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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 15-16 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna et al. (US Patent No. 5,598,845) in view of Tchang et al. (US Pub No. 2018/0263597) and Tomassi et al. (US Pub No. 2015/0305709), as evidenced by Montecalvo et al. (EP 0800 788), or, alternatively, further in view of Montecalvo et al..
With regards to claim 15, Chandraratna et al. disclose a wearable ultrasound probe system comprising:
an ultrasound probe (i.e. “spherical transducer assembly”) comprising a transducer face (i.e. bottom of the spherical transducer assembly) (Abstract; column 4, lines 13-50, referring to the spherical transducer assembly which comprises a spherical shaped, hollow enclosure (6), a top cover (10) and an acoustic transducer means (16) mounted inside the bottom of the enclosure (6), wherein the acoustic transducer means (16) utilizes piezoelectric elements; Figures 2-6);
a coupling medium comprising a gel (20) covering an entirety of the transducer face and is operable to directly contact both the transducer face and the patient to provide an acoustic coupling of the transducer face to the patient (column 5, lines 5-13, referring to the aqueous gel (20) being placed on the skin (21) surface so that the gel (20) is between the transducer assembly and the patient’s body, forming a coupling medium; Figures 3, 5-6); and
a fixture comprising a probe attachment portion (8, 14) (column 4, line 51-column 5, line 4, referring to the ring portion (14) which fits inside a collar (8) which is attached to the top side of the cloth portion (4), wherein the ring portion (14) holds the transducer enclosure (6) in position without further movement after the enclosure portion has been manually adjusted for scanning the patient; Figures 2-6), wherein:
the probe attachment portion is configured to secure to the ultrasound probe (column 4, line 51-column 5, line 4, referring to the inner surface of the ring portion (14) being curved and sized in diameter to fit closely over the outside surface of the transducer enclosure (6), wherein the ring portion (14) inner surface is roughened to provide a friction engagement with the outside surface of the transducer enclosure (6), which is done to ensure the ring portion (14) will hold the transducer enclosure (6) in position without further movement; Figures 2-6);
the fixture (8, 14) is operable to secure the ultrasound probe at a desired position with respect to the patient with the pad (4) between the ultrasound probe and the patient (column 4, line 51-column 5, line 4, referring to the ring portion (14) which fits inside a collar (8) which is attached to the top side of the cloth portion (4), wherein the ring portion (14) holds the transducer enclosure (6) in position without further movement after the enclosure portion has been manually adjusted for scanning the patient; Figures 2-6, which depicts the pad (4) being between the ultrasound probe and the patient (21) along at least one direction).
However, Chandraratna et al. do not specifically disclose that the coupling medium is a pad comprising a first side that is tacky and a second side that is moistened, wherein the second side becomes tacky when moisture is absorbed and/or evaporates, wherein the first side of the pad is operable to be affixed directly to a first of a patient or the transducer face of the ultrasound probe and the second side of the pad that is moistened provides a provisional slidable surface for manipulating the ultrasound probe with respect to the patient.
Further, Chandraratna et al. do not specifically disclose that the fixture further comprises a patient attachment portion, wherein the patient attachment portion is operable to secure to the patient.
Tchang et al. disclose a device for holding an interchangeable ultrasound probe for medical application, wherein the device comprises a base (101) which is arranged for being fixed on a patient’s body (Abstract; paragraph [0067]; Figures 1-2, 10-11). A fastening means (120a, b, c, d; “patient attachment portion”) are attached to the base (101), wherein the fastening means may comprise straps which can be used to fixate the device to the patient (paragraphs [0067], [0072], [0115]; Figures 1, 5).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the fixture of Chandraratna et al. further comprise a patient attachment portion, wherein the patient attachment portion is operable to secure to the patient, as taught by Tchang et al., in order to provide an additional mechanism for fixating the ultrasound probe to the patient (paragraphs [0067], [0072], [0115]), thereby ensuring the ultrasound probe does not move even when the patient moves.
However, the above combined references do not specifically disclose that the coupling medium is a pad comprising a first side that is tacky and a second side that is moistened, wherein the second side becomes tacky when moisture is absorbed and/or evaporates, wherein the first side of the pad is operable to be affixed directly to a first of a patient or the transducer face of the ultrasound probe and the second side of the pad that is moistened provides a provisional slidable surface for manipulating the ultrasound probe with respect to the patient.
Tomassi et al. disclose conductive pads that are disposable, shape-stable lubricous hydrogel couplants that can be used in place of liquid gel couplants in the field of ultrasound, wherein liquid gel couplants have the disadvantage of being messy and necessitating the cleaning of both the test subject and the ultrasound transducer after each use and must be frequently replenishd (Abstract; paragraph [0002]). The conductive pad can comprise of a dual-layer hydrogel (106) which includes a first layer (208) and a second layer (210), wherein the first layer (208) and the second layer (210) can include different or the same hydrogel polymer composition (paragraph [0028]; Figures 1, 2C; further as evidenced by Montecalvo et al. (see pg. 5, lines 4-10 of Montecalvo et al.), a hydrogel sheet increases in tackiness when body moisture are absorbed by the sheet, and thus the hydrogel pad of has the inherent property of becoming tacky when moistened). The first layer (208), which may be coupled to the probe (102), may be configured to be “substantially tackier” than the lubricous second layer (210), which interfaces with the patient’s skin (paragraph [0028]; Figures 1, 2C, note that the first side of the pad is operable to be affixed directly to the transducer face of an ultrasound probe and the pad covers an entirety of the transducer face and is operable to directly contact both the transducer face and the patient to provide an acoustic coupling of the transducer face to the patient). The lubricious surface enables the conductive pad (106) to slide across the surface (104) and the tacky or less lubricious surface enables the conductive pad (106) to remain affixed to the probe (102) as the conductive pad (106) is slid across the surface (104) (paragraph [0026]; Figures 1-2). In other examples, the tacky side of the conductive pad (106) may be placed toward the surface (104; patient surface) and the lubricious surface of the conductive pad (106) is toward the probe (102) such that the conductive pad (106) remains in place on the surface (104) as the probe (102) slides across the lubricious surface of the conductive pad (106) (paragraph [0029]; Figures 1-2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the coupling medium of Chandraratna et al. be a pad comprising a first side that is tacky and a second side that is moistened, wherein the second side becomes tacky when moisture is absorbed and/or evaporates, wherein the first side of the pad is operable to be affixed directly to a first of a patient or the transducer face of the ultrasound probe and the second side of the pad that is moistened provides a provisional slidable surface for manipulating the ultrasound probe with respect to the patient, as taught by Tomassi et al., in order to avoid the disadvantages of using a gel coupling medium, which includes being messy and necessitating the cleaning of both the test subject and the ultrasound transducer after each use and the need to be frequently replenished (Abstract; paragraph [0002]).
With regards to the limitation concerning the “second side that is moistened, wherein the second side becomes tacky when moisture is absorbed and/or evaporates”, alternatively, if it is not clear that the hydrogel material of the above combined references has this inherent property, Montecalvo et al. disclose a flexible, ultrasonic biomedical couplant hydrogel pad/sheet that increases in tackiness when body moistures are absorbed by the sheet (pg. 5, lines 4-10).
Therefore, alternatively, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the hydrogel material of the second side of the pad of above combined references with a hydrogel material that has a second side that is moistened, wherein the second side becomes tacky when moisture is absorbed and/or evaporates, as the substitution of one known hydrogel material for another yields predictable results (i.e. providing an effective coupling medium) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Further, with regards to the limitations concerning “and a second side that is moistened, …the second side that is moistened provides a provisional slidable surface for manipulating the ultrasound probe with respect to the patient”, though the above limitation is met by the above combined references, it should be noted that the limitations are directed to an intended use and/or manner of operating the claimed apparatus/probe system. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the “second side” of the above combined references comprises of a hydrogel pad, the second side is capable of being moistened (such as by body moisture or applied moisture by a user) and further is capable of providing a provisional slidable surface for manipulating the ultrasound probe when moistened as hydrogels have the inherent property of providing a slidable surface when moistened due to the natural lubricity of hydrogel [as evidenced by Montecalvo et al., see above description of Montecalvo et al.], and thus the above combined references meet the above limitations.
With regards to claim 16, as discussed above, the above combined references meet the limitations of claim 15. With regards to the limitation that “the moisture of the second side of the pad is absorbed and/or evaporates to adhere the second side to a second, opposite the first of the patient of the patient or the transducer face of the ultrasound probe”, the limitation is directed to an intended use and/or manner of operating the claimed apparatus/probe system. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the second side of the pad of the above combined references comprises of a hydrogel, which has the inherent property of increasing in tackiness/stickiness when moisture is absorbed and/or evaporated, the second side of the pad of the above combined references has the capability of adhering the second side to a second, opposite the first, of the patient or the ultrasound probe.
With regards to claim 24, Tchang et al. disclose that the system further comprises one or more straps attached to the fixture, wherein the straps are operable to secure the fixture to the patient; and/or an adhesive tape attached to the fixture and the patient, wherein the adhesive tape is operable to secure the fixture to the patient (paragraph [0067], referring to the fastening means (120 a,b,c,d) being straps; Figures 1, 5).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna et al. in view of Tchang et al. and Tomassi et al., as evidenced by Montecalvo et al., or, alternatively, further in view of Montecalvo et al., as applied to claim 15 above, and further in view of Shoudy et al. (US Pub No. 2022/0361844).
With regards to claim 23, as discussed above, the above combined references meet the limitations of claim 15. However, the above combined references do not specifically disclose that the system further comprises visual indicators integrated on the ultrasound probe, the visual indicators comprising a display device and/or light emitting diodes configured to present feedback for manipulating the ultrasound probe to the desired position with respect to the patient; a display system communicatively coupled to the ultrasound probe, the display system configured to present the feedback for manipulating the ultrasound probe to the desired position with respect to the patient;a speaker configured to output audible tones to provide the feedback for manipulating the ultrasound probe to the desired position with respect to the patient; and/or a haptic device embedded within the ultrasound probe and configured to vibrate to provide the feedback for manipulating the ultrasound probe to the desired position with respect to the patient.
Shoudy et al. disclose probe positioning structures that allows the device to be used repeatedly to target the anatomic region, wherein the system (10) guides the user using optical, audible, and/or haptic feedback or cues to move the probe (14) in the x- and y- dimensions relative to the acoustic window (180) to obtain alignment with the target region (Abstract; paragraph [0060]). For example, a binary yes/no or the feedback via providing beeping faster or louder (or similar visual feedback) may be used to indicate if the user gets closer to the aligned position (paragraph [0060], note that it is inherent that such visual feedback would inherently require a display and such audible feedback using “beeps” would inherently require a speaker).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the system further comprises visual indicators integrated on the ultrasound probe, the visual indicators comprising a display device and/or light emitting diodes configured to present feedback for manipulating the ultrasound probe to the desired position with respect to the patient; a display system communicatively coupled to the ultrasound probe, the display system configured to present the feedback for manipulating the ultrasound probe to the desired position with respect to the patient; a speaker configured to output audible tones to provide the feedback for manipulating the ultrasound probe to the desired position with respect to the patient; and/or a haptic device embedded within the ultrasound probe and configured to vibrate to provide the feedback for manipulating the ultrasound probe to the desired position with respect to the patient, as taught by Shoudy et al., in order to obtain alignment with the target region (paragraph [0060]).
Allowable Subject Matter
Claim 25 is allowed.
Claims 17-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claims 17 and 25, the prior art does not teach or suggest a snap-on assembly operable to affix the pad directly to the transducer face of the ultrasound probe, the snap-on assembly comprising an upper ring comprising an inner side and an outer side, the upper ring defines an aperture extending through the upper ring, the aperture comprising an upper end and a lower end, wherein the upper end is configured to receive the ultrasound probe and wherein the pad has an outer perimeter portion affixed to the outer side of the upper ring and covering the lower end of the aperture in the upper ring, in combination with the other claimed elements.
The dependent claims are indicated allowable due to their dependency.
Response to Arguments
Applicant’s arguments with respect to claim(s) 15-16 and 23-24 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. Tomassi has been introduced to teach a pad comprising a first side that is operable to be affixed directly to a first of a patient or the transducer face of the ultrasound probe, etc..
With regards to claims 17 and 25, Applicant’s arguments, see pg. 31, filed February 13, 2026, with respect to claims 17 and 25, have been fully considered and are persuasive. The rejection of claims 17-22 and 25 has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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