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 Objections
Claim 1 objected to because of the following informalities: line 5/6 recites “a ultrasound” and should be changed to “an ultrasound”. Appropriate correction is required.
Claims 2-17 are objected to because of the following informalities: “The system” should be changed to “The assembly”. 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 2, 5-7, 16, and 17 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 2, line 3 recites “ultrasound probe”. However, it is unclear if this is the same or different “ultrasound probe” recited in claim 1. For examination purposes, it shall be considered the same.
Regarding claim 5, line 1 recites “the hydrogel”. There is insufficient antecedent basis for this limitation. For examination purposes, it shall be considered as “a hydrogel”.
Regarding claim 6, line 3 recites “ultrasound probe”. However, it is unclear if this is the same or different “ultrasound probe” recited in claim 1. For examination purposes, it shall be considered the same.
Regarding claim 7, lines 1 recites “the conforming support”. There is insufficient antecedent basis for this limitation. For examination purposes, it shall be considered as “the conforming interface”.
Regarding claim 16 line 1 recites “the base of the gel”. There is insufficient antecedent basis for this limitation. For examination purposes, it shall be considered as “a base of the gel”.
Regarding claim 17, line 2 recites “the hydrogel”. There is insufficient antecedent basis for this limitation. For examination purposes, it shall be considered as “a hydrogel”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 5, 13, 14, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel et al., (US20110087107A1) in view of Valois et al., (US20210212661A1).
Regarding claim 1, Lindekugel teaches a gel pad assembly for ultrasonic imaging systems, the gel pad assembly comprising (figs. 16-18 cap system for ultrasound imaging that includes a hydrogel):
a gel pad (fig. 18A spacer component includes a hydrogel material [0054]);
and a gel pad tray (fig. 18A cap 110 holds the spacer component 118 [0054]), the gel pad tray configured to releasably attach to a handheld ultrasound probe ([0053] the cap is releasably attached to the probe), the gel pad tray configured to hold the gel pad in a fixed position relative to the ultrasound probe and maintain acoustic coupling with a ultrasound transducer when the ultrasound probe is coupled to the gel pad tray (fig. 18A the space component is hole 130 of the cap, of which is attached to probe);
wherein the gel pad extends through an opening in a housing of the gel pad tray, the opening formed by sidewalls of the gel pad tray (fig. 18B the cap has a retention lip within hole 130 so that it holds the spacer component);
wherein the gel pad creates a standoff between a bottom surface of the gel pad and the ultrasound probe (fig. 18B skin contact surface 126 of the spacer component[0054]);
the gel pad tray housing comprising a first engagement component which maintains contact between an acoustic window of the ultrasound probe and the gel pad (fig. 18B engagement features 114 releasably and mechanically attaches cap 110 to probe 12, thereby maintaining contact between the acoustic surface or acoustic window and the spacer component [0054]).
However, Lindekugel is silent regarding the contact sufficient to eliminate air gaps between the gel pad and the ultrasound probe and maintain air gap free contact.
In the same ultrasound field of endeavor, Valois teaches the contact sufficient to eliminate air gaps between the gel pad and the ultrasound probe and maintain air gap free contact ([0033] ultrasound gel pad serves as the interface between the transducers of the probe and the patient to eliminate air pockets)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Lindekugel with the gel pad of Valois, as this would improve the ultrasound interface (see Valois [0040]).
Regarding claim 2, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches a probe connector wherein the probe connector interfaces with the first engagement component of the gel pad tray and interfaces with an ultrasound probe to connect the gel pad tray and ultrasound probe (see annotated fig. 18B, the probe connector is a part of/interfaces with the engagement portion and the ultrasound probe to connect the probe 12 and the probe cap 110)
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Regarding claim 4, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches the gel pad is comprised of a hydrogel (fig. 18A spacer component includes a hydrogel material [0054]).
Regarding claim 5, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches wherein the gel pad is formed by pouring the hydrogel into the gel pad tray housing while the gel pad tray housing is positioned in a form or mold (fig. 18A the resulting gel pad product is taught by the spacer component 118 comprising a hydrogel disposed within the hole 130 of probe cap 110, wherein peripheral lip 128 retains the spacer component 118 within cap 110 by being between cap 110 and probe head 32, [0054]-[0055]; Although Lindekugel does not explitcitly disclose the manufacturing process of the gel pad, the patentability of a product-by-process limitation is determined based on the resulting product, not the process it was made).
Regarding claim 13, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches a sterile bag interface disposed on the gel pad tray (fig. 11 sheath 72 is attached to cap 70 to provide a sterile barrier for the ultrasound probe 10, so the area where the sheath is attached to the cap is the sterile bag interface [0047]).
Regarding claim 14, modified Lindekugel teaches the system of claim 13, wherein Lindekugel further teaches wherein the sterile bag interface is located on the interior surface of the gel pad tray sidewalls (fig. 11 sheath 72 is attached to the interior side walls of cap 70 [0047]).
Regarding claim 15, modified Lindekugel teaches the system of claim 14, wherein Lindekugel further teaches a sterile bag (fig. 11 sheath 72) coupled to the sterile bag interface, wherein the sterile bag allows a transducer to be coupled to the gel pad tray and covered by the sterile bag (fig. 11 the sheath 72 covers probe head 32 which would contain the transducers [0047]).
Regarding claim 17, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches at least one textural feature along at least one sidewall of the gel pad tray providing an attachment location for the hydrogel to form (see annotated fig. 18B, the side walls of the probe are textural and are used to place the lip 128 of the spacer component 118).
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Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel in view of Valois as applied to claim 1 above, and further in view of Wendelken et al., (US20050096547A1).
Regarding claim 3, modified Lindekugel teaches the system of claim 1, but fail to explicitly disclose wherein the standoff is a fixed thickness.
In the same ultrasound field of endeavor, Wendelken teaches wherein the standoff is a fixed thickness ([0003] the standoff pad is 1cm pad, and is the same all around).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Lindekugel with the standoff of Wendelken, as this would allow the clinician to analyze superficial structures (see Wendelken [0003]).
Regarding claim 16, modified Lindekugel teaches the system of claim 1, but fail to explicitly disclose wherein the gel pad is flush with the base of the gel pad tray or extends a fixed distance beyond the base of the gel pad tray.
In the same ultrasound field of endeavor, Wendelken teaches wherein the gel pad extends a fixed distance beyond the base of the gel pad tray. (fig. 12 the gel insert extends a fixed distance beyond the base of the elastic collar 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Lindekugel with the standoff of Wendelken, as this would allow the clinician to analyze superficial structures (see Wendelken [0003]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel in view of Valois as applied to claim 1above, and further in view of Buchalter et al., (US20080200810A1).
Regarding claim 6, modified Lindekugel teaches the system of claim 1, wherein Lindekugel teaches the gel pad tray (fig. 18B probe cap 110)but fails to explicitly disclose a conforming interface disposed on the interior of at least one side of the gel pad tray capable of compressing between the tray and ultrasound probe and conforming to the shape of the ultrasound probe when the gel pad tray is joined to the probe.
In the same ultrasound field of endeavor, Buchalter teaches a conforming interface disposed on the interior of the device capable of compressing between the device and ultrasound probe and conforming to the shape of the ultrasound probe when the gel pad tray is joined to the probe (fig. 3 is the transducer side, and has a conforming interface on the interior comprising a frame 8 [0040]; frame 8 is made of reticulated foam, which would be able to be compressed and conform to the shape of the probe [0036]).
It would have been obvious to modify the interior of the probe cap of modified Lindekugel to include the frame of Buchalter, as this would isolate the gel pad from ambient dirt and air, and further prevents liquid from the gel pad from leaking out (see Buchalter [0018]).
Regarding claim 7, modified Lindekugel teaches the system of claim 6, but fails to explicitly disclose wherein the conforming support comprises a compressible foam with adhesive.
In the same ultrasound field of endeavor, Buchalter teaches wherein the conforming support comprises a compressible foam with adhesive ([0036] Frame 8 is made of elastic foam, and is attached using an adhesive).
It would have been obvious to modify the interior of the probe cap of modified Lindekugel to include the frame of Buchalter, as this would isolate the gel pad from ambient dirt and air, and further prevents liquid from the gel pad from leaking out (see Buchalter [0018]).
Claims 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel in view of Valois as applied to claim 1 above, and further in view of Morgan (US20160128670A1).
Regarding claim 8, modified Lindekugel teaches the system of claim 1, but fails to explicitly disclose wherein the gel pad tray comprises an expandable section disposed along at least one edge of the gel pad tray and locking mechanism wherein the expandable gel pad tray section is movable between a compressed and expanded orientation, wherein the compressed orientation engages the gel pad tray with an ultrasound probe disposed within the gel pad tray and the expanded orientation releases the gel pad tray from the ultrasound probe.
In the same ultrasound field of endeavor, Morgan teaches wherein the gel pad tray comprises an expandable section disposed along at least one edge of the gel pad tray and locking mechanism wherein the expandable gel pad tray section is movable between a compressed and expanded orientation, wherein the compressed orientation engages the gel pad tray with an ultrasound probe disposed within the gel pad tray and the expanded orientation releases the gel pad tray from the ultrasound probe (fig. 5A/5B the top edge of the adaptor 500 can be opened/expanded with the cap 510, wherein it moves between its closed/compressed state and its open/expanded state [0089]-[0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Lindekugel with the locking mechanism of Morgan, as this would improve the ability to handle and control the medium and prevent medium from falling out of the device during a procedure (see Morgan [0036]).
Regarding claim 12, modified Lindekugel teaches the system of claim 1, but fails to explicitly disclose further comprising a groove disposed on first section of the gel pad tray and a mating tab disposed on a second section of the gel pad tray, wherein the mating tab is located within the groove when the first and second sections of the gel pad tray are joined together.
In the same ultrasound field of endeavor, Morgan teaches further comprising a groove disposed on first section of the gel pad tray (fig. 5D recess 540 [0094] ) and a mating tab disposed on a second section of the gel pad tray (fig. 5D latch tab 545 [0094]), wherein the mating tab is located within the groove when the first and second sections of the gel pad tray are joined together ([0094] the latch tab 545 press fits, snaps, or hooks onto the latch recess).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Lindekugel with the locking mechanism of Morgan, as this would improve the ability to handle and control the medium and prevent medium from falling out of the device during a procedure (see Morgan [0036]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel in view of Valois and Morgan as applied to claim 8 above, and further in view of Robles (US20220192635A1).
Regarding claim 9, modified Lindekugel teaches the system of claim 8, but fails to explicitly disclose a sawtooth strip and the locking mechanism comprises a movable tab with an opposing surface to the sawtooth strip, wherein the locking tab is configurable between a locked and unlocked position.
In the same ultrasound field of endeavor, Robles teaches a sawtooth strip (fig. 8 notes 188 [0062]) and the locking mechanism comprises a movable tab with an opposing surface to the sawtooth strip (fig. 8/9 pawl 184 [0062]), wherein the locking tab is configurable between a locked and unlocked position ([0062] pawl 184 can engage the notches 188 and also be released through lever 189).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the probe cap of modified Lindekugel to include the locking mechanism of Robles, as this would secure the assembly to the probe (see Robles [0062]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel in view of Valois as applied to claim 1 above, and further in view of Hall (US20170284971A1).
Regarding claim 10, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches the gel pad tray (fig. 18B probe 110) but fails to explicitly disclose wherein the first engagement component comprises a magnetic surface disposed on the interior of the gel pad tray.
In the same ultrasound field of endeavor, Hall teaches wherein the first engagement component comprises a magnetic surface disposed on the interior of the gel pad tray ([0022] magnetic connection between the base module and the coupling module).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the probe cap of modified Lindekugel to use a magnetic coupling system as taught by Hall, as this would provide for a simple attachment for coupling the module (see Hall [0086]).
Regarding claim 11, modified Lindekugel teaches the system of claim 10, wherein Lindekugel further teaches wherein the first engagement component comprises a raised portion disposed on the interior of the gel pad tray, wherein the raised portion is capable of lockably interfacing with an opposing surface located on a transducer, when the transducer is disposed within the gel pad tray (See annotated fig. 18B).
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Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel in view of Valois as applied to claim 1 above, and further in view of Scully et al, (US 20170303894 A1).
Regarding claim 13, modified Lindekugel teaches the system of claim 1, wherein Lindekugel further teaches the gel pad tray (fig. 18B probe 110) but fails to explicitly disclose a sterile bag interface disposed on the probe.
In the same ultrasound field of endeavor, Scully teaches a sterile bag interface disposed on the probe (figs. 12A/B the external sheath provides a sterile interface between the patient and the probe [0146]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Lindekugel with the sheath of Scully, as this would allow for ultrasound probe couplers that are easy to use and can facilitate compliance and reduce infection rates (see Scully [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
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