DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 10 and 11 are objected to because of the following informalities:
Claims 10 and 11 appear to be written in an independent form, yet also refers back to the other independent claim 1 (and claim 10). In an interpretation, claims 10 and 11 may be construed as independent claims; and in another interpretation they may also be construed as a dependent claim. In order to prevent any foreseeable ambiguity, it is suggested to bring the entire claim 1 in to the claim 10 (and claim 11 as well respectively) to have the claims construed as a proper independent claim; or, correct the dependency of the claims 10 and 11 (as shown in other depending claims e.g., claim 12, claim 2, etc.) to have the claim construed as a proper dependent claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gamm et al (US 20200330162 A1) in view of Mariampillai et al (US 20180078317 A1).
Regarding claim 1, Gamm teaches
An optical monitoring device for tracking (tracker 10) comprising;
a base layer that serves as a sterile drape and has an interior face intended to face skin of a patient and an exterior face opposite the interior face (paragraph 77 discloses the tracker 10, which can be attached to the surface of the skin and which therefore has an inner surface and an outer surface);
the base layer comprising an intervention region corresponding to an opening or to a region that is intended to be cut in order to expose an zone of the patient's skin where the intervention is to take place (figure 6A shows the base layer in the form of a covering which is then shown in figure 6B with an incision made in the middle in order to interact with the patient's skin where the intervention is to take place);
and a marking region (14) that at least partially surrounds the intervention region (see figures 6A and 6B),
wherein said marking region comprising:
on the interior face, an adhesive material for fixing the optical tracking device on to the patient's skin (paragraph 77 discloses that the tracker 10 is attached to the surface of the skin by an adhesive);
on the exterior face, at least three optical markers (14) or at least three fixing supports each intended to receive an optical marker (see figures 6A and 6B);
a fiber optic sensor fastened to the base layer and comprising at least one measurement point associated with each of the optical markers or fixing supports (paragraph 40 and figures 6A and B disclose the tracker supported by the patch 12, which are electrical connectors, and that the markers 14 may comprise a light source and an optical fibre),
Gamm does not point out the specifics of an optical fiber incorporating Bragg gratings.
However, in the same field of endeavor, Mariampillai teaches present disclosure relates to guidance and tracking systems for tracking flexible implements, such as flexible medical instruments. More specifically, the present disclosure relates to an integrated system of markers (active or passive) and fiber Bragg grating (FBG) arrays arranged for interventional and/or surgical procedures and the tracking of flexible medical implements used in these procedures [0002]. A Fiber Bragg Grating (FBG) is a type of optical sensor, which can be constructed by exposing a photosensitive fiber to a spatially varying distribution of light to induce a periodic index of refraction change within the core of the fiber [0007].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Mariampillai because measurements can be used to infer a local bending radius of curvature the FBG undergoes, yielding information about the shape of the fiber and/or a device to which it is securely attached ([0012] of Mariampillai).
Regarding claim 2, Gamm teaches wherein the base layer is a polyethylene film lined with a cellulose absorbent film (“The patch 12 comprises a deformable material. The patch 12 may, for example, comprise at least one of polyimide (PI), liquid crystal polymer (LCP) and polyurethane (PU), such as thermoplastic PU (TPU). Additionally or alternatively, the patch 12 may comprise other materials that result in a deformability of the patch 12, such as rubber or textile. The patch 12 may comprise an open-pored and/or closed-pored foamed material. The patch 12 may be manufactured as a molded article.” [0036]).
Regarding claim 3, Gamm teaches the intervention region is precut in the base layer (opening 28 is arranged over an incision 30 made on the patient's surface and therefore predetermined [0077]).
Regarding claim 4, Gamm teaches the base layer comprises visual indications defining the marking region (see e.g., figures 6A & 6B and the associated pars).
Regarding claims 5, Gamm teaches the adhesive material takes the form of an adhesive tape connecting together the various points at which the optical markers or the fixing supports are situated (“The tracker 10 shown in FIGS. 6A, B is attached to a skin surface of a patient (e.g., by an adhesive), wherein the opening 28 is arranged over an incision 30 made in the surface of the patient.” [0077]).
Regarding claims 8 and 12, Gamm teaches all the claimed limitations except for active optical marker being configured to emit a differently modulated infrared signal.
However, in the same field of endeavor, Mariampillai teaches an optical tracking system may be configured to operate with visible or infrared light [0091].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Mariampillai because measurements can be used to infer a local bending radius of curvature the FBG undergoes, yielding information about the shape of the fiber and/or a device to which it is securely attached ([0012] of Mariampillai).
Regarding claims 9, Gamm teaches the optical markers are passive and there are at least four optical markers (see e.g., figures 6A & 6B and the associated pars).
Regarding claims 10, Gamm teaches an optical monitoring device of claim 1 (see rejections above for claim 1) said optical monitoring device being equipped with optical markers (“tracker element in form of a light source 14” [0040])
a measuring device configured to cooperate with the fiber optic sensor to determine a relative position of each of the optical markers in a frame of reference of the measuring device (“tracker 10 and a sensor system (not shown) configured to detect information indicative of at least one degree of freedom (e.g., position and orientation) of the tracker 10” [0041]; “light source 14 may comprise at least one of a light emitting diode (LED)… an optical fibre” [0040]), and
a locating device configured to cooperate with the optical markers to determine a position of each of the optical markers in a frame of reference of the locating device (“the tracker 10 and a sensor system (not shown) configured to detect information indicative of at least one degree of freedom (e.g., position and orientation) of the tracker 10” [0048]).
Regarding claims 11, Gamm teaches an optical navigation method utilizing an optical navigation system of claim 10 (see the above rejections for claim 10), said method comprising:
determining with the aid of the locating device of the position of at least one optical marker visible to the locating device identifying said at least one visible optical marker from among all the optical markers determining with the aid of the measuring device of the positions of all of the optical markers relative to one another (“tracker 10 further comprises tracker element in form of a light source 14 supported by the patch 12. The light source 14 may comprise at least one of a light emitting diode (LED), an organic light emitting diode (OLED), a laser, an incandescent light source and an optical fibre. The tracker 10 may comprise a plurality of light sources 14. With a larger number (such as two, three, four, or more) of light sources 14, the amount of trackable degrees of freedom and/or the tracking” [0040]),
determining the position of at least one optical marker that is not visible to the locating device on the basis of the position of the visible optical marker and the positions of the optical markers relative to one another (“the tracker 10 and a sensor system (not shown) configured to detect information indicative of at least one degree of freedom (e.g., position and orientation) of the tracker 10” [0041]), and
estimating the position of the optical monitoring device from the positions of at least three optical markers (“the tracker 10 is attached to the skin of the patient, a force is acting on the tracker 10. The patch 12 and the electrical connections 16 (due to their meandering shape) are deformable and can therefore adapt to the force by deformation. FIG. 6B shows the tracker 10 in a deformed configuration. In its deformed configuration, a distance between the light sources 14 is increased. The increased distance is compensated by a (partial) straightening of the meandering shapes of the electrical connections 16. From the deformed position illustrated in FIG. 6B, the tracker 10 may deform back to the non-deformed position illustrated in FIG. 6A when the incision is closed again, without impairing or interrupting the tracking process. Deviations of individual light sources 14 from their preceding position upon deformation or relaxation can easily be compensated” [0079]).
Regarding claims 13, Gamm teaches the optical markers are passive and there are at least four optical markers (see e.g., figures 6A & 6B and the associated pars), the distances between two optical markers taken two by two all differ by at least one predetermined margin value, and the method further comprises:
determining with the aid of the locating device of the position of at least three optical markers visible to the locating device (see e.g., fig. 6 and the associated pars)
identifying said three optical markers from among all of the optical markers on the basis of the distances between two optical markers determined for at least two different pairs of optical markers formed from among said at least three visible optical markers (“FIG. 6B shows the tracker 10 in a deformed configuration. In its deformed configuration, a distance between the light sources 14 is increased. The increased distance is compensated by a (partial) straightening of the meandering shapes of the electrical connections 16. From the deformed position illustrated in FIG. 6B, the tracker 10 may deform back to the non-deformed position illustrated in FIG. 6A when the incision is closed again, without impairing or interrupting the tracking process” [0079]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gamm et al (US 20200330162 A1) in view of Mariampillai et al (US 20180078317 A1) further in view of Buchalter (US20130150703A1).
Regarding claim 6, Gamm teaches all the claimed limitations except for adhesive tape is a polyethylene film coated with an acrylic adhesive or a rayon woven fabric covered with an acrylic adhesive.
However, in the same field of endeavor, Buchalter teaches biopsy grid is provided that is useful in medical imaging. Strips that serve as markers in an image. The biopsy grid can be used to locate the position of the marker relative to a tissue of interest in a medical image (abst). Identifying the location of a marker relative to a tissue of interest in medical images [0005]. Medical grade adhesive that is suitable for affixing the grid to the skin of a subject. In some embodiments, the adhesive layer is made of acrylic [0015]. The adhesive layer 30 may be, for example, a low tack acrylic based adhesive made of medical grade adhesive suitable for releasably securing the frame to the skin of a subject, such as an animal or human patient. A release liner 20 may be used to cover the adhesive layer 30 to prevent drying of the adhesive and the hydrogel prior to use. The release liner 20 may be provided with a pull tab 22 for easy removal. The release liner is widely available from many suppliers (e.g., Avery Dennison, Brea, Calif.) and is typically polyethylene material coated [0025]
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with adhesive tape is a polyethylene film coated with an acrylic adhesive as taught by Buchalter because it provides an improved manufacturing method for making marking grids, and improved materials for use in the radio-opaque strip material ([0003] of Buchalter).
Regarding claims 7, Gamm teaches all the claimed limitations except for radio-opaque markers.
However, in the same field of endeavor, Buchalter teaches biopsy grid is provided that is useful in medical imaging. Strips that serve as markers in an image. The biopsy grid can be used to locate the position of the marker relative to a tissue of interest in a medical image (abst). Identifying the location of a marker relative to a tissue of interest in medical images [0005]. Marking grids are useful for locating the position on the surface of a patient where a biopsy needle should be inserted. The grids typically include a radiopaque material, arranged in strips, mounted on a radio translucent border or frame [0002].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with radio-opaque markers as taught by Buchalter because it provides an improved manufacturing method for making marking grids, and improved materials for use in the radio-opaque strip material ([0003] of Buchalter).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive at least for the following reasons.
Regarding the objections to the claims, the applicant argues the following;
Claims 10 and 11 stand objected to. The rejection alleges claims 10 and 11 appear to be both independent and dependent, rendering the scope unclear. This objection is respectfully traversed.
35 U.S.C. 112(d) requires that dependent claims contain a reference to a previous claim in the same application, specify a further limitation of the subject matter claimed, and include all the limitations of the previous claim. Claims 10 and 11 meet the statutory requirement for a dependent claim. Moreover, MPEP 608.01(n)(III) explicitly states "the fact that a dependent claim, which is otherwise proper might relate to a separate invention that would require a separate search or be separately classified from the claim on which it depends would not render it an improper dependent claim." (emphasis added). Applicant has amended claims 10 and 11 for antecedents to clarify the subject matter on which they depend, but nevertheless maintains the scope of claim 10 and 11 is clear, and claims 10 and 11 are in proper dependent form as they are presently recited.
Withdrawal of this objection is respectfully requested.
However, initially it is noted that the claims are OBJECTED to and they are NOT REJECTED under 35 USC 112. Further, claim 1 (which the objected claims 10 and 11 refer back to), in the preamble recites “An optical monitoring device comprising”. Whereas, in a striking difference, the objected claims, for instance claim10, in the preamble recites “An optical navigation system comprising:” and claim 11, in the preamble recites “An optical navigation method”
These are clearly different inventions since claim 1 is directed to “optical monitoring device” and in different inventions the objected claims are directed “optical navigation system/method”. Yet, these objected different invention of claims 10 and 11 further refer back to the “optical monitoring device”.
Therefore, the objected claims, should rather make this clear whether the claims 10 and 11 are either independent claims or dependent claims.
For doing so, if the applicant intends to have the claims be interpreted as an INDEPDENT claim, it is suggested to bring the entire claim 1 in to the claim 10 (and claim 11 as well respectively) to have the claims construed as a proper independent claim. Rather if the applicant intends to have the claims be interpreted as DEPEDENT claims, correct the dependency of the claims 10 and 11 (as shown in other depending claims e.g., claim 12, claim 2, etc.) to have the claim construed as a proper dependent claim.
It is further noted that the work fees sheet shows that the applicant paid for ONLY TWO independent claims. Accordingly, it is assumed that claims 10 and 11 are meant to be drafted/construed as dependent claims. Therefore, the applicant may consider correcting the dependency of the claims 10 and 11 to be like the proper dependent claims, e.g., claim 2 which in the preamble properly states “The optical monitoring device of claim 1, wherein the base…”
Regarding the rejections of the claims, the applicant argues the following;
First, Gamm does not disclose an optical monitoring device comprising a base layer that serves as a sterile drape. Gamm instead discloses a patch to be adhered to the patient's skin. A sterile drape as recited in claim 1 and as used throughout the specification relates to a specific piece of medical equipment consistent with the accepted definition of sterile drape in the relevant technological field. (See, for example, Applicant Fig. 3, item 11 and paragraph [0005] of the published specification). The patch described in Gamm is not a sterile drape, nor can it be otherwise configured to serve as a sterile drape. Claim 1 is therefore allowable over Gamm for at least this reason alone.
Contrary to the applicant’s assertion, it is initially noted that the claim merely and BROADLY recites “sterile drape” without any further definition to the limitation. Further, as per MPEP 2111, claims must be given their broadest reasonable interpretation consistent with the specification though understanding the claim language may be aided by explanations contained in the written description. Yet, it is important not to import into a claim limitation that are not part of the claim. In light of the MPEP, it is noted that claim merely requires “base layer that serves as a sterile drape” and drape as in the general meaning of e.g., to cover or adorn with or as if with folds of cloth.
Accordingly, Gamm specifically teaches that plane meaning of “base layer that serves as a sterile drape” without any further definition of the limitation.
[0077] FIGS. 6A, B show a top view of a fifth embodiment of a tracker 10 in a nonbiased (FIG. 6A) and a deformed (FIG. 6B) configuration. The tracker 10 comprises a plurality of light sources 14 supported by a deformable patch 12. The patch 12 has the shape of a rectangular frame enclosing a central opening 28. The tracker 10 shown in FIGS. 6A, B is attached to a skin surface of a patient (e.g., by an adhesive), wherein the opening 28 is arranged over an incision 30 made in the surface of the patient. The incision may, for example, be an abdominal incision.
[0078] The patch 12 comprises a plurality of electrical connections 16 that are coupled in series with the plurality of light sources 14. The electrical connections 16 could also be configured otherwise (see, e.g., FIGS. 3 and 4 A-C). The tracker 10 further comprises a controller 22 electrically connected with the light sources 14 and configured to operate the light sources 14.
[0079] When opening the incision in order to access the surgery site, skin around the incision deforms and is mainly pushed in a direction away from the incision. Since the tracker 10 is attached to the skin of the patient, a force is acting on the tracker 10. The patch 12 and the electrical connections 16 (due to their meandering shape) are deformable and can therefore adapt to the force by deformation. FIG. 6B shows the tracker 10 in a deformed configuration. In its deformed configuration, a distance between the light sources 14 is increased. The increased distance is compensated by a (partial) straightening of the meandering shapes of the electrical connections 16. From the deformed position illustrated in FIG. 6B, the tracker 10 may deform back to the non-deformed position illustrated in FIG. 6A when the incision is closed again, without impairing or interrupting the tracking process. Deviations of individual light sources 14 from their preceding position upon deformation or relaxation can easily be compensated using the technique presented in EP 2 944 283 A, the corresponding content of which is herewith incorporated by reference.
Furthermore, the drape is merely recited in the preamble and only limited weight is given to the limitations in preamble under MPEP 2111.02.
The applicant further argues the following;
Second, Gamm does not disclose the claimed optical sensor, namely an optical fiber incorporating Fiber Bragg gratings ("FBG sensor"). The rejection acknowledges this and thus relies on Mariampillai for this teaching. (Office Action p. 4). However, there is no obvious nexus between Mariampillai and Gamm that would suggest to one having ordinary skill in the art that the tracking patch of Gamm could incorporate an FBG sensor to achieve the claimed tracking capability by way of the optical monitoring device of claim 1.
The claimed FBG allows for information regarding the relative spatial positions of the optical markers with respect to one another to be obtained, even if one of the optical markers is obscured from the view of the localization device. (See, e.g., published application, [0013]). Because deformation of the optical fiber leads to a change in the period of the microstructure and consequently also a change in the wavelength of the Bragg grating, it is possible to determine a deformation applied to the optical fiber at the level of each Bragg grating by measuring a difference between a reference wavelength of the Bragg grating (the wavelength of the Bragg grating with no deformation) and a measured wavelength of the Bragg grating (the wavelength of the deformed Bragg grating). (Published application, [0063]). Accordingly, the measurement of the various deformations applied at the level of the various respective Bragg gratings enables determination of their positions in space relative to one another. (Id.). Therefore, in a case when line of sight between the localization device and an optical marker is obstructed, measurements from the FBG sensor can estimate the position the obscured optical marker(s) using the deformation data from the FBG sensor in conjunction with the known position of at least one visible optical marker.
While Gamm mentions that the tracker may include an optical fiber, this is solely in relation to the tracking means itself, i.e., a specific embodiment of the illuminated tracking element. In Gamm, the tracking element is an illumination source, such as an LED, a laser, or an optical fiber. Thus, Gamm only discloses an optical fiber as an illumination source, and not for the inclusion in any sensor. Accordingly, Gamm cannot disclose the recitations of claim 1 according to which the FBG sensor comprises at least one measurement point associated with each of the optical markers (or with each of the optical marker mounting supports).
On the contrary, Gamm specifically teaches “[0040] The tracker 10 further comprises tracker element in form of a light source 14 supported by the patch 12. The light source 14 may comprise at least one of a light emitting diode (LED), an organic light emitting diode (OLED), a laser, an incandescent light source and an optical fibre.”
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As clearly stated in the office action “Gamm does not point out the specifics of an optical fiber incorporating Bragg gratings.” Which, Mariampillai was brought in to specifically teaches the guidance and tracking systems for tracking flexible implements, such as flexible medical instruments. More specifically, the present disclosure relates to an integrated system of markers (active or passive) and fiber Bragg grating (FBG) arrays arranged for interventional and/or surgical procedures and the tracking of flexible medical implements used in these procedures [0002]. A Fiber Bragg Grating (FBG) is a type of optical sensor, which can be constructed by exposing a photosensitive fiber to a spatially varying distribution of light to induce a periodic index of refraction change within the core of the fiber [0007].
In addition, the applicant further argues the following;
Mariampillai discloses an FBG sensor integrated into a flexible medical instrument (for example, a needle, a catheter, or an endoscope) that may undergo deflection during insertion into the patient's body. (Mariampillai, [0006], [0099]). The incorporated sensor can therefore be used for tracking the bending profile of the medical instrument and the calibration of the medical instrument. (Mariampillai, [0013]). In Mariampillai, the medical instrument is bent along known bending profiles to calibrate the device, then the FBG sensor is used to track the medical instrument during a procedure despite deflections. (See, Mariampillai, [0006], [0013]).
Further, in Mariampillai, the measurement points of the FBG sensor are denoted by reference numeral 225 in Figure 4. (See also, Mariampillai, Figure 9 and [0128]). Based on this, it is clear that the measurement points of the FBG sensor in Mariampillai are not associated with the optical markers of the assembly and therefore cannot be used to determine information regarding the relative spatial positions of the optical markers with respect to one another. Additionally, in Mariampillai, the relative spatial positions of the optical markers with respect to one another do not change over time because the assembly (240) supporting the optical markers is rigid. (Mariampillai, [0098]). Consequently, there is no reason in Mariampillai et al to seek to determine the relative spatial positions of the optical markers with respect to one another. Therefore, even if combined with Gamm, the combination still fails to disclose a fiber optic sensor fastened to the base layer and comprising at least one measuring point associated with each of the optical markers or the fixing supports. Accordingly, no prima facie case of obviousness exists.
Finally, nothing in Mariampillai suggests that the FBG sensor, used to track bending of a bendable device, could be integrated into an optical tracking device intended to be positioned on a patient's skin, wherein the sensor data is used as an input for determining the relative position of the optical markers, such as in the case where one or more optical markers are obscured. Because Gamms optical fiber is an illumination source used as the tracking element itself, it would not be obvious to one having ordinary skill in the art to replace the optical fiber of Gamm with the FBG sensor of Mariampillai to arrive at the claimed invention. Such a modification would both change the principle of operation of Gamm (i.e., changing the manner by which the optical detector interacts with the tracking elements) and would render Gamm inoperative for its intended purpose (i.e., an illuminating tracking element is replaced with an FBG sensor).
It is further noted that Mariampillai was merely brought in to show the optical fiber incorporating Bragg gratings. Therefore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, the rejections are maintained.
Conclusion
Claim 14 is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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