DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 20 is objected to because of the following informalities: in line 3 the phrase “disposed relative to the at least coil” should be drafted as “disposed relative to the at least one coil”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 6-8, 11, 14-18, 20-21, and 25-27 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.
Specifically, independent claims 1 and 11 both recite that the invention comprises a “monolithic tracking device having a monolithic tubular flexible circuit body … wherein the monolithic tracking device is a monolithic tubular printed circuit board extending from the proximal end to the distal end of the elongated body” which is not found in terminology or scope in the originally filed disclosure. In more detail, the term “monolithic” appears exactly and identically once in the original disclosure and then only recites:
“In another form, a surgical instrument includes an elongated tubular body portion, and a monolithic tubular flexible circuit portion having a trace defining a navigation coil.”
Notably, this citation does not address a flexible printed circuit board (fPCB) at all, and instead addresses only a flexible circuit which is a subtle difference in wording but a profound difference in scope (e.g. Burg’s invention would read on a flexible circuit spanning the entirety of the proximal to the distal end but would not read on an fPCB spanning that distance). Therefore, the specification offers insufficient disclosure to support the claim language for a first reason.
Secondly and relatedly, the citation does not address a flexible monolithic circuit spanning the entire length of the elongated body from the proximal to the distal end as is claimed, rather the citation addresses that the flexible monolithic circuit has a proximal and distal end, something which is both inherent and directly taught by Seter who teaches forming the trace defining the navigation coil on a monolithic fPCB, but something which is not commensurate with the scope of the claim language that requires the proximal and distal ends of the fPCB to span the entire distance from the proximal to the distal ends of the elongated body. Therefore, the specification offers insufficient disclosure to support the claim language for a second reason.
Third and most importantly, the applicant mentions the invention being monolithic in only this single statement and does not provide even a single detail as to how or why to make an invention where any individual part, much less the entirety from proximal to distal end, is monolithic. There is simply no detail at all to consider in the specification. As such there is a prima facie case that there is not adequate disclosure of how to make in invention commensurate with the scope of the claims.
As such and for the foregoing reasons the cited newly claimed limitation is held to have insufficient disclosure and, as the limitation was added by amendment, the claims are likewise held to contain new matter.
Additionally and relatedly Claims 3 and 26 are also further affected insofar as they address the lead traces, but it is not described how to make a “monolithic” fPCB with helically disposed lead traces mounted therein in the originally filed disclosure and, if instead mounted thereon this would seemingly be two-part and thus potentially contradict being monolithic such that regardless of interpretation the claimed limitations appear to be inadequately described and new matter for these and the foregoing inherited reasons.
Additionally and relatedly Claims 20-21 are also further affected insofar as they require the invention to be simultaneously a multi-layered “laminate” structure and also “monolithic” which is never described in the originally filed disclosure and appears to be potentially self-conflicting such that the claimed limitations appear to be inadequately described and new matter for these and the foregoing inherited reasons.
Claims 3, 6-8, 14-18, 20-21, and 25-27 are each similarly affected at least by virtue of dependency from one of claims 1 or 11.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3, 6-8, 11, 14-18, 20-21, and 25-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20110270081 A1 by Burg et al. (hereafter Burg, previously of record) further in view of US 20130066194 A1 by Seter et al. (hereafter Seter, previously of record), alternatively further in view of US 20070219551 A1 by Honour et al. (hereafter Honour, newly of record).
Regarding claim 1, Burg teaches: 1. An instrument (see Burg’s Abstract or Figs. 1), comprising:
an elongated body having a length extending from a proximal end to a distal end (see Burg’s Figs. 1-2);
a handle coupled to the proximal end of the elongated body (see Burg’s Fig. 2 part 114);
a monolithic (noting that the BRI of the term, as per the definition included in the conclusion section is merely “consisting of or constituting a single unit” then the invention of Burg is monolithic when assembled as per any depiction thereof, e.g. see any of Figs. 2-12 noting that the whole assembly is depicted as being put together and can be considered as a unit, as such being “monolithic” will not hereinafter be addressed as unless the parts art explicitly separate and not in contact then they can be considered monolithic – where the term monolithic therefore applied in each instance hereafter) tracking device (see Burg’s Fig. 2 part 118 which is a tracking sensor arrangement, and therefore comprises the device at least as broadly constructed in the claims) having a monolithic tubular (see any or all of Burg’s Figs. 2-12 noting that in all instances the device is arranged around a tubular surgical instrument 100 and is even call “tube assembly 110”, see e.g. [0034]) flexible (note the invention as a whole is malleable/flexible as per [0033] and the structures regarded below are also specifically designed to be flexible enough to bend during use as per [0047]) circuit (again see any of Figs. 2-12 and note that the inclusion of coils and lead wires necessarily mean that this is/comprises a circuit, see also [0042]) body extending around and along the length of the elongated body from the proximal end to the distal end of the elongated body, the monolithic tracking device having, (i) a pair of lead traces extending from the proximal end towards the distal end; and (ii) at least one coil trace defining at least one coil at the distal end and couples to the par of lead traces (see Burg’s Figs. 4-6 or 11 noting that the plurality of coils 214/214’ are located at the distal end and where the plurality of twisted pairs of lead traces including at least 228 and 236 extend to the proximal end as depicted therein or described in [0042] as cited above. Additionally and to fully compact prosecution one can even note that these extend or connect to elements beyond the proximal end, e.g. to interface with the EM tracking system 60 as shown in Fig. 1);
wherein the monolithic tracking device is a monolithic … configured to cooperate with a navigation system to track the distal end of the elongated body (see Burg’s Fig. 2 part 118 which is a tracking sensor arrangement, and therefore comprises the device at least as broadly constructed in the claims, which would be fully capable of as much; however and for compact prosecution purposes the examiner notes that e.g. [0025]-[0028] generally describe navigation system 10 as it relates to the tracking as do many other sections such as [0008] or [0038] etc. such that it is clear that not only are tracking coils fully capable of as much but that in fact Burg teaches the navigation system which is for use therewith).
In the foregoing the examiner omitted, as indicated by ellipsis, the phrase “tubular printed circuit board …” because the circuit of Burg is not provided as a printed circuit board and therefore Burg alone would fail to fully teach the claimed invention.
However Seter, in the same or eminently related field of tracking devices associated with medical instruments having a shaft (Abstract and Fig. 1) teaches coils and other electrical elements can be formed onto/as a flexible tubular printed circuit board (see Seter’s Figs. 3-9 and [0008], [0027]-[0044] noting that [0008] and Fig. 5 are exemplary) and further goes on to teach that forming these electronics onto/as a flexible PCB is advantageous ([0007] and [0044] plainly stated).
Therefore and in the alternative it would have been obvious to a person having ordinary skill in the art at the time of invention to improve the device of Burg by mounting his coils and other electronics on or providing his coils and other electronics as a FPCB as taught by Seter in order to advantageously provide the same functionality while simultaneously both reducing the complexity and cost of constructing the tracking device while and also providing a tracking device that is advantageously thinner.
Additionally, while the combination of Burg and Seter teaches the foregoing, Seter’s fPCB does not extend “from the proximal end to the distal end of the elongated tubular body” so as to fail to fully teach all claim limitations.
However, this limitation is obvious in at least two ways starting with the fact that it is prima facie obvious because it is a mere design choice and/or a mere change in the size, shape, or proportion of the fPCB already taught by Seter. That is, nothing in the claims or specification nor in the prior art of Seter or Burg addresses why one would or would not want the substrate of the fPCB (e.g. part 48 of Seter’s various Figs.) to extend for any particular length nor any change in function or utility of such an arrangement. As such this is clearly merely a design choice of the sort addressed in MPEP 2144.04(I), something made even more clear when one notes that whether or not the fPCB extends the claimed distance the form and format of the invention will be otherwise identical and have no difference in function and utility and where all electrical elements are the same regardless of the substrate and all physical elements will still be both supported from below (e.g. see Burg’s elongated tubular body part 126 in the various Figs. cited above such as Fig. 6) and from above (e.g. see Burg’s heat shrink layer 272 in Fig. 6) such that in any event all metal traces will be encapsulated on both sides and function identically whether or not the length of the substrate of the fPCB is long enough to reach the proximal end. Likewise and even if, arguendo, this change could be characterized as anything more than mere design choice it is still at most merely the lengthening of an already existing element which in no way changes the function of that element or of the invention as a whole such that one could further modify Seter’s teaching by lengthening substrate 48 in the manner set forth in MPEP 2144.04(IV) which describes that changes in the size, shape, or proportion of an element is a prima facie obvious modification.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to modify the combination of Burg and Seter by elongating the substrate of the fPCB used by Seter such that it extended to the proximal end at least in light of the legal precedent set forth in MPEP 2144.04(I) and/or MPEP 2144.04(IV).
Additionally or alternatively, Honour in the same or eminently related field of catheterized medical instruments (see Honour’s Abstract, also while Honour uses electrodes as a base use case addressed in many sections thereof, the examiner notes that Honour can equally be for mapping, diagnostics, or in a general medical device as per [0059] further iterating why these can be seen as the same field instead of merely related) teaches that one can use an fPCB that spans the entire distance from the proximal to the distal end of the device (see Honour’s Figs. 2, 4, and 17-19. More specifically, regardless of whether one is referring to Honour’s internal teachings shown in Figs. 2 and 4, or external teachings shown in Figs. 17-19 it is the case that Honour teaches extending the fPCB, with lead traces/connecting wires mounted thereon, all the way to the proximal end, further noting that this is modifying the fPCB of Seter which is already mounted externally and already has twisted pairs of lead wires mounted externally when modifying Seter by Honour’s teachings it is irrelevant whether or not the reader looks to the internal or external embodiments since the same advantage applies and Honour is modifying references that already mount the electronics in the claimed configuration excepting the length of the fPCB only) and Honour goes on to teach an advantage to this sort of arrangement (see Honour’s [0013] noting that general arrangements of lead wires such as are present in Burg and Seter can be disadvantageous as bending can stress the connecting wires, which is solved by mounting them on the fPCB as shown above as stated in [0018] and/or [0059]. Likewise, while Honour has both internal and external embodiments it is noted by the examiner that the external embodiments are slightly more relevant to the instant combination (e.g. Burg’s coil and lead traces are already external as addressed above, as are Seter’s fPCB and lead traces as addressed above) and Honour further states why his external fPCB embodiments in particular are advantageous in [0016] where by overlaying the fPCB on the exterior of the medical device there is no need to pierce the elongated member which reduces the risk of leaking, distortion, shorting, and other problems).
Therefore and in the alternative, it would have been obvious to one of ordinary skill in the art prior to the date of invention to modify the invention to Burg IVO Seter with Honour’s teachings of extending the fPCB all the way to the proximal end in order to advantageously reduce the stress on the connecting/lead wires when the catheter is bent.
Regarding claim 3, Burg further teaches: 3. The instrument of claim 1, wherein the pair of lead traces are disposed around the monolithic tubular flexible circuit body at an angle up to 85 degrees and 2 mm to 45 mm apart (the examiner notes that the angle is both shown and described in Figs. 5 and [0045] which uses an acute winding angle or claim 6 which uses a 30 degree angle and the spacing is taught by Burg at claim 3 which directly teaches the claimed range).
Regarding claim 6, Burg further teaches: 6. The instrument of claim 1, further comprising an outer polymeric shrink fit layer covering the monolithic tubular flexible circuit body (see Burg’s Fig. 6 part 272 in light of [0047]).
Regarding claim 7, Burg further teaches: 7. The instrument of claim 1, wherein the monolithic tubular flexible circuit body include a lubricous coating on an outer surface thereof (see Burg’s [0044]-[0045] and [0051] noting the use of a lubricious coating such as Teflon).
Regarding claim 8, Burg further teaches: 8. The instrument of claim 1, wherein the at least one coil traces includes three coil traces (this can be seen in myriad sections of Burg such as any of Figs. 4, 8-9, or 11-12 noting parts 214 and/or in [0028] or [0042]; likewise this is also taught by Seter at e.g. [0019] or Fig. 10 parts 162) defined on the monolithic tubular flexible circuit body in one of a non-overlapping manner, an over-lapping manner and an interleaved manner, relative to each other to define three coils at the distal end (see Burg’s Figs. 11-12 which show overlapping and non-overlapping coils respectively).
Regarding claim 11, Burg teaches: 11. An instrument (see Burg’s Abstract or Figs. 1), comprising:
an elongated tubular body having a length extending from a proximal end to a distal end (see Burg’s Figs. 1-2);
a handle coupled to the proximal end of the body (see Burg’s Fig. 2 part 114);
a monolithic (noting that the BRI of the term, as per the definition included in the conclusion section is merely “consisting of or constituting a single unit” then the invention of Burg is monolithic when assembled as per any depiction thereof, e.g. see any of Figs. 2-12 noting that the whole assembly is depicted as being put together and can be considered as a unit, as such being “monolithic” will not hereinafter be addressed as unless the parts art explicitly separate and not in contact and not considerable as a unit then they can be considered monolithic – where the term monolithic therefore applied in each instance hereafter) tubular (see any or all of Burg’s Figs. 2-12 noting that in all instances the device is arranged around a tubular surgical instrument 100 and is even call “tube assembly 110”, see e.g. [0034]) flexible (note the invention as a whole is malleable/flexible as per [0033] and the structures regarded below are also specifically designed to be flexible enough to bend during use as per [0047]) circuit (again see any of Figs. 2-12 and note that the inclusion of coils and lead wires necessarily mean that this is/comprises a circuit, see also [0042]) body extending around and along the length of the elongated body from the proximal end to the distal end of the elongated body, the monolithic tubular flexible circuit body having, (i) a first pair, a second pair and a third pair of lead traces extending from the proximal end towards the distal end; (ii) a first coil trace coupled to the first pair of lead traces to define a first coil at the distal end; (iii) a second coil trace coupled to the second pair of lead traces to define a coil at the distal end; and (iv) a third coil trace coupled to the third pair of lead traces to define a third coil at the distal end (see Burg’s Figs. 4-6 or 11-12 noting that the plurality of coils 214/214’/214’’ are located at the distal end and noting that even where one coil assembly is shown in a particular figure it is described that this can be plural including explicitly 3, see e.g. [0037]-[0038], where each coil assembly interfaces with a pair of lead traces 236 as described in [0044] and where the lead traces are depicted going from the distal end proximally in the foregoing but make it entirely to the proximal end noting e.g. Fig. 7 and [0046]-[0048]);
wherein the monolithic tubular flexible circuit body is a monolithic … and forms a monolithic tracking device configured to cooperate with a navigation system to track the distal end (see Burg’s Fig. 2 part 118 which is a tracking sensor arrangement fully capable of the claimed cooperation; however and for compact prosecution purposes the examiner notes that e.g. [0025]-[0028] generally describe navigation system 10 as it relates to the tracking as do many other sections such as [0008] or [0038] etc. such that it is clear that not only are tracking coils fully capable of as much but that in fact Burg teaches the navigation system which is for use therewith).
In the foregoing the examiner omitted the limitation that the flexible circuit body comprises a printed circuit board containing the coil traces because Burg alone would not teach this limitation.
However Seter, in the same or eminently related field of tracking devices associated with medical instruments having a shaft (Abstract and Fig. 1) teaches coils and other electrical elements can be formed onto/as a flexible tubular printed circuit board (see Seter’s Figs. 3-9 and [0008], [0027]-[0044] noting that [0008] and Fig. 5 are exemplary) and further goes on to teach that forming these electronics onto/as a flexible PCB is advantageous ([0007] and [0044] plainly stated).
Therefore it would have been obvious to a person having ordinary skill in the art at the time of invention to improve the device of Burg by mounting his coils and other electronics on or providing his coils and other electronics as a FPCB as taught by Seter in order to advantageously provide the same functionality while simultaneously both reducing the complexity and cost of constructing the tracking device while and also providing a tracking device that is advantageously thinner.
Additionally, while the combination of Burg and Seter teaches the foregoing, Seter’s fPCB does not extend “from the proximal end to the distal end of the elongated tubular body” so as to fail to fully teach all claim limitations.
However, this limitation is obvious in at least two ways starting with the fact that it is prima facie obvious because it is a mere design choice and/or a mere change in the size, shape, or proportion of the fPCB already taught by Seter. That is, nothing in the claims or specification nor in the prior art of Seter or Burg addresses why one would or would not want the substrate of the fPCB (e.g. part 48 of Seter’s various Figs.) to extend for any particular length nor any change in function or utility of such an arrangement. As such this is clearly merely a design choice of the sort addressed in MPEP 2144.04(I), something made even more clear when one notes that whether or not the fPCB extends the claimed distance the form and format of the invention will be otherwise identical and have no difference in function and utility and where all electrical elements are the same regardless of the substrate and all physical elements will still be both supported from below (e.g. see Burg’s elongated tubular body part 126 in the various Figs. cited above such as Fig. 6) and from above (e.g. see Burg’s heat shrink layer 272 in Fig. 6) such that in any event all metal traces will be encapsulated on both sides and function identically whether or not the length of the substrate of the fPCB is long enough to reach the proximal end. Likewise and even if, arguendo, this change could be characterized as anything more than mere design choice it is still at most merely the lengthening of an already existing element which in no way changes the function of that element or of the invention as a whole such that one could further modify Seter’s teaching by lengthening substrate 48 in the manner set forth in MPEP 2144.04(IV) which describes that changes in the size, shape, or proportion of an element is a prima facie obvious modification.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to modify the combination of Burg and Seter by elongating the substrate of the fPCB used by Seter such that it extended to the proximal end at least in light of the legal precedent set forth in MPEP 2144.04(I) and/or MPEP 2144.04(IV).
Additionally or alternatively, Honour in the same or eminently related field of catheterized medical instruments (see Honour’s Abstract, also while Honour uses electrodes as a base use case addressed in many sections thereof, the examiner notes that Honour can equally be for mapping, diagnostics, or in a general medical device as per [0059] further iterating why these can be seen as the same field instead of merely related) teaches that one can use an fPCB that spans the entire distance from the proximal to the distal end of the device (see Honour’s Figs. 2, 4, and 17-19. More specifically, regardless of whether one is referring to Honour’s internal teachings shown in Figs. 2 and 4, or external teachings shown in Figs. 17-19 it is the case that Honour teaches extending the fPCB, with lead traces/connecting wires mounted thereon, all the way to the proximal end, further noting that this is modifying the fPCB of Seter which is already mounted externally and already has twisted pairs of lead wires mounted externally when modifying Seter by Honour’s teachings it is irrelevant whether or not the reader looks to the internal or external embodiments since the same advantage applies and Honour is modifying references that already mount the electronics in the claimed configuration excepting the length of the fPCB only) and Honour goes on to teach an advantage to this sort of arrangement (see Honour’s [0013] noting that general arrangements of lead wires such as are present in Burg and Seter can be disadvantageous as bending can stress the connecting wires, which is solved by mounting them on the fPCB as shown above as stated in [0018] and/or [0059]. Likewise, while Honour has both internal and external embodiments it is noted by the examiner that the external embodiments are slightly more relevant to the instant combination (e.g. Burg’s coil and lead traces are already external as addressed above, as are Seter’s fPCB and lead traces as addressed above) and Honour further states why his external fPCB embodiments in particular are advantageous in [0016] where by overlaying the fPCB on the exterior of the medical device there is no need to pierce the elongated member which reduces the risk of leaking, distortion, shorting, and other problems).
Therefore and in the alternative, it would have been obvious to one of ordinary skill in the art prior to the date of invention to modify the invention to Burg IVO Seter with Honour’s teachings of extending the fPCB all the way to the proximal end in order to advantageously reduce the stress on the connecting/lead wires when the catheter is bent.
Regarding claim 13, Burg teaches the base invention as given above in regards to claim 11; however, while Burg’s invention is a tubular flexible circuit, it is not constructed as a “printed circuit board (PCB)” and therefore fails to fully teach: “13. The instrument of Claim 11, wherein the tubular flexible circuit body is a printed circuit board (PCB).”
However Seter in the same field of tracking devices associated with medical instruments having a shaft (Abstract and Fig. 1) teaches coils and other electrical elements can be formed onto/as a flexible tubular printed circuit board (see Seter’s Figs. 3-9 and [0008], [0027]-[0044] noting that [0008] and Fig. 5 are exemplary) and further goes on to teach that forming these electronics onto/as a flexible PCB is advantageous ([0007] and [0044] plainly stated).
Therefore and in the alternative it would have been obvious to a person having ordinary skill in the art at the time of invention to improve the device of Burg by mounting his coils and other electronics on or providing his coils and other electronics as a FPCB as taught by Seter in order to advantageously provide the same functionality while simultaneously both reducing the complexity and cost of constructing the tracking device while and also providing a tracking device that is advantageously thinner.
Regarding claim 14, Burg further teaches: 14. The instrument of claim 11, wherein the of first coil trace and the second coil trace respectively having a first normal axis and a normal axis orientated in a non-parallel configuration relative to each other (see any of Burg’s Figs. 4 or 11-12 where all parts 214/214’/214’’ are shown as such and/or see claim 27).
Regarding claim 15, Burg further teaches: 15. The instrument of claim 11, wherein the first, second, and third coil traces are orientated at an acute angle relative to a longitudinal axis of the elongated tubular body (see Burg’s [0037] for a direct recitation, noting the angles and that this can encompass three coils; however, many of Burg’s Figs. appear to show as much such as 4-5 and Fig. 11).
Regarding claim 16, Burg IVO Seter alternatively IVO Honour teaches the basic invention as given above in regards to claim 15; however, Burg and Seter do not disclose that the coils are distributed along the length of the elongated body and therefore fail to fully teach: “16. The instrument of claim 15, wherein the first coil trace is a first longitudinal distance from the distal end and the second coil trace is a second longitudinal distance from the distal end, the first longitudinal distance being greater than the second longitudinal distance.”
However, the examiner notes that the claim is therefore a prima facie obvious variant of what is taught by Burg in at least three ways. First, the examiner notes that this is the mere rearrangement with no modification on the operation of the device (see Burg’s Fig. 4-5 and 11-12 and note that plural coils 214/214’/214’’ are provided but that the invention only needs one coil to function (e.g. as per claim 16 IVO claim 1 – similar to the applicant’s own claims which allow one or more coil to be used for tracking) thus one could move one or more of these coils to another position without modifying or even affecting the core operation of the device. See also MPEP 2144.04(VI)(C)). Second, this arrangement and its utility are old and well known in the art (i.e. see MPEP 2144.03 as this constitutes official notice, where the examiner notes that the applicant has not challenged the previously provided notice so as to be taken as admitted prior art under the second paragraph of MPEP 2144.03(C)) as distributing sensors along the length of the instrument allows for tracking the path of the instrument as a whole instead of merely its tip which in itself is advantageous as it provides the clinician with more information but which also in turn allows for determining and even projecting an instrument’s path; which is vastly more useful than merely tracking the tip of the instrument’s location alone. Third, the examiner also notes that this could have equally been arrived at by various other non-inventive ways using mere legal precedent (e.g. by simply duplicating one or more sensor of the sensor coil arrangement at different locations. See MPEP 2144.04(VI)(B). E.g. even including duplicating the whole three coil arrangement depicted in Fig. 12 at one or more additional locations along the length of the instrument so as to allow determining the P&O of multiple portions of the instrument in 6 DoF).
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to modify the combination of Burg and Seter either by that which is well known to be advantageous or with mere rearrangement or mere duplication in light of the legal precedent provided by MPEP 2144.04 so as to arrive at the claimed invention.
Regarding claim 17, Burg further teaches: 17. The instrument of claim 11, wherein the instrument further includes a flexible outer layer (see Burg’s Fig. 6 part 272 and/or [0047] where the heat shrink is both fully capable of flexing and also described in [0051] to be flexible).
Regarding claim 18, Burg further teaches: 18. The instrument of claim 17, wherein the monolithic flexible tubular circuit is captured between the flexible outer layer and the elongated tubular body (see Burg’s Fig. 6 as depicted and/or see [0047] or [0051] such that the first, second, and third coil traces and lead traces would be captured as this overwraps all components).
Regarding claim 20, Seter further teaches: 20. The instrument of claim 1, wherein the monolithic tubular flexible circuit body is a laminate structure having, a support layer disposed relative to the at least [one] coil; wherein the support layer stiffens an area at the at least one coil (Seter’s fPCB is a multi-layer laminate, see e.g. [0030]-[0031], [0034], and [0042] and while the applicant does not actually recite the material composition of the stiffening layer or its rigidity requirements such that any second layer of those referred to above would seemingly read on the claim as it is broadly constructed, the examiner notes for compact prosecution purposes that one of Seter’s layers can be a support layer per se, noting that [0034] states: “As shown in phantom line in FIG. 5, the method of fabricating the sensor 52a may involve the use of a body portion 68 having a shape corresponding to the final desired shape of the sensor 52a. The body portion 68 may comprise a portion of the final sensor, for example, functioning as a support member” where Fig. 5 depicts a layer under 52 that is the support layer. While the foregoing is one of the same sections cited by the examiner above and shows how one would make the fPCB brought into claim 1 and therefore is part of the same modification already made for claim 1, the examiner notes that for compact prosecution purposes this also would have also/alternatively been understood to be advantageous had it not been part of the same modification as Seter is clear that this particular support layer provides 2 advantages of: 1) supporting the tracking device so as to allow it to maintain its shape, and 2) increasing the detection sensitivity).
Regarding claim 21, Burg teaches the basic invention as given above in regards to claim 11; however, Burg’s flexible circuit is not a layered/laminate structure and therefore Burg fails to teach: 21. The instrument of claim 11, wherein the monolithic tubular flexible circuit body is a laminate structure having, a support layer having at least one of a first stiffened section and a second stiffened section; wherein the first stiffened section stiffens a first area at the first coil and the second stiffened section stiffens a second area at the second coil”.
However Seter, in the same or eminently related field of tracking devices associated with medical instruments having a shaft (Abstract and Fig. 1) teaches coils and other electrical elements can be formed onto/as a flexible tubular printed circuit board (see Seter’s Figs. 3-9 and [0008], [0027]-[0044] noting that [0008] and Fig. 5 are exemplary) which is a laminate structure having support layers in the area of the coil traces (Seter’s fPCB is a multi-layer laminate, see e.g. [0030]-[0031], [0034], and [0042] and while the applicant does not actually recite the material composition of the stiffening layer or its rigidity requirements such that any second layer of those referred to above would seemingly read on the claim as it is broadly constructed, the examiner notes for compact prosecution purposes that one of Seter’s layers can be a support layer per se, noting that [0034] states: “As shown in phantom line in FIG. 5, the method of fabricating the sensor 52a may involve the use of a body portion 68 having a shape corresponding to the final desired shape of the sensor 52a. The body portion 68 may comprise a portion of the final sensor, for example, functioning as a support member” where Fig. 5 depicts a layer under 52 that is the support layer.) and Seter further goes on to teach that forming these electronics onto/as a flexible PCB is advantageous ([0007] and [0044] plainly stated) and forming the coil traces on a support layer in particular is also advantageous (see [0034] noting that Seter establishes that using a stiff support such as a ferromagnetic material has multiple advantages including at least 1) providing mechanical support and stability, and 2) increasing the coil’s detection sensitivity).
Therefore and in the alternative it would have been obvious to a person having ordinary skill in the art at the time of invention to improve the device of Burg by mounting his coils and other electronics on or providing his coils and other electronics as a FPCB with a support layer as taught by Seter in order to advantageously provide the same functionality while simultaneously both reducing the complexity and cost of constructing the tracking device while and also providing a tracking device that is advantageously thinner while also increasing mechanical stability and detection sensitivity.
Regarding claims 25-26, Burg further teaches: 25. The instrument of claim 1, wherein the at least one coil defined by the at least one coil trace is circular or elliptical and having a generally concave shape to define a detection axis angled relative to a longitudinal axis of the elongated body. 26. The instrument of claim 1, wherein the at least one coil trace is circumferentially disposed around the monolithic tubular flexible circuit body and about a longitudinal axis of the elongated body such that a directional vector axis is aligned with the longitudinal axis (regarding both of these, see Burg’s Figs. 2-12 noting coils 214, 214’, and 214’’ which show as much in multiple ways and/or see [0037]-[0039] which explains that the coils can be aligned in a number of ways including from 0-90 degrees with respect to the longitudinal axis).
Regarding claim 27, Burg and Seter teach the basic invention as given above in regards to claim 1, and both Burg and Seter each further teaches coupling the lead traces to the coil at the distal end and coupling the lead traces to the navigation system at the proximal end (for Burg, see any of the various Figs that show the distal end, e.g. Fig. 5, show the coils 214 being coupled through lead wires 228 and 236 extending proximally, and then see Fig. 7 and [0046] which depict and describe respectively that the lead wires extend to the proximal end, enter the handle a the proximal end, and electrically connect to a connector assembly 258 which connects to a navigation probe interface 80 of EM navigation system 60 as shown in Fig. 1; for Seter note that as per [0029] and [0037] a twisted pair of lead traces leaves each coil assembly and connects to the MPS at the proximal end, also seen in Figs. 1 and 7 thereof). While it is clear from context in Burg, and explicitly stated in Seter (see Seter’s [0052] “Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements.”) that these types of connections at the proximal end should be interpreted broadly and are clearly generic to the species of the claims, the examiner notes that neither reference explicitly uses “coupling pads”. Therefore neither Burg nor Seter fully teaches: “27. The instrument of claim 1, where the monolithic tracking device further includes a pair of coupling pads at the proximal end and coupled to the pair of lead traces configured to connect the at least one coil with the navigation system.”
However, the examiner notes that given the extremely common use of coupling pads (e.g. contact pads, bond pads) there is a prima facie case of obviousness where one could not accomplish a “connection” but must instead choose a type of connection and where the prior art recognizes that coupling pads are suitable for connecting electrical components. See MPEP 2144.07. Likewise to demonstrate that coupling pad based connections are suitable see either Burg’s use of a coupling pad for connecting intermediate wires to the lead wires (see Fig. 5 noting coupling pads 240 provided for each connection between 28 and 236, that is Burg uses this exact type of coupling in this exact pathway between the coil and lead wire just at a different location, rather Burg simply does not describe or depicted using this (or any other/different) type of coupling for the proximal connection) and/or see the prior art included in the conclusion section below.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to utilize the known suitable coupling pad type of electrical connection as the electrical connection of generic and unspecific type found in Burg and Seter.
Response to Arguments
Applicant’s arguments, see page 7, filed 11/15/2024, with respect to the objection of claim 14 have been fully considered and are persuasive. The associated objection of the previous office action has been withdrawn.
Applicant’s arguments, see pages 7-11, filed 11/15/2024, with respect to the rejection(s) of claim(s) 11, 14-15, and 16-18 under Burg alone have been fully considered and are persuasive in light of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Seter and alternatively in view of Honour.
Applicant's arguments filed 11/15/2024 with respect to the 103(a) grounds of rejection featuring Burg IVO Seter have been fully considered but they are not persuasive.
As an initial issue, the applicant uses and relies on the term “monolithic” in the arguments. From context it is clear that the applicant defines this term in a way far more narrowly than is being applied by the examiner. The examiner notes that the specification does not define the term, does not contain the limitations present in the independent claim in scope or terminology, does not give examples that could be used to flesh out or imply a definition, etc. To that end, the examiner notes that they have taken the initiative to provide the definition of the term and show that the broadest reasonable interpretation thereof, which is e.g. “consisting of or constituting a single unit”, according to Merriam-Webster. This definition is far broader than the applicant’s usage of the term and appears to render all of the arguments presented by the applicant to be deficient. That is, when put simply any collection of things, even if not integrally connected, can be considered as a single unit. The fact that Burg connects all his components and the applicant admits as much in the argument (page 9, cited below) is also telling and clarifies that the examiner’s rejection more narrowly applies the term “monolithic” than is necessary to form a proper rejection. However, until and unless the applicant can point out a definition in their specification that is in line with their narrow interpretation of “monolithic” all arguments relying on this term are prima facie unconvincing given the difference between the broadest reasonable interpretation of the term as supported by the provided definition and the applicant’s argued usage of the term.
The applicant begins their argument on pages 7-9 by asserting that Burg discloses separate coil assemblies which must be separately connected during the construction of the device and therefore that Burg does not disclose a monolithic tracking device. In this instance the examiner notes that whether or not Burg’s coils are separately mounted and connected before the point where Burg’s invention is assembled and ready for use is irrelevant for discussing what Burg does or does not teach as the instant invention is an apparatus and not a method of manufacture. As such the applicant’s arguments cannot be held convincing for a first reason. Likewise, the fact that the applicant admits that these are “connected together and coupled to the instrument 100” on page 9 also confirms that the examiner’s position is correct and clearly demonstrates that Burg in fact does teach a monolithic tracking device, at least when one considers the apparatus of Burg and not the early stages of the method of manufacturing/assembling the invention of Burg.
On pages 9-10 the applicant further refines their argument to iterate that Burg does not disclose a fPCB mounting the claimed elements and therefore opines that Burg neither anticipates nor obviates the claimed invention. While the examiner would agree that Burg does not mount his various elements on an fPCB and thus does not anticipate the claim, the examiner notes that for claim 1 previously, and for claim 11 hereafter, Burg is not used as a 102 reference and does obviate the claim limitations for reasons iterated in the rejection above. Therefore this argument, which addresses Burg alone, is not convincing with respect to obviousness even though it is correct with respect to anticipation, with the reason it is not convincing with respect to obviousness being further addressed below in the rebuttal to the applicant’s remarks about Seter.
On page 11 the applicant addresses Seter. The applicant opines without evidence that Seter discloses “multiple separate components required to extend from a proximal end to a distal end of device 26. Thus, Seter further does not disclose a monolithic tracking device …” This does not appear to be correct, e.g. Seter describes and depicts in detail how to form a single coil (as iterated in the rejection above) and states that multiple coils can be used (e.g. Seter at [0020]) but does not address that these need to be separate and the applicant certainly fails to convincingly argue/include citations for this even if it was relevant. However, and in addition to being unconvincing for failing to properly point out any deficiency in Seter, this is incorrect and unconvincing for at least two additional reasons. First, this is spurious as piecemeal analysis as it does not address the fact that, as already admitted on page 9 of the remarks, the base reference of Burg has a connected set of such elements and Seter is only brought in to teach providing these elements on a fPCB such that this cannot be convincing since it ignores the combination. Secondly this is also addressing an unclaimed feature. Nothing in any claim states that the invention may not be comprised of multiple components. In fact, this sort of limitation would be contrary to the claims which have multiple separate components (e.g. multiple coils, multiple lead traces, coupling pads, etc.). As such this argument is simply spurious because it addresses unclaimed and unclaimable features that do not relate to the invention.
Lastly, the examiner notes that the applicant’s argument includes the new claim language but does not specifically argue that the length of the substrate of the fPCB renders the claim unobvious over Burg and Seter; however, the examiner notes that this new limitation does require that the examiner amend their rejection. Thus a new grounds of rejection has been presented as iterated above to cover the limitation that the fPCB extends “from the proximal to the distal end of the elongated tubular body”. Likewise, while Burg and Seter do obviate this limitation without further references, the examiner noted that at least with regards to certain dependent claims it would compact prosecution to show that additional elements can be mounted on the fPCB if it extended to span to the proximal end. To that end the examiner has also addressed this new limitation in an alternative grounds of rejection featuring the new art of Honour which also rebuts the applicant’s argument for patentability of claims 1 and 11 from a second perspective.
Therefore and for the foregoing reasons the applicant’s arguments are unconvincing to overcome the rejection under 103(a) featuring Burg and Seter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Monolithic by Merriam-Webster is a dictionary definition for the term monolithic which shows how broadly the term can be interpreted, specifically noting definition 2C. As such this reference is useful for showing why the applicant’s claims do not define over the prior art and for showing why the arguments based on the applicant’s use of the term monolithic are not convincing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798