood teaches a probe configured to direct an electrical stimulation to an internal organ of a patient while concurrently directing ultrasound energy to said internal organ of the patient (see Fig. 1, 2B, 2C and 3A-B; "The head unit 111 is configured to support both US imaging and electrical stimulation treatment" [0036]; " some acts may occur in different orders and/or concurrently with other acts or events." [0017]), wherein the probe is in electrical communication with a pulse generator (see Fig. 1, 2B, 2C and 3A-B, electrical communication between probe and electrical stimulation (NIS) components 102),
an ultrasound wave generator (see Fig. 1, 2B, 2C and 3A-B, electrical communication between probe and ultrasound (US) components 104; "The US imaging component 104 can be coupled to a transducer 112 for generating and receiving sound waves in a patient" [0025]),
at least one processor configured to process reflected ultrasound waves (see fig. 2C, ultrasound (US) components 104; "Like a conventional US imaging component, the US imaging component 104 can be configured to include a grayscale or B-mode ultrasonography processor 106 for producing typical US images." [0025]) and
a display (see Fig. 2C, display 118; "The housing 101 can also include a display 118" [0032]),
the probe comprising:
a housing body (see Fig. 1, 2B, 2C and 3A-B);
an ultrasound probe positioned within the housing body, wherein the ultrasound probe comprises a plurality of transmitting elements and a plurality of receiving elements (see Fig. 1, 2B, 2C and 3A-B, ultrasound transducer 112; “transducer 112, such as in the form of a piezo-electric element array” [0037]); and
one or more electrodes coupled to an exterior of the housing body (see Fig. 1, 2B, 2C and 3A-B; par. [0025]);
wherein the one or more electrodes are coupled to the pulse generator using connecting wires (see fig. 2C).
Furthermore, Hazelwood shows wherein each of the one or more electrodes is positioned such that a periphery of each of the one or more electrodes is at least at a some distance from a periphery of each of the plurality of receiving elements (see Fig. 1, 2B, 2C and 3A-B shows that that at least one electrode is positioned at a distance from the ultrasound receiving element), and wherein the one or more electrodes are positioned such that the one or more electrodes do not interfere with ultrasound imaging generating using the plurality of receiving elements (see Fig. 1, 2B, 2C and 3A-B shows that that at least one electrode is positioned at a distance from the ultrasound receiving element which therefor the electrode does not block and interfere with the ultrasound receiving element), but Hazelwood fails to explicitly state that the distance is at least 2 mm. However, it would have been obvious and routine to one of ordinary skill in the art to have the distance to be at least 2 mm because it is held that optimum size or changes in size or shape is obvious to one of ordinary skill in the art.
Furthermore, Hazelwood fails to explicitly teach connecting wires having a thickness ranging from 10 American Wire Gauge (AWG) to 28 AWG.
Alam teaches electrostimulation, electrodes, and connecting wires having a thickness ranging from 10 American Wire Gauge (AWG) to 28 AWG (“gauge of the wire or wires may be 0-40 AWG, preferably 1-38 AWG, more preferably 4-34 AWG” [0103]).
Alam is considered analogous to the claimed invention because they are in the same field of electrostimulation systems. Therefore, 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 invention of Hazelwood with connecting wires having a thickness ranging from 10 American Wire Gauge (AWG) to 28 AWG, as taught by Alam to control and reduce side effects from the electrical stimulation that affect the patient ([0044] of Alam).
Regarding the limitations of claim 1 “...to reduce interference..." is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hazelwood and Alam is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 2, the combination noted above teaches the probe of claim 1.
Hazelwood further teaches wherein the pulse generator is configured to provide an electric current of a predefined amplitude for stimulating the internal organ ("Neuromuscular Interactive Stimulation [(e-stim)] can be used to identify the dysfunctional tissues. In such a configuration, electrical stimulation is provided via electrodes 114" [0058]; "where the parameters for e-stim are modified. Thereafter, the method returns to step 910 for additional stimulation using the new parameters" [0074]).
Regarding claim 10, the combination noted above teaches the probe of claim 1.
Hazelwood further teaches wherein the ultrasound probe is coupled to an ultrasound machine comprising a display screen and a control board ("system 100...can also include a display… the display can be concurrently or alternatively coupled to the US imaging component 104 " [0032]; "The system can also include a user interface 120 with human interface elements (not shown) such as a keyboard or keypad, a pointing selection device, a touchscreen, or any other elements suitable for providing user input to controller 116 for controlling the various components of system 100" [0032]).
Claims 3, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hazelwood et al (US20190142337A1; hereinafter Hazelwood), in view of Alam (US20180085573A1) as applied to the claim 1 above, and further in view of Hanin (US20030178029A1).
Regarding claim 3, the combination noted above teaches the probe of claim 1.
The above relied on combination does not seem teach wherein the one or more electrodes are single-use disposable electrodes.
However, in the same field of endeavor, Hanin teaches an electromyography (EMG) device and electrodes wherein the one or more electrodes are single-use disposable electrodes (“disposable self-adhesive, pre-gelled Ag-AgCl surface electrodes (1 cm in diameter recording area) are used for all measurements” [0070]).
Hanin is considered analogous to the claimed invention because they are in the same field of electrodiagnostics. Therefore, 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 invention of the combination relied upon above with single-use disposable electrodes as taught by Hanin in order for a new set of electrodes can be used for each patient at each visit, to maintain good adhesion to the skin and to minimize noise ([0070] of Hanin).
Regarding claim 9, the combination noted above teaches the probe of claim 1, furthermore, Hazelwood shows at least two electrodes (see par. [0024]).
The above relied on combination does not seem to teach wherein a distance between the one or more electrodes is in a range of 10 mm to 25 mm.
However, in the same field of endeavor, Hanin teaches an electromyography (EMG) device and electrodes wherein a distance between two electrodes is in a range of 10 mm to 25 mm (The inter-mid-electrode distance is 1 cm [0068]).
Hanin is considered analogous to the claimed invention because they are in the same field of electrodiagnostics. Therefore, 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 invention of the combination relied upon above with a distance between two electrodes is in a range of 10 mm to 25 mm as taught by Hanin to increase recording accuracy of the frontalis muscle fibers ([0068] of Hanin).
Regarding claim 11, the combination noted above teaches the probe of claim 1.
The above relied combination does not explicitly teach the probe further comprising an amplifier coupled to the one or more electrodes and configured to process electrical activity of the internal organ.
However, in the same field of endeavor, Hanin teaches an electromyography (EMG) device, electrodes, and further comprising an amplifier coupled to the one or more electrodes and configured to process electrical activity of the internal organ (“The EMG processor has independent isolated channels, each with differential amplifiers” [0069]).
Hanin is considered analogous to the claimed invention because they are in the same field of electrodiagnostics. Therefore, 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 invention of the combination relied upon above with further comprising an amplifier coupled to the one or more electrodes and configured to process electrical activity of the internal organ as taught by Hanin to enhance the signal to noise ratio and minimize electrical noise and 50 Hertz (Hz) artifact interference ([0069] of Hanin).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hazelwood et al (US20190142337A1; hereinafter Hazelwood), in view of Alam (US20180085573A1), in view of Hanin (US20030178029A1) as applied to claim 3 above, and further in view of Van de Pas et al (US 20180368807 A1; hereinafter, “Van de Pas”).
Regarding claim 4, the combination noted above teaches the probe of claim 3.
Hazelwood teaches wherein the one or more single-use electrodes are coupled with the housing body (see Fig. 1, 2B, 2C, 3A-B and 4A, housing 111, electrode #1 114; “the electrode 114 can be removable coupled to the probe 111, mechanically and electrically. This can be performed via one or more clips or other types of fasteners for establishing both mechanical and electrical connections." [0051]).
The above relied on combination does not explicitly teach coupling using adhesive or molded housing.
However, in the same field of endeavor, Van de Pas teaches an ultrasound sound probe and elements coupled with the housing body using adhesive (see Fig. 1; “Localization system 100, that comprises three ultrasound emitters 107 a, b, c, arranged on a frame 110” [0018]; “The frame may be attached to ultrasound imaging probe 101 by various means including a press-fit connection, a snap fit connection, an elastic strap or using an adhesive.” [0020]).
Van de Pas is considered analogous to the claimed invention because they are in the same field of ultrasound systems. Therefore, 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 invention of the combination relied upon above with coupling elements to the housing body as taught by Van de Pas to keep the arranged predetermined, spaced-apart, configuration in position ([0020] of Van de Pas).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hazelwood et al (US20190142337A1; hereinafter Hazelwood), in view of Alam (US20180085573A1) as applied to claim 1 above, and further in view of Berezovsky et al. (BR PI0602186; hereinafter Berezovsky).
Regarding claim 8, the combination noted above teaches the probe of claim 1.
Hazelwood and Alam do not teach wherein the connecting wires further comprise touchproof or Deutsches Institut für Normung (DIN) connecting wires.
However, in the same field of endeavor, Berezovsky teaches electrodiagnostics, electrodes, and connecting wires wherein the connecting wires comprise touchproof or DIN connecting wires ("Used plugs V and VI for the electronic connection is made of brass and bordering on the silver for improving the electrical conductivity (figure 4), but also can be manufactured with plugs the type "Touchproof" for meeting the international regulatory requirements" (p. 9 line 1-4)).
Berezovsky is considered analogous to the claimed invention because they are in the same field of electrodiagnostic systems. Therefore, 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 invention of the combination relied upon above with connecting wires comprised of touchproof or DIN connecting wires to meet the international regulatory requirements (p. 9 line 4 of Berezovsky).
Response to Arguments
Applicant's arguments filed on 06/24/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on pages 4-7, the examiner respectfully disagrees. The Applicant argues that prior art Hazelwood merely shows the presence of stimulation electrodes and an ultrasound transducer within the same probe assembly, and silent regarding any imaging degradation caused by electrode placement and provides no teaching regarding how electrode placement should be selected to preserve ultrasound image quality during simultaneous operation, however, claim 1 does not recite any limitation directed to simultaneous operation between the electrode stimulation and ultrasound image, and does not limit the specific placement of the electrode and ultrasound transducer to help with imaging degradation caused by the electrode placement. The claim 1 limits having each of one or more electrodes at least 2mm from a periphery of each of the plurality of receiving elements of the ultrasound probe, wherein the one or more electrodes are positioned such that the one or more electrodes do not interfere with ultrasound imaging. The claim 1 does not limit how the electrodes do not interfere with the ultrasound receiving elements, and under broadest interpretation the interference can be merely interpreted as the electrode do not block the ultrasound receiving elements. Hazelwood shows wherein each of the one or more electrodes is positioned such that a periphery of each of the one or more electrodes is at least at some distance from a periphery of each of the plurality of receiving elements (see Fig. 1, 2B, 2C and 3A-B shows that that at least one electrode is positioned at a distance from the ultrasound receiving element). Therefore, the examiner maintains that Hazelwood does show wherein the one or more electrodes are positioned such that the one or more electrodes do not interfere with ultrasound imaging generating using the plurality of receiving elements (see Fig. 1, 2B, 2C and 3A-B shows that that at least one electrode is positioned at a distance from the ultrasound receiving element which therefor the electrode does not block and interfere with the ultrasound receiving element).
Furthermore, the Applicant argues that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The examiner notes that prior art Hazelwood shows wherein each of the one or more electrodes is positioned such that a periphery of each of the one or more electrodes is at least at a some distance from a periphery of each of the plurality of receiving elements (see Fig. 1, 2B, 2C and 3A-B shows that that at least one electrode is positioned at a distance from the ultrasound receiving element), therefore, it would have been obvious and routine to one of ordinary skill in the art to have the distance to be at least 2 mm because it is held that optimum size or changes in size or shape is obvious to one of ordinary skill in the art.
Furthermore, the Applicant in middle of page 6 argues that the claim limitation of “ at least 2 mm” is not an arbitrary design choice because during the restriction practice the office recognized distinctions between embodiment in which electrodes are positioned less than 2 mm from the receiving elements and embodiments in which electrodes are positioned 2 mm or more from the receiving elements, the examiner respectfully disagrees. The examiner notes as stated above, prior art Hazelwood shows wherein each of the one or more electrodes is positioned such that a periphery of each of the one or more electrodes is at least at some distance from a periphery of each of the plurality of receiving elements. MPEP states (SEE MPEP 2144.04) if the only difference between the prior art and the claim is a recitation of relative dimensions, and the claimed device would perform the same as the prior art device, then the claim is not patentably distinct. The examiner notes that the obvious statement with regards to the claim limitation of “at least 2 mm” is in view of what is disclosed by prior art Hazelwood. Hazelwood shows that the electrodes and ultrasound receiving elements are separated by a distance, but does not disclose the specific distance, however, the distance may be more than 2mm. Therefore, the examiner maintains that therefore, one of ordinary skill in the art would have found it obvious and routine to one of ordinary skill in the art to have the distance to be at least 2 mm because it is held that optimum size or changes in size or shape is obvious to one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wang et al. (US 2022/0117503) discloses separation between electrode and ultrasound transducer cam be 0.0 cm (see par. [0108]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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