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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/605,716 filed 12/04/2023.
Status of Claims
This Office Action is responsive to the claims filed on 03/18/2026. Claims 1, 10, 13, and 17 have been amended. Claims 1-20 are presently pending in this application.
Claim Objections
Claims 1 and 13 is objected to because of the following informalities:
Claim 1, line 8; and claim 13, line 8: “while patient lies over some of the plurality of apertures” should be amended to read “while the patient lies over some of the plurality of apertures”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a coordinate tracking unit” in claim 10, line 2.
The corresponding structure for the “coordinate tracking unit” defined within the specification is “a tracker or depth camera” (Pg. 14, Line 23-Pg. 15, ln. 2) and any functional equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-8, 10, 11, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Helm (US 20240341891) in view of White (US 20170216121 A1).
Regarding claim 1, Helm teaches an intraoperative anatomical imaging system (Paragraph [0009]; an imaging system may be used to acquire image data of a subject, Fig. 1) comprising:
a support panel having a support surface configured for supporting a patient (Paragraph [0092]; the subject 30 may be positioned on a support, such as the surgical table 104, Fig. 1);
at least one peg secured to the support surface (Paragraph [0092]-[0093]; a hip holder or support 357; hip holder or patient positioner 357, Fig. 6), the at least one peg configured to position the patient on the support surface (Paragraph [0092]-[0093]; a hip holder or support 357; appropriate support for the subject 30, Fig. 6);
at least one ultrasound probe unit (Paragraph [0066]; imaging device 33 may include the US probe 33, Fig. 1; Paragraph [0092]; an ultrasound array or imaging system 360, Fig. 6); and
a controller (Paragraph [0058]; image device controller 96) being communicatively coupled to the ultrasound probe unit (Paragraph [0058]; Image data acquired from the imaging system 33, or any appropriate imaging system, can be acquired at and/or forwarded from an image device controller 96), the controller having a processor (Paragraph [0058]; a processor module) and a memory (Paragraph [0150]; the controller 96 may include a processor and/or memory) having stored thereon instructions (Paragraph [0222]-[0223]; Instructions may be executed by a processor; apparatuses and methods described in this application may be partially or fully implemented by a processor) that when executed by the processor perform the step of:
controlling the at least one ultrasound probe unit (Paragraph [0132]; The beam steering or beam forming may be performed substantially automatically by operating or controlling the ultrasound probe 400 and the transducers therein, such as with a selected processor system as discussed above) to emit ultrasound signals towards an anatomical feature of the patient (Paragraph [0132]; The beam steering or beam forming may be used to collect image data at selected positions relative to the subject without physically moving the ultrasound probe 400),
measuring echo signals returning from the anatomical feature (Paragraph [0188]; the ultrasound image 930 may include portions that are echogenic at the selected settings of the ultrasound transducers… include portions of the vertebra 934 that may be identified, Fig. 17), and
generating an ultrasound image of the anatomical feature based on the echo signals (Paragraph [0187]-[0188]; may generate an ultrasound image 930, as illustrated in FIG. 17.; illustrated in the image 930, a vertebra 934 may be included in the data 930);
wherein the at least one ultrasound probe unit is secured to at least one of the at least one peg and the support surface (Paragraph [0092]; The ultrasound array 360 positioned in the hip holder or patient positioner 357, Fig. 6) such that the ultrasound image of the anatomical feature is obtainable when the patient is positioned on the support surface (Paragraph [0092]; may allow the ultrasound array 360 to be positioned relative to the subject 30 for the selected portion of the procedure. This may assist in holding the ultrasound array 360 relative to the subject 30 without requiring additional support).
Helm does not explicitly teach the support surface defining a plurality of apertures distributed thereon, wherein the patient lies over some of the plurality of apertures; and
the at least one peg having an extremity insertable in one of the apertures such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface by contact of the patient with the at least one peg while patient lies over some of the plurality of apertures.
White, however, teaches a support surface (Abstract; pegboards that can be used to support different portions of a patient's body in different planes) defining a plurality of apertures (Paragraph [0026]; This exemplary embodiment of the MPPS 10 includes at least first pegboard 25 and second pegboard 30… have peg holes 35 therein) distributed thereon, wherein the patient lies over some of the plurality of apertures (Paragraph [0046]; For example, as shown in FIG. 13, the MPPS may include at least one pegboard 25′ for positioning on a surgical table and supporting a portion of a patient, Fig. 13 and 14 depicts a patient lying over at least some of the plurality of apertures); and
the at least one peg having an extremity insertable in one of the apertures (Paragraph [0045]-[0046]; generic patient positioning member 200 used to cover at least two pegs 85 being used to retain the portion of the patient's upper body; The positioning member has a plurality of holes 210 in a lower portion thereof. A plurality of pegs 85 are positioned in peg holes 35 at locations where it is desired to position the positioning member 200; Fig. 13 and 14) such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface by contact of the patient with the at least one peg while patient lies over some of the plurality of apertures (Paragraph [0046]; at least two pegs 85 being used to retain the portion of the patient's upper body that is to be operated on in a desired surgical position… the upper portion 202 for contacting a portion of the patient's body; and the lower portion 203 having a plurality of blind holes 210 for receiving pegs 85; Figs. 13 and 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the support surface of Helm to have included a plurality of apertures distributed thereon, wherein the patient lies over some of the plurality of apertures; and the at least one peg having an extremity insertable in one of the apertures such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface by contact of the patient with the at least one peg while patient lies over some of the plurality of apertures as taught by White because it would have allowed a doctor to retain a patient a portion of the patient's upper body that is to be operated on in any desired position, thereby ensuring minimal noise due to patient motion during imaging and allowing the doctor to position the imaging device in any position with respect to the patient.
Regarding claim 2, together Helm and White teach all of the limitations of claim 1 as noted above.
Helm further teaches the ultrasound probe comprises a plurality of ultrasound probe units mounted to at least one of the support surface and the at least one peg (Paragraph [0093]; ultrasound array portion 364a, 364b, and 364c; ultrasound array 360 may be provided with the window portion 362 such that to the array portion 364; Fig. 6; Each array portion is considered to be a probe unit as understood in its broadest reasonable interpretation).
Regarding claim 3, together Helm and White teach all of the limitations of claim 1 as noted above.
Helm further teaches at least one of the support surface and the at least one peg is configured to propagate the ultrasound signals and the echo signals (Paragraph [0092]; hip holder 357, or other portions of the surgical support, such as the surgical table 104, may include or have incorporated there with an ultrasound array or imaging system 360; Paragraph [0093]; 360 may include a window or patient contacting portion 362. The window 362 may also be a hole or passage formed in the support 357… Therefore, ultrasound waves from the ultrasound array 360 may be passed to the subject 30 to allow for imaging).
Regarding claim 4, together Helm and White teach all of the limitations of claim 1 as noted above.
Helm further teaches the ultrasound probe unit is integrated inside at least one of the at least one peg (Paragraph [0092]; the table 104, the hip holder 357, or other portions of the surgical support, such as the surgical table 104, may include or have incorporated there with an ultrasound array or imaging system 360).
Regarding claim 6, together Helm and White teach all of the limitations of claim 1 as noted above.
Helm further teaches generating an ultrasound image of the anatomical feature includes generating an anatomical feature model of the anatomical feature based at least on the echo datasets (Paragraph [0199]-[0200]; The ultrasound data may then be correlated or registered to the segmented portions in the segmented mock CT 990; segmented image 990, which may be registered to the tracked ultrasound data, may be used to generate the model 1020 as illustrated in FIG. 20.).
Regarding claim 7, together Helm and White teach all of the limitations of claim 6 as noted above.
Helm further teaches merging the ultrasound image with a reference model of the anatomical feature (Paragraph [0201]; production or generation of the mock CT image data or mock CT data may allow for the registration of the ultrasound data to the three-dimensional data of the MR image 900; Paragraph [0186]; MR image 900 may include any appropriate type of image data which may include three-dimensional data of the subject 30; Paragraph [0192]; MR image 900 may also be used to generate or be processed to generate a mock computer tomography (mock CT) image or data space. The mock CT may be an exemplary data or feature space that is generated based upon the MR image; The CT mock made from the MR image is considered to be a reference model as understood in its broadest reasonable interpretation).
Regarding claim 8, together Helm and White teach all of the limitations of claim 7 as noted above.
Helm further teaches the reference model is obtained from a magnetic resonance imaging scan (Paragraph [0186]; MR image 900 may include any appropriate type of image data which may include three-dimensional data of the subject 30; Paragraph [0192]; MR image 900 may also be used to generate or be processed to generate a mock computer tomography (mock CT) image or data space. The mock CT may be an exemplary data or feature space that is generated based upon the MR image).
Regarding claim 10, together Helm and White teach all of the limitations of claim 1 as noted above.
Helm further teaches a coordinate tracking unit (Paragraph [0052]-[0055]; precise knowledge of the position of the image capturing portion can be used in conjunction with a tracking system to determine the position of the image capturing portion and the image data relative to the tracked subject; Various tracking systems, such as one including an optical localizer 88 or an electromagnetic (EM) localizer 92 can be used to track the instrument 68) tracking coordinates of at least one of the support panel (Paragraph [0116]; The base 34 may be fixed to the patient support 104… The origin or position of the base 34 relative to the subject may be determined in any appropriate manner, such as by tracking a portion of the base 34 relative to the subject 30; Paragraph [0056], EM localizer 94 Fig. 1), the at least one peg and the ultrasound probe unit (Paragraph [0094]; Further, a tracking portion 370 may be associated with of the tracking array 360, such as fixed to the tracking array 360 and/or fixed to a portion relative to the tracking array. For example, the tracking portion 370 may be fixed to the hip support 357. Similarly, the imaging system 360 may be fixed to the hip support 357. Therefore, the tracking member 370 may be at a fixed position relative to the imaging array 360.).
Regarding claim 11, together Helm and White teach all of the limitations of claim 10 as noted above.
Helm further teaches the controller is communicatively coupled to the coordinate tracking unit (Paragraph [0059]; the navigation system 26 can further include the tracking system including either or both of the electromagnetic (EM) localizer 94 and/or the optical localizer 88. The tracking systems may include a controller and interface portion 110. The controller 110 can be connected to the processor portion 102, which can include a processor included within a computer) and the memory has stored thereon instructions that when executed by the processor perform the steps of:
generating corresponding coordinate datasets (Paragraph [0044]; The tracking system may include a localizer that is configured to determine the position of the tracking device in a navigation system coordinate system),
registering the corresponding coordinate datasets in a common coordinate system (Paragraph [0044]-[0045]; A determination or correlation between the two coordinate systems may allow for or also be referred to as a registration between two coordinate systems.), and
tracking a position and orientation of the anatomical feature based on said registering the echo datasets in the common coordinate system (Paragraph [0082]; As the ultrasound arrays 222 are registered to the subject 330 using the navigation system 26, the image data required of the subject 30, such as of the vertebrae 244, may also have its pose determined in navigation space within the navigation system 26).
Regarding claim 17, Helm teaches an intraoperative anatomical imaging system (Paragraph [0009]; an imaging system may be used to acquire image data of a subject, Fig. 1) comprising:
a processor (Paragraph [0058]; a processor module); and
a memory (Paragraph [0150]; the controller 96 may include a processor and/or memory) having stored thereon instructions (Paragraph [0222]-[0223]; Instructions may be executed by a processor; apparatuses and methods described in this application may be partially or fully implemented by a processor) that when executed by the processor perform the step of:
emitting ultrasound signals (Paragraph [0132]; The beam steering or beam forming may be performed substantially automatically by operating or controlling the ultrasound probe 400 and the transducers therein, such as with a selected processor system as discussed above) towards an anatomical feature of the patient (Paragraph [0132]; The beam steering or beam forming may be used to collect image data at selected positions relative to the subject without physically moving the ultrasound probe 400), from a peg projecting (Paragraph [0092]-[0093]; a hip holder or support 357; hip holder or patient positioner 357, Fig. 6) from a support panel (Paragraph [0092]-[0093]; a hip holder or support 357; appropriate support for the subject 30, Fig. 6), with the anatomical feature captive against the peg and support panel (Paragraph [0092]; may allow the ultrasound array 360 to be positioned relative to the subject 30 for the selected portion of the procedure. This may assist in holding the ultrasound array 360 relative to the subject 30 without requiring additional support),
measuring echo signals returning from the anatomical feature (Paragraph [0188]; the ultrasound image 930 may include portions that are echogenic at the selected settings of the ultrasound transducers… include portions of the vertebra 934 that may be identified, Fig. 17), and
generating and outputting an ultrasound image of the anatomical feature based on the echo signals (Paragraph [0187]-[0188]; may generate an ultrasound image 930, as illustrated in FIG. 17.; illustrated in the image 930, a vertebra 934 may be included in the data 930).
Helm does not explicitly teach the patient lies on the support panel and is in contact with the peg, the peg received in an aperture from a plurality of apertures distributed on a support surface of the support panel, whereby the patient lies over some of the plurality of apertures.
White, however, teaches a support surface (Abstract; pegboards that can be used to support different portions of a patient's body in different planes) defining a plurality of apertures (Paragraph [0026]; This exemplary embodiment of the MPPS 10 includes at least first pegboard 25 and second pegboard 30… have peg holes 35 therein) distributed thereon, wherein the patient lies over some of the plurality of apertures (Paragraph [0046]; For example, as shown in FIG. 13, the MPPS may include at least one pegboard 25′ for positioning on a surgical table and supporting a portion of a patient, Fig. 13 and 14 depicts a patient lying over at least some of the plurality of apertures); and
he patient lies on the support panel and is in contact with the peg (Paragraph [0046]; at least two pegs 85 being used to retain the portion of the patient's upper body that is to be operated on in a desired surgical position… the upper portion 202 for contacting a portion of the patient's body; and the lower portion 203 having a plurality of blind holes 210 for receiving pegs 85; Figs. 13 and 14), the peg received in an aperture from a plurality of apertures distributed on a support surface of the support panel, whereby the patient lies over some of the plurality of apertures (Paragraph [0045]-[0046]; generic patient positioning member 200 used to cover at least two pegs 85 being used to retain the portion of the patient's upper body; The positioning member has a plurality of holes 210 in a lower portion thereof. A plurality of pegs 85 are positioned in peg holes 35 at locations where it is desired to position the positioning member 200; Fig. 13 and 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the support surface of Helm to have the patient lie on the support panel and be in contact with the peg, the peg received in an aperture from a plurality of apertures distributed on a support surface of the support panel, whereby the patient lies over some of the plurality of apertures as taught by White because it would have allowed a doctor to retain a patient a portion of the patient's upper body that is to be operated on in any desired position, thereby ensuring minimal noise due to patient motion during imaging and allowing the doctor to position the imaging device in any position with respect to the patient.
Regarding claim 18, together Helm and White teaches all of the limitations of claim 17 as noted above.
Helm further teaches generating an ultrasound image of the anatomical feature includes generating an anatomical feature model of the anatomical feature based at least on the echo datasets (Paragraph [0199]-[0200]; The ultrasound data may then be correlated or registered to the segmented portions in the segmented mock CT 990; segmented image 990, which may be registered to the tracked ultrasound data, may be used to generate the model 1020 as illustrated in FIG. 20.).
Regarding claim 19, together Helm and White teaches all of the limitations of claim 18 as noted above.
Helm further teaches generating the anatomical feature model includes merging the ultrasound image with a reference model of the anatomical feature (Paragraph [0201]; production or generation of the mock CT image data or mock CT data may allow for the registration of the ultrasound data to the three-dimensional data of the MR image 900; Paragraph [0186]; MR image 900 may include any appropriate type of image data which may include three-dimensional data of the subject 30; Paragraph [0192]; MR image 900 may also be used to generate or be processed to generate a mock computer tomography (mock CT) image or data space. The mock CT may be an exemplary data or feature space that is generated based upon the MR image; The CT mock made from the MR image is considered to be a reference model as understood in its broadest reasonable interpretation).
Regarding claim 20, together Helm and White teaches all of the limitations of claim 19 as noted above.
Helm further teaches said reference model is obtained from a magnetic resonance imaging scan (Paragraph [0186]; MR image 900 may include any appropriate type of image data which may include three-dimensional data of the subject 30; Paragraph [0192]; MR image 900 may also be used to generate or be processed to generate a mock computer tomography (mock CT) image or data space. The mock CT may be an exemplary data or feature space that is generated based upon the MR image).
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Helm in view of White as applied to claim 1 above, and further in view of McCaw (US 20210018606).
Regarding claim 5, together Helm and White teach all of the limitations of claim 1 as noted above.
Together Helm and White do not explicitly teach the ultrasound probe unit is on an underside of the support surface.
McCaw, however, teaches an intraoperative anatomical imaging system (Paragraph [0011]; a method for measuring a mechanical property of an object using an ultrasound system having a transducer is provided) wherein the ultrasound probe unit is on an underside of the support surface (Paragraph [0104]; The body 220 is supported by a flexible substrate such as a resilient mat 230 having an aperture 232 through which HDVE inertial driver devices 202b contact the body 220, Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the least one ultrasound probe unit of Helm in view of White to have included another ultrasound probe unit on an underside of the support surface as taught by McCaw because it would have allowed the arrays to contact and be conformed to the body in the area of interest (Paragraph [0020]).
Regarding claim 12, together Helm and White teach all of the limitations of claim 1 as noted above.
Together Helm and White do not explicitly teach the at least one ultrasound probe unit includes a first ultrasound probe unit configured to emit ultrasound signals towards the anatomical feature of the patient, and a second ultrasound probe unit for measuring echo signals returning from the anatomical feature.
McCaw, however, teaches an intraoperative anatomical imaging system (Paragraph [0011]; a method for measuring a mechanical property of an object using an ultrasound system having a transducer is provided) comprising at least one ultrasound probe unit includes a first ultrasound probe unit configured to emit ultrasound signals towards the anatomical feature of the patient (Paragraph [0093]; the ultrasound imaging apparatus includes a transducer module for converting an electric signal into an ultrasonic signal; Paragraph [0104]; an imaging system 200b having an HDVE inertial driver apparatus 202b that includes controller 210, Fig. 2B), and a second ultrasound probe unit for measuring echo signals returning from the anatomical feature (Paragraph [0104]; analyzer 222, and acoustic sensor 224; Paragraph [0108]; Method 300 includes sending acoustic pulses and receiving acoustic echoes by an acoustic sensor held against the body (block 306), Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Helm in view of White to have included a second ultrasound probe unit for measuring echo signals returning from the portions of the anatomical feature as taught by McCaw because it would have provided the ability to image tissues to the full scan depth of ultrasound and obtain improved deep tissue resolution (McCaw, Paragraph [0053]). It would further allow calculating shear wave speeds from the tissue displacements or velocities in the volume of tissue on at least one of the frequencies in the multiple frequency wave signal to determine stiffness of the tissue, thereby allowing one to map areas of healthy and unhealthy tissue (Paragraph [0051]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Helm in view of White as applied to claim 7 above, and further in view of Mahfouz (US 20170347991).
Regarding claim 9, together Helm and White teach all of the limitations of claim 7 as noted above.
Together Helm and White do not explicitly teach said reference model is obtained from a bone atlas of models.
Mahfouz, however, teaches an intraoperative anatomical imaging system (Paragraph [0045]-[0047]; an ultrasound instrument 50 and computer system, Fig. 1) comprising merging the ultrasound image (Paragraph [0062]; during image acquisition… B-mode images, similar to the one shown in FIG. 9, may also be processed from the gathered data (Block 154) for subsequent visualization and overlain with the bone contours, as described in detail below) with a reference model of the anatomical feature (Paragraph [0093]; The reconstruction begins with a determination of a bone model from which the 3-D patient-specific model is derived (Block 210). The bone model may be a generalized model based on multiple patient bone models) wherein said reference model is obtained from a bone atlas of models (Paragraph [0093]; The bone model may be a generalized model based on multiple patient bone models and may be selected from a principle component analysis (“PCA”) based statistical bone atlas.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Helm in view of White sure that the reference model is obtained from a bone atlas of models as taught by Mahfouz because it would allow making patient specific models of the bones using ultrasound without having to expose the patient to radiation for X-ray or CT imaging, or performing more costly MRI procedures (Mahfouz, Paragraphs [0003], [0004], and [0008]).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Helm (US 20240341891) in view of White (US 20060016006) and McCaw (US 20210018606).
Regarding claim 13, Helm teaches an intraoperative anatomical imaging system (Paragraph [0009]; an imaging system may be used to acquire image data of a subject, Fig. 1) comprising:
a support panel having a support surface configured for supporting a patient (Paragraph [0092]; the subject 30 may be positioned on a support, such as the surgical table 104, Fig. 1), the support surface defining a plurality of apertures distributed thereon;
at least one peg having an extremity insertable in one of the apertures such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface (Paragraph [0092]-[0093]; a hip holder or support 357; hip holder or patient positioner 357, Fig. 6), the at least one peg configured to position the patient on the support surface (Paragraph [0092]-[0093]; a hip holder or support 357; appropriate support for the subject 30, Fig. 6); and
at least one ultrasound probe unit (Paragraph [0066]; imaging device 33 may include the US probe 33, Fig. 1; Paragraph [0092]; an ultrasound array or imaging system 360, Fig. 6) secured to the at least one peg (Paragraph [0092]; The ultrasound array 360 positioned in the hip holder or patient positioner 357, Fig. 6) the ultrasound probe unit configured for emitting ultrasound signals towards different portions of an anatomical feature of the patient (Paragraph [0132]; The beam steering or beam forming may be used to collect image data at selected positions relative to the subject without physically moving the ultrasound probe 400), whereby an ultrasound image of the anatomical feature is obtainable when the patient is positioned on the support surface (Paragraph [0092]; may allow the ultrasound array 360 to be positioned relative to the subject 30 for the selected portion of the procedure. This may assist in holding the ultrasound array 360 relative to the subject 30 without requiring additional support).
Helm does not explicitly teach the support surface defining a plurality of apertures distributed thereon, wherein the patient lies over some of the plurality of apertures; and
the at least one peg having an extremity insertable in one of the apertures such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface by contact of the patient with the at least one peg while patient lies over some of the plurality of apertures; and
and a second ultrasound probe unit for measuring echo signals returning from the portions of the anatomical feature.
White, however, teaches a support surface (Abstract; pegboards that can be used to support different portions of a patient's body in different planes) defining a plurality of apertures (Paragraph [0026]; This exemplary embodiment of the MPPS 10 includes at least first pegboard 25 and second pegboard 30… have peg holes 35 therein) distributed thereon, wherein the patient lies over some of the plurality of apertures (Paragraph [0046]; For example, as shown in FIG. 13, the MPPS may include at least one pegboard 25′ for positioning on a surgical table and supporting a portion of a patient, Fig. 13 and 14 depicts a patient lying over at least some of the plurality of apertures); and
the at least one peg having an extremity insertable in one of the apertures (Paragraph [0045]-[0046]; generic patient positioning member 200 used to cover at least two pegs 85 being used to retain the portion of the patient's upper body; The positioning member has a plurality of holes 210 in a lower portion thereof. A plurality of pegs 85 are positioned in peg holes 35 at locations where it is desired to position the positioning member 200; Fig. 13 and 14) such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface by contact of the patient with the at least one peg while patient lies over some of the plurality of apertures (Paragraph [0046]; at least two pegs 85 being used to retain the portion of the patient's upper body that is to be operated on in a desired surgical position… the upper portion 202 for contacting a portion of the patient's body; and the lower portion 203 having a plurality of blind holes 210 for receiving pegs 85; Figs. 13 and 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the support surface of Helm to have included a plurality of apertures distributed thereon, wherein the patient lies over some of the plurality of apertures; and the at least one peg having an extremity insertable in one of the apertures such that when the extremity is inserted in the aperture the at least one peg is secured to the support surface by contact of the patient with the at least one peg while patient lies over some of the plurality of apertures as taught by White because it would have allowed a doctor to retain a patient a portion of the patient's upper body that is to be operated on in any desired position, thereby ensuring minimal noise due to patient motion during imaging and allowing the doctor to position the imaging device in any position with respect to the patient.
Helm and White do not explicitly teach a second ultrasound probe unit for measuring echo signals returning from the portions of the anatomical feature.
McCaw, however, teaches an intraoperative anatomical imaging system (Paragraph [0011]; a method for measuring a mechanical property of an object using an ultrasound system having a transducer is provided) comprising at least one ultrasound probe unit (Paragraph [0093]; , the ultrasound imaging apparatus includes a transducer module for converting an electric signal into an ultrasonic signal; Paragraph [0104]; an imaging system 200b having an HDVE inertial driver apparatus 202b that includes controller 210, Fig. 2B) configured for emitting ultrasound signals towards different portions of an anatomical feature of the patient (Paragraph [0100]; controller 210 generates he independent sequenced driver signals 208 that induce a shear wave field 216 within tissue 218 of a body 220, Fig. 2B), and a second ultrasound probe unit for measuring echo signals returning from the portions of the anatomical feature (Paragraph [0104]; analyzer 222, and acoustic sensor 224; Paragraph [0108]; Method 300 includes sending acoustic pulses and receiving acoustic echoes by an acoustic sensor held against the body (block 306), Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Helm in view of White to have included a second ultrasound probe unit for measuring echo signals returning from the portions of the anatomical feature as taught by McCaw because it would have provided the ability to image tissues to the full scan depth of ultrasound and obtain improved deep tissue resolution (McCaw, Paragraph [0053]). It would further allow calculating shear wave speeds from the tissue displacements or velocities in the volume of tissue on at least one of the frequencies in the multiple frequency wave signal to determine stiffness of the tissue, thereby allowing one to map areas of healthy and unhealthy tissue (Paragraph [0051]).
Regarding claim 14, together Helm, White, and McCaw teach all of the limitations of claim 13 as noted above.
Helm further teaches the at least one ultrasound probe unit is integrated inside at least one of the at least one peg (Paragraph [0092]; the table 104, the hip holder 357, or other portions of the surgical support, such as the surgical table 104, may include or have incorporated there with an ultrasound array or imaging system 360).
Regarding claim 15, together Helm, White, and McCaw teach all of the limitations of claim 13 as noted above.
McCaw further teaches the at least one ultrasound probe unit includes another ultrasound probe unit on an underside of the support surface (Paragraph [0104]; The body 220 is supported by a flexible substrate such as a resilient mat 230 having an aperture 232 through which HDVE inertial driver devices 202b contact the body 220, Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the least one ultrasound probe unit of Helm in view of White and McCaw to have included another ultrasound probe unit on an underside of the support surface as further taught by McCaw because it would have allowed the arrays to contact and be conformed to the body in the area of interest (Paragraph [0020]).
Regarding claim 16, together Helm, White, and McCaw teach all of the limitations of claim 13 as noted above.
McCaw further teaches the at least one ultrasound probe unit includes a first ultrasound probe unit configured to emit ultrasound signals towards the anatomical feature of the patient (Paragraph [0093]; , the ultrasound imaging apparatus includes a transducer module for converting an electric signal into an ultrasonic signal; Paragraph [0104]; an imaging system 200b having an HDVE inertial driver apparatus 202b that includes controller 210, Fig. 2B), and a second ultrasound probe unit for measuring echo signals returning from the anatomical feature (Paragraph [0104]; analyzer 222, and acoustic sensor 224; Paragraph [0108]; Method 300 includes sending acoustic pulses and receiving acoustic echoes by an acoustic sensor held against the body (block 306), Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Helm in view of White to have included a second ultrasound probe unit for measuring echo signals returning from the portions of the anatomical feature as taught by McCaw because it would have provided the ability to image tissues to the full scan depth of ultrasound and obtain improved deep tissue resolution (McCaw, Paragraph [0053]). It would further allow calculating shear wave speeds from the tissue displacements or velocities in the volume of tissue on at least one of the frequencies in the multiple frequency wave signal to determine stiffness of the tissue, thereby allowing one to map areas of healthy and unhealthy tissue (Paragraph [0051]).
Response to Arguments
Claim Objections
Examiner acknowledges the amendments to the claims and withdraws all objections to the claims. The amendments to the claims raises new objections which are now presented.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to claims 1 and 17 and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 and 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
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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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/02/26
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