DETAILED ACTION
This Office action is responsive to communications filed on 04/28/2026. Claims, 1-7, 10-12, 20-29 are amended. Claims 8-9, 13-19 are canceled. Claims 21-29 are newly added. Presently, Claims 1-7, 10-12, 20-29 remain pending and are hereinafter examined on the merits.
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 .
Response to Arguments
Previous claim objections are withdrawn in view of the amendments filed on 04/28/2026
Previous specification object regarding the violation of 37 CFR 1.75(h) and MPEP 608.01(i) is maintained. See ¶000124 which includes numbered provisions presented in formal claim structure, including expression of dependence from and referring to other formal claim structures. Although the specification characterizes these as “definitions” there substantive form and operation argue otherwise, and are those of patent claims. Correction is required by deleting these claims from the specification or rewriting them as ordinary descriptive disclosure that does not purport to claims.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on 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) for Claims 1-2, 4-6, 10-13, and 20; 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) for claim 3; 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) for claim 7 applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The new grounds of rejection now relies on the following:
Claims 1, 23-25, & 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salcudean et al (US 2012/0071757 A1).
Claims 2, 4-7, 10-12, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1), as applied to claim 1, in further view of Shmayahu et al (US 2022/0323158 A1).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1), as applied to claim 1, in further view of Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1) in view of Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1), as applied to claim 1, in further view of Marcus et al (US 20180110436 A1).
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.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 20, “second portion[[s]]”. Appropriate correction is required.
Claim 26, after the preamble there is a missing a comma. A comma is needed after preambles.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 10-12, 20-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites:
“perform a registration by registering optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor with locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor while within the body.”
Claim 20 recites:
“perform a registration by registering optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor with locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor while within the body.”
Claim 22 recites:
“wherein the controller is configured to register the optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor in real time with the locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor in real time.”
Claim 23 recites:
“wherein the controller is further configured to superimpose the optical data captured by the optical sensor and the ultrasound data captured by the ultrasound sensor based upon the registration.”
Claim 24 recites:
“wherein the controller is configured to perform the registration by registering the optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor in real time with the locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor in real time.”
Claim 25 recites:
‘wherein the controller is configured to perform the registration by registering the optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor in real time with the locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor in real time.”
The claim is rejected under 35 USC § 112(a) for a lack of written description. Proper written description cannot be identified in the specification, claims, and drawings directed the full scope of the steps of the registration. The specification does not provide a specifical algorithmic approach or reasonably demonstrate/provide the operational computation of the particular manner of producing the desired results via the registration. The specification performs this registration with a high-level of functional description of the process rather than the underlying algorithmic steps. In addition, there is no computational flow of how the software achieves this registration as claimed.
An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). This can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015), see MPEP § 2161(I).
These limitations are computer/processor-implemented functional claim limitation as it is directed to a processor-controlled algorithm configured to execute alignment of the optical and ultrasound marker locations. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
Consequently, one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended to achieve the aforementioned features of the registration of the above noted claims. In addition, asserting that methods such as subtraction method could have been used does not demonstrate that the inventors actually did so or had procession of the specific functional relationship recited in the claims. Since the instant specification fails to provide proper operational computational flow the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
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.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 29, “the sensor”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). It is unclear if the sensor refers to or is separate from the optical sensor or the ultrasound sensor. For examination purposes, the Examiner assumes the optical sensor. Consistent claim language is required when referring to the same term. Accordingly, proper antecedent basis is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
Claims 1, 23-25, & 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salcudean et al (US 2012/0071757 A1).
Claim 1: Salcudean discloses, An ultrasound sensing system (¶Abstract, ¶0023) comprising:
passive ultrasound detectable markers (ultrasound surface fiducials 115, ¶0021-0023) to be positioned on an exterior surface of an internal organ within a body; (¶Abstract, ¶0023, FIG. 1, ¶0041, ¶0042)
an optical sensor to sense locations of the passive ultrasound detectable markers on the exterior surface of the internal organ; (¶0023-0024, the camera system (i.e., the optical sensors) views the registration tool 105. ¶0022-0024, while the camera images the “optical markers”, the system mathematically senses the location of the ultrasound markers. Because the relationship between the optical markers and the ultrasound surface fiducials is exactly known, ¶0030, the system uses the optical data to calculate exact position vectors of the ultrasound fiducials with the camera’s coordinate system, ¶0030-0032. Under the broadest reasonable interpretation, utilizing optical marks to calculate the precise location of these ultrasound markers (i.e., fiducials) demonstrates the limitation of an optical sensor sensing their locations, where these markers are on the exterior surface of the internal organ.)
an ultrasound sensor to be positioned within the body; and (¶0034-0035, ¶0041, Salcudean teaches the use of 3D trans-rectal ultrasound probe, an endorectal transducer, or a 3D laparoscopic probe. These devices are positioned within the body to capture ultrasound volumes.)
a controller configured to: perform a registration by registering optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor with locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor while within the body. (¶0033, the premise of the invention of Salcudean is to solve this exact registration as generically claimed to improve the accuracy of registration to achieve re-positioning at several different positions. The system of Salcudean uses the offset vectors derived from the camera’s optical data to determine the position of the ultrasound fiducials in the camera’s coordinate system, ¶0031-0033. It localizes those same fiducials in the ultrasound coordinate system, ¶0026-0027. Lastly, the system performs a registration to solve the homogenous transformation between the two coordinate systems by matching common points (i.e., the fiducials) using a least-squares minimization calculation, ¶0030-0033. This also occurs during surgical procedures, ¶0041.)
Claim 23: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the controller (¶0030-0033) is further configured to superimpose the optical data captured by the optical sensor and the ultrasound data captured by the ultrasound sensor (¶0005, ¶0041-0043) based upon the registration (¶0030-0033, ¶0041-0043).
Claim 24: Salcudean discloses all the elements above in claim 22, Salcudean discloses, wherein the controller is configured to register the optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor in real time with the locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor in real time. (¶Abstract, ¶0006, ¶0021-0024, ¶0027, ¶0030-0033, ¶0038-0043)
Claim 25: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the controller is configured to register the optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor in real time with the locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor in real time. (¶Abstract, ¶0006, ¶0021-0024, ¶0027, ¶0030-0033, ¶0038-0043)
Claim 28: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the optical sensor comprises an endoscopic sensor. (¶0022-0024, ¶0034, ¶0042-0043),
Claim 29: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the sensor is stereoscopic. (¶0022-0024, ¶0034, ¶0042-0043),
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 2, 4-7, 10-12, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1), as applied to claim 1, in further view of Shmayahu et al (US 2022/0323158 A1).
Claim 2: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the passive ultrasound detectable markers (¶0021-0023) are supported by an organ panel (¶0015, FIG. 1, ¶0035, ¶0041-0043, the tool 105 is considered a small plate that is rigid.) and are part of a pattern of passive ultrasound detectable markers supported by the organ panel. (Fig. 1, ¶0030-0033)
Salcudean fails to disclose that the organ panel is an organ conformable panel.
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 4: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the passive ultrasound detectable markers (¶0021-0023) are supported by an organ panel, (Fig. 1, ¶0030-0033)
Salcudean fails to disclose that the organ panel is an organ conformable panel, & the system 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.
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104)
the system 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)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ conformable panel of modified Salcudean to comprise 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 as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 5: Modified Salcudean discloses all the elements above in claim 4, Salcudean discloses, wherein the passive ultrasound detectable markers (¶0021-0023)
Salcudean fails to disclose are optically visible from a second face of the organ conformable panel.
However, Shmayahu in the context of tracking organ conformable panels discloses, are optically visible from a second face of the organ conformable panel. (¶0026, ¶0077, ¶0103, ¶0104, ¶0105-0106)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify system of modified Salcudean to incorporate the teachings as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 6: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the passive ultrasound detectable markers(¶0021-0023) are supported by an organ panel, (¶0015, FIG. 1, ¶0035, ¶0041-0043, the tool 105 is considered a small plate that is rigid.)
Salcudean fails to disclose that the organ panel is an organ conformable panel. & wherein the organ conformable panel has a first face to face the exterior surface of the internal organ and a second face opposite the first face and wherein the passive ultrasound detectable markers are optically visible on the second face.
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104) wherein the organ conformable panel has a first face to face the exterior surface of the internal organ and a second face opposite the first face and wherein the passive ultrasound detectable markers are optically visible on the second face. (¶0019-0020, ¶0103) (¶0026, ¶0077, ¶0103, ¶0104, ¶0105-0106)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify system of modified Salcudean to incorporate the teachings as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 7: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the passive ultrasound detectable markers (¶0021-0023) are supported by an organ panel, (¶0015, FIG. 1, ¶0035, ¶0041-0043, the tool 105 is considered a small plate that is rigid.) wherein the organ panel has a first face to face the exterior surface of the internal organ and a second face opposite the first face (FIG. 1) and wherein the passive ultrasound detectable markers are not optically visible from the second face, the ultrasound sensing system further comprising optical markers (optical markers 110, FIG. 1) supported by the organ panel at locations corresponding to the passive ultrasound detectable markers, the optical markers 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.
Salcudean fails to disclose that the organ panel is an organ conformable panel.
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 10: Salcudean discloses all the elements above in claim 1, Salcudean fails to disclose: wherein the passive ultrasound detectable markers are shaped and located to identify a targeted region of the internal organ for surgical removal.
However, Shmayahu in the context of tracking organ conformable panels discloses, wherein the passive ultrasound detectable markers are shaped (¶0015-0016, ¶0110-0111, ¶0123, ¶0124, FIG. 6) and located to identify a targeted region of the internal organ for surgical removal (¶0106, ¶0109).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify system of modified Salcudean to incorporate the teachings as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 11: Salcudean discloses all the elements above in claim 1, Salcudean fails to disclose: wherein the passive ultrasound detectable markers are shaped and located to identify portions of the internal organ not designated for surgical removal.
However, Shmayahu in the context of tracking organ conformable panels discloses, wherein the passive ultrasound detectable markers are shaped and located to identify portions of the internal organ not designated for surgical removal. (¶0104, ¶0106, ¶0109, FIG. 6)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify system of modified Salcudean to incorporate the teachings as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 12: Salcudean discloses all the elements above in claim 1, Salcudean fails to disclose: the passive ultrasound detectable markers are supported by an organ conformable panel, and wherein the organ conformable panel is sufficiently flexible and configured to overlie and conform to a tumor bulging from the exterior surface of the internal organ.
However, Shmayahu in the context of tracking organ conformable panels discloses, passive ultrasound detectable markers are supported by an organ conformable panel, and wherein the organ conformable panel is sufficiently flexible and configured to overlie and conform to a tumor bulging from the exterior surface of the internal organ. (¶0077-¶0079, ¶0088, ¶0102-¶0104)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify system of modified Salcudean to incorporate the teachings as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 26: Salcudean discloses all the elements above in claim 1, Salcudean discloses, further comprising an organ panel supporting the passive ultrasound detectable markers. (FIG. 1, ¶0021-0023, ¶0035, ¶0041-0043, the tool 105 is considered a small plate that is rigid.)
Salcudean fails to disclose that the organ panel is an organ conformable panel.
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1), as applied to claim 1, in further view of Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875).
Claim 3: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the passive ultrasound detectable markers (¶0021-0023) are supported by an organ panel, (¶0015, FIG. 1, ¶0035, ¶0041-0043, the tool 105 is considered a small plate that is rigid.) the system further comprising a second passive ultrasound detectable marker (¶0021-0023, FIG. 1 there are multiple surface fiducials) supported by the organ panel, (Fig. 1, ¶0030-0033)
Salcudean fails to disclose that the organ panel is an organ conformable panel.
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
Salcudean fails to disclose: the passive ultrasound detectable markers having a first acoustic impedance, the second passive ultrasound detectable marker having a second
However, Lewis in the context of automatic ultrasonic localization of implants in a portion of the anatomy, discloses: the passive ultrasound detectable markers having a first acoustic impedance, the second passive ultrasound detectable marker having a second([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 Salcudean. 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].
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1) in view of Shmayahu et al (US 2022/0323158 A1) in view of Lewis et al (US 5,394,875).
Claim 20: Salcudean discloses, An apparatus comprising: (¶Abstract, ¶0023)
an organ panel (105, FIG. 1) having a face to extend across an external surface of an organ within a body, the face comprising: (¶0015, FIG. 1, ¶0035, ¶0041-0043, the tool 105 is considered a small plate that is rigid. There is a face to extend across and external surface of an organ within a body.)
an optical sensor to sense a location of the passive ultrasound detectable markers (ultrasound surface fiducials 115, ¶0021-0023) on the external surface of the organ; (¶0023-0024, the camera system (i.e., the optical sensors) views the registration tool 105. ¶0022-0024, while the camera images the “optical markers”, the system mathematically senses the location of the ultrasound markers. Because the relationship between the optical markers and the ultrasound surface fiducials is exactly known, ¶0030, the system uses the optical data to calculate exact position vectors of the ultrasound fiducials with the camera’s coordinate system, ¶0030-0032. Under the broadest reasonable interpretation, utilizing optical marks to calculate the precise location of these ultrasound markers (i.e., fiducials) demonstrates the limitation of an optical sensor sensing their locations, where these markers are on the exterior surface of the internal organ.)
an ultrasound sensor to within the body; and (¶0034-0035, ¶0041, Salcudean teaches the use of 3D trans-rectal ultrasound probe, an endorectal transducer, or a 3D laparoscopic probe. These devices are positioned within the body to capture ultrasound volumes.)
a controller configured to:
perform a registration by registering optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor with locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor while within the body. (¶0033, the premise of the invention of Salcudean is to solve this exact registration as generically claimed to improve the accuracy of registration to achieve re-positioning at several different positions. The system of Salcudean uses the offset vectors derived from the camera’s optical data to determine the position of the ultrasound fiducials in the camera’s coordinate system, ¶0031-0033. It localizes those same fiducials in the ultrasound coordinate system, ¶0026-0027. Lastly, the system performs a registration to solve the homogenous transformation between the two coordinate systems by matching common points (i.e., the fiducials) using a least-squares minimization calculation, ¶0030-0033. This also occurs during surgical procedures, ¶0041.)
Salcudean fails to disclose that the organ panel is an organ conformable panel.
& a first portion formed from a first material; and
a second portion formed from a second material, the second portion serving as passive ultrasound detectable markers;
However, Shmayahu in the context of tracking organ conformable panels discloses, an organ conformable panel. (¶0077, ¶0104) this organ conformable panle also has a face to extend across an external surface of an organ, the face comprising: (¶Abstract, ¶0076-0077, ¶0104)
& a first portion formed from a first material; (¶Abstract, ¶0076-0077, ¶0104) and
a second portion formed from a second material, (¶0076-0077, ¶0093) the second portion serving as passive ultrasound detectable markers;
-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.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify organ panel of Salcudean to be a organ comfortable panel that is a flexible material as taught by Shymayhu for the advantage of providing an improved system and method being able to be configured to wrap around an object and accept a shape of the object once attach thereto, ¶0104.
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 Salcudean to incorporate the teachings of Shymayhu. The motivation to do this yield predictable results such as determine coordinates of a surface contour of soft tissue relatively quickly, easily, and accurately, as suggested by Shymayhu, ¶0077.
Salcudean fails to disclose that the first material has a first acoustic impedance; and the second material has 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 Salcudean 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 21: Salcudean as modified discloses all the elements above in claim 20, Salcudean discloses, wherein the controller (¶0030-0033) is further configured to superimpose the optical data captured by the optical sensor and the ultrasound data captured by the ultrasound sensor (¶0005, ¶0041-0043) based upon the registration (¶0030-0033, ¶0041-0043).
Claim 22: Salcudean as modified discloses all the elements above in claim 20, Salcudean discloses, wherein the controller is configured to register the optically captured locations of the passive ultrasound detectable markers in the optical data captured by the optical sensor in real time with the locations of the passive ultrasound detectable markers in ultrasound data captured by the ultrasound sensor in real time. (¶Abstract, ¶0006, ¶0021-0024, ¶0027, ¶0030-0033, ¶0038-0043)
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al (US 2012/0071757 A1), as applied to claim 1, in further view of Marcus et al (US 20180110436 A1).
Claim 27: Salcudean discloses all the elements above in claim 1, Salcudean discloses, wherein the controller is configured to perform the registration (¶0030-0033)
Salcudean fails to disclose: performing the registration while the ultrasound sensor is directly coupled to a surface of the organ.
However, Marcus in the context of spatial locational of flexible ultrasound patches discloses, performing the registration while the ultrasound sensor is directly coupled to a surface of the organ. (¶0034, ¶0067-0068, ¶0070-0072)
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 registration of Salcudean to incorporate the teachings of Marcus. The motivation to do this yield predictable results such as providing advanced mapping available at smaller clinics, as suggested by Marcus, ¶0067.
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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/N.A.R./Examiner, Art Unit 3798
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