DETAILED ACTION
Election/Restrictions
Applicant’s election of Group 2 which appeared to be a typo (it should have been Group 1, read on claims 1-17) in the reply filed on 6/4/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/4/2026.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-13, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3073913 to Hubert in view of Glossop U.S 2016/0008074 and further view of EP 2155136 to Invivo Corporation.
Claim 1: Hubert discloses a perineal access device (for transperineal access, para [0027]) comprising: a base (see table 1, Fig 1; patient table 1, para [0022]);
first and second leg separators (see 8a and 8b to attach leg separators 5a and 5b, Fig 1; 8a and 8b are used to align leg shells 5, para[0031]; for spreading legs, para [0026]) removably secured to said base (see how the assembly including 8a and 8b is removably attached to 1 by a base plate 13, Fig 1-2; base plate 13 is used to put the entire device on the patient table 1, para [0032]); a guidance assembly mounted to said base (see guidance assembly comprising 10a, 10b and 11 mounted to 1, Fig 1-2) and disposed between said first and second leg separators (see how 10a, 10b and 11 are disposed between 8a and 8b, Fig 2), the guidance assembly including:
an access frame (see frame holding 11, Flg 2) having an upper window configured to provide access to a patient's perinium (see an upper window with grid 11 to provide access to the perineum, Fig 1-2; grid 11 enables transperineal access, para [0027]) and a lower window configured to provide access to the patient's rectum (see a lower window below 11 configured to provide access to the rectum, Fig 1-2),
the access frame being supported by first and second frame legs (see how the frame is supported by legs 10a and 10b, Fig 1-2), a top platter extending from the access frame (see a top surface above 11, Fig 2), the top platter forming a platter angle with the access frame (see how the top surface is perpendicular relative to the vertical frame, Fig 2), a guidance plate disposed within the access frame (see grid plate 11 within the upper window, Fig 2), the guidance plate including a grid having one or more channels (see how 11 includes channels, Fig 2; grid 11 to provide transperineal access with targeted alignment, para [0027]), but does not explicitly teach first and second multi-modal markers attached to the first and second frame legs, respectively; and
an optical head attached to one of the first and second leg separators and positioned at a pitch angle to provide a maximum field of view for said optical head.
Hubert teaches wherein the device is used for insertion of surgical instruments such as a biopsy needle under the control and monitoring using imaging methods including optical imaging (insertion of needle into the grid is carried out under control and monitoring using imaging methods, para [0032]; universal applicability of the device allows for optical imaging as well, para [0012]) and wherein the device is
configured to place the subject in a position to produce images of areas of interest (para [0032]) such as of the perineum area (for transperineal, para [0032]), but does not explicitly teach using an optical head attached to one of the first and second leg separators and positioned at a pitch angle to provide a maximum field of view for said optical head. Glossop further teaches a transperineal access device (see device for acccessing perineum 902, Fig 9, perineum 902, para [0150]) comprising a guidance assembly frame (see template 900, Fig 9, template 900 used in guided procedure, para [0150]) having a plurality of multi-modal markers attached in various locations (900 may comprises template 600, para [0158]; see a plurality of fiducial features 604
attached to template 600, Fig 6; fiducial features 604, para [0131]; fiducial features 604 may be filled with contrast agent hence used for both visual and an imaging modality, para [0134]) including on a leg of the frame (see how at least one markers 604 is positioned on the right leg of 600, Fig 6) in order to use the markers to locate the guidance frame (604 used to locate 600, para [0134]), and an optical head
comprising a camera positioned near the patient (904 such as an optical camera array is positioned near the patient, para [0150]) in order to perform a guided interventional procedure (para [0150]). Invivo further teaches a perineal access device (see a patient positioning device to provide access to a patient's perineum, Fig 2A-D;
patient table configured for prostate imaging and intervention, para [0017]) comprising a base (see 182, Fig 2A; patient support module 182, para [0016]) and a specialized table component removably secured to the base for supporting a particular anatomy of interest for imaging and intervention such as a leg of the patient (see 202 removably secured to 182, Fig 2A; specialized anatomical patient support modules mated to 182, para [0016]; such as 202 for prostate imaging and intervention including stirrup posts 212 and stirrups 214 for the legs, para [0017]), wherein the specialized table component may include a mounting structure for mounting optical imaging components
(specialized anatomical module may comprise a receptacle for components of optical imaging, para [0016]; 202 may comprise additional mounting structures, para [0017]) in order to provide a patient support better designed for prostate imaging and intervention (para [0017]). Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the system of Hubert such that it further comprises an optical head positioned near the patient and to modify the guidance assembly such that it further comprises first and second multi-modal markers attached to the first and second frame legs as taught by Glossop in order to perform an image guided interventional
procedure with the markers used to locate the guidance frame. Further, it would have been obvious to a person having ordinary skill in the art to modify the device such that it further comprises a mounting structure for mounting optical imaging components at the specialized support structure for supporting the legs as taught by Invivo in order to provide a patient support table better designed for optical imaging of prostate interventions. Further, it would have been obvious to a person having ordinary skill in the art for the mounting structure to be attached to one of the first and second leg separators and positioned such that the attached optical head is positioned at a pitch angle to provide a maximum field of view in order to position the optical head in a convenient location for producing images of the areas of interest of the guidance assembly in the perineum area.
As to claim 2, Hubert, Glossop and Invivo teach the perineal access device of claim 1 and Hubert teaches wherein the platter angle is between 90 degrees and 120 degrees (see how the top surface is perpendicular relative to the vertical frame, Fig 2).
As to claim 3, Hubert, Glossop and Invivo teach the perineal access device of claim 2 and as modified Glossop teaches further comprising at least one multi-modal marker mounted on the top platter (see 604 on the top surface of 600, Fig 6, fiducial features 604, para [0131], para [0134]).
As to claim 5, Hubert, Glossop and Invivo teach the perineal access device of claim 1 and as modified Glossop teaches further comprising at least one multi-modal marker attached to said guidance assembly (see at least one 604, Fig 6; fiducial features 604 attached, para [0131], para [0134]).
As to claim 6, Hubert, Glossop and Invivo teach the perineal access device of claim 5 but do not explicitly teach wherein the at least one multi-modal marker is attached to the access frame and disposed at an acute marker angle. Glossop teaches wherein the multi-modal markers are attached (para [0131], para [0134]) but does not specify an angle at which they are disposed. However, it would have been obvious to a person having ordinary skill in the art to modify the device such that at least one multi-
modal marker is attached to the access frame and disposed at an acute marker angle in order to optimize the placement of the marker
such that it is easily visible to the optical head.
As to claim 7, Hubert, Glossop and Invivo teach the perineal access device of claim 6 but do not explicitly teach wherein the marker angle is between 45 degrees and 90 degrees. However, it would have been obvious to a person having ordinary skill in the art to modify the device such that at least one multi-modal marker is attached to the access frame and disposed at an acute marker angle between 45 degrees and 90 degrees in order to optimize the placement of the marker such that it is easily visible to the optical head.
As to claim 8, Hubert, Glossop and Invivo teach the perineal access device of claim 6 but do not explicitly teach wherein the marker angle is between 75 degrees and 80 degrees. However, it would have been obvious to a person having ordinary skill in the art to modify the device such that at least one multi-modal marker is attached to the access frame and disposed at an acute marker angle between 75 degrees and 80 degrees in order to optimize the placement of the marker such that it is easily visible to the optical head.
As to claim 9, Hubert, Glossop and Invivo teach the perineal access device of claim 1 but Hubert does not explicitly teach wherein the guidance plate is integrally formed with the upper window. Hubert does not specify whether the guidance plate is integrally formed with the upper window of the access frame or removably engaged
(see 11 positioned in the upper window of the access frame, Fig 2; at the apex of the supports 10 there is a grid 11, para [0027]). However, it would have been obvious to a person having ordinary skill in the art to modify the guidance plate such that it is integrally formed with the upper window in order to provide a simple guidance assembly without requiring installation of the plate.
As to claim 10, Hubert, Glossop and Invivo teach the perineal access device of claim 1 but Hubert does not explicitly teach wherein the guidance plate is removably engaged with the upper window. Hubert teaches wherein the guidance plate is used to enable transperineal access with targeted alignment (para [0027]) but does not
specify whether the guidance plate is integrally formed with the upper window of the access frame or removably engaged (see 11 positioned in the upper window of the access frame, Fig 2; at the apex of the supports 10 there is a grid 11, para [0027]).
However, it would have been obvious to a person having ordinary skill in the art to modify the guidance plate such that it is removably engaged with the upper window in order to attach a customized guidance plate for targeted alignment for a specific procedure performed using the device.
As to claims 11-12, Hubert, Glossop and Invivo teach the perineal access device of claim 1 but Hubert does not explicitly teach wherein at least one of the one or more channels of the grid has orthogonal walls or an acute angled walls.
Hubert teaches wherein the grid enables transperineal access with targeted alignment for taking tissue samples (para [0027]) in order to better orient and localize the insertion of a biopsy needle (para [0032]) but does not explicitly specify the orientation of the channels of the grid. However, it would have been obvious to a person having ordinary skill in the art to modify the channels such that one or more
channels of the grid has orthogonal walls or acute angled walls in order to use the grid to insert a biopsy needle in a straight path as desired for a procedure using the device.
As to claim 13, Hubert, Glossop and Invivo teach the perineal access device of claims 1 but Hubert does not explicitly teach at least one of the one or more channels of the grid has obtuse angled walls. Hubert teaches wherein the grid enables transperineal access with targeted alignment for taking tissue samples (para [0027]) in order to better orient and localize the insertion of a biopsy needle (para [0032]) but does not explicitly specify the orientation of the channels of the grid. However, it would have been obvious to a person having ordinary skill in the art to modify the channels such that one or more channels of the grid has obtuse angled walls in order to use the grid to insert a biopsy needle in an obtuse angled path as desired for a
procedure using the device.
As to claim 15, Hubert, Glossop and Invivo teach the perineal access device of claim 1 but do not explicitly teach wherein said optical head
is fixedly mounted to one of the first and second leg separators.
However, it would have been obvious to a person having ordinary skill in the art to modify the optical head such that it is fixedly mounted to
one of the first and second leg separators in order to use the device in a repeatable manner such that the optical head provides the same
field of view during repeated use the of the device.
As to claim 16, Hubert, Glossop and Invivo teach the perineal access device of claim 1 and Hubert teaches wherein said guidance assembly is adjustably mounted to said base (see how the guidance assembly is attached to 1 by a movable slide 9, Fig 1-2; slide 9 that can be moved relative to 1, para [0027]).
As to claim 17, Hubert, Glossop and Invivo teach the perineal access device of claim 16 but Hubert does not explicitly teach including means for adjusting a height of said guidance assembly. Glossop further teaches an adjustable support mechanism holds the guidance assembly (see support mechanism 922 which holds
template assembly 900 including a frame, Fig 9; support mechanism 922 holds a frame assembly that supports template 900, para [0155]; support mechanism 922 includes dials or controls to move template 900/500 into position, para [0156]-[0157]), and wherein adjustment of the guidance assembly includes adjusting the height of the guidance plate to align it with the prostate (template 500 may be aligned to
prostate 501 by moving up/down, para [0130]). Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the device of Hubert such that it further comprises an adjustable support mechanism for the guidance assembly in order to adjust the height of the guidance plate as taught by Glossop such that it is aligned with the prostate of a patient.
Claim 4 is rejected as being obvious over Hubert in view of Glossop in further view of Invivo and infurther view of US 2002/0038117 A1 to Tokita et al. (hereinafter 'Tokita').
As to claim 4, Hubert, Glossop and Invivo teach the perineal access device of claim 1 but Hubert does not teach wherein each of the first and second frame legs includes an interior post receptacle and further comprising first and second height adjustment posts disposed in the first and second interior post receptacles, respectively.
Tokita further teaches a guidance assembly for guiding a needle through the perineum and into the prostate (see assembly comprising template 1 and frame 2, Fig 2; template to guide needle through the perineum and into the prostate, para [0008], para [0046]) comprising an access frame (see frame 2, Fig 2; frame 2, para [0046]) supported by first and second frame legs (see pair of frame legs 2a, Fig 2; frame 2 having pair of legs 2a, para [0048]), teach of the frame legs including an interior post receptacle (see how the legs 2a include interior receptacles for posts 4 and 5, Fig 2, Fig 4) and further comprising first and second height adjustment posts disposed in the first and
second interior post receptacles (see first and second height adjustment posts 4, 5 disposed in the interior post receptacles, Fig 2, Fig 4; vertical grid posts 4, 5 to provide arrangement of the height of template 1, para [0052]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the first and second frame legs of Hubert such that each includes an interior post receptacle and further comprising first and second height adjustment posts disposed in the first and second interior post receptacles, respectively as taught by Tokita in order to provide for adjusting the height of the guidance assembly for better guiding a needle through the perineum and into the prostate.
Claim 14 is rejected as being obvious over Hubert in view of Glossop in further view of Invivo and in further view of US 2017/0143442 A1 to CamPlex, Inc (hereinafter 'CamPlex').
As to claim 14, Hubert, Glossop and Invivo teach the perineal access device of claim 1 but do not explicitly teach wherein said optical head includes a plurality of optical sensors and a plurality of adjustable light sources. CamPlex further teaches an optical assembly for use in a stereoscopic surgical imaging system (see optical assembly 53 for using in an imaging head 51, Fig 4A; optical assembly 53 for use in imaging system 51 such as in Fig 4A, para [1220]-[1221]]) comprising a plurality of
optical sensors (one or more cameras, para [1224]) and a plurality of adjustable light sources (light source may be adjustable, para [1222]; plurality of light sources, para [1224]) in order to better direct light in the field of view of cameras/optical sensors imaging the object (para [1224]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the optical head such that it includes a plurality of optical sensors and a plurality of adjustable light sources as taught by CamPlex in order to better direct light in the field of view of a plurality of cameras/optical sensors imaging the guidance assembly.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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