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 .
Specification
The disclosure is objected to because of the following informalities:
CROSS REFERENCE TO RELATED APPLICATIONS should be amended to include the patent numbers of the patented applications as follows: “This application is a continuation of U.S. Patent Application 17/585,629, filed January 27, 2022, now U.S. Patent No. 12,178,666 which is a continuation in part of PCT Patent Application PCT/IB2020/056893, filed July 22, 2020, which is a continuation in part of U.S. Patent Application 16/524,258, filed July 29, 2019, now U.S. Patent No. 11,980,506. Each of the foregoing applications is hereby incorporated by reference herein in its entirety.”
Appropriate correction is required.
Claim Objections
Claims 6 and 7 are objected to because of the following informalities:
Claim 6, line 2 “each of the group having” should read “each of the groups having”.
Claim 7, line 2 “each of the group comprising” should read “each of the groups comprising”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 6, 8, 23, 26, 27, 28, 29, and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable respectively over claims (1, 3, 13, 16, 22, and 23), 1, 23, 7, 1, 21, 2, (1, 13, and 22), 3, (1, 13, and 22), and 2, of U.S. Patent No. 11,980,506 in view of US 2015/0150641 Daon et al., hereinafter “Daon”.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,980,506, in view of US 2015/0150641 Daon et al., hereinafter “Daon”, further in view of US 2018/0311011 Van Beek et al., hereinafter “Van Beek”.
Current Application No. 18/949,164
U.S Patent No. US 11,980,506
1. An apparatus for image guided surgery, the apparatus, comprising: a retaining structure for attachment to a bone of a patient; and a fiducial marker, the fiducial marker comprising; a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a sigmoid mounting arm having a first end fixedly connected to the radiotransparent plate, a second end containing one or more fastening receptacles configured for removable connection of the sigmoid mounting arm to the retaining structure, and a straight section orthogonal to the radiotransparent plate and fixedly connecting the first end to the second end.
1. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end containing one or more fastening receptacles configured for removable connection of the mounting arm to the surgical clamp, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
3. The apparatus according to claim 1, wherein the mounting arm comprises a first curved section connected to a second curved section by a straight section.
And/or
13. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end configured to be removably attached to the surgical clamp by one or more fastening receptacles, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
16. The apparatus according to claim 13, wherein the mounting arm comprises a first curved section connected to a second curved section by a straight section.
And/or
22. A set of medical devices, comprising: a surgical clamp for attachment to a bone of a patient; and a set of medical marking devices to be registered with a patient anatomy close to a site of an operation, each medical marking device of the set of medical marking devices comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end configured to be removably attached to the surgical clamp by one or more fastening receptacles, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient; wherein the mounting arm of each medical marking device of the set of medical marking devices has a different length.
23. The set of medical devices according to claim 22, wherein the first ends are connected to the second ends by straight sections, and wherein the different lengths of the mounting arms are formed by varying lengths of the straight sections.
2. (Currently Amended) The apparatus according to claim 1, wherein the retaining structure comprises a clamp, and the bone comprises at least one spinous process of the patient, and wherein the clamp is configured to be clamped to the at least one spinous process.
1. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end containing one or more fastening receptacles configured for removable connection of the mounting arm to the surgical clamp, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
4. (Currently Amended) The apparatus according to claim 1, further comprising one or more additional sigmoid mounting arms, each of the one or more additional sigmoid mounting arms having the straight section with a different respective length.
23. The set of medical devices according to claim 22, wherein the first ends are connected to the second ends by straight sections, and wherein the different lengths of the mounting arms are formed by varying lengths of the straight sections.
6. (Original) The apparatus according to claim 5, wherein each predefined pattern is formed as a group of rectangles, each of the group having a different respective ratio of sides.
7. The apparatus according to claim 1, wherein the predefined pattern of the plurality of radiopaque elements comprises points on sides of a rectangle.
8. (Currently Amended) The apparatus according to claim 1, wherein on connection of the sigmoid mounting arm to the retaining structure, the radiotransparent plate is below a region of connection of the sigmoid mounting arm to the retaining structure.
1. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end containing one or more fastening receptacles configured for removable connection of the mounting arm to the surgical clamp, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
23. (New) The apparatus according to claim 1, wherein the plurality of radiopaque elements comprise a plurality of radiopaque spheres.
21. The apparatus according to claim 13, wherein the radiopaque elements of the plurality of radiopaque elements comprise spheres.
26. (New) The apparatus according to claim 1, wherein the sigmoid mounting arm is radiotransparent.
2. The apparatus according to claim 1, wherein the mounting arm is radiotransparent.
27. (New) An apparatus for image guided surgery, the apparatus comprising: a retaining structure for attachment to a bone of a patient; and a fiducial marker, the fiducial marker comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a sigmoid mounting arm having a first end fixedly connected to the radiotransparent plate and a second end containing one or more fastening receptacles configured for removable connection of the sigmoid mounting arm to the retaining structure, wherein the second end of the sigmoid mounting arm comprises a lower plane surface that is parallel to an upper surface of the radiotransparent plate and that is positioned above the upper surface of the radiotransparent plate.
13. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end configured to be removably attached to the surgical clamp by one or more fastening receptacles, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
And/or
1. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end containing one or more fastening receptacles configured for removable connection of the mounting arm to the surgical clamp, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
And/or
22. A set of medical devices, comprising: a surgical clamp for attachment to a bone of a patient; and a set of medical marking devices to be registered with a patient anatomy close to a site of an operation, each medical marking device of the set of medical marking devices comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end configured to be removably attached to the surgical clamp by one or more fastening receptacles, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient; wherein the mounting arm of each medical marking device of the set of medical marking devices has a different length.
28. (New) The apparatus according to claim 27, wherein the sigmoid mounting arm further comprises a straight section between the first end and the second end, the straight section being orthogonal to the upper surface of the radiotransparent plate.
3. The apparatus according to claim 1, wherein the mounting arm comprises a first curved section connected to a second curved section by a straight section.
29. (New) The apparatus according to claim 27, wherein the retaining structure comprises a clamp.
1. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end containing one or more fastening receptacles configured for removable connection of the mounting arm to the surgical clamp, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
And/or
13. Apparatus, comprising: a surgical clamp for attachment to a bone of a patient; and a medical marking device to be registered with a patient anatomy close to a site of an operation, the medical marking device comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end configured to be removably attached to the surgical clamp by one or more fastening receptacles, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient.
And/or
22. A set of medical devices, comprising: a surgical clamp for attachment to a bone of a patient; and a set of medical marking devices to be registered with a patient anatomy close to a site of an operation, each medical marking device of the set of medical marking devices comprising: a radiotransparent plate comprising a plurality of radiopaque elements embedded therein in a predefined pattern; and a mounting arm having a sigmoid shape between a first end connected to the radiotransparent plate and a second end configured to be removably attached to the surgical clamp by one or more fastening receptacles, the sigmoid shape providing both a lateral offset and a vertical offset relative to the second end so as to position the radiotransparent plate close to the site of the operation and vertically below the second end when the medical marking device is attached to the surgical clamp and the surgical clamp is configured to be attached to the bone of the patient; wherein the mounting arm of each medical marking device of the set of medical marking devices has a different length.
31. (New) The apparatus according to claim 27, wherein the sigmoid mounting arm is radiotransparent.
2. The apparatus according to claim 1, wherein the mounting arm is radiotransparent.
Regarding claim 1, U.S Patent No. US 11,980,506 does not explicitly state a straight section orthogonal to the radiotransparent plate.
However, Daon discloses a straight section orthogonal to the radiotransparent plate (Figure 3N shows element 11 orthogonal to plate 12).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight orthogonal section as taught by Daon, in the invention of U.S Patent No. US 11,980,506, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 2, U.S Patent No. US 11,980,506 does not explicitly state the bone comprises at least one spinous process of the patient.
However, Van Beek discloses the bone comprises at least one spinous process of the patient (Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a spinous process as taught by Van Beek, in the invention of U.S Patent No. US 11,980,506, in order to track positioning in spine surgery (Van Bekk; Para 50).
Regarding claim 27, U.S Patent No. US 11,980,506 does not explicitly state wherein the second end of the sigmoid mounting arm comprises a lower plane surface that is parallel to an upper surface of the radiotransparent plate and that is positioned above the upper surface of the radiotransparent plate.
However, Doan discloses the second end of the sigmoid mounting arm comprises a lower plane surface that is parallel to an upper surface of the radiotransparent plate and that is positioned above the upper surface of the radiotransparent plate (Figure 3N shows element 11 orthogonal to plate 12 with the lower surface of element 17 parallel to the upper plate plane 12).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight orthogonal section as taught by Daon, in the invention of U.S Patent No. US 11,980,506, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 28, U.S Patent No. US 11,980,506 does not explicitly state a straight section orthogonal to the upper surface of the radiotransparent plate.
However, Daon discloses a straight section orthogonal to the upper surface of the radiotransparent plate (Figure 3N shows element 11 orthogonal to plate 12).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight orthogonal section as taught by Daon, in the invention of U.S Patent No. US 11,980,506, in order to position a tracking marker in the appropriate location (Daon; Para 90).
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.
Claim(s) 1, 4-8, 19-21, 23, 26-28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0311011 Van Beek et al., hereinafter “Van Beek”, in view of US 2015/0150641 Daon et al., hereinafter “Daon”.
Regarding claim 1, Van Beek discloses an apparatus for image guided surgery (Abstract and Para 40), the apparatus (Shown in Figure 5), comprising:
a retaining structure (Figure 5, element 2, Para 49; “percutaneous pin”) for attachment to a bone of a patient (Para 49 and Figure 5 shows the pin 2 in the spinous process); and
a fiducial marker (Figure 5, elements 30 and 31), the fiducial marker comprising:
a radiotransparent plate (Figure 5, element 30; Para 59 “registration phantom 30 is made of a radiotransparent material”) comprising a plurality of radiopaque elements embedded therein in a predefined pattern (Figure 5, element 31 and Para 59; “a plurality of radiopaque fiducials 31 having a known shape and size (e.g. balls or pins) arranged in a known position”); and
a mounting arm (Figure 5, element 10) having a first end fixedly connected to the radiotransparent plate (Figure 5, element 12 is the first end that connects to plate 30), a second end containing one or more fastening receptacles configured for removable connection of the sigmoid mounting arm to the retaining structure (Figure 9 shows a plurality of different ways that the bottom end of element 10 can connect to the “pin”, therefore showing that the pin is removable. See for example disclosure of Para 83).
Van Beek does not disclose a sigmoid mounting arm and a straight section orthogonal to the radiotransparent plate and fixedly connecting the first end to the second end.
However, Daon discloses tracking system that is using in a surgical monitoring setting using image processing (Abstract) and teaches a sigmoid mounting arm (Best shown in Figure 3F as arm 11) and a straight section (Annotated Figure 3F) orthogonal to the radiotransparent plate (See annotated Figure 3F that shows the orthogonal relationship between the straight section and the plate 12, see Para 9 that describes the radiotransparent material) and fixedly connecting the first end to the second end (Figure 3F the arm 11 connects plate 12 to fastening end 17).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight orthogonal section as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
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Annotated Figure 3F
Regarding claim 4, Van Beek discloses comprising one or more additional sigmoid mounting arms (Figure 11, arm 34 that connects base 10 from plate 30), each of the one or more additional sigmoid mounting arms having the section with a different respective length (Para 88; “The elongated members 26, 34 are represented by dashed lines, their shape and dimension being dependent from the intended surgical application”).
Van Beek does not disclose a straight section.
However, Daon teaches a straight section (Annotated Figure 3F).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight section as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 5, Van Beek discloses one or more additional fiducial markers (Para 63 discloses that the plate 30 can take any shape or size depending on the application), each of the one or more additional fiducial markers having a radiotransparent plate (Para 59) with a different respective predefined pattern for the embedded radiopaque elements (See examples in Figure 1, element 30 with pattern 31, Figure 4A, element 30, pattern 31, or Figure 11, element 30, pattern 31) and a sigmoid mounting arm having the section with a different respective length (Para 88; “The elongated members 26, 34 are represented by dashed lines, their shape and dimension being dependent from the intended surgical application”).
Van Beek does not disclose a straight section.
However, Daon teaches a straight section (Annotated Figure 3F).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight section as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 6, Van Beek discloses predefined pattern (Figure 5, elements 31 show a predefined pattern).
Van Beek does not disclose the predefined pattern is formed as a group of rectangles, each of the groups having a different respective ratio of sides.
However, Daon teaches the predefined pattern is formed as a group of rectangles, each of the groups having a different respective ratio of sides (Figure 3N, element 12 shows the different ratio of sides; the long end is showing around 9 groups and the short end is showing about 3 groups and Para 22 describes that the tiles can be rectangular in shape).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed rectangular pattern as taught by Daon, in the invention of Van Beek, in order to create a unique identifiable pattern for the surgical purpose (Daon; Para 22).
Regarding claim 7, Van Beek discloses predefined pattern (Figure 5, elements 31 show a predefined pattern).
Van Beek does not disclose each predefined pattern is formed as a group of polygons each of the groups comprising a different polygon.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included any shape of the pattern of Van Beek and Daon because Applicant has not disclosed that the specified shape of the pattern provide an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section IV.B. “CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS”). One of ordinary skill in the art, furthermore, would expect Van Beek and Daon’s devices to perform equally as well as the applicant’s invention in terms of detecting optical marks in predefined patterns.
Therefore, it would have been prima facie obvious to modify Van Beek and Daon to obtain the invention as specified in claim 7, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Van Beek and Daon.
Regarding claim 8, Van Beek discloses on connection of the sigmoid mounting arm to the retaining structure, the radiotransparent plate is below a region of connection of the sigmoid mounting arm to the retaining structure (Figure 11 shows plate 30 positioned below the region of connection between element 34 and 10).
Even if Van Beek does not disclose on connection of the sigmoid mounting arm to the retaining structure, the radiotransparent plate is below a region of connection of the sigmoid mounting arm to the retaining structure.
Daon teaches on connection of the sigmoid mounting arm to the retaining structure, the radiotransparent plate is below a region of connection of the sigmoid mounting arm to the retaining structure (Figure 3N, shows the plate 12 below region of connection 17).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a radiotransparent plate below a region of connection to retaining structure as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 19, Van Beek discloses the retaining structure comprises one or more studs (Figure 9B, elements 2b on either side of the pin 2) positioned to fit within the one or more fastening receptacles of the second end of the sigmoid mounting arm (Figure 9B, elements 10e on either side of the pin 2).
Regarding claim 20, Van Beek discloses the one or more studs comprises two studs (Figure 9B, elements 2b on either side of the pin 2), and the one or more fastening receptacles comprises two fastening receptacles (Figure 9B, elements 10e on either side of the pin 2).
Regarding claim 21, Van Beek discloses the second end of the sigmoid mounting arm comprises a lower plane surface (Figure 11, lower surface of element 10) that is positioned above an upper surface of the radiotransparent plate (Figure 11, lower surface of element 10 is above the upper surface of element 30).
Even if Van Beek does not disclose the second end of the sigmoid mounting arm comprises a lower plane surface that is positioned above an upper surface of the radiotransparent plate.
Daon discloses the second end of the sigmoid mounting arm comprises a lower plane surface (Figure 3N, lower surface of element 17) that is positioned above an upper surface of the radiotransparent plate (Figure 3N, lower surface of element 17 is above the upper surface of element 12).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a radiotransparent plate below a region of connection to retaining structure as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 23, Van Beek discloses the plurality of radiopaque elements comprise a plurality of radiopaque spheres (Figure 11, elements 31 are shown as spheres, see also Para 59 that states “a plurality of radiopaque fiducials 31 having a known shape and size (e.g. balls or pins) arranged in a known position”, where a ball shape is known to be a sphere).
Regarding claim 26, Van Beek discloses the sigmoid mounting arm is radiotransparent (Para 47).
Regarding claim 27, Van Beek discloses an apparatus for image guided surgery (Abstract and Para 40), the apparatus (Shown in Figure 5) comprising:
a retaining structure (Figure 5, element 2, Para 49; “percutaneous pin”) for attachment to a bone of a patient (Para 49 and Figure 5 shows the pin 2 in the spinous process); and
a fiducial marker (Figure 5, elements 30 and 31), the fiducial marker comprising:
a radiotransparent plate (Figure 5, element 30; Para 59 “registration phantom 30 is made of a radiotransparent material”) comprising a plurality of radiopaque elements embedded therein in a predefined pattern (Figure 5, element 31 and Para 59; “a plurality of radiopaque fiducials 31 having a known shape and size (e.g. balls or pins) arranged in a known position”); and
a mounting arm (Figure 5, element 10) having a first end fixedly connected to the radiotransparent plate (Figure 5, element 12 is the first end that connects to plate 30), a second end containing one or more fastening receptacles configured for removable connection of the sigmoid mounting arm to the retaining structure (Figure 9 shows a plurality of different ways that the bottom end of element 10 can connect to the “pin”, therefore showing that the pin is removable. See for example disclosure of Para 83),
Van Beek does not disclose a sigmoid mounting arm and the second end of the sigmoid mounting arm comprises a lower plane surface that is parallel to an upper surface of the radiotransparent plate and that is positioned above the upper surface of the radiotransparent plate.
However, Daon discloses tracking system that is using in a surgical monitoring setting using image processing (Abstract) and teaches a sigmoid mounting arm (Best shown in Figure 3F as arm 11) and the second end of the sigmoid mounting arm comprises a lower plane surface (Figure 3F lower plane of element 17) that is parallel to an upper surface of the radiotransparent plate and that is positioned above the upper surface of the radiotransparent plate (Figure 3F, lower plane of element 17 is parallel to upper plane of plate 12 that is above it).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a lower end of the sigmoid arm end is parallel to the radiotransparent plane as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 28, Van Beek discloses all the limitations of claim 27.
Van Beek does not disclose the sigmoid mounting arm further comprises a straight section between the first end and the second end, the straight section being orthogonal to the upper surface of the radiotransparent plate.
However, Daon teaches the sigmoid mounting arm (Best shown in Figure 3F as arm 11) further comprises a straight section between the first end and the second end (Annotated Figure 3F), the straight section being orthogonal to the upper surface of the radiotransparent plate (See annotated Figure 3F that shows the orthogonal relationship between the straight section and the plate 12, see Para 9 that describes the radiotransparent material).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a straight orthogonal section as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Regarding claim 30, Van Beek discloses the retaining structure comprises a pin (Figure 5, element 2).
Regarding claim 31, Van Beek discloses the sigmoid mounting arm is radiotransparent (Para 47).
Claim(s) 2-3, 22, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0311011 Van Beek et al., hereinafter “Van Beek”, in view of US 2015/0150641 Daon et al., hereinafter “Daon”, further in view of US 2018/0092699 Finley, hereinafter “Finley”.
Regarding claim 2, Van Beek discloses the bone comprises at least one spinous process of the patient (Figure 5 shows the pin 2 in the spinous process of a patient).
Van Beek does not disclose the retaining structure comprises a clamp, and wherein the clamp is configured to be clamped to the at least one spinous process.
However, Finley discloses a surgical navigation system (Abstract) and teaches the retaining structure comprises a clamp (Para 11 and Figure 8D, element 124), and wherein the clamp is configured to be clamped to the at least one spinous process (Para 93; “the spinal clamp 124 allow for secure and releasable attachment of the array 38, connecting the array 38 with the anatomical feature 4, such as a vertebrae, or more specifically, a spinous process”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a spinal clamp as taught by Finley, in the invention of Van Beek, in order to allow for secure and releasable attachment to the vertebrae (Finely; Para 93).
Regarding claim 3, Van Beek discloses all the limitations of claim 1.
Van Beek does not disclose the retaining structure comprises an iliac pin, and the bone comprises an ilium of the patient, and wherein the iliac pin is configured to be rigidly inserted into the ilium.
However, Finley teaches the retaining structure comprises an iliac pin (Figure 8A shows the pin 52), and the bone comprises an ilium of the patient, and wherein the iliac pin is configured to be rigidly inserted into the ilium (Para 128 discloses the retaining structure can be affixed to the iliac crest, which is part of the ilium).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a pin as taught by Finley, in the invention of Van Beek, in order to allow for secure attachment to the ilium (Finely; Para 93 and 128).
Regarding claim 22, Van Beek discloses the second end of the sigmoid mounting arm is positioned above the upper surface of the radiotransparent plate (Figure 11, the second end 10 is positioned above the upper surface of plate 30).
Even if Van Beek does not disclose the second end of the sigmoid mounting arm is positioned above the upper surface of the radiotransparent plate.
Daon teaches the second end of the sigmoid mounting arm is positioned above the upper surface of the radiotransparent plate (Figure 3N, element 17 is positioned above the upper surface of element 12).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a radiotransparent plate below a region of connection to retaining structure as taught by Daon, in the invention of Van Beek, in order to position a tracking marker in the appropriate location (Daon; Para 90).
Van Beek does not disclose plate comprises a cover at an upper side of the radiotransparent plate.
However, Finley teaches plate (Figure 5, element 38) comprises a cover at an upper side of the plate (Figure 5, element 70).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a cover as taught by Finley, in the invention of Van Beek, in order to protect the markers (Finley; Para 86).
Regarding claim 29, Van Beek discloses all the limitations of claim 27.
Van Beek does not disclose the retaining structure comprises a clamp.
However, Finley discloses a surgical navigation system (Abstract) and teaches the retaining structure comprises a clamp (Para 11 and Figure 8D, element 124).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a clamp as taught by Finley, in the invention of Van Beek, in order to allow for secure and releasable attachment to the vertebrae (Finely; Para 93).
Claim(s) 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0311011 Van Beek et al., hereinafter “Van Beek”, in view of US 2015/0150641 Daon et al., hereinafter “Daon”, further in view of US 2015/0196369 Glossop et al., hereinafter “Glossop”.
Regarding claim 24, Van Beek discloses all the limitations of claim 1.
Van Beek does not disclose the radiotransparent plate comprises a biocompatible plastic.
However, Glossop discloses fiducials cooperative with imaging modalities (Abstract) and teaches the radiotransparent plate comprises a biocompatible plastic (Para 52).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed biocompatible plastic as taught by Glossop, in the invention of Van Beek, for safe interactive with users’ tissue and bone (Glossop; Para 52-53).
Regarding claim 25, Van Beek discloses the sigmoid mounting arm comprises plastic (Para 47).
Van Beek does not disclose the sigmoid mounting arm comprises the same biocompatible plastic as the radiotransparent plate.
However, Glossop discloses fiducials cooperative with imaging modalities (Abstract) and teaches the sigmoid mounting arm comprises the same biocompatible plastic as the radiotransparent plate (Para 52; the entire casing/device shown in Figure 2 is made of the biocompatible plastic).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed biocompatible plastic as taught by Glossop, in the invention of Van Beek, for safe interactive with users’ tissue and bone (Glossop; Para 52-53).
Conclusion
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/TAMMIE K MARLEN/
Primary Examiner, Art Unit 3796
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