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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/13/2026 has been entered.
Response to Arguments
Applicant’s arguments, with respect to the rejection of claim 1 under 35 U.S.C. 103, in Applicant’s responses filed 02/13/2026 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Withdrawn objections
Pursuant of Applicant’s amendments filed 02/13/2026, the objections made to the drawings have been withdrawn.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-3, 5-8, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, Y., US 20140275964 A1 in view of Meglan, D., US 20070123748 A1, Nemanic, et al., US 20170100202 A1 and Leibinger, et al., US 5394457 A.
Regarding claim 1, Kim teaches a diagnostic marker tool (see figs. 1-3) for use with x-ray imaging and/or magnetic resonance imaging diagnostic methods (the marker-flange is used achieved the intended purpose of being used with x-ray imaging and/or magnetic resonance imaging according [0013]),
the diagnostic marker tool (marker-flange 100 of figs. 1-3 and [0036]) comprising:
a marker body having first and second opposed major surfaces (see figs. 1-3 and [0039] states that “As shown in the example of FIG. 1, the first and second faces A/B may be formed with planar surfaces. Alternatively, one or both of the faces A/B may be formed with shaped faces that may include concave, convex, and wave-like contours.”) the marker body including a shaped fluid chamber therein which receives a non-metallic and/or radio-opaque fluid to form the non-metallic and/or radio-opaque indicator element ([0015] states that “The marker agent contained within the hollow chamber of the marker-flange is an MR imaging responsive liquid marker material that generates MR image signal intensities sufficient to overcome susceptibility artifacts generated by titanium materials when subjected to MR imaging”);
an orientation indicator for determining correct placement of the diagnostic marker tool in-use ([0047] states that “In one example the hollow chamber 118 may be formed in an isosceles triangular shape, such that the orientation of the base angles and the vertex angle in the isosceles triangle may be used as reference points for both the marker position and orientation, as well as the position and orientation of a brachytherapy applicator on which the marker-flange 100 is affixed”. Of note, the examples provided in the section of the document are not separate embodiments).
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Kim does not teach that the marker flange includes a first suction element positioned at the first major surface; a second suction element positioned at the second major surface.
However, within the same field of endeavor, Meglan teaches a miniature robotic device to be introduced, in the case of the heart, into the pericardium through a port, attach itself to the epicardial surface, and then, under the direct control of the user or physician, travel to the desired location for diagnosis or treatment (see abstract). [0037] states that “Shown in FIG. 3 is a location sensing tracking device 50 or marker so that the position or orientation can be identified electromagnetically or under fluoroscopy…One or more suction or gripping devices can also be placed on the top of central body 12, that is, on the opposite side from element 28, to provide for attachment of the second side of the device to a second cavity wall or surface”. Meaning that in this configuration, the miniature robotic device comprises a marker with body 12 (see fig. 1) and two suction or gripping elements, 28, with each of the suction or gripping elements 28 positioned on two opposing sides or surfaces of the body 12.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim’s marker flange to include a first suction element positioned at the first major surface; a second suction element positioned at the second major surface, as taught by Meglan, to provide stable placement or positioning of the marker ([0037]).
Kim in view of Meglan fails to teach the orientation indicator being on the first major surface of the marker body or the second major surface of the marker body.
However, within the same field of endeavor, Nemanic teaches fiducial markers that include a sealed casing member containing a mixture of iodine and water that includes about 1-300 mg/ml iodine. The fiducial markers may be distinguishable on at least two imaging modalities, such as CT and MRI. See abstract and annotated fig. 1H below. [0020] includes that In various embodiments, to assign the fiducial marker a polarity or directionality, an additional feature may be included in or near one or more sides or corners of the fiducial marker. In various embodiments, this positional indicator may be placed in a chosen relationship to the patient so that it may be visualized on one or more imaging modalities. In general, any feature may be used for a positional indicator, so long as it is visible on a desired imaging modality and does not create undesirable imaging artifacts. Specific, non-limiting examples of suitable positional indicators include a crimp in one or more sides or corners, a physical compression, constriction, or extension, or an augmentation, such as a fold, ridge, crease, wrinkle, bead, or a clip, such as a metal clip. In various embodiments, such a clip (or other augmentation) may be attached to the body of imaging device at any position that helps define marker orientation. [0021] also indicates that Another example of a suitable augmentation for use as a positional indicator is a suture ligand, ligature, or other strand, which may be tied around the body of the fiducial marker to provide a slight bend that may be appreciated on imaging and help identify position/orientation of the fiducial marker.
[AltContent: textbox (Positional indicator)][AltContent: arrow]
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim as modified by Meglan, wherein the orientation indicator being on the first major surface of the marker body or the second major surface of the marker body, as taught by Nemanic, to provide cost effective, consistent, and reliable fiducial markers were available that may be used for both CT and MRI ([0026]).
Kim in view of Meglan and Nemanic fail to teach an inlet of the shaped fluid chamber located on an upper edge of a circumference of the marker body.
However, within the same field of endeavor, Leibinger teaches A device for marking body sites for imaging medical examinations, such as nuclear spin resonance tomography (NMR), computed tomography (CT), roentgen ray analysis (X-ray), or positron emission tomography (PET), comprises fixtures (10) which are adapted to be fastened to the body and/or to a stereotaxic means or a mask arrangement. Markers (18) containing a substance (20) which provides sharp contrast in the generation of images are adapted to be slid selectively into those fixtures (see abstract). Col. 4, lines 10-19 state that The embodiment illustrated in FIG. 3 differs from the one described above with reference to FIG. 2 in that the head 24 is formed with a channel 30 through which a contrasty substance can be injected into a cavity 28. The substance used may be a contrast medium containing gadolinium. Following the injection, the channel 30 is closed by suitable means. The channel 30 also may be of such design that the surface tension of the contrast medium (being a liquid) will prevent it from leaking out. See reproduced fig. 3 below.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan and Nemanic, to include an inlet of the shaped fluid chamber located on an upper edge of a circumference of the marker body, as taught by Leibinger, as such modification would improve the accuracy of determining relative positions of the patient (col. 2, lines 1-8) and improving the reproducibility of the examination or surgical procedures (col. 2, lines 19-22).
Regarding claim 2, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim further teaches wherein the marker body includes a shaped fluid chamber therein which receives a non-metallic and/or radio-opaque fluid to form the non-metallic and/or radio-opaque indicator element ([0015] states that “The marker agent contained within the hollow chamber of the marker-flange is an MR imaging responsive liquid marker material that generates MR image signal intensities sufficient to overcome susceptibility artifacts generated by titanium materials when subjected to MR imaging”).
Regarding claim 3, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 2.
Kim further teaches wherein the shaped fluid chamber includes a removable cap to permit replacement of the non-metallic and/or radio-opaque fluid ([0017] states that “the marker-flange may be configured for sterilization and refilling (enabling the removal and replacement of a marker agent) so as to permit repeated uses”).
Regarding claim 5, Kim in view of Meglan, Nemanic, and Leibinger teaches all the limitations of claim 2.
Kim in view of Meglan fail to teach wherein the non-metallic and/or radio-opaque fluid comprises gadolinium for MRI- compatibility.
However, Nemanic further teaches wherein the non-metallic and/or radio-opaque fluid comprises gadolinium for MRI- compatibility, indicating that iodinated contrast media were used in the markers ([0019]) and then further indicating in [0048] that the degree of contrast between the markers and tissue were examined both for MRI and CT and in [0050] that the contrast solution is gadolinium.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan, Nemanic and Leibinger above, wherein the non-metallic and/or radio-opaque fluid comprises gadolinium for MRI- compatibility, as taught by Nemanic, to provide cost effective, consistent, and reliable fiducial markers were available that may be used for both CT and MRI ([0026]).
Regarding claim 6, Kim in view of Meglan, Nemanic, and Leibinger teaches all the limitations of claim 2.
Kim in view of Meglan fail to teach wherein the non-metallic and/or radio-opaque fluid comprises barium sulphate or other radiographic contrast media for x-ray imaging compatibility.
However, Nemanic further teaches wherein the non-metallic and/or radio-opaque fluid comprises barium sulphate or other radiographic contrast media for x-ray imaging compatibility ([0052] states that “Compounds having atoms of high atomic number (Z) are considered more opaque on x-rays or more attenuating on CT due to this phenomenon. Notable contrast medium compounds frequently used in medicine include barium and iodine. As described previously, iopamidol is an iodinated, non-ionic compound and its use in both human and veterinary medicine is highly documented. However, as disclosed herein, the use of 100% iopamidol 300 solution did not result in adequate marker intensity on MRI and provided excessive artifact on CT. To address this issue, water was used to dilute the iodinated solution, until the most suitable concentration was identified”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan, Nemanic and Leibinger above, wherein the non-metallic and/or radio-opaque fluid comprises barium sulphate or other radiographic contrast media for x-ray imaging compatibility, as taught by Nemanic, to provide cost effective, consistent, and reliable fiducial markers were available that may be used for both CT and MRI ([0026]).
Regarding claim 7, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim further teaches wherein the marker body is formed from a radiolucent material ([0038] states that “The flange body 110 is formed from a biocompatible material which is MR imaging compatible to the extent that it will not interfere with the generation of MR image signals from an MR image responsive marker agent contained within the hollow chamber 118. The flange body can be made out of plastic material such as polyethelene. Examples of suitable materials for forming the flange body 110 include polysulfone, acetal, carbon fiber, polytetrafluoroethylene, fluorinated ethylene propylene, polytetrafluoroethylene-perfluoroalkyrl vinyl ether copolymer, polyvinyl chloride, polypropylene, polyethelene, polyethylene terephthalate, broad fluoride, and similar biocompatible plastics.” One of ordinary skill in the imaging art would recognize these materials are radiolucent because they allow X-rays to pass through them).
Regarding claim 8, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 7.
Kim further teaches wherein the marker body is formed from a plastics material ([0038] states that “The flange body 110 is formed from a biocompatible material which is MR imaging compatible to the extent that it will not interfere with the generation of MR image signals from an MR image responsive marker agent contained within the hollow chamber 118. The flange body can be made out of plastic material such as polyethelene. Examples of suitable materials for forming the flange body 110 include polysulfone, acetal, carbon fiber, polytetrafluoroethylene, fluorinated ethylene propylene, polytetrafluoroethylene-perfluoroalkyrl vinyl ether copolymer, polyvinyl chloride, polypropylene, polyethelene, polyethylene terephthalate, broad fluoride, and similar biocompatible plastics.”).
Regarding claim 12, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim further teaches wherein the marker body is disciform (see reproduced fig. 1 above and figs. 2-3).
Regarding claim 13, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim further teaches wherein the diagnostic marker tool is devoid of a chain or hanger (see the marker-flange of figs. 1-3 and [0013]-[0015] which is devoid of a chain or hanger).
Regarding claim 14, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim does not teach wherein the first and second suction elements have a width which is less than that of the marker body.
However, Meglan further teaches wherein the first and second suction elements have a width which is less than that of the marker body ([0012] states that “Once the device is within the pericardial sac, it attaches itself to the surface of the heart by means of suction or approaches which provide a connection that keeps the device firmly connected to the epicardium such as, for example, micro-grippers or direct molecular adhesion. Suction holds onto the heart surface and rides with it while having a size small enough to not interfere with normal heart function during the procedure” and evidenced by the size of the suction element 28 in fig. 3 compared to the body 12 of the marker, it is implicit that the suction elements have a width which is less than that of the marker body).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim’s marker flange wherein the first and second suction elements have a width which is less than that of the marker body, as taught by Meglan, to provide stable placement or positioning of the marker ([0037]).
Furthermore, “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). See MPEP 2144.04(IV)(A). In the instant case, Meglan’s depiction of the suction element 28 in fig. 3, as smaller, with respect to the marker body, and disclosure in [0037] that a second suction element is provided at the top of the central body 12, is patentably indistinguishable from the recited limitation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, Y., US 20140275964 A1 in view of Meglan, D., US 20070123748 A1, Nemanic, et al., US 20170100202 A1 and Leibinger, et al., US 5394457 A, as applied to claim 1 above, and further in view of Johnson, A.A., US 20130341412 A1.
Regarding claim 10, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim further teaches wherein the marker body includes an aperture therethrough (see figs. 1-3), but Kim in view of Meglan, Nemanic, and Leibinger fails to teach the first and second suction elements being formed by a double-sided suction element received through the aperture.
However, Johnson, in attempting to solve a reasonably pertinent problem of providing a mounting apparatus that permits easy and quick attachment and removal of a device to smooth surfaces using double-sided suction cup units (abstract), teaches a mounting apparatus comprising a card as a generally-planar platform having a connection mechanism on both sides of the card, for connecting an electronic or other device to a surface or object ([0009] and figs. 1-10), and double-sided suction cups (12 of figs. 1-10 and [0055]) and holes or slots 22 of figs. 1-10, [0049] stating that “The card 11 comprises holes or "slot openings" or "slots" 22, and suction cup units 12 are inserted into/through the slots 22. The suction cup units 12 are securely held in place within the slots 22 due to the central suction cup body 13 of each unit 12 fitting sufficiently tightly in its respective slot 22 that it will not fall out or be forced out during normal use while suspending an electronic device”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan, Nemanic and Leibinger, the first and second suction elements being formed by a double-sided suction element received through the aperture, as taught by Johnson, to secure the device, such as electronic device 32 of [0059] such that that the electronic device will not fall out or be forced out during normal use while suspending an electronic device ([0049]).
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Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, Y., US 20140275964 A1 in view of Meglan, D., US 20070123748 A1, Nemanic, et al., US 20170100202 A1 and Leibinger, et al., US 5394457 A, as applied to claim 1 above, and further in view of Krupnick, et al., US 4918715 A.
Regarding claim 11, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim in view of Meglan, Nemanic, and Leibinger fails to teach wherein the non-metallic and/or radio-opaque indicator element is a 'left' or 'right' indicator.
However Krupnick teaches a device for producing plural lines on a film bearing a radiographic image of a portion of the body of a living being to facilitate the location of a part of the being's body within that image (see abstract and fig. 1), col. 4, lines 29-40 stating that “As can be seen in FIG. 1 the sheet 20 may also include other indicia thereon. Such indicia may be in the form of numbers and/or letters used to identify the respective lines forming the grid-like pattern 28. If such additional indicia are used they may also be formed of the radio-opaque material forming the grid pattern so that they will appear in the X-ray when it s developed. Other indicia (which may also be radio-opaque) can be provided on the sheet to carry other information, such as direction (e.g., use of the character "L" to signify "left"), patient identity (e.g. "NAME.sub.-- "), date of the X-ray (e.g., "DATE.sub.-- "), etc.”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan, Nemanic, and Leibinger, wherein the non-metallic and/or radio-opaque indicator element is a 'left' or 'right' indicator, as taught by Krupnick, as such a modification would improve the ease of use of the marker (col., 1, lines 24-35).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, Y., US 20140275964 A1 in view of Meglan, D., US 20070123748 A1, Nemanic, et al., US 20170100202 A1 and Leibinger, et al., US 5394457 A, as applied to claim 1 above, and further in view of Andersen, et al., US 20150359951 A1.
Regarding claim 15, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim in view of Meglan, Nemanic and Leibinger fails to teach wherein the first and second suction elements are transparent or translucent.
However, Andersen, faced with solving a reasonably pertinent problem of increasing the visibility of a wound marker (see [0012]), teaches a suction device attached to a wound cover member. The suction device comprises an attachment portion adapted to be attached to a wound cover member. The suction device comprises a fluid inlet which is at least partially circumscribed by the attachment portion. The suction device also comprises a fluid outlet (see abstract), wherein the first and second suction elements are transparent or translucent ([0108] states that “the suction device is envisaged wherein substantially the entire suction device is transparent”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan, Nemanic and Leibinger, wherein the first and second suction elements are transparent or translucent, as taught by Anderson, to allow viewing of a marker underneath the suction cup ([0020]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, Y., US 20140275964 A1 in view of Meglan, D., US 20070123748 A1, Nemanic, et al., US 20170100202 A1 and Leibinger, et al., US 5394457 A, as applied to claim 1 above, and further in view of Champleboux, G., US 20150196372 A1.
Regarding claim 16, Kim in view of Meglan, Nemanic and Leibinger teaches all the limitations of claim 1.
Kim in view of Meglan, Nemanic and Leibinger fails to teach wherein the marker body is formed by an additive manufacturing process.
However, Champleboux a fiducial element 81 of fig. 10 and [0117], for use as a surgical guide ([0183]) wherein the marker body is formed by an additive manufacturing process ([0183] states that the surgical guide is formed by additive manufacturing methods).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Kim, as modified by Meglan, Nemanic and Leibinger, wherein the marker body is formed by an additive manufacturing process, to allow the fiducial or surgical guide to be formed accurately during the manufacturing process ([0004]) which would improve patient outcomes ([0005]-[0007]).
NB: Claim 16 is a product-by-process claim, hence, while Champleboux has been introduced to teach the additive manufacturing process, the marker body is not limited by the additive manufacturing process. See MPEP 2113.
Conclusion
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/FAROUK A BRUCE/ Examiner, Art Unit 3797