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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10 2023 207 904.6, filed on 08/17/2023.
Status of Claims
This Office Action is responsive to the claims filed on 08/06/2026. Claim 10 has been amended. Claim 5 was previously cancelled. Claims 1-4 and 6-16 are presently pending in this application.
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 light guidance device” in claim 1, ln. 3, and claim 13, ln. 3; and “a reflector element” in claim 1, ln. 4, claim 10, ln. 3, and claim 13, ln. 4.
The corresponding structure for the “light guidance device” defined within the specification is “a light source or a laser” (Paragraph [0009], Line 1-2) and any functional equivalents. The corresponding structure for the “reflector element” defined within the specification is “a mirror” (Paragraph [0010], Line 10) 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, 2, 7, 8, 10, 11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kitaevich (US 5598269) in view of Borja (US 20100063508 A1).
Regarding claim 1, Kitaevich teaches a system (Col. 2, ln. 46-57; highly accurate laser-guided alignment apparatus) for providing support during an orienting of a medical object (Col. 6, ln. 66-Col. 7, ln. 13; a biopsy instrument 100, Fig. 7 and 8; Col. 1, ln. 11-20; such as needles, localization wires or other biopsy tools) according to a target positioning (Col. 2, ln. 46-57; it provides for highly accurate positioning and insertion of the biopsy instrument), the system comprising:
a light guidance device (Col. 6, ln. 66-Col. 7, ln. 24; laser light source 106, Fig. 7 and 8) configured to emit a predefined light distribution (Col. 2, ln. 58-60; laser light source for producing a laser line beam, Fig. 7 and 8; Col. 5, ln. 57-60; such that the laser light can be directed at an angle, Fig. 7 and 8);
a reflector element (Col. 6, ln. 66-Col. 7, ln. 24; reflective material or mirror 102,114, Fig. 7 and 8) configured to be fixedly mounted in a defined arrangement on the medical object or wherein the reflector element is integrated into the medical object in the defined arrangement (Col. 6, ln. 66-Col. 7, ln. 24; affixed to its trailing end 101, Fig. 7 and 8), wherein the reflector element, when illuminated by the light distribution (Col. 6, ln. 66-Col. 7, ln. 24; laser line beam 104, Fig. 7 and 8), is configured to reflect at least a part of the light distribution in a defined manner relative to the medical object (Col. 6, ln. 66-Col. 7, ln. 24; reflecting laser line beam to ensure proper alignment thereof; angled mirror 114 that reflects laser line beam 104 in a perpendicular direction; Fig. 7 and 8); and
a projection surface comprising at least a visibly identifiable marker (Col. 6, ln. 66-Col. 7, ln. 24; sensor; calibrated scale with graduated scale 110; A graduated scale is considered to be visibly identifiable as understood in its broadest reasonable interpretation);
wherein the projection surface and the light guidance device are arranged in a defined positional relationship with respect to one another (Col. 6, ln. 66-Col. 7, ln. 24; in maintaining such alignment, laser light source 106 may be provided with a sensor (not specifically shown) for sensing the reflected beam 108. When the biopsy tool is misaligned, the reflected or return beam 108 will not be sensed by the sensor, Fig. 7; In this arrangement, the trailing end 101 of instrument 100 is provided with a prism or angled mirror 114 that reflects laser line beam 104 in a perpendicular direction to strike graduated scale 110, as shown, Fig. 8).
Kitaevich does not explicitly teach the light distribution is a predefined light distribution, wherein the reflected part of the predefined light distribution projects a light pattern having a geometric shape onto the projection surface, the visibly identifiable marker being illuminated by the light pattern only when the medical object reaches a target orientation.
Borja, however, teaches a system for providing support during an orienting of a medical object according to a target positioning (Paragraph [0013]; a monitoring system can be provided for monitoring an orientation of a surgical orientation device having an associated three-dimensional coordinate reference system during an orthopedic procedure), the system comprising:
a light guidance device (Paragraph [0113]; the visible alignment indicators 1106 can comprise one or more lasers) configured to emit a predefined light distribution (Paragraph [0113]; The laser light can be used to project a point, a plane, and or a cross-hair onto a target or targets; A cross-hair is considered to be a predefined light distribution);
a reflector element (Paragraph [0220]; an hold or attach a device for confirming a cut line or plane, for example a mirror 226 as shown in FIG. 22A of the system 210. The mirror 226 can be coupled to or integrally formed with the universal jig; an hold or attach a device for confirming a cut line or plane, for example a mirror 226 as shown in FIG. 22A of the system 210. The mirror 226 can be coupled to or integrally formed with the universal jig);
a projection surface (Paragraph [0181]-[0184]; Target probes 18a, 18b; can comprise an area on the target probe 18a, 18b which, as described further herein, is configured to indicate whether the target probe 18a, 18b is aligned with the surgical orientation device 12 and/or cutting block 84.; Figs. 20 and 21B) comprising at least a visibly identifiable marker (Paragraph [0183]; the target portion 108 can comprise one or more target shapes 110, in the form of markings, slits, or other structures… FIG. 20 illustrates an embodiment of a target probe 18b with a target shape 110 in the form of a single slot, and a target probe 18a with two slots in the form of a cross, for example formed as two perpendicular lines or slots);
wherein the reflected part of the predefined light distribution projects a light pattern having a geometric shape onto the projection surface (Paragraph [0183]; can be wide enough to allow a beam of laser light, such as for example a beam in the form of a plane or a cross-hair beam, to pass through the target shapes 110), the visibly identifiable marker being illuminated by the light pattern only when the medical object reaches a target orientation (Paragraph [0183]; configured to indicate whether the target probe 18a, 18b is aligned with the surgical orientation device 12 and/or cutting block 84; With at least one cross-hair laser beam pointing towards the ankle, the knobs on the universal jig 16 can be adjusted until the laser beam illuminates a target shape 110 on the target portion 108 of target probe 18a).
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 light distribution and projection surface of Kitaevich to have been a predefined light distribution, wherein the reflected part of the predefined light distribution projects a light pattern having a geometric shape onto the projection surface, the visibly identifiable marker being illuminated by the light pattern only when the medical object reaches a target orientation as taught by Borja because it would have been a known method of aligning a medical object that further ensure alignment of the medical device along two perpendicular axes (Paragraph [0113]) and assist the operator in positioning a medical device in an exact position and orientation for a medical operation (Paragraphs [0207]-[0210]).
Regarding claim 2, Kitaevich and Borja teaches all of the limitations of claim 1 as noted above.
Kitaevich further teaches a medical imaging device (Col. 4, ln. 55-Col. 5, ln. 6; Col. 7, ln. 25-45; a CT scanning device 10, Fig. 1 and 9), wherein the light guidance device and the projection surface are arranged on the medical imaging device in a defined positional relationship with respect to one another and/or are integrated at least partly into the medical imaging device (Col. 7, ln. 25-45; a support post 120 is rigidly affixed to a CT scanner 10 as by bracket 122; alignment apparatus includes an arcuate, calibrated member 128 and laser light source 134… member 128 can be positioned in an appropriate position such that line beam 132 emitted from laser light source 134 is at the desired angle relative to vertical, as required for the biopsy or other procedure; operator follows the same procedure of aligning the biopsy tool with line beam 132 as described hereinabove, Fig. 9).
Regarding claim 7, Kitaevich and Borja teaches all of the limitations of claim 1 as noted above.
Kitaevich further teaches the projection surface has a plurality of visibly identifiable markers for a respective potential target positioning of the medical object (Col. 6, ln. 66-Col. 7, ln. 24; graduated scale 110… move down along ruler 110 a distance proportional to the insertion depth), wherein the reflected part of the predefined light distribution only illuminates a corresponding visibly identifiable marker when the medical object is oriented according to the respective target positioning (Col. 6, ln. 66-Col. 7, ln. 24; the reflected beam 104 will move down along ruler 110 a distance proportional to the insertion depth, thereby indicating the depth of insertion of instrument 100, Fig. 8;).
Regarding claim 8, Kitaevich and Borja teaches all of the limitations of claim 7 as noted above.
Kitaevich further teaches the plurality of visibly identifiable markers form a scale (Col. 6, ln. 66-Col. 7, ln. 24; graduated scale 110).
Regarding claim 10, Kitaevich teaches a medical device (Col. 6, ln. 66-Col. 7, ln. 13; a biopsy instrument 100, Fig. 7 and 8) comprising:
a medical object (Col. 6, ln. 66-Col. 7, ln. 13; a biopsy instrument 100, Fig. 7 and 8; Col. 1, ln. 11-20; such as needles, localization wires or other biopsy tools); and
a reflector element (Col. 6, ln. 66-Col. 7, ln. 24; reflective material or mirror 102,114, Fig. 7 and 8), wherein the reflector element is disposed in a defined arrangement on the medical object or is integrated into the medical object in the defined arrangement (Col. 6, ln. 66-Col. 7, ln. 24; affixed to its trailing end 101, Fig. 7 and 8), wherein the reflector element, when illuminated by a light distribution (Col. 6, ln. 66-Col. 7, ln. 24; laser line beam 104, Fig. 7 and 8), is configured to reflect at least a part of the light distribution in a defined manner relative to the medical object (Col. 6, ln. 66-Col. 7, ln. 24; reflecting laser line beam to ensure proper alignment thereof; angled mirror 114 that reflects laser line beam 104 in a perpendicular direction; Fig. 7 and 8),
onto a projection surface comprising at least a visibly identifiable marker (Col. 6, ln. 66-Col. 7, ln. 24; sensor; calibrated scale with graduated scale 110; A graduated scale is considered to be visibly identifiable as understood in its broadest reasonable interpretation), the projection surface arranged in a defined positional relationship to a source of the light distribution (Col. 6, ln. 66-Col. 7, ln. 24; in maintaining such alignment, laser light source 106 may be provided with a sensor (not specifically shown) for sensing the reflected beam 108. When the biopsy tool is misaligned, the reflected or return beam 108 will not be sensed by the sensor, Fig. 7; In this arrangement, the trailing end 101 of instrument 100 is provided with a prism or angled mirror 114 that reflects laser line beam 104 in a perpendicular direction to strike graduated scale 110, as shown, Fig. 8).
Kitaevich does not explicitly teach the reflected part of the predefined light distribution projects a light pattern having a geometric shape onto the projection surface, the visibly identifiable marker being illuminated by the light pattern only when the medical object reaches a target orientation.
Borja, however, teaches a system for providing support during an orienting of a medical object according to a target positioning (Paragraph [0013]; a monitoring system can be provided for monitoring an orientation of a surgical orientation device having an associated three-dimensional coordinate reference system during an orthopedic procedure), the system comprising:
a light guidance device (Paragraph [0113]; the visible alignment indicators 1106 can comprise one or more lasers) configured to emit a predefined light distribution (Paragraph [0113]; The laser light can be used to project a point, a plane, and or a cross-hair onto a target or targets; A cross-hair is considered to be a predefined light distribution);
a reflector element (Paragraph [0220]; an hold or attach a device for confirming a cut line or plane, for example a mirror 226 as shown in FIG. 22A of the system 210. The mirror 226 can be coupled to or integrally formed with the universal jig; an hold or attach a device for confirming a cut line or plane, for example a mirror 226 as shown in FIG. 22A of the system 210. The mirror 226 can be coupled to or integrally formed with the universal jig);
a projection surface (Paragraph [0181]-[0184]; Target probes 18a, 18b; can comprise an area on the target probe 18a, 18b which, as described further herein, is configured to indicate whether the target probe 18a, 18b is aligned with the surgical orientation device 12 and/or cutting block 84.; Figs. 20 and 21B) comprising at least a visibly identifiable marker (Paragraph [0183]; the target portion 108 can comprise one or more target shapes 110, in the form of markings, slits, or other structures… FIG. 20 illustrates an embodiment of a target probe 18b with a target shape 110 in the form of a single slot, and a target probe 18a with two slots in the form of a cross, for example formed as two perpendicular lines or slots);
wherein the reflected part of the predefined light distribution projects a light pattern having a geometric shape onto the projection surface (Paragraph [0183]; can be wide enough to allow a beam of laser light, such as for example a beam in the form of a plane or a cross-hair beam, to pass through the target shapes 110), the visibly identifiable marker being illuminated by the light pattern only when the medical object reaches a target orientation (Paragraph [0183]; configured to indicate whether the target probe 18a, 18b is aligned with the surgical orientation device 12 and/or cutting block 84; With at least one cross-hair laser beam pointing towards the ankle, the knobs on the universal jig 16 can be adjusted until the laser beam illuminates a target shape 110 on the target portion 108 of target probe 18a).
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 light distribution and projection surface of Kitaevich to have been a predefined light distribution, wherein the reflected part of the predefined light distribution projects a light pattern having a geometric shape onto the projection surface, the visibly identifiable marker being illuminated by the light pattern only when the medical object reaches a target orientation as taught by Borja because it would have been a known method of aligning a medical object that further ensure alignment of the medical device along two perpendicular axes (Paragraph [0113]) and assist the operator in positioning a medical device in an exact position and orientation for a medical operation (Paragraphs [0207]-[0210]).
Regarding claim 11, Kitaevich and Borja teaches all of the limitations of claim 10 as noted above.
Kitaevich further teaches the medical object comprises a distal (Col. 6, ln. 66-Col. 7, ln. 24; portion of instrument 100 away from trailing end 101, Fig. 7 and 8) and a proximal section (Col. 6, ln. 66-Col. 7, ln. 24; trailing end 101, Fig. 7 and 8), wherein the distal section is configured to be arranged at least partly in an examination subject (Col. 6, ln. 66-Col. 7, ln. 24; instrument 100 is inserted into the patient), wherein the proximal section is configured to be arranged outside of the examination subject when the distal section is arranged inside the examination subject (Col. 6, ln. 66-Col. 7, ln. 24; instrument positioned such that the laser line beam strikes the trailing end of the instrument, Fig. 11), wherein the reflector element is arranged on the proximal section (Col. 6, ln. 66-Col. 7, ln. 24; biopsy instrument 100 which has affixed to its trailing end a reflective material or mirror 102 for reflecting laser line beam, Fig. 7 and 8).
Regarding claim 13, Kitaevich a method for orienting a medical object according to a target positioning (Col. 6, ln. 31-54; structural details of alignment apparatus 30, its method of use), the method comprising:
emitting a predefined light distribution (Col. 5, ln. 57-60; such that the laser light can be directed at an angle, Fig. 7 and 8) by a light guidance device (Col. 6, ln. 66-Col. 7, ln. 24; laser light source 106, Fig. 7 and 8), wherein the light distribution illuminates a reflector element (Col. 6, ln. 66-Col. 7, ln. 24; reflective material or mirror 102,114, Fig. 7 and 8) that is fixedly mounted in a defined arrangement on the medical object (Col. 6, ln. 66-Col. 7, ln. 13; a biopsy instrument 100, Fig. 7 and 8; Col. 1, ln. 11-20; such as needles, localization wires or other biopsy tools) or is integrated into the medical object in the defined arrangement (Col. 6, ln. 66-Col. 7, ln. 24; affixed to its trailing end 101, Fig. 7 and 8), wherein the reflector element reflects at least a part of the light distribution in a defined manner relative to the medical object (Col. 6, ln. 66-Col. 7, ln. 24; reflecting laser line beam to ensure proper alignment thereof; angled mirror 114 that reflects laser line beam 104 in a perpendicular direction; Fig. 7 and 8); and
checking whether a specified visibly identifiable marker on a projection surface (Col. 6, ln. 66-Col. 7, ln. 24; sensor; calibrated scale with graduated scale 110; A graduated scale is considered to be visibly identifiable as understood in its broadest reasonable interpretation) is illuminated by the reflected part of the light distribution (Col. 6, ln. 66-Col. 7, ln. 24; biopsy tool is misaligned, the reflected or return beam 108 will not be sensed by the sensor and an alarm will be generated signaling the misalignment to the operator), wherein the projection surface and the light guidance device are arranged in a defined positional relationship with respect to one another (Col. 6, ln. 66-Col. 7, ln. 24; in maintaining such alignment, laser light source 106 may be provided with a sensor (not specifically shown) for sensing the reflected beam 108. When the biopsy tool is misaligned, the reflected or return beam 108 will not be sensed by the sensor, Fig. 7; In this arrangement, the trailing end 101 of instrument 100 is provided with a prism or angled mirror 114 that reflects laser line beam 104 in a perpendicular direction to strike graduated scale 110, as shown, Fig. 8), wherein the medical object is repositioned and checking is repeated if the check proves negative (Col. 6, ln. 66-Col. 7, ln. 24; signaling the misalignment to the operator. Upon correction of the misalignment, the sensor will once again sense return beam 108 and the operator will be assured of proper positioning of the instrument).
Kitaevich does not explicitly teach the light distribution is a predefined light distribution,
and repeatedly checking until the specified visibly identifiable marker is illuminated by the reflected part of the predefined light distribution indicating that the medical object has reached a target orientation.
Borja, however, teaches a system for providing support during an orienting of a medical object according to a target positioning (Paragraph [0013]; a monitoring system can be provided for monitoring an orientation of a surgical orientation device having an associated three-dimensional coordinate reference system during an orthopedic procedure), the system comprising:
a light guidance device (Paragraph [0113]; the visible alignment indicators 1106 can comprise one or more lasers) configured to emit a predefined light distribution (Paragraph [0113]; The laser light can be used to project a point, a plane, and or a cross-hair onto a target or targets; A cross-hair is considered to be a predefined light distribution);
a reflector element (Paragraph [0220]; an hold or attach a device for confirming a cut line or plane, for example a mirror 226 as shown in FIG. 22A of the system 210. The mirror 226 can be coupled to or integrally formed with the universal jig; an hold or attach a device for confirming a cut line or plane, for example a mirror 226 as shown in FIG. 22A of the system 210. The mirror 226 can be coupled to or integrally formed with the universal jig);
a projection surface (Paragraph [0181]-[0184]; Target probes 18a, 18b; can comprise an area on the target probe 18a, 18b which, as described further herein, is configured to indicate whether the target probe 18a, 18b is aligned with the surgical orientation device 12 and/or cutting block 84.; Figs. 20 and 21B) comprising at least a visibly identifiable marker (Paragraph [0183]; the target portion 108 can comprise one or more target shapes 110, in the form of markings, slits, or other structures… FIG. 20 illustrates an embodiment of a target probe 18b with a target shape 110 in the form of a single slot, and a target probe 18a with two slots in the form of a cross, for example formed as two perpendicular lines or slots);
wherein the medical object is repositioned and checking is repeated until the specified visibly identifiable marker is illuminated by the reflected part of the predefined light distribution (Paragraph [0205]; the knobs on the universal jig 16 can be adjusted until the laser beam illuminates a target shape 110 on the target portion 108 of target probe 18a) indicating that the medical object has reached a target orientation (Paragraph [0183]; The target portion 108 can comprise an area on the target probe 18a, 18b which, as described further herein, is configured to indicate whether the target probe 18a, 18b is aligned with the surgical orientation device 12 and/or cutting block 84; Paragraph [0184]; Such adjustment provides one technique for aligning an orthopedic fixture, a surgical orientation device, or an orthopedic fixture and surgical orientation device, with a coronal or sagittal plane.).
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 method of Kitaevich to have included a predefined light distribution, and repeatedly checking until the specified visibly identifiable marker is illuminated by the reflected part of the predefined light distribution indicating that the medical object has reached a target orientation as taught by Borja because it would have been a known method of aligning a medical object that further ensure alignment of the medical device along two perpendicular axes (Paragraph [0113]) and assist the operator in positioning a medical device in an exact position and orientation for a medical operation (Paragraphs [0207]-[0210]).
Regarding claim 14, Kitaevich and Borja teaches all of the limitations of claim 13 as noted above.
Kitaevich further teaches the predefined light distribution projects a light pattern having a geometric shape (Col. 2, ln. 58-60; laser light source for producing a laser line beam, Fig. 7 and 8; the projection of the line beam onto the surface of the sensor or graduated scale is considered to be a geometric shape as understood in its broadest reasonable interpretation).
Borja further teaches a predefined light distribution projects a light pattern having a geometric shape (Paragraph [0113]; The laser light can be used to project a point, a plane, and or a cross-hair onto a target or targets; A cross-hair is considered to be a predefined light distribution).
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 light distribution to project any geometric shape as taught by Borja because it would have improved the ability for a user to perform alignment.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kitaevich in view of Borja as applied to claim 2 above, and further in view of Grossman (US 20010053915).
Regarding claim 3, together Kitaevich and Borja teaches all of the limitations of claim 2 as noted above.
Kitaevich further teaches the medical imaging device comprises an X-ray source and an X-ray detector (Col. 4, ln. 55-Col. 5, ln. 6; Col. 7, ln. 25-45; CT scanner 10).
Kitaevich does not explicitly teach the X-ray source and an X-ray detector are mounted so as to be movable, wherein the projection surface is a surface of the X-ray detector facing toward the X-ray source.
Grossman, however, teaches a X-ray source and an X-ray detector are mounted so as to be movable (Paragraph [0058] and [0067]; C-arm 64, C-arm can be rotated either obliquely (side to side), or cephalad (toward the head), or caudad (toward the feet)), wherein the projection surface is a surface of the X-ray detector facing toward the X-ray source (Paragraph [0058]; the reflecting element 60 can comprise a swinging element 66 of radiolucent material pivotal about a pivot 68 such that the element 66 can easily located in proximity to the undersurface of the C-arm 64, Fig. 1; the reflective surface receiving light from the light element is considered to be a projection surface as understood in its broadest reasonable interpretation. The reflective surface is on the surface of the C-arm as shown in Fig. 1).
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 X-ray source and an X-ray detector of Kitaevich in view of Borja to have been mounted so as to be movable, wherein the projection surface is a surface of the X-ray detector facing toward the X-ray source as taught by Grossman because it would have ensured alignment with the center of the x-ray system. This provides an advantage as less fluoroscopic pictures are taken and less fluoroscopy exposure is needed. Fluoroscopy machines will last longer and more importantly the clinician and others, as well as the patient, will receive less radiation exposure. (Grossman, Paragraph [0037]).
Regarding claim 4, together Kitaevich, Borja, and Grossman teach all of the limitations of claim 3 as noted above.
Kitaevich discloses the invention as claimed and discussed above, but fails to explicitly disclose the X-ray source and the X-ray detector are mounted so as to be movable around a common isocenter, wherein the predefined light distribution illuminates the isocenter.
Grossman, however, further teaches the X-ray source and the X-ray detector are mounted so as to be movable around a common isocenter (Paragraph [0067]; The C-arm 64 fluoroscopic machine; C-arm can be rotated either obliquely (side to side), or cephalad (toward the head), or caudad (toward the feet), Fig. 1), wherein the predefined light distribution illuminates the isocenter (Paragraph [0067]; initially positioned by the technician by centering the target site 14 with the center of the undersurface of the C-arm 64… optimal alignment, the C-arm 64 is positioned so the anatomic structure of interest 14 is visualized in the center of the image recorded).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Kitaevich in view of Borja and Grossman such that the X-ray source and the X-ray detector are mounted so as to be movable around a common isocenter, wherein the predefined light distribution illuminates the isocenter because images in the center of the screen are more accurate than are the images off to the side of the screen. Therefore, it is advantageous for the clinician to place the anatomic structure of interest in the center of the screen (Grossman, Paragraph [0038]).
Claims 6, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kitaevich in view of Borja as applied to claims 1 and 14 above, respectively, and further in view of Rahimian (US 8758263).
Regarding claim 6, together Kitaevich and Borja teach all of the limitations of claim 1 as noted above.
Kitaevich further teaches the light guidance device is configured to emit a further predefined light distribution (Col. 2, ln. 58-60; a second laser light source for producing a laser fan beam, Fig. 6) for illuminating the projection surface, that, in an operating state of the system, projects a further light pattern onto the projection surface (Col. 7, ln. 44-Col. 8, ln. 9; laser light source 150 may also include a laser fan beam to further aid in the alignment of the biopsy needle with respect to the calibrated grid 164 on upper compression paddle 144).
Kitaevich does not explicitly teach the projection of the further light pattern on the projection surface at least partly forms the visibly identifiable marker.
Rahimian, however, teaches a system for providing support during an orienting of a medical object according to a target positioning (Col. 2, ln. 40-67; performing a frameless image-guided biopsy using a laser guidance system) comprising a light guidance device (Col. 10, ln. 27-36; Optical Distance Indicator system (ODI) 400, Fig. 10a and 10b) configured to emit a predefined light distribution (Col. 10, ln. 27-36; cross hairs 440, Fig. 10a and 10b) and a further predefined light distribution (Col. 10, ln. 27-36; distance indicator light 410, Fig. 10a); wherein
the projection of the further light pattern on the projection surface at least partly forms the visibly identifiable marker (Col. 10, ln. 27-49; a graduated scale 420 mounted on the distance indicator… the projected scale is seen on the patient's body surface within the light beam; The scale 450 as projected on the patient surface can be seen together with the light beam from the field localizer, as shown in FIG. 10b., Fig. 10a and 10b).
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 marker of Kitaevich in view of Borja to have been formed by the further light distribution as taught by Rahimian, such that the projection of the further light pattern on the projection surface at least partly forms the visibly identifiable marker as it would have allowed the laser and ODI assembly can move on a virtual spherical surface and thereby make generally any biopsy approach point feasible while being able to indicate a specific distance based on where the rays meet the rays of the fan beam (Rahimian, Col. 10, ln. 14-49).
Regarding claim 15, together Kitaevich and Borja teaches all of the limitations of claim 14 as noted above.
Kitaevich further teaches the light guidance device emits a further predefined light distribution (Col. 2, ln. 58-60; a second laser light source for producing a laser fan beam, Fig. 6) for illuminating the projection surface, which further light distribution projects a further light pattern onto the projection surface (Col. 7, ln. 44-Col. 8, ln. 9; laser light source 150 may also include a laser fan beam to further aid in the alignment of the biopsy needle with respect to the calibrated grid 164 on upper compression paddle 144).
Kitaevich does not explicitly teach the projection of the further light pattern on the projection surface at least partly forms the visibly identifiable marker.
Rahimian, however, teaches a system for providing support during an orienting of a medical object according to a target positioning (Col. 2, ln. 40-67; performing a frameless image-guided biopsy using a laser guidance system) comprising a light guidance device (Col. 10, ln. 27-36; Optical Distance Indicator system (ODI) 400, Fig. 10a and 10b) configured to emit a predefined light distribution (Col. 10, ln. 27-36; cross hairs 440, Fig. 10a and 10b) and a further predefined light distribution (Col. 10, ln. 27-36; distance indicator light 410, Fig. 10a); wherein
the projection of the further light pattern on the projection surface at least partly forms the marker (Col. 10, ln. 27-49; a graduated scale 420 mounted on the distance indicator… the projected scale is seen on the patient's body surface within the light beam; The scale 450 as projected on the patient surface can be seen together with the light beam from the field localizer, as shown in FIG. 10b., Fig. 10a and 10b).
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 marker of Kitaevich in view of Borja to have been formed by the further light distribution as taught by Rahimian, such that the projection of the further light pattern on the projection surface at least partly forms the marker as it would have allowed the laser and ODI assembly can move on a virtual spherical surface and thereby make generally any biopsy approach point feasible while being able to indicate a specific distance based on where the rays meet the rays of the fan beam (Rahimian, Col. 10, ln. 14-49).
Regarding claim 16, together Kitaevich, Borja, and Rahimian teach all of the limitations of claim 15 as noted above.
Kitaevich discloses the invention as claimed and discussed above, but fails to explicitly disclose the projection of the further light pattern on the projection surface completely forms the specified marker.
Rahimian, however, further teaches the projection of the further light pattern on the projection surface completely forms the specified visibly identifiable marker (Col. 10, ln. 27-49; the projected scale is seen on the patient's body surface within the light beam, Fig. 10a and b show the scale is complexly formed by the projection of the distance indicator light).
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 marker of Kitaevich in view of Borja and Rahimian to have been completely formed from the projection of the further light pattern on the projection surface as taught by Rahimian because it would have allowed the laser and ODI assembly can move on a virtual spherical surface and thereby make generally any biopsy approach point feasible while being able to indicate a specific distance based on where the rays meet the rays of the fan beam (Rahimian, Col. 10, ln. 14-49).
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kitaevich in view of Borja as applied to claims 1 and 11 above, respectively, and further in view of Kienzle (US 20020193800).
Regarding claim 9, together Kitaevich and Borja teach all of the limitations of claim 1 as noted above.
Kitaevich does not explicitly teach the reflector element is configured to be moved along a longitudinal extension direction of the medical object and to be releasably secured to the medical object in the defined arrangement.
Kienzle, however, teaches a reflector element (Paragraph [0026]; localizing devices comprising reflectors, Figs. 6-8) is configured to be moved along a longitudinal extension direction of the medical object and to be releasably secured to the medical object in the defined arrangement (Paragraph [0039]; mounted on either side of a removable housing that attaches rigidly anywhere on a drill, Figs. 6 and 7 show the localizer with reflectors is configured to be moved along a longitudinal extension direction of the medical object).
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 reflector element of Kitaevich in view of Borja to have been configured to be moved along a longitudinal extension direction of the medical object and to be releasably secured to the medical object in the defined arrangement as taught by Kienzle because it would have allowed reusing the reflector among multiple medical objects and allow mounting such that it would be visible to the light source (Kitaevich, Paragraph [0039]).
Regarding claim 12, together Kitaevich and Borja teaches all of the limitations of claim 11 as noted above.
Kitaevich does not explicitly teach the reflector element is configured to be moved along a longitudinal extension direction of the medical object and to be releasably secured to the medical object in the defined arrangement.
Kienzle, however, teaches a reflector element (Paragraph [0026]; localizing devices comprising reflectors, Figs. 6-8) is configured to be moved along a longitudinal extension direction of the medical object and to be releasably secured to the medical object in the defined arrangement (Paragraph [0039]; mounted on either side of a removable housing that attaches rigidly anywhere on a drill, Figs. 6 and 7 show the localizer with reflectors is configured to be moved along a longitudinal extension direction of the medical object).
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 reflector element of Kitaevich in view of Borja to have been configured to be moved along a longitudinal extension direction of the medical object and to be releasably secured to the medical object in the defined arrangement as taught by Kienzle because it would have allowed reusing the reflector among multiple medical objects and allow mounting such that it would be visible to the light source (Kitaevich, Paragraph [0039]).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to the claims and withdraws all objections to the claims.
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant's arguments filed 08/06/2026 have been fully considered but they are not persuasive.
Regarding arguments to claims 1, 10, and 13, Applicant argues the prior art of Borja does not teach the reflected part of the light distribution illuminates a visibly identifiable marker as recited in the claims. In particular, Applicant points out the prior art of Borja teaches projecting a cross-hair shape is a directed beam and not a reflected beam as recited by the claims. Examiner respectfully disagrees with the scope of the claim interpretation as described by Applicant. The claim merely recites the reflected part of the light distribution projections a light pattern. Kitaevich does not explicitly teach a projection of a specific geometric shape on the light surface. Borja is thus relied upon to each projections of a cross which is considered to be a geometric shape as understood in its broadest reasonable interpretation. Furthermore, Borja teaches the projection surface as having a crosshair which is illuminated upon being properly aligned as described in at least paragraph [0183] and Figure 21B. This is considered to read to be “light distribution illuminates a visibly identifiable marker” as understood in its broadest reasonable interpretation. One of ordinary skill in the art would have realized projecting light in the shape of a cross hair to illuminate the markers in Kitaevich would have resulted in the claimed limitations. One would have been motivated to make such a modification because it would have improved alignment of the medical object along multiple axes.
Applicant further argues the prior art of Kitaevich does not teach the light pattern being illuminated only when the light medical object reaches a target orientation. Applicant points out the graduated scale of Kitaevich describes a measurement of depth and thus does not describe a static target orientation. Examiner respectfully disagrees. Examiner would like to point out Kitaevich teaches arranging the biopsy tool in a specific arrangement such that the light beam will move with a distance proportional to the depth. Such an arrangement is understood to be a target orientation as understood in its broadest reasonable interpretation. The light illuminating the ruler is considered to read on the claimed limitation of “the visibly identifiable marker being illuminated by the light pattern” as understood in its broadest reasonable interpretation. Furthermore, Kitaevich, further explains positioning the biopsy tool to be aligned with the light beam as described later in col. 7, ln. 40-45. For these reasons, rejections of claims 1, 10, and 13 are maintained.
Regarding arguments to claim 3, Applicant argues the arrangement of Grossman contradicts the structural arrangement of claim 1, requiring a reflector mounted onto the medical object. Examiner respectfully disagrees. The prior art of Kitaevich fails to explicitly teach where the projecting surface is in relation to the X-ray detector and source. Gross is relied upon to show that light from the medical object can be directed toward the surface of the x-ray detector. In at least Figure 6 and Paragraphs [0058] and [0067], the reflective surface which the light projected from the medical device is directed toward is considered to be a projection surface as understood in its broadest reasonable interpretation. One of reasonable skill in the art would have understood that the light reflected from the medical device could be directed onto any surface, including for example a surface of the x-ray detector as taught by Grossman. One would have been motivated to adjust the projection surface to along a surface of the detector because it would have ensured the tool was aligned with the center of the x-ray system as described by Grossman. For these reasons, the rejection of claim 3 is maintained.
Regarding arguments to claims 6 and 15, applicant further argues the modification of Rahimian breaks the functional arrangement of the claimed invention and base reference. In particular, Applicant points out that Rahimian teaches projecting a scale onto skin whereas Kitaevich teaches reflecting a beam upwards onto a physical mounted scale. Further, the scale is used to measure the depth, and does not suggest using this scale as an orientation marker. Examiner respectfully disagrees. As noted earlier, the scale of Kitaevich which is used to measure depth is already considered to be a marker that indicates orientation. Furthermore, the teachings of Rahimian is relied upon to teach that a scale can be projected onto a surface for forming markers. Modification of using projected scale markers as taught by Rahimian in the system of Kitaevich would thus result in the claimed limitations of “projects a further light pattern onto the projection surface, wherein the projection of the further light pattern on the projection surface at least partly forms the visibly identifiable marker” as understood in its broadest reasonable interpretation. One would be motivated to use a projected scale as taught by Rahimian because it would further allow moving the arrangement around and while being able to indicate a specific distance as described in Rahimian. For these reasons, rejections of claims 6 and 15 are maintained.
Regarding arguments to claim 7, Applicant argues the graduated scales of Kitaevich do not indicate “target positioning” and thus the scale markers of Kitaevich do not teach “a plurality of visibly identifiable markers for a respective potential target positioning of the medical object”. Examiner respectfully disagrees. As noted above, Kitaevich teaches arranging the biopsy tool in a specific arrangement such that the light beam will move with a distance proportional to the depth. Furthermore, the depth of the tool inserted into the patient is considered to be a “positioning” of the tool as understood in the broadest reasonable interpretation. As such, each depth being indicated by a scale marker is considered to read on the claimed limitations as understood in its broadest reasonable interpretation. For these reasons, rejection of claim 7 is maintained.
Regarding arguments to claims 9 and 12, Applicant argues the prior art of Kienzle does not teach the reflector is configured to be moved along a longitudinal extension direction of the medical object as required by the claims. Examiner respectfully disagrees. Examiner would like to point out that Figures 6 and Figure 7 show the reflector is attached to the drill and shown to slide onto the drill bit 105 into position along a longitudinal direction along the length, l. This is considered to read on the claimed limitation as understood in its broadest reasonable interpretation. For these reasons, rejection of claim 7 is maintained.
Rejections of claims 1-4 and 6-16 under 35 USC 103 are all maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
9/3/26
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