DETAILED ACTION
This Office action is responsive to communications filed on 1/14/2026. Claims 1-20 remain pending. Claims 14-19 are withdrawn. Claims 1-13 & 20 are rejected.
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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-13 & 20 in the reply filed on 01/14/2026 is acknowledged. Claims 1-20 remain pending. Claims 14-19 are withdrawn. Claims 1-13 & 20 are rejected.
Examiners Notes
Applicant is reminded of manner of making amendment in application according to 37 C.F.C. 1.121.(c). The current status of all the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers that includes (withdrawn). See MPEP 714,II,C,(A),
The status of claims 14-19 should be corrected to (withdrawn).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: Claims are improperly presented at ¶000124 within the specification in volitation of 37 CFR 1.75(h) and MPEP 608.01(i). Applicant is required to remove claims from the specification and present claims only in a separate claims section.
The disclosure is further objected to because of the following informalities and should recite:
¶0076, line 5, “that marker [[324]]334”.
¶0085, in lines 3 & 5, “aperture [[740]]734”.
¶0096, line 10, “panel [[330]]panel 1130”.
¶0097, line 15, “corresponding marker [[434]]1234”.
¶0100, line 11, “optical markers [[1236]]2336”.
¶0101, line 6, “markers [[1436]]1434”.
Appropriate correction is required.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1: line 6, “the passive ultrasound detectable marker”.
Claim 2: line 3, “the second passive ultrasound detectable marker”.
Claim 3-4: line 1, “The ultrasound sensing system 1,”. There requires a comma after the preamble.
Claim 6: line 2, “the internal organ”.
Claim 7: line 2 & 5, “the internal organ”.
Claim 7: line 4, “is not optically visible to the second face”.
Claim 10: line 3, “the internal organ”.
Claim 11: lines 2-3, “the internal organ”.
Claim 12: line 2, “flexible and configured to overlie and conform to a tumor”.
Claim 12: line 3, “the internal organ”.
Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-6, 10-13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875).
Claim 1: Schmayahu discloses, An ultrasound sensing system (¶0029, ¶0077-0078, ¶0093, ¶0106-0107, ¶0110, ¶0116, ¶0118) comprising:
an organ conformable panel to be positioned on an exterior surface of an internal organ; and (¶Abstract, ¶0076-0077, ¶0104)
a passive ultrasound detectable marker supported by the organ conformable panel, (¶0076-0077, ¶0093)
-Schmayahu states that the flexible material (organ conformable panel) may comprise “optically transparent or semitransparent material”, ¶0105. While the tracking markers (passive ultrasound detectable marker[s]) are described as “passive fiducials [...] (e.g., ultrasound fiducial, magnetic fiducials, [...])”, ¶0077, wherein the fiducial markers are “recognized on real-time ultrasound scans”, ¶0078, thus identifying them when the system obtains an image to determine their position, ¶Abstract. This indicates that the passive markers and the flexible material are comprised of different materials or materials with distinct physical properties, rather than being the same continuous material.
Schmayahu fails to explicitly disclose the implant having a first acoustic impedance; and the marker having a second acoustic impedance different than the first acoustic impedance.
However, Lewis in the context of automatic ultrasonic localization of implants in a portion of the anatomy, discloses: the implant having a first acoustic impedance; and the marker having a second acoustic impedance different than the first acoustic impedance ([Col 18 l.44-48], ‘receiving echoes from said pulsed ultrasound transducer arising from a difference in an acoustic impedance of a portion of the implanted fiducial marker and an acoustic impedance of a material located near said portion of the implanted fiducial marker’, see also Claim 19 and Claim 24, and ¶Abstract, [Col 3. l.16-23], [Col 3. 46-61]-regarding the passive principles of Lewis’s present invention. The marker relies solely on material properties to reflect externally generated ultrasound waves for detection thereby constituting as a passive ultrasound detectable marker. Lewis further teaches that different materials possess different characteristic acoustic impedances and that these differences are fundamental principles of ultrasound, ¶Abstract, [Col 3. l.16-23], [Col 3. 46-61].)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the organ conformable panel and passive detectable marker of Schmayahu to have different acoustic impedances in view of known teachings of Lewis. The motivation to do this yield predictable results such as improving localization accuracy of an implant with respect to surrounding tissue, as suggested by Lewis, ¶Abstract, [Col.3-4]. The modified combination would disclose the organ conformable panel having a first acoustic impedance; and the marker having a second acoustic impedance different than the first acoustic impedance.
Claim 2: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, wherein the passive ultrasound detectable marker is part of a two-dimensional array of passive ultrasound detectable markers supported by the organ conformable panel, (¶0076-0077, ¶0101, ¶0106, FIG. 2A thru 3B)
Schmayahu fails to disclose: each passive ultrasound detectable marker having an acoustic impedance different than the first acoustic impedance.
However, Lewis in the context of automatic ultrasonic localization of implants in a portion of the anatomy, discloses: each passive ultrasound detectable marker having an acoustic impedance different than the first acoustic impedance. ([Col 18 l.44-48], ‘receiving echoes from said pulsed ultrasound transducer arising from a difference in an acoustic impedance of a portion of the implanted fiducial marker and an acoustic impedance of a material located near said portion of the implanted fiducial marker’, see also Claim 19 and Claim 24, and ¶Abstract, [Col 3. l.16-23], [Col 3. 46-61]-regarding the passive principles of Lewis’s present invention. The marker relies solely on material properties to reflect externally generated ultrasound waves for detection thereby constituting as a passive ultrasound detectable marker. Lewis further teaches that different materials possess different characteristic acoustic impedances and that these differences are fundamental principles of ultrasound, ¶Abstract, [Col 3. l.16-23], [Col 3. 46-61].)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to apply the known teachings of Lewis to the array of passive ultrasound detectable markers of modified Schmayahu. The motivation to do this yield predictable results such as improving localization accuracy of an implant with respect to surrounding tissue, as suggested by Lewis, ¶Abstract, [Col.3-4]. The modified combination would disclose each of the passive ultrasound detectable markers having an acoustic impedance different than the first acoustic impedance.
Claim 4: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, further comprising an adhesive layer on a first face of the organ conformable panel to adhere the organ conformable panel to the exterior surface of the internal organ. (¶0019-0020, ¶0103)
Claim 5: Schmayahu as modified discloses all the elements above in claim 4, Schmayahu discloses, wherein the passive ultrasound detectable marker is optically visible from a second face of the organ conformable panel. (¶0026, ¶0077, ¶0103, ¶0104, ¶0105-0106)
Claim 6: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, wherein the organ conformable panel has a first face to face the exterior surface of the organ and a second face opposite the first face and wherein the passive ultrasound detectable marker is optically visible on the second face. (¶0019-0020, ¶0103) (¶0026, ¶0077, ¶0103, ¶0104, ¶0105-0106)
Claim 10: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, wherein the passive ultrasound detectable marker is shaped (¶0015-0016, ¶0110-0111, ¶0123, ¶0124, FIG. 6) and located to identify a targeted region of the organ for surgical removal (¶0106, ¶0109.
Claim 11: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, wherein the passive ultrasound detectable marker is shaped and located to identify portions of the organ not designated for surgical removal. (¶0104, ¶0106, ¶0109, FIG. 6)
Claim 12: Schmayahu as modified discloses all the elements above in claim 12, Schmayahu discloses, wherein the organ conformable panel is sufficiently flexible so as to overlie and conform to a tumor bulging from the exterior surface of the organ. (¶0077-¶0079, ¶0088, ¶0102-¶0104)
Regarding the limitations of claim 1 “a tumor bulging from the exterior surface of the organ" 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 invention Johnson is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claim 13: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, wherein the tumor is designated for removal by a cutting tool and wherein the organ conformable panel is cuttable by the cutting tool. (¶0077-0079, ¶0102-¶0105, ¶0109)
Claim 20: Schmayahu discloses, An apparatus comprising: (¶0029, ¶0077-0078, ¶0093, ¶0106-0107, ¶0110, ¶0116, ¶0118)
an organ conformable panel having a face to extend across an external surface of an organ, the face comprising: (¶Abstract, ¶0076-0077, ¶0104)
a first portion form a first material; and (¶Abstract, ¶0076-0077, ¶0104)
a second portion formed form a second material. (¶0076-0077, ¶0093)
-Schmayahu states that the flexible material (organ conformable panel) may comprise “optically transparent or semitransparent material”, ¶0105. While the tracking markers (passive ultrasound detectable marker[s]) are described as “passive fiducials [...] (e.g., ultrasound fiducial, magnetic fiducials, [...])”, ¶0077, wherein the fiducial markers are “recognized on real-time ultrasound scans”, ¶0078, thus identifying them when the system obtains an image to determine their position, ¶Abstract. This indicates that the passive markers and the flexible material are comprised of different materials or materials with distinct physical properties, rather than being the same continuous material.
Schmayahu fails to disclose that the first material having a first acoustic impedance; and the second material having a second acoustic impedance different than the first acoustic impedance.
However, Lewis in the context of automatic ultrasonic localization of implants in a portion of the anatomy, discloses: the first material having a first acoustic impedance; and the second material having a second acoustic impedance different than the first acoustic impedance. ([Col 18 l.44-48], ‘receiving echoes from said pulsed ultrasound transducer arising from a difference in an acoustic impedance of a portion of the implanted fiducial marker and an acoustic impedance of a material located near said portion of the implanted fiducial marker’, see also Claim 19 and Claim 24, and ¶Abstract, [Col 3. l.16-23], [Col 3. 46-61]-regarding the passive principles of Lewis’s present invention. The marker relies solely on material properties to reflect externally generated ultrasound waves for detection thereby constituting as a passive ultrasound detectable marker. Lewis further teaches that different materials possess different characteristic acoustic impedances and that these differences are fundamental principles of ultrasound, ¶Abstract, [Col 3. l.16-23], [Col 3. 46-61].)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the first and second material of the first and second portions of modified Schmayahu to have different acoustic impedances in view of known teachings of Lewis. The motivation to do this yield predictable results such as improving localization accuracy of an implant with respect to surrounding tissue, as suggested by Lewis, ¶Abstract, [Col.3-4]. The modified combination would disclose the organ conformable panel having a first acoustic impedance; and the marker having a second acoustic impedance different than the first acoustic impedance.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875), as applied to claim 1, in further view of Marcus et al (US 2018/0110436) in view of Wald et al (US 2022/0125526 A1).
Claim 3: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, further comprising a second passive ultrasound detectable marker supported by the organ conformable panel, (¶0076-0077, ¶0101, ¶0106, FIG. 2A thru 3B)
Schmayahu fails to disclose: the second marker having a third acoustic impedance and the second acoustic impedance different than the first acoustic impedance.
However, Marcus in the context of spatial locational of flexible ultrasound patches discloses, the second marker having a third acoustic impedance and the second acoustic impedance different than the first acoustic impedance. (¶0033, ‘the material used to create the fiducial markers 35 may be any material that has acoustic properties different from those of human tissue. The greater the difference, the more the signal from the fiducial markers 35 will be evident.’; ¶0034, ‘Each fiducial marker 35 that makes up one of these rows may have a unique width. There may also be multiple strips of fiducial markers 35 arranged in columns orthogonal to the rows. Each fiducial marker 35 that makes up one of these columns may have a unique width. The US system may identify the unique width associated with a given row and the unique width associated with a given column at locations where the rows and columns intersect.’; ¶0035, ‘fiducial markers 35 may be arranged as columns orthogonal to the rows, with each fiducial marker 35 in the column having a unique width. The US system may identify the unique width associated with a given row and the unique width associated with a given column.’; ¶0038, ‘The fiducial markers 35 may also be within the same plane, and be made of a material with easily differentiable acoustic impedances so as not to be confused with other materials.’, ¶0067, ‘fiducial markers 35 may work in a passive manner to correlate the US images to fiducial markers only when the fiducial marker 35 is placed invasively within the patient's body.’; ¶0070, ‘the fiducial layer 32 may be constructed from a material that has acoustic properties similar to human tissue.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to apply the known teachings of Lewis to the array of passive ultrasound detectors and organ conformable panel of modified Schmayahu. The motivation to do this yield predictable results such as improving localization accuracy of an implant with respect to surrounding tissue, as suggested by Lewis, ¶Abstract, [Col.3-4]. The modified combination would disclose: the second marker having a third acoustic impedance and the second acoustic impedance different than the first acoustic impedance.
Schmayahu as modified fails to disclose the second marker having a third acoustic impedance different than the second acoustic impedance (i.e., at least one passive ultrasound detectable marker and at least another passive ultrasound detectable marker have different acoustic impedances)
However, Wald in the context of tracking fiducial markers disclose, a third acoustic impedance different than the second acoustic impedance. (¶0134, ‘Different passive fiducial markers may be configured to have unique echogenic properties relative to one or more other passive fiducial markers, such that individual passive fiducial markers can be specifically identified and distinguished from other passive fiducial markers represented in the image data’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the array of passive ultrasound detectors of modified Schmayahu in view of the teachings of Wald for the advantage of providing an improved apparatus being able to be identified and distinguished from other passive fiducial markers in the image data, as suggested by Wald, ¶0134. The modified combination of Schmayahu in view of Lewis in view of Marcus in view of Wald would disclose the second marker having a third acoustic impedance different than the first acoustic impedance and different than the second acoustic impedance.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875), as applied to claim 1, in further view of Salcudean et al (US 2012/0071757 A1).
Claim 7: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu discloses, wherein the organ conformable panel has a first face to face the exterior surface of the organ and a second face opposite the first face and (¶0019-0020, ¶0103) (¶0026, ¶0077, ¶0103, ¶0104, ¶0105-0106)
Schmayahu fails to disclose wherein the passive ultrasound detectable marker is not optically visible the second face, the ultrasound sensing system further comprising an optical marker supported by the organ panel at a location corresponding to the passive ultrasound detectable marker, the optical marker being optically visible from the second face.
However, Salcudean in the context of ultrasound registration discloses: wherein the passive ultrasound detectable marker (fiducials 115, FIG. 1) is not optically visible the second face, the ultrasound sensing system further comprising an optical marker (optical markers 110, FIG. 1) supported by the organ panel at a location corresponding to the passive ultrasound detectable marker, the optical marker being optically visible from the second face. (FIG. 1)
-The ultrasound passive fiducials, ¶0021, are at the interface with the tissue and thus obscured from the camera’s 140 direct line sight by the tissue 135, FIG. 1, thus the passive ultrasound detectable marker is not optically visible to the second face. The second face is disposed at the location of the optical markers 110. The optical markers 110 are supported by the organ panel, 105, at a location that corresponds to the opposite side to the passive ultrasound detectable markers, FIG. 1. The optical markers 110 are visible from the second face as defined by the optical vectors 150 from camera 140, ¶0024.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the organ conformable panel of modified Schmayahu such that it includes optical markers visible form the second face in view of the teachings of Salcudean. The motivation to do this yield predictable results such as improve the visibility of features at tissue surface and localization with respect the ultrasound system as suggested by Salcudean, ¶0038-¶0040. The modified combination would disclose wherein the passive ultrasound detectable marker is not optically visible the second face, the ultrasound sensing system further comprising an optical marker supported by the organ conformable panel at a location corresponding to the passive ultrasound detectable marker, the optical marker being optically visible from the second face.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875), as applied to claim 1, in further view of Nguyen et al (US 2025/0213751 A1).
Claim 8: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu fails to disclose: wherein the organ conformable panel comprises a gel.
However, Nguyen in context of adaptive patches for dynamic organs discloses, wherein the organ conformable panel comprises a gel. (¶Abstract, ¶0006, Claim 1)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the organ comfortable panel of modified Schmayhu to comprise a gel as taught by Nguyen. The motivation to do this yield predictable results such as improving stretchability and bio adhesion to wet tissue through the hydrogen and ionic bonding, as suggested by Nguyen, ¶0134-0135, ¶0145.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875), as applied to claim 1, in further view of Kerr et al (US 2013/0253645 A1).
Claim 9: Schmayahu as modified discloses all the elements above in claim 1, Schmayahu fails to disclose: wherein the organ conformable panel comprises a fabric.
However, Kerr in the context of organ conformable panels discloses, wherein the organ conformable panel comprises a fabric. (¶0003, ¶0034-0035, ¶0045-0046, ¶0050, Claim 1).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the organ comfortable panel of modified Schmayhu to comprise a fabric as taught by Kerr. The motivation to do this yield predictable results such to allow for controlled stretch in specific directions, as suggested by Kerr, ¶0017, ¶0051-0052.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798