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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5 and 25-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is indefinite because it is unclear what the bounds of the relative term generally are.
Claim 3 is indefinite because it is what two respective vectors are generated by the third and fourth coils. It is unclear how two vectors are created when the coils are connected in series as recited in claim 2 from which claim 3 depends. The specification fails to provide support for two vectors from the recited coils in claim 3.
Claim 4 is indefinite because it is unclear what the bounds of the relative term generally are.
Regarding claim 25, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 30 is indefinite because it is unclear how an angular offset is operable to do anything in the presently claimed device.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites two vectors from coils placed in series with each other. The specification fails to provide support for the claimed subject matter. The specification also fails to provide support for a navigation vector generally along the longitudinal axis in the context of the third and fourth coils.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-10, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,253,770 B1 to Acker et al., in view of U.S. PG Pub. No. 2007/0197899 A1 to Ritter et al., and in view of U.S. PG Pub. No. 20100145337 A1 to Janna et al.
Regarding claim 1, Acker discloses an instrument, comprising: an exterior wall that is operable to be moved relative to a subject, wherein the exterior wall defines and extends along a longitudinal axis wherein a centerline of a first position extends (i) through a center of the first position, (ii) perpendicular to the longitudinal axis and (ii) through a center of a second position; and a tracking device comprising (1) a first conductive wire wound to define a first coil at least partially disposed in the first position, wherein the first conductive wire is wound around a first axis of rotation, wherein the first axis of rotation extends through and is at a winding angle of about 20 degrees to about 70 degrees relative to the longitudinal axis (ii) a second conductive wire connected in series with the first conductive wire, wherein the second conductive wire is wound to define a second coil at least partially disposed in the second position, wherein the second conductive wire is wound around a second axis of rotation, wherein the second axis of rotation extends through and is at a second angle relative to the longitudinal axis, and wherein the first oval-shaped coil and the second oval- shaped coil are positioned about 180 degrees from one another around the longitudinal axis; wherein the first coil and the second coil are both disposed away from the longitudinal axis of the exterior wall, wherein the first and second coils are connected in series such that both operate as a single coil to increase the electromagnetic signal; and wherein distal ends of the first and second oval-shaped coils are positioned at a common longitudinal distance from the distal end of the instrument (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36, noting for example coils 74 A and B, 76 A and B, or 74 C and D and that the coils of Fig. 8 have multiple vectors summed together for a stronger combined signal strength).
Acker does not specifically disclose that the coil positions are depression in the wall and that the coils are oval shaped.
Janna discloses a similar coil based medical positioning device, wherein a holding portion defined by the instrument comprises a first depression formed in the exterior wall and a second depression formed in the exterior wall, and wherein a centerline of the first depression extends (i) through a center of the first depression, (ii) perpendicular to the longitudinal axis and (iii) through a center of the second depression (see Figs. 18-20 and para 115-119).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Janna because doing so would save space inside the core of the Acker device and would ensure that the wires stayed in place. Moreover, recessing the coils in an oval depression would protect the coils and hold them in place.
Ritter discloses a similar magnetic medical positioning device, wherein the wire coils are shaped in an oval shape (see Fig. 9, para 41, and claim 12).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Ritter because doing so would provide a device with a larger magnetic moment that would improve detectability and signal quality (see Fig. 9, para 41, and claim 12).
In the alternative to Acker disclosing coil winding angles of about 20-70 degrees.
It would have been an obvious matter of design choice to adjust the coil winding angles, since applicant has not disclosed that such an arrangement solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with coils arranged parallel or at an angle to the instrument axis. Changing the arrangement of coils would have predictably altered the field strengths and location of the coils relative to the instrument axis. Such a change would have been predictable to a skilled artisan because the field strengths are based on well-known field theory and geometry.
Further, Examiner notes that Acker indicates that changing the angles of coil windings relative to the instrument axis is a mere design choice to accommodate the shape of the device and vary the field strengths of the coil elements (see col 9 ln 8-col 10 ln 28).
It would have been obvious to one of skill in the art to use the further teachings of Acker to rearrange the coils because doing so would predictably alter the field strengths and locations relative to the instrument.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to shift the location of the coils, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would have been obvious to one of skill in the art to have altered the location of the coils because doing so would allow coils to be placed such that varying internal and external instrument geometries can be accommodated. Said another way, it would have been obvious to place coils along the exterior of the device at an angle when the interior or exterior of the device was angled or required an angled location of the coils.
Examiner also notes that commensurate subject matter was already found obvious by the Patent Board on June 28, 2017 in the parent application.
Regarding claim 2, Acker, Ritter, and Janna discloses a device, wherein: the exterior wall comprises a third depression formed in the exterior wall and a fourth depression formed in the exterior wall; the fourth depression is on an opposite side of the exterior wall than the third depression, wherein a centerline of the third depression extends (i) through a center of the third depression, (ii) perpendicular to the longitudinal axis and (iii) through a center of the fourth depression, and wherein the centerline of the third depression extends perpendicular to the centerline of the first depression; and the tracking device further comprises a third conductive wire wound to define a third oval-shaped coil disposed in the third depression, and a fourth conductive wire wound to define a fourth oval-shaped coil disposed in the fourth depression, wherein the third and fourth oval-shaped coils are connected in series; wherein the third oval-shaped coil and the fourth oval-shaped coil operate as a single coil to increase the electromagnetic signal (see the citations and reasons to combine for claim 1 that incorporated by reference). In particular Acker discloses the third and fourth coils; Ritter discloses oval shapes; and Janna teaches holding the coils in depressions.
A skilled artisan would have used oval coils to increase signal strength and would have used depressions to hold coils firmly in place while maintain the profile of the device.
Regarding claim 3 and in light of the Section 112 deficiencies in the claim, Acker discloses a device, wherein the third oval-shaped coil and the fourth oval-shaped coil define respective navigation vectors that are at different angles relative to a navigation vector that would generally be along the longitudinal axis (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36, noting that vectors also are intended uses that the device of Acker is capable of performing).
Noting that Ritter already discloses oval shaped coils.
Regarding claim 4, Acker discloses a device, further comprising a fifth conductive wire wrapped around the instrument and the longitudinal axis, wherein the fifth conductive wire defines a navigation vector that is generally along the longitudinal axis. (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36, noting that vectors also are intended uses that the device of Acker is capable of performing).
Regarding claims 6-10, Acker discloses a device, wherein the second angle is different than the first angle; wherein the second angle is a same angle as the first angle, wherein the second angle is 180° different than the first angle; wherein the second axis of rotation extends through and is at a second angle relative to the longitudinal axis; wherein: the second axis of rotation is at a second angle relative to the longitudinal axis; and the second angle is an inverse of the first angle.
Further and in the alternative, regarding claims 6-10, it would have been an obvious matter of design choice to adjust the distances for the first and second ends, since applicant has not disclosed that such an arrangement solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with coils arranged parallel or at an angle to the instrument axis. Changing the arrangement of coils would have predictably altered the field strengths and location of the coils relative to the instrument axis. Such a change would have been predictable to a skilled artisan because the field strengths are based on well-known field theory and geometry.
Further, Examiner notes that Acker indicates that changing the angles of coils relative to the instrument axis is a mere design choice to accommodate the shape of the device and vary the field strengths of the coil elements (see col 9 ln 8-col 10 ln 28).
It would have been obvious to one of skill in the art to use the further teachings of Acker to rearrange the coils because doing so would predictably alter the field strengths and locations relative to the instrument.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to shift the location of the coils, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would have been obvious to one of skill in the art to have altered the location of the coils because doing so would allow coils to be placed such that varying internal and external instrument geometries can be accommodated. Said another way, it would have been obvious to place coils along the exterior of the device at an angle when the interior or exterior of the device was angled or required an angled location of the coils.
Finally, changing the shape of the coil would have been an obvious matter of design to adjust the coil strength and to fit in the device as suggested in Acker. It would have been an obvious matter of design choice to change the coil, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 21, Acker discloses an instrument, comprising: an exterior wall operable to be configured and having a distal end that is operable to be moved relative to a subject and a longitudinal axis, wherein the exterior wall is tubular-shaped and includes a bore for insertion of an insertable member; and a tracking device defined by a first conductive wire wound around a first axis of rotation a first distance from the distal end to form a first coil, a second conductive wire wound around a second axis of rotation at the first distance from the distal end to form a second coil, and wherein the first coil is connected in series with the second coil and both are configured to sense an electromagnetic field; and wherein the tracking device is connected to the exterior wall including the first coil and the second coil disposed such that (i) the first axis of rotation extends through and is at a first angle relative to the longitudinal axis (ii) the second axis of rotation extends through and is at a second angle relative to the longitudinal axis, wherein the second angle is different than the first angle, and (iii) first coil and the second coil are positioned about 180 degrees from one another around the longitudinal axis and are positioned within the exterior wall to assist in substantially maintaining an outer diameter of the instrument (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36, noting for example coils 74 A and B, 76 A and B, or 74 C and D and that the coils of Fig. 8 have multiple vectors summed together for a stronger combined signal strength).
Acker does not specifically disclose that the coil locations are depression in the wall, that the coils are oval shaped, or that the first angle is less than 90°.
Ritter discloses a similar magnetic medical positioning device, wherein the wire coils are shaped in an oval shape (see Fig. 9, para 41, and claim 12).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Ritter because doing so would provide a device with a larger magnetic moment that would improve detectability and signal quality (see Fig. 9, para 41, and claim 12).
Janna in combination with Acker discloses a similar coil based medical positioning device, wherein a holding portion defined by the instrument comprises a first depression and a second depression in the exterior wall, wherein the second depression is on an opposite side of the exterior wall than the first depression, and wherein a centerline of the first depression extends (i) through a center of the first depression, (ii) perpendicular to the longitudinal axis and (iii) through a center of the second depression (see Janna Figs. 18-20 and para 115-119 and noting that Acker discloses coils on opposite sides).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Janna because doing so would save space inside the core of the Acker device and would ensure that the wires stayed in place. Moreover, recessing the coils in an oval depression would protect the coils and hold them in place.
Claim 21 further recites a first conductive wire wound around a first winding axis to form a first oval coil, wherein the first angle is less than 90°.
It would have been an obvious matter of design choice to adjust the distances for the first and second ends, since applicant has not disclosed that such an arrangement solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with coils arranged parallel or at an angle to the instrument axis. Changing the arrangement of coils would have predictably altered the field strengths and location of the coils relative to the instrument axis. Such a change would have been predictable to a skilled artisan because the field strengths are based on well-known field theory and geometry.
Further, Examiner notes that Acker indicates that changing the angles of coils relative to the instrument axis is a mere design choice to accommodate the shape of the device and vary the field strengths of the coil elements (see col 9 ln 8-col 10 ln 28).
It would have been obvious to one of skill in the art to use the further teachings of Acker to rearrange the coils because doing so would predictably alter the field strengths and locations relative to the instrument.
Finally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to shift the location of the coils, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would have been obvious to one of skill in the art to have altered the location of the coils because doing so would allow coils to be placed such that varying internal and external instrument geometries can be accommodated. Said another way, it would have been obvious to place coils along the exterior of the device at an angle when the interior or exterior of the device was angled or required an angled location of the coils.
Examiner also notes that commensurate subject matter was already found obvious by the Patent Board on June 28, 2017 in the parent application.
Claims 22 and 23 fail to recite further structural limitations and only recite intended use limitations. The device of the combined prior art is capable of performing the recited intended uses.
Further regarding claim 22 and the amendment of December 16, 2024, Acker discloses the structural limitation that the coils are angularly offset (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36). The remainder of the amended subject matter is recited as a functional limitation of the coil locations and not a function of the navigation system. The structural arrangement of Acker is capable of being used in the functional manner claimed and therefore Acker reads on the claims as written.
Regarding claim 24, Acker discloses a device, wherein the first axis of rotation and the second axis of rotation are angularly positioned 180-degrees from one another around the longitudinal axis of the instrument (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Acker, Ritter, and Janna as applied to claim 4 above, and further in view of U.S. PG Pub. No. 2005/0171508 A1 to Gilboa.
Regarding claim 5, Acker, discloses a navigation system comprising: the instrument of claim 4; a localizer operable to generate the electromagnetic field; wherein the first conductive wire and the second conductive wire are connected in series and generate a first signal output, wherein the third conductive wire and the fourth conductive wire are connected in series and general a second signal output, and wherein the fifth conductive wire is wound about the longitudinal axis and generates a third signal output; and a navigation processor configured to execute instructions to determine locations of the tracking devices based on signals from the tracking devices (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36). Examiner notes that the sensing claimed is merely an intended use and the coils and system of Acker are capable of performing said intended use.
Gilboa in combination with Acker, Ritter, and Janna discloses a similar medical positioning device comprising a navigation system, comprising: the instrument of claim 4; a localizer operable to generate the electromagnetic field; wherein the first conductive wire and the second conductive wire are connected in series and generate a first signal output, wherein the third conductive wire and the fourth conductive wire are connected in series and general a second signal output, and wherein the fifth conductive wire is wound about the longitudinal axis and generates a third signal output; and a navigation processor configured to execute instructions to determine locations of the tracking devices based on signals from the tracking devices. (see para 51 and 52 and abstract).
It would have been obvious to one of skill in the art to have combined the method of Acker with the further teachings of Gilboa because doing so would allow a user to see and visually track a device position over time on a conventional monitor display.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,253,770 B1 to Acker et al., in view of U.S. PG Pub. No. 2007/0197899 A1 to Ritter et al., in view of U.S. PG Pub. No. 20100145337 A1 to Janna et al., and further in view of U.S. PG Pub. No. 2005/0171508 A1 to Gilboa.
Regarding claim 25, Acker discloses a navigation system, comprising: an instrument that is operable to be moved relative to a subject and having an exterior wall, a distal end and an instrument axis, wherein the instrument axis extends longitudinally from the distal end to a proximal end of the instrument, wherein the instrument comprises a holding portion with first and second positions, wherein the second position is on an opposite side of the exterior wall than the first position; a tracking device having (1) a first conductive wire wound around a first winding axis to form a first coil, (2) a second conductive wire in series with the first conductive wire and wound around a second winding axis to form a second coil, wherein the first coil and the second coil are angularly offset about the exterior wall with respect to and disposed away from the instrument axis, and (3) a third conductive wire wound around a third winding axis and connected in series to (4) at least a fourth conductive wire wound around a fourth winding axis, wherein all of the first conductive wire, the second conductive wire, the third conductive wire, and the fourth conductive wire are positioned in the holding portion of the instrument; a localizer and the first oval coil, the second oval coil, the third conductive wire and the fourth conductive wire configured to generate a tracking signal; and a navigation processor configured to execute instructions to determine locations of the tracking devices based on signals from the tracking devices; wherein the first coil is positioned in the first position and the second coil is positioned in the second position, and the first coil and the second coil are positioned about 180 degrees from one another around the instrument axis and have a winding angle such as about 20 degrees to about 70 degrees relative to the instrument axis (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36, noting for example coils 74 A and B, 76 A and B, or 74 C and D and that the coils of Fig. 8 have multiple vectors summed together for a stronger combined signal strength).
Ritter discloses a similar magnetic medical positioning device, wherein the wire coils are shaped in an oval shape (see Fig. 9, para 41, and claim 12).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Ritter because doing so would provide a device with a larger magnetic moment that would improve detectability and signal quality (see Fig. 9, para 41, and claim 12).
Janna in combination with Acker discloses a similar coil based medical positioning device, wherein the instrument comprises a holding portion defined by the instrument and within a surface of the exterior wall, wherein the holding portion defines first and second oval depressions, wherein the second oval depression is on an opposite side of the exterior wall than the first oval depression (see Janna Figs. 18-20 and para 115-119 and noting that Acker discloses coils on opposite sides).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Janna because doing so would save space inside the core of the Acker device and would ensure that the wires stayed in place. Moreover, recessing the coils in an oval depression would protect the coils and hold them in place.
Gilboa in combination with Acker, Ritter, and Janna discloses a similar medical positioning device comprising a navigation system, comprising a localizer to generate an electromagnetic field, wherein the first conductive wire, the second conductive wire, the third conductive wire and the fourth conductive wire sense the electromagnetic field generated by the localizer and generate a signal regarding a position and orientation information of the instrument; and a navigation processor operable to execute instructions to determine a plurality of degrees of freedom of location information regarding the instrument based on the generated signal from the tracking device (see para 51 and 52 and abstract).
It would have been obvious to one of skill in the art to have combined the method of Acker with the further teachings of Gilboa because doing so would allow a user to see and visually track a device position over time on a conventional monitor display.
Regarding the amendment of April 21, 2025, Examiner notes that the last element of the claim is merely an intended use of the system and functional in nature. The device of the combined prior art is capable of performing said limitation. Further, no structure of the navigation system is positively claimed as part of the instrument of claim 1 and therefore little to no weight is provided for said element. For example, the functional limitation is not tied to the localizer, a processor or computer, or a means plus function element that would give the functional limitation more patentable weight.
In the alternative to Acker disclosing coil winding angles of about 20-70 degrees.
It would have been an obvious matter of design choice to adjust the coil winding angles, since applicant has not disclosed that such an arrangement solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with coils arranged parallel or at an angle to the instrument axis. Changing the arrangement of coils would have predictably altered the field strengths and location of the coils relative to the instrument axis. Such a change would have been predictable to a skilled artisan because the field strengths are based on well-known field theory and geometry.
Further, Examiner notes that Acker indicates that changing the angles of coil windings relative to the instrument axis is a mere design choice to accommodate the shape of the device and vary the field strengths of the coil elements (see col 9 ln 8-col 10 ln 28).
It would have been obvious to one of skill in the art to use the further teachings of Acker to rearrange the coils because doing so would predictably alter the field strengths and locations relative to the instrument.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to shift the location of the coils, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would have been obvious to one of skill in the art to have altered the location of the coils because doing so would allow coils to be placed such that varying internal and external instrument geometries can be accommodated. Said another way, it would have been obvious to place coils along the exterior of the device at an angle when the interior or exterior of the device was angled or required an angled location of the coils.
Examiner also notes that commensurate subject matter was already found obvious by the Patent Board on June 28, 2017 in the parent application.
Regarding claim 26, Acker in combination with Ritter teach a device, wherein the third conductive wire and the fourth conductive wire are wound around the third and fourth winding axes in a shape of an oval such that windings of the third conductive wire and the fourth conductive wire have a major radius aligned with the instrument axis of the instrument (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36).
Ritter discloses a similar magnetic medical positioning device, wherein the wire coils are shaped in an oval shape (see Fig. 9, para 41, and claim 12).
It would have been obvious to one of skill in the art to have combined the device of Acker with the further teachings of Ritter because doing so would provide a device with a larger magnetic moment that would improve detectability and signal quality (see Fig. 9, para 41, and claim 12).
Regarding claim 27, Examiner notes that Acker indicates that changing the angles of coils relative to the instrument axis is a mere design choice to accommodate the shape of the device and vary the field strengths of the coil elements (see col 9 ln 8-col 10 ln 28).
It would have been obvious to one of skill in the art to use the further teachings of Acker to rearrange the coils because doing so would predictably alter the field strengths and locations relative to the instrument.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to shift the location of the coils, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would have been obvious to one of skill in the art to have altered the location of the coils because doing so would allow coils to be placed such that varying internal and external instrument geometries can be accommodated. Said another way, it would have been obvious to place coils along the exterior of the device at an angle when the interior or exterior of the device was angled or required an angled location of the coils.
Consequently, a skilled artisan would have found a device, wherein each of the major radii is angled relative to the instrument axis of the instrument, such that each of the major radii does not extend in a direction parallel to the instrument axis, obvious in light of the teachings of Acker that indicate that coils can be angled and adjusted to accommodate different field strengths and instrument shapes.
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Acker, Ritter, Janna, and Gilboa as applied to claim 26 above, and further in view of U.S. PG Pub. No. 2006/0025677 A1 to Verdad et al.
Regarding claim 28, Acker discloses a device, wherein the first conductive wire includes a plurality of turns around the first winding axis; wherein the second conductive wire includes a plurality of turns around the second winding axis; wherein the third conductive wire includes a plurality of turns around the third winding axis; and wherein the fourth conductive wire includes a plurality of turns around the fourth winding axis (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36).
Verdad discloses a similar medical tracking device, comprising a guide post having a slanted wall extending from the exterior wall configured to assist in aligning a winding (see Fig. 6 and para 297-299).
It would have been obvious and predictable to have used guide posts to hold coils in place at angles.
Regarding claim 29, Acker discloses a device, wherein the first conductive wire and the second conductive wire are connected in series and angularly positioned 180- degrees from one another around and spaced away from the instrument axis of the instrument (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36).
Regarding claim 30, Acker discloses a device, wherein the third conductive wire and the fourth conductive are connected in series to one another and angularly positioned 180-degrees from one another around and spaced away from the axis of the instrument wherein the angular offset is operable by the navigation processor to identify different positions of the respective coil segments relative to the insturment (see Figs. 4A-C and 8 and col 8 ln 28-col 13 ln 36).
The wherein clause noting operability of the angular offset is a functional limitation and the device of the cited prior art is capable of performing the claimed function.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-10 and 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over the allowed claims of U.S. Patent No. 10,492,868. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim elements are merely arranged in a different order and are more specific in the allowed claims.
Response to Arguments
Although moot in view of the new grounds of rejection, Applicant's arguments filed September 4, 2025 have been fully considered but they are not persuasive.
Applicant rehashes arguments regarding design choice and the placement of coil elements.
First, Applicant’s remarks are unpersuasive because the claims include the term “about” that renders the claims broad enough to read on the primary reference without the need for a design choice rationale. Second, the Patent Board decision dated June 28, 2017 in parent application 13/016762 has already decided the same or similar issue and found that the arrangement of coils in the present device is a mere matter of design for several reasons. For example, the Board agreed with the Examiner that Acker teaches the desirability and predictability of rearraigning the geometry, location, and orientation of coils at page 8 of the Brief. Consequently, the Examiner is bound by the decision of the Board.
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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/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798