DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 January 2026 has been entered.
Response to Arguments
Applicant’s argument on Page 8 regarding the objection to Claim 1 has been fully considered. The objection is withdrawn in view of the amendments.
Applicant’s argument on Pages 8-10 regarding the rejection of Claim 1 under 35 U.S.C. 103 over Hansen in view of Cermak has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 10 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Claim Objections
Claims 4-5, 8-9, and 23-24 are objected to because of the following informalities: minor error in antecedent basis. The claims should be amended to “[…] the one or more elastic securing component […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-14, 17, 19, 23-29, and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “optionally allow for needle or injectable device insertion” renders the claim indefinite. It is unclear if needle or injectable device insertion is required of the system. For purposes of applying prior art, it is interpreted that needle or injectable device insertion is required, as in Fig. 10 and Claims 1 (Line 6), 18, and 29.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Regarding Claim 5, it is unclear how the one or more [elastic] securing component can be both allowing for slidable engagement with the ultrasound transducer (Claim 1) and comprise one or more of a band, a clip, a strap, or an adhesive (Claim 5), which would necessitate limited/non-slidable engagement (unlike a track feature). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4-5, 7, 9, 19, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20210259662) in view of Bappoo et al. (WO 2022221913), cited from its respective US Patent Application Publication, US 20240180523.
Regarding Claim 1, Yang teaches a system for affixing an ultrasound transducer to a patient, (Fig. 1 and [0025] “scanning system 100”), the system comprising:
a) one or more base component, (Fig. 1 and [0025] “a probe 110 operating on a track structure 120, a track stand 130”) defining an aperture, (Fig. 1 and [0028] “track frame 124”), wherein the one or more base component is configured to be removably affixed to the patient near or adjacent to a target patient anatomy, (Fig. 1 and [0079] “positioning the track system […] track stand 130 may be clipped, screwed, clamped, or latched onto track structure 120 and positioned over the necessary area of patient.”);
b) the ultrasound transducer, wherein the ultrasound transducer is configured for a user of the system to one or more of move, position, re-position, orient, or re-orient, the ultrasound transducer within the aperture of the one or more base component, ([0028] “Probe holder 122 may secure probe 110 in track structure 120 and advance probe 110 along a linear path of a track 126 in track frame 124. Probe holder 122 may slide or move along track 126.”), and wherein the system is configured for the user to choose or select where to couple the ultrasound transducer to one or more of one or more elastic securing component, the patient, a patient contact surface, or the target patient anatomy ([0061] “a technician may select an appropriate track stand 130 for scanning system 100 to be used over a particular area of interest (e.g., a patient's abdomen, an arm, a leg, etc.). The technician may attach track stand 130 to the track structure 120, secure probe 110 to probe holder 122, and position scanning system 100 on/over the patient.”); and
c) the one or more elastic securing component, wherein the system is configured for removable attachment of the ultrasound transducer directly or indirectly to the one or more elastic securing component, ([0031] “The operator installs probe 110 in the probe holder 122”), wherein the ultrasound transducer is slidably engageable with the one or more elastic securing component, ([0028] “Probe holder 122 may slide or move along track 126.”), and wherein the one or more elastic securing component is configured to (a) substantially maintain contact of said ultrasound transducer with one or more of the patient, the patient contact surface, or the target patient anatomy, (Fig. 1), and (b) allow for movement or adjustment of the ultrasound transducer in at least two different planes, axes, or combinations thereof, within the aperture and across the patient contact surface, (Fig. 1, [0028] “Probe holder 122 may slide or move along track 126,” and [0039] “Height controller 215 may include instructions to control vertical movement of probe holder 122.”).
However, Yang does not explicitly teach wherein the aperture includes a patient-facing opening and a user-facing opening such that the aperture provides user access to insert a needle, or an injectable device, through the aperture, into the patient, and into or towards the target patient anatomy, and wherein the one or more elastic securing component is configured to optionally allow for needle or injectable device insertion into the patient at any location within the aperture when the ultrasound transducer is detached from the one or more securing component.
In an analogous portable ultrasound device field of endeavor, Bappoo teaches a system for affixing an ultrasound transducer to a patient, the system comprising:
a) a patient-facing opening and a user-facing opening such that the aperture provides user access to insert a needle, or an injectable device, through the aperture, into the patient, and into or towards the target patient anatomy, (Figs. 1 and 3 and [0141] “The user can then conveniently proceed to inserting a needle or cannula through an insertion notch 310 at the base 102A of the portable ultrasound device 109, without needing to hold it in place.”), and
b) wherein the one or more elastic securing component is configured to optionally allow for needle or injectable device insertion into the patient at any location within the aperture when the ultrasound transducer is detached from the one or more securing component (The notch 310 is located physically on the portable ultrasound device 109, meaning that, when detached from fastening means 107, interpreted as the elastic securing component, the needle may still be inserted, see Figs. 1 and 3.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Yang with the aperture for the needle of Bappoo provided directly on the probe because the modification allows for an easier process for a user to insert a needle into the patient by providing accurate positioning for needle insertion.
Regarding Claim 4, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, Yang teaches wherein the one or more securing component is in operable communication with a positioning apparatus, the positioning apparatus configured to be manipulable by the user to substantially maintain, or optionally set, an ultrasound transducer angulation relative to the target patient anatomy ([0060] “legs 606 may include height adjustors to allow the angle of track structure 120 to allow frame 124 of track structure 120 to be mounted at a preferred orientation”).
Regarding Claim 5, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, Yang teaches wherein the one or more securing component comprises one or more of a band, ([0059] “track stand 130 may include a pair of hoops 604 which wrap around the limb and attach to track structure 120.”), a clip, a strap, or an adhesive.
Regarding Claim 7, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, Yang teaches wherein the one or more elastic securing component comprises at least one elastic securing component having a first end connected to a first location of the one or more base component and having a second end connected to a second location of the one or more base component, (Fig. 1, there are two legs of track stand 130, each end of track frame 124 and probe holder 122 are attached to.), wherein the at least one elastic securing component traverses the aperture between the first location and the second location, such that the directly or indirectly attached and slidably engageable ultrasound transducer is movable within the aperture while maintaining patient contact with or near the patient contact surface, the target patient anatomy, or both (Fig. 1, the combined component of the probe 110 and probe holder 122 slide along track frame 124 that forms track 126 between each end of the track stand 130.).
Regarding Claim 9, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, Yang teaches wherein the one or more securing component is physically integrated with a probe sheath, ([0028] “probe holder 122”), or a drape.
Regarding Claim 19, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, Yang teaches a cable connected to the ultrasound transducer, wherein the cable is oriented relative to one or more of the ultrasound transducer and the one or more base component, to at least one of minimize a vertical profile of the ultrasound transducer relative to the patient contact surface or the target patient anatomy, stabilize one or more of the ultrasound transducer and the one or more base component, and maximize procedure access around a base of the ultrasound transducer (Fig. 1, which shows the cable 144 on the probe 110 minimizing a vertical profile of the ultrasound transducer relative to the patient contact surface or the target patient anatomy, stabilizing one or more of the ultrasound transducer and the one or more base component, and maximizing procedure access around a base of the ultrasound transducer.).
Regarding Claim 27, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, Yang teaches wherein an orientation of the ultrasound transducer and two-dimensional ultrasound image data is processed by a computer processor to form a volumetric three-dimensional ultrasound dataset to formulate a visualization of the target patient anatomy ([0029] “Base unit 140 can acquire regularly spaced 2D ultrasound frames that can be collected and integrated into a 3D ultrasound volume via a reconstruction process” and [0054] “probe holder 510 may adjust and monitor a height (H) of probe holder 510 relative to frame 520, along with the linear position (L) within track frame 520. The height and linear position may be collectively referred to as location information. The location information may be used when constructing the 3D volumetric image data from 2D ultrasound scans.”).
Regarding Claim 28, the modified system of Yang teaches all limitations of Claim 27, as discussed above. Furthermore, Yang teaches wherein the orientation of the ultrasound transducer is used by the computer processor to relate a location of a two-dimensional ultrasound scan plane to the user relative to an anatomical reference comprised of at least one of an ultrasound dataset or a reference model of the target patient anatomy (Fig. 1 and [0030] “Base unit 140 includes a display 142 to allow an operator to view processed results from an ultrasound scan, and/or to allow operational interaction with respect to the operator during operation of probe 110. For example, display 142 may include an output display/screen, such as a liquid crystal display (LCD), light emitting diode (LED) based display, or other type of display that provides text and/or image data to an operator. For example, display 142 may provide artifact visualizations overlaid on B-mode images to help determine the quality/accuracy of an ultrasound scan. Display 142 may also display two-dimensional or three-dimensional images of the selected anatomical region.”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20210259662) in view of Bappoo et al. (WO 2022221913), cited from its respective US Patent Application Publication, US 20240180523, as applied to Claim 9 above, further in view of Hansen (WO 2021236348.
Regarding Claim 10, the modified system of Yang teaches all limitations of Claim 9, as discussed above. However, the modified system of Yang does not explicitly teach wherein the probe sheath or the drape completely or partially cover the ultrasound transducer to substantially maintain a sterile field.
In an analogous ultrasound-based intravascular placement guide structure field of endeavor, Hansen teaches a system for affixing an ultrasound transducer to a patient, (Abstract “A guide structure (10) is configured for placement on a patient’s skin and holding a medical probe (61) for adjustable positioning over the patient’s skin during vascular line placement.”), wherein the probe sheath or the drape completely or partially cover the ultrasound transducer to substantially maintain a sterile field (Figs. 1A and 1B and [0056] “guide structure 10 is made of medical grade materials to facilitate sterilization of guide structure 10 prior to use.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Hansen because this prevents harm to the patient undergoing treatment.
Claims 18 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20210259662) in view of Bappoo et al. (WO 2022221913), cited from its respective US Patent Application Publication, US 20240180523, as applied to Claim 9 above, further in view of DeSilets et al. (US 20180303693).
Regarding Claim 18, the modified system of Yang teaches all limitations of Claim 1, as discussed above. However, the modified system of Yang does not explicitly teach wherein the one or more base component further comprises or is attached to a drape for covering all or a portion of a patient's body nearby or adjacent to a location where the needle, or the injectable device is to be inserted into the patient.
In an analogous patient positioning field of endeavor, DeSilets teaches a system, (Abstract “A system for positioning a patient before, during or after a medical procedure”), for affixing an ultrasound transducer to a patient, ([0131] “ultrasound probes,” where one of ordinary skill in the art would understand that an ultrasound probe comprises an ultrasound transducer), wherein the one or more base component further comprises or is attached to a drape for covering all or a portion of a patient's body nearby or adjacent to a location where the needle, or the injectable device is to be inserted into the patient ([0131] “The fastener components 2105A-D hold the objects in place, including objects that may pass through the surgical opening 2104. The objects may include surgical instruments or surgical tools that are required for a surgical procedure. These surgical instruments or surgical tools may include, for example, including but not limited to, […] mechanical devices like […] ultrasound probes. The fastener components 2105A-D may secure portions of those objects,” where the portion for needle insertion is taught by Zijlstra.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the drape of DeSilets because proper positioning of a patient prior to any medical procedure can be important, as taught by DeSilets in [0002], and the modification ensures sterilization of the treatment site while maintaining proper positioning of the patient.
Regarding Claim 32, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, DeSilets teaches wherein the one or more base component comprises or is integrated into a procedural drape ([0131] “The fastener components 2105A-D hold the objects in place, including objects that may pass through the surgical opening 2104. The objects may include surgical instruments or surgical tools that are required for a surgical procedure. These surgical instruments or surgical tools may include, for example, including but not limited to, […] mechanical devices like […] ultrasound probes. The fastener components 2105A-D may secure portions of those objects”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of DeSilets because proper positioning of a patient prior to any medical procedure can be important, as taught by DeSilets in [0002], and the modification ensures sterilization of the treatment site while maintaining proper positioning of the patient.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20210259662) in view of Bappoo et al. (WO 2022221913), cited from its respective US Patent Application Publication, US 20240180523, as applied to Claim 1 above, further in view of Geelen et al. (US 20200015780).
Regarding Claim 23, the modified system of Yang teaches all limitations of Claim 1, as discussed above. However, the modified system of Yang does not explicitly teach one or more sensor for measuring an absolute or a relative orientation of the ultrasound transducer relative to at least one of the one or more base component, the one or more securing component, the patient contact surface, or the patient anatomy.
In an analogous ultrasound probe arrangement field of endeavor, Geelen teaches a system for affixing an ultrasound transducer to a patient, (Abstract “An ultrasound probe is carried by the probe carrier and makes contact with the surface, e.g. skin. This arrangement enables the probe to be held in a desired orientation so that a clinician can work hands-free.”), comprising one or more sensor for measuring an absolute or a relative orientation of the ultrasound transducer relative to at least one of the one or more base component, the one or more securing component, the patient contact surface, or the patient anatomy ([0084] “a position sensor arrangement for sensing the relative position between the holder 18 and the housing 14. The positioning system is used to track the orientation angles of the ultrasound probe.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the sensor of Geelen because when the probe is stationary for long periods of time, a sensor is able to detect in real-time if the probe has unintentionally moved, disrupting the procedure, as taught by Geelen in [0120].
Regarding Claim 24, the modified system of Yang teaches all limitations of Claim 23, as discussed above. Furthermore, Geelen teaches wherein at least one of the one or more sensor is disposed within a housing of the ultrasound transducer, ([0122] “One orientation sensor may be attached to the housing”), and wherein at least one of the one or more sensor is disposed within at least one of the one or more base component or the one or more securing component ([0122] “One orientation sensor may be attached to the housing, and a second to the probe carrier.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the sensor of Geelen for the same reasons as Claim 23, as discussed above.
Claims 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20210259662) in view of Bappoo et al. (WO 2022221913), cited from its respective US Patent Application Publication, US 20240180523, as applied to Claim 1 above, further in view of McGrath et al. (US 20210228186)
Regarding Claim 26, the modified system of Yang teaches all limitations of Claim 1, as discussed above. However, modified system of Yang does not explicitly teach wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays and a longitudinal slot, the two ultrasound transducer arrays disposed on opposing sides of the longitudinal slot.
In an analogous medical imaging using multiple arrays field of endeavor, McGrath teaches a system for affixing an ultrasound transducer to a patient, ([0172] “a device 10 of the present disclosure includes generally three components—a housing 100, a base 200, and an inserter assembly 300” and [0173] “The base 200 provides for positioning and securing the device adjacent to the skin surface of a patient.”), wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays, (Fig. 50), and a longitudinal slot, ([0294] “slot 1510’”), the two ultrasound transducer arrays disposed on opposing sides of the longitudinal slot (Fig. 50).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the dual-array probe of McGrath because the modification allows for surgical procedures (or needle insertion) while the transducer array is placed on the target body zone, as taught by McGrath in [0294].
Regarding Claim 29, the modified system of Yang teaches all limitations of Claim 1, as discussed above. Furthermore, McGrath teaches wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe with dual-arrays, (Fig. 50), disposed on opposing sides of a longitudinal slot, ([0294] “slot 1510’” and Fig. 50), and wherein the longitudinal slot and imaging generated by the dual-arrays provide in-plane guidance for insertion of the needle, or the injectable device into an insertion cavity of the patient ([0009] “The present disclosure generally relates generally to visualization techniques associated with devices used in medical procedures. In particular, the present disclosure relates to such devices that can perform a variety of functions including, for example, locating potential intravenous puncture sites on the patient, navigating and manipulating a needle or cannula to the located puncture site (which may include fine-tuning or auto-correction of the position and/or trajectory of a manually or semi-manually inserted needle or cannula through target and/or needle stabilization), and moving the needle or cannula into and through the puncture site to a desired location within a circulatory system of the patient.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the dual-array probe of McGrath because the modification allows for surgical procedures (or needle insertion) while the transducer array is placed on the target body zone, as taught by McGrath in [0294].
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20210259662) in view of Bappoo et al. (WO 2022221913), cited from its respective US Patent Application Publication, US 20240180523, as applied to Claim 1 above, further in view of Zijlstra (US 20220039829).
Regarding Claim 25, the modified system of Yang teaches all limitations of Claim 1, as discussed above. However, the modified system of Yang does not explicitly teach wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays.
In an analogous vascoscope field of endeavor, Zijlstra teaches a system for affixing an ultrasound transducer to a patient, (Claim 1 “A device for assisting entry of a needle comprising a probe comprising at least one array of n*m ultrasound electro-acoustical elements” and Figs. 1a-d, 3a), wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays ([0048] “the array of electro-acoustical elements 11 may comprise n*m electro-acoustical elements, wherein n∈[1,10] and m∈[2,210], and optionally at least one second array of electro-acoustical elements located under an angle of 45-90° with respect to the at least one first array of electro-acoustical elements, such as in the form of a (combined) T or X” and [0051] “the present device may comprise at least one array of first electro-acoustical elements, and/or may comprise at least one array of second electro-acoustical elements.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Zijlstra because the modification of a dual-array ultrasound probe reduces interference, provides real-time imaging, and has quality resolution, which are advantages in the insertion procedure and tracking the inserted devices within the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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