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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
Prosecution Reopened
Prosecution on the merits of this application is reopened on Claims 57-71 considered unpatentable for the reasons indicated below.
Presently, Claims 57-78 remain pending. Claims 72-78 are withdrawn. Claims 57-71 are hereinafter examined on the merits.
Claim Objections
Claims 57, 67, and 71 are objected to because of the following informalities:
With regard to Claim 57, it is suggested that Applicant adopt spacing and indents to clarify scope of the claim. A suggested amendment to the claim is:
--A conductive device for use with a medical imaging device, the conductive device comprising:
a three-dimensional shape including:
a top surface,
a bottom surface, and
a sidewall extending between the top surface and the bottom surface,
wherein the three-dimensional shape is flexible and formed of a conductive material, and
wherein the three-dimensional shape includes a cavity shaped to receive at least a portion of the medical imaging device.--
With regard to Claim 67, the claim should be re-written as follows:
--A kit comprising:
at least one medical imaging device; and
at least one conductive device comprising a three-dimensional shape including:
a top surface,
a bottom surface, and
a sidewall extending between the top surface and bottom surface,
wherein the three-dimensional shape is flexible and formed of a conductive material, and wherein the three-dimensional shape includes a cavity shaped to receive at least a portion of the at least one medical imaging device.--
.Appropriate correction is required.
With regard to Claim 71, “medical device” should be changed to --medical imaging device--.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 57-59, 66, and 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Maracaja (US 2018/0289355).
With regard to Claim 57, Maracaja discloses in Figs. 1-6 a conductive device for use with a medical imaging device, the conductive device comprising:
a three-dimensional shape including:
a top surface (110),
a bottom surface (112), and
a sidewall (114) extending between the top surface and the bottom surface,
wherein the three-dimensional shape is flexible (Para. [0037], “In certain aspects base 212 can flex to conform to the surface contours of a target. In other embodiments the conducting medium in the chamber or cell extends beyond base 212 and is malleable enough to conform with the surface contours of a target”) and formed of a conductive material (Para. [0037], “The chamber or cell can be filled with a conducting medium that is permissive for sound wave propagation through the chamber or cell. Sound waves can travel from the transducer engaged at connector 210 to base 212 and/or from base 212 to the transducer”), and
wherein the three-dimensional shape includes a cavity (530) shaped to receive at least a portion of the medical imaging device (Para. [0036], “Connector 110 comprises a locking or snapping mechanism that engages an ultrasound transducer and locks the standoff device onto the transducer for operational purposes. In certain aspects the transducer can be removed from the standoff device after use.”).
With regard to Claim 58, Maracaja discloses the device set forth above further comprising an engaging element (locking or snapping mechanism) secured to the top surface, the engaging element adapted to engage the conductive material to the medical imaging device (Para. [0036], “Connector 110 comprises a locking or snapping mechanism that engages an ultrasound transducer and locks the standoff device onto the transducer for operational purposes. In certain aspects the transducer can be removed from the standoff device after use.”).
With regard to Claim 60, Maracaja discloses the device set forth above, wherein the engaging element (locking or snapping mechanism) is a mechanical structure adapted to mechanically connect to the medical imaging device (Para. [0036]).
With regard to Claim 63, Maracaja discloses the device set forth above, wherein the portion of the sidewall forms an acute angle with the bottom surface, and a portion of the bottom surface is offset from a surface area of the top surface and an engaging element (locking or snapping mechanism, Para. [0036]) (see illustration below).
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With regard to Claims 64 and 65, Maracaja discloses the device set forth above, wherein the bottom surface is shaped to correspond to a surface of a target anatomy of an individual patient (Para. [0037], “In certain aspects base 212 can flex to conform to the surface contours of a target. In other embodiments the conducting medium in the chamber or cell extends beyond base 212 and is malleable enough to conform with the surface contours of a target.”).
Claim(s) 57-59, 66, and 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Scully (US 2017/0303894).
With regard to Claim 57, Scully discloses in Figs. 4-7 a conductive device (10) for use with a medical imaging device (110), the conductive device comprising:
a three-dimensional shape including:
a top surface (10t + top surface of 10f),
a bottom surface (bottom surface of floor 10f contacting patient), and
a sidewall (10w) extending between the top surface and the bottom surface,
wherein the three-dimensional shape is flexible and formed of a conductive material, and
wherein the three-dimensional shape includes a cavity (10c) shaped to receive at least a portion of the medical imaging device (see, generally, Figs. 5-7).
With regard to Claim 58, Scully discloses the conductive device set forth above, further comprising an engaging element (adhesive layer) secured to the top surface, the engaging element adapted to engage the conductive material to the medical imaging device (Para. [0110]).
With regard to Claim 59, Scully discloses the device set forth above, wherein the engaging element is an adhesive layer adapted to adhere to the medical imaging device (Para. [0110]).
With regard to Claim 66, Scully discloses the device set forth above, wherein the top surface (10t + top surface of 10f) is shaped to correspond to a distal probe surface of the medical imaging device.
With regard to Claim 67, Scully discloses in Figs. 4-7 a kit comprising:
at least one medical imaging device (110); and
at least one conductive device (10) comprising a three-dimensional shape including:
a top surface (10t + top surface of 10f),
a bottom surface (bottom surface of floor 10f contacting patient), and
a sidewall (10w) extending between the top surface and bottom surface,
wherein the three-dimensional shape is flexible and formed of a conductive material, and wherein the three-dimensional shape includes a cavity (10c) shaped to receive at least a portion of the at least one medical imaging device (see, generally, Figs. 5-7).
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.
Claim(s) 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Maracaja (US 2018/0289355).
With regard to Claims 61 and 62, Maracaja discloses the device set forth above, but lacks a clear disclosure of the conductive device being configured to allow passage of a medical instrument into and through the three-dimensional shape, wherein the conductive device is adapted to allow passage of the medical instrument through both a portion of the sidewall and the bottom surface.
In another embodiment, Maracaja discloses in Figs. 12A-C a device comprising, among other features, a conductive device configured to allow passage (1270) of a medical instrument (marking device) into and through the three-dimensional shape, wherein the conductive device is adapted to allow passage of the medical instrument through both a portion of the sidewall and the bottom surface.
Before the effective filing date of the present application, it would have been obvious to modify Maracaja by providing a passage of a medical instrument through the three-dimensional shape, as taught by the embodiment illustrated in Figs. 12A-C of Maracaja, in order to provide proper positioning of the ultrasound probe.
Claim(s) 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Scully (US 2017/0303894).
With regard to Claims 68 and 69, Scully discloses the kit set forth above, but lacks a clear and explicit disclosure of the at least one conductive device including a plurality of conductive devices, wherein each conductive device of the plurality is adapted to be used with the medical imaging device, and each conductive device of the plurality differs from one another according to size of the conductive device, shape of the conductive device, material of the conductive device, or any combination thereof AND/OR the at least one conductive device includes a plurality of conductive devices and the at least one medical imaging device includes a plurality of medical imaging devices, wherein each conductive device of the plurality is adapted to be used with at least one of the medical imaging devices, and each conductive device of the plurality differs from one another according to size of the conductive device, shape of the conductive device, material of the conductive device, or any combination thereof.
Scully however at least suggests the cavity (10c) having a size and shape that corresponds to a shape of a target end of an ultrasound probe (110), said size and shape being oval and/or having a dimension that is about 2-5x longer than a short dimension thereof, but other sizes and shapes are contemplated (Para. [0126], see also Figs 5, 6, 7A, 7B, 8A, 8B, 9A, 9B, 10A, and 10B). With different shapes and/or dimensions, one of ordinary skill in the art would recognize that there would be different shapes, dimensions, and/or sizes for the conductive devices adaptable to a plurality of different imaging devices.
Accordingly, before the effective filing date of the present application, it would have been obvious to modify Scully to provide a plurality of different conductive devices and/or medical imaging devices, as claimed, in order to increase the number of medical applications for the kit.
Claim(s) 70 and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Scully (US 2017/0303894) in view of Hakkens et al. (WO 2017/216084).
With regard to Claims 70 and 71, Scully discloses the kit set forth above, wherein the at least one conductive device is flexible, but lacks a clear disclosure of the at least one medical imaging device also being flexible, wherein the at least one conductive device and the at least one medical imaging device flex about a common axis or plane such that contact between a contacting surface of the conductive device and a contacting surface of the medical device is maintained in a flexed state.
In an analogous ultrasound field of endeavor, Hakkens et al. discloses in Figs. 8 and 9 wherein at least one medical imaging device (100) is also being flexible (“…the ultrasound probe 100 may be implemented as a flexible mat for confirming to the surface (body) of the subject 200”), wherein the at least one conductive device and the at least one medical imaging device flex about a common axis or plane such that contact between a contacting surface of the conductive device and a contacting surface of the medical device is maintained in a flexed state.
It is herein asserted that the combination of Scully, which teaches a flexible conductive device and Hakkens et al., which discloses a flexible medical imaging device, when combined, would provide flexing about a common axis or plane such that contact between a contacting surface of the conductive device and a contacting surface of the medical device is maintained in a flexed state.
Before the effective filing date of the present application, it would have been obvious to modify Scully, as taught by Hakkens et al., in order to provide image outputs of greater quality.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PASCAL M. BUI-PHO whose telephone number is (571)272-2714. The examiner can normally be reached M-F: 8:30 AM - 5:00 PM EST.
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/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights