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 7 is objected to because of the following informalities: “include” in line 2 should be drafted as ---includes---. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: a colon ---:--- should be inserted after “comprising” in line 2. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: a colon ---:--- should be inserted after “comprising” in line 2. 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.
Claim 16 is 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.
In this instance the examiner notes that parent claim 11 has been amended to iterate that the first and second coils are overlapping or interleaved and claim 16 requires that the coils are at different distances from the distal end; however, the applicant’s specification never describes an embodiment wherein overlapped or interleaved coils are found at different distances from the distal end. In more detail see Applicant’s Fig. 4 noting that while individual coils can be at a variety of distances this is not the case for overlapped or interleaved coils. For instance, see Fig. 5 and the written description thereof which clearly differentiates between individual coils 152 and overlapped/interleaved coil cluster 156 where the written description never mentions nor do the figures ever depict that the overlapped/interleaved coils can be at different distances from the distal end. The examiner notes that this limitation was added by amendment; therefore, the claims are held to contain new matter that is not adequately disclosed to the degree required to allow one of ordinary skill in the art to make or use an invention commensurate in scope with claim 16.
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 1, 3, 6-7, 11, 14-18, 20-21, and 27 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 1 recites the limitations "a proximal end” and “a distal end” in line 8. Both of these statements have improper antecedence given the recitation of the same in line 2 of the same claim.
Claim 1 recites the limitations "the proximal end” and “the distal end” in line 10. These have unclear antecedence given the iteration of multiple proximal and distal ends earlier in the claim. See lines 2 and 8 which both establish both of “a proximal end” and “a distal end”. For compact prosecution purposes the examiner will interpret this as being the ends of the substrate and thus recommends replacing “the proximal end towards the distal end” with ---the proximal end of the tubular substrate towards the distal end of the tubular substrate---.
Claim 3 recites the limitation "the plurality of conductive traces" in line 9. There is insufficient antecedent basis for this limitation in the claim. For compact prosecution purposes the examiner notes that ---the plurality of conductive lead traces--- would have proper antecedence.
Claim 11 recites the limitations "a proximal end” and “a distal end” in line 7. Both of these statements have improper antecedence given the recitation of the same in line 2 of the same claim.
Claim 11 recites “the distal end” in each of lines 9 12, 15, and 18; however, these have unclear antecedence given the multiple iterations of “a distal end” earlier in the claim. See lines 2 and 7 of the same claim which both establish “a distal end”.
Claim 20 recites the limitation "the tubular body" in line 1-2 bridging. There is insufficient antecedent basis for this limitation in the claim. For compact prosecution purposes the examiner notes that ---the elongated tubular body--- would have proper antecedence.
Claim 21 recites the limitation "the tubular body" in line 1-2 bridging. There is insufficient antecedent basis for this limitation in the claim. For compact prosecution purposes the examiner notes that ---the elongated tubular body--- would have proper antecedence.
Claims 3, 6-7, 14-18, 20-21, and 27 are each similarly affected by one or more of the foregoing issues, at least by virtue of dependency from 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, 6-7, 11, 14-18, 20-21, and 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, previously of record).
Regarding claim 1, Burg teaches: 1. 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 elongated body (see Burg’s Fig. 2 part 114);
a 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) comprising a 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 … extending around and along the length of the elongated body (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]), wherein the tubular flexible … circuit … comprises: a plurality of … conductive lead traces … extending from the proximal end towards the distal end (see Burg’s Figs. 2-10 and note the plurality of lead traces 236 extending as depicted); a first … coil trace … at a first angle relative to a longitudinal axis of the elongated tubular body and extending circumferentially around the tubular substrate to define a first coil that is electrically coupled to the plurality of conductive lead traces; and a second … coil trace … at a second angle relative to the longitudinal axis of the elongated tubular body and extending circumferentially around the tubular substrate to define a second coil, wherein the second angle is different than the first angle and the second … coil trace is interleaved or overlapping with the first … coil trace (while the foregoing has been generic to all embodiments of Burg, for this particular arrangement see Burg’s Fig. 11 noting the three overlapped coils 214’ which are each angled with respect to each other and with respect to the longitudinal axis and which are coupled to the lead traces 236 as depicted, see also [0054]/claim 20 which textually states as much),
wherein the tracking device is a 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, various iterations of or references to a “printed circuit board” e.g. (“… circuit …” is used for “printed circuit board”) and the statement that the substrate of the fPCB was “a tubular substrate having a proximal and a distal end” because while Burg teaches a flexible circuit that extends around a tube as iterated above, he does not utilize an fPCB. Therefore, Burg alone fails to fully teach the claimed limitations.
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, wherein this description and depiction shows this to be tubular and wherein all things that physically exist inherently have proximal and distal ends, including the substrate of the fPCB taught by Seter, but which is of course also depicted, e.g. in Setter’s cited Figs. 5 and 9, which define a clearly elongated shape and thus clear proximal and distal ends) 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.
The foregoing fully rejects the currently drafted claim language as best understood, at least because the amendment removes the requirement that the tubular substrate’s proximal and distal end extend to the elongated body’s proximal and distal end. However, it may still compact prosecution to note the two following alternative grounds of rejection that address tubular substrates whose proximal and distal ends extend to the proximal and distal ends of the elongated body as follows:
As a first additional/alternative grounds of rejection, 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).
As a second grounds of additional or alternatively rejection, 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 IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 3. The instrument of claim 1, wherein the plurality of conductive traces are disposed around the tubular flexible printed circuit board 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 IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 6. The instrument of claim 1, further comprising an outer polymeric shrink fit layer covering the tubular flexible printed circuit board (see Burg’s Fig. 6 part 272 in light of [0047]).
Regarding claim 7, Burg IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 7. The instrument of claim 1, wherein the tubular flexible printed circuit board 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 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 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 … extending around and along the length of the elongated body from the proximal end to the distal end of the elongated body (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]), the tubular flexible … circuit … including: … a first pair, a second pair and a third pair of traces … and extending from the proximal end towards the distal end; a first … coil trace … coupled to the first pair of traces and extending circumferentially around the tubular substrate to define a first coil at the distal end; a second … coil trace … coupled to the second pair of traces and extending circumferentially around the tubular substrate to define a second coil at the distal end; and a third … coil trace … coupled to the third pair of traces and extending circumferentially around the tubular substrate 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]); and
a plurality of insulating substrates disposed between, at least one of, the first … coil trace, the second … coil trace, and the third … coil trace (the examiner notes that this is entirely inherent in Burg. It could not be otherwise than that the coil traces are electrically isolated by an insulating layer or they would not function. See Burg’s Fig. 11 noting coils 214’ as depicted and/or see [004] / claim 20 as described wherein if these things are built and functional then they are necessarily insulated from each other. For compact prosecution purposes this is also alternatively addressed below),
wherein first … coil trace, second … coil trace, and third … coil trace are interleaved or overlapping one another (while the foregoing has been generic to all embodiments of Burg, this limitation is taught by Burg’s Fig. 11 noting coils 214’ as depicted and/or see [0054] / claim 20 which textually describes as much),
wherein the tubular flexible … circuit body … forms a 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, as indicated by ellipsis, various iterations of “printed” or references to a “printed circuit board” e.g. (“… circuit …” is used for “printed circuit board”) or features such as the “substrate” of the fPCB or, at least in the alternative, the limitation that “a plurality of insulating substrates disposed between, at least one of, the first printed coil trace, the second printed coil trace, and the third printed coil trace,” because while Burg teaches a flexible circuit that extends around a tube as iterated above, he does not utilize an fPCB. Therefore, Burg alone fails to fully teach the claimed limitations.
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). Additionally, the examiner notes that Seter’s substrate is insulating and therefore even if forming the simplest possible overlapping coil arrangement wherein the coils were merely physically stacked with no other precautions or insights (i.e. assembled at a level vastly below that of ordinary skill in the art and in a manner starkly contrary to the care and teachings demonstrated in Seter) one would sill arrive at a stacked coil arrangement wherein a plurality of insulating substrates disposed between, at least one of, the first printed coil trace, the second printed coil trace, and the third printed coil trace (see Seter’s Figs. 3-4 noting substrate 48 forms the base layer of each coil which alone is enough to ensure the otherwise inherent claim language but as seen in any of 5-7 and 9 this would wrap entirely/circumferentially around once assembled) however and for compact prosecution purposes the examiner notes that Seter describes how to form coils on fPCBs in more detail than is present in the applicants own specification and includes information that would clearly cause one of ordinary skill in the art to understand that the leads must be electrically isolated and that this can be accomplished by employing insulating layers (see Seter’s [0008]-[0009], [0031]-[0033], [0041]-[0042], which expressly includes electrically insulating the leads using insulating layers as well as creating multi-layered structures using layers and vias as needed).
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 14, Burg IVO Setter teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 14. The instrument of claim 11, wherein the of first printed coil trace and the second printed 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. 11 where all parts 214’ are shown as such and/or see claim 27).
Regarding claim 15, Burg IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 15. The instrument of claim 11, wherein the first, second, and third printed coil traces are orientated at an acute angle relative to a longitudinal axis of the elongated tubular body (see Burg’s [0054] for a direct recitation, many of Burg’s Figs. appear to show as much Fig. 11 or see claim 28).
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 printed coil trace is a first longitudinal distance from the distal end and the second printed 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 IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and 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 IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 18. The instrument of claim 17, wherein the flexible tubular printed circuit board 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, Burg IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 20. The instrument of claim 1, wherein the tubular flexible body includes a laminate structure comprising a support layer disposed relative to the first coil or the second coil; wherein the support layer stiffens an area at the first coil or the second coil (see Burg’s Fig. 6 noting the support 190 under the coil(s) region (e.g. one coil is depicted, that’s enough for the current claim drafting, but [0038] also iterates that this depiction is a simplification and that a larger number of coils can be utilized) wherein this support comprises multiple layers including at least 130 and 190 so as to be a laminate and wherein either those could be the support that at least [0035] iterated that 130 is intended for providing additional support in the vicinity of the coil(s)).
Regarding claim 21, Burg IVO Setter alternatively IVO Honour teaches that the traces should be formed on an fPCB as iterated above, and Burg further teaches: 21. The instrument of claim 11, wherein the tubular flexible body includes a laminate structure comprising a support layer comprising 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 section coil (see Burg’s Fig. 6 noting the supports 130 and 190 under the coil(s) region (e.g. one coil is depicted, that’s enough for the current claim drafting, but [0038] also iterates that this depiction is a simplification and that a larger number of coils can be utilized) wherein this support comprises multiple layers including at least 130 and 190 so as to be a laminate and wherein either those could be the support that at least [0035] iterated that 130 is intended for providing additional support in the vicinity of the coil(s)).
Regarding claim 27, Burg and Seter alternatively IVO Honour teaches 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 coils 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 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 first 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 7-8, filed 12/15/2025, with respect to the previously issued 112(a) rejections and claim objections have been fully considered and are persuasive. The associated objection of the previous office action has been withdrawn.
Applicant's arguments filed 12/15/2025 with respect to the 103(a) rejection have been fully considered but they are not persuasive as follows:
On pages 8-13 the applicant addresses the 103(a) rejection and opines that the amendment causes Burg IVO Seter alternatively IVO Honour to be deficient for various reasons. The examiner notes that the accompanying amendment is extensive and has caused the examiner to substantively redraft their rejection. Therefore, the best rebuttal to all arguments of pages 8-13 is to see the new claim rejection, incorporated herein by reference, to show why the limitations are in fact taught by the art.
While the foregoing is a full and complete rebuttal, for compact prosecution purposes the examiner can additionally address the arguments more narrowly and notes: from pages 8-9 the applicant restates the new claim wording, notes that Burg is admitted by the examiner not to teach forming the coils on an fPCB, then notes on pages 9-10 that Seter only generate plural single coils instead of one coil assembly containing multiple overlapped or interleaved coils. Both of these statements are fundamentally true, but they do not cause the rejection to be deficient in any way as this is spurious piecemeal analysis where the applicant implies that because neither reference is a 102/teaches the elements taught by the other, than the combination does not teach the claim. However, and if we actually focus on what the references teach instead of what they do not teach it is abundantly clear that Burg teaches the overlapped multi-coil assembly of the claims and this feature is not debated by the applicant. Likewise, the examiner has been abundantly clear that Seter teaches how to form coils on fPCBs which is not debated by the applicant. Therefore, when actually reviewing the rejection being presented it can be seen that there are no deficits in the rejection and the argument falls apart. The applicant then continues of page 11 that the only way to arrive at the applicant’s claimed invention would be the use of impermissible hind sight. The examiner notes that the reasons for combination in each instance are clearly stated and taken directly from the prior art with citations provided in all instances. See e.g. the previous office action mailed 09/16/2025 noting that in the rejection of claim 1 the rational for combining Burg and Seter is expressly provided in the last paragraph of page 7 and the first paragraph of page 8 – or simply see above as the examiner again details how and why Seter teaches advantages that would motivate the combination. This is not taken from the applicant’s disclosure at all and therefore does not involve any impermissible hindsight contrary to the argument. On a related note, the applicants next arguments on pages 11-12 ironically admits that Burg and Seter are in fact combinable (which serves as an additional rebuttal to all of the foregoing) but opines that there is not motivation to do so. The examiner again would refer the either or both of the previous office action mailed 09/16/2025 noting that in the rejection of claim 1 the rational for combining Burg and Seter is expressly provided in the last paragraph of page 7 and the first paragraph of page 8 – or simply see above as the examiner again details how and why Seter teaches advantages that would motivate the combination; so as to fully rebut the argument. The applicant then opines on page 12 that Honour fails to cure the deficiencies of Burg and Seter. In this instance the examiner is not convinced, for the foregoing reasons, that any such deficiency exists; regardless the examiner notes that Honour is only referenced as an alternative rejection related to extending the fPCB to the proximal end which while still relevant (especially to claim 11) is fundamentally not required by claim 1 as amended and thus would not have overcome the rejection of Burg IVO Seter. The applicant then concludes on page 13 by addressing that due to their arguments against claim 1 and due to claim 11s similar drafting and claim 3, 6-7, 14-18, 21-22, and 27s dependency that all claims should be allowable. While the examiner can appreciate that claim 11 is similarly drafted and the remaining claims are dependents from one of claims 1 or 11, the examiner was not convinced by the argument that claim 1 is patentable for the foregoing reasons and therefore is not convinced by the conclusory argument at this juncture.
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.
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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/MICHAEL S KELLOGG/ Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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