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 .
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 16 - 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 24 of U.S. Patent No. 11,980,506 in view of Daon et al. (US 2015/0150641) and Finley (US 2018/0092699, of record).
Claims 16, 21, 25, and 30 are suggested by reference claim 1, 10, 13, and/or 22, as the methods of the instant claims would naturally flow from normal use of the apparatus of the reference claims. However, the reference claims do not explicitly recite the limitations of the instant claims that are directed towards obtaining the offset, determining a spatial transformation/registration, and presenting a stored image of the patient aligned with the patient.
Daon discloses determining 3D location and orientation of identification markers. Daon teaches obtaining an offset (software of the monitoring system is pre-programmed with the configuration of each particularly identified fiducial key, tracking pole, and tracking marker, so that the location calculations are only changed according to the changed configuration parameters, [0090]; [0097] - [0098]), and determining a spatial transformation/registration (transformation matrix, [0075] and registration process in figs. 4A - 4C).
Finley discloses surgical navigation for spine surgery. Finley teaches in response to registration of the frames of reference, presenting to a professional performing surgery on the patient a stored image of the patient aligned with the patient (“… display different view of the surgical site…”, [0124] and figs. 21 - 22, 26 - 28, and 31 - 39).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include obtaining the offset and determining a spatial transformation/registration, as taught by Daon, in order to advance the effectiveness of surgical procedures, as suggested by Daon ([0005]).
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include presenting a stored image of the patient aligned with the patient, as taught by Finley, in order improved surgeon visualization, as suggested by Finley ([0009]).
Claims 17 and 26 are suggested by reference claim 2 and/or 15.
Claims 18 and 27 are suggested by reference claim 3 and/or 16.
Claims 19 and 28 are suggested by reference claim 4 and/or 17.
Claims 20 and 29 are suggested by reference claim 5 and/or 18.
Claims 21 and 30 are suggested by reference
Claims 22 and 31 are suggested by reference claim 12 and/or 24.
Claims 23 - 24 are suggested by reference claim 1, 10, 13, and/or 22.
Regarding claim 32, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to have the protrusion comprise a stud extending from the upper surface of the support structure, in order to facilitate attachment of the components using well-understand and conventional attachment mechanisms.
Claims 16 - 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim claims 1 - 30 of copending Application No. 18/949164 (reference application) in view of Daon et al. (US 2015/0150641) and Finley (US 2018/0092699, of record).
Claims 16, 21, 25, and 30 are suggested by reference claim 2 and/or 29, as the methods of the instant claims would naturally flow from normal use of the apparatus of the reference claims. However, the reference claims do not explicitly recite the limitations of the instant claims that are directed towards obtaining the offset, determining a spatial transformation/registration, and presenting a stored image of the patient aligned with the patient.
Daon discloses determining 3D location and orientation of identification markers. Daon teaches obtaining an offset (software of the monitoring system is pre-programmed with the configuration of each particularly identified fiducial key, tracking pole, and tracking marker, so that the location calculations are only changed according to the changed configuration parameters, [0090]; [0097] - [0098]), and determining a spatial transformation/registration (transformation matrix, [0075] and registration process in figs. 4A - 4C).
Finley discloses surgical navigation for spine surgery. Finley teaches in response to registration of the frames of reference, presenting to a professional performing surgery on the patient a stored image of the patient aligned with the patient (“… display different view of the surgical site…”, [0124] and figs. 21 - 22, 26 - 28, and 31 - 39).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include obtaining the offset and determining a spatial transformation/registration, as taught by Daon, in order to advance the effectiveness of surgical procedures, as suggested by Daon ([0005]).
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include presenting a stored image of the patient aligned with the patient, as taught by Finley, in order improved surgeon visualization, as suggested by Finley ([0009]).
Claims 17 and 26 are suggested by reference claim 26 and/or 31.
Regarding claims 18 - 19 and 27 - 28, the sigmoid mounting arm of the reference claims necessarily comprises curved and straight sections as recited, as the word “section” is not limiting in the context of the claims.
Regarding claims 20 and 29, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to have the predefined pattern have no axis of symmetry and no plane of symmetry, in order to ensure that the pose of the device may be uniquely determined from the scan data.
Regarding claims 22 and 31, the predefined pattern and the mechanical offset of the reference claims are in a one-to-one correspondence.
Claims 23 - 24 are suggested by reference claim 26 and/or 31.
Regarding claim 32, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to have the protrusion comprise a stud extending from the upper surface of the support structure, in order to facilitate attachment of the components using well-understand and conventional attachment mechanisms.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 16 and 18 - 24 are rejected under 35 U.S.C. 103 as being unpatentable over Van Beek et al. (US 2018/0311011,of record) in view of Daon et al. (US 2015/0150641) and Finley (US 2018/0092699, of record).
Regarding claim 16, Van Beek shows a method comprising:
attaching a structure (base 10, [0088] and fig. 11) to a bone of a patient (“base is fixed to the bone”, [0088]; “base is rigidly attached to the bone”, [0092] and step 101 in figs. 12 - 13);
embedding a plurality of radiopaque elements (radiopaque fiducials 31, [0059] - [0060]; [0088] and figs. 10 - 11), arranged in a predefined pattern (“known position,” [0059] - [0060]), in a radiotransparent (“registration phantom 30 is made of a radiotransparent material,” [0059]) plate (registration phantom 30, [0087] - [0088] and figs. 10 - 11);
connecting (“registration phantom is attached to the base using the reproducible fixation means,” [0093] and step 102 of figs. 12 and 13) a first end (bottom portion of elongated member 34 in fig. 11) of a sigmoid mounting arm (elongated member 34, [0088] and fig. 11) to the structure, the arm defining a second end (top portion of elongated member 34 that is connected to base 10 in fig. 11) fixedly connected to the radiotransparent plate (see this arrangement in fig. 11), and having a mechanical offset between the first end and the second end (“…elongated member 26, 34 that allows placing the and/or the registration phantom in an offset position relative to the base …”, [0088]);
fluoroscopically scanning the radiotransparent plate, the sigmoid mounting arm, and the structure to form a fluoroscopic scan (“… intraoperatively acquired fluoroscopic images”, [0003]; fluoro-navigation, [0040]; [0060]; “acquires images of the patient in the region of the bone”, [0094] and step 103 in figs. 12 - 13); and
in response to the mechanical offset and the fluoroscopic scan, determining a spatial transformation between the patient and the structure, and determining based on the offset and the spatial transformation, a registration between a frame of reference of the patient and a frame of reference of the structure (registration, [0095] - [0096]).
Van Beek fails to show obtaining the offset based on correspondence between the known mechanical offset and the predefined pattern of the plurality of radiopaque elements. Van Beek also fails to show that the structure comprises a surgical clamp. Further, Van Beek fails to show in response to the registration, presenting a stored image of the patient aligned with the patient.
Daon discloses determining 3D location and orientation of identification markers. Daon teaches obtaining an offset based on correspondence between a known mechanical offset and a predefined pattern of the plurality of radiopaque elements (software of the monitoring system is pre-programmed with the configuration of each particularly identified fiducial key, tracking pole, and tracking marker, so that the location calculations are only changed according to the changed configuration parameters, [0090]; [0097] - [0098]).
Finley discloses surgical navigation for spine surgery. Finley teaches a structure that comprises a surgical clamp (“spinous clamp 124 serves to secure the array 38 with the anatomic feature 4 by clamping onto the feature 4 and providing an interface for releasably securing the array 38,” [0096] and figs. 8D - 8E). Finley also teaches in response to the registration, presenting a stored image of the patient aligned with the patient (“… display different view of the surgical site…”, [0124] and figs. 21 - 22, 26 - 28, and 31 - 39).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Van Beek to include obtaining the offset based on correspondence between the known mechanical offset and the predefined pattern of the plurality of radiopaque elements, as taught by Daon, in order to advance the effectiveness of surgical procedures, as suggested by Daon ([0005]).
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Van Beek and Daon to have the structure comprise a surgical clamp, as taught by Finley, in order to secure the marking device to an anatomic feature by clamping onto the feature and to provide an interface for releasably securing the marking device, as suggested by Finley ([0096]), when the surgeon deems that clamping is a more appropriate attachment technique for the patient’s needs. It is noted that Finley demonstrates that spine pins and spine clamps are suitably equivalent (“spine pin or a spine clamp,” abstract, [0011]), and conventionally selected as needed by those in the art.
Further, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Van Beek and Daon to include, in response to registration of the frames of reference, presenting to a professional performing surgery on the patient a stored image of the patient aligned with the patient, as taught by Finley, in order improved surgeon visualization, as suggested by Finley ([0009]).
Regarding claim 18, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the sigmoid mounting arm comprises a first curved section connected to a second curved section by a straight section, as the elongated member 34 positions the registration phantom near the center of the imaged region, in an offset position relative to the base ([0088] and fig. 11). As a matter of logic, it follows that the elongated member 34 is not completely straight, and thus necessarily comprises at least two microscopic portions that are curved and connected therebetween by at least a microscopic portion that is straight.
Regarding claim 19, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the sigmoid mounting arm comprises a first curved section connected directly to a second curved section, as the elongated member 34 positions the registration phantom near the center of the imaged region, in an offset position relative to the base ([0088] and fig. 11). As a matter of logic, it follows that the elongated member 34 is not completely straight, and thus necessarily comprises at least a first microscopic portion that is curved and connected directly to at least a microscopic portion that is straight.
Regarding claim 20, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above.
Van Beek fails to show that the predefined pattern has no axis of symmetry and no plane of symmetry.
Daon teaches a predefined pattern that has no axis of symmetry and no plane of symmetry (asymmetry, abstract; [0079] - [0080]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Van Beek to have the predefined pattern have no axis of symmetry and no plane of symmetry, as taught by Daon, in order to ensure that the pose of the device may be uniquely determined from the scan data obtained of the surgical site with the device attached to the surgical site at the time of the scan, as suggested by Daon ([0079]).
Regarding claim 21, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above. Further, in the combined invention of the prior art, the presentation would be to a professional performing surgery on the patient.
Regarding claim 22, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the predefined pattern and the mechanical offset are in a one-to-one correspondence, at least because only one predefined pattern and mechanical offset are used at a time. Alternatively, Daon provides such a correspondence (Daon: [0090]).
Regarding claims 23 - 24, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the connecting the first end of the sigmoid mounting arm to the structure comprises engaging a lower surface of the first end of the sigmoid mounting arm with an upper surface of a support portion of the structure (see this arrangement in fig. 11), wherein the connecting the first end of the sigmoid mounting arm to the structure further comprises engaging a protrusion extending from one of the upper surface or the lower surface with a hole in the other of the upper surface or the lower surface (fixation system [0020] - [0023]; cooperating fixation means 12, 32, [0062]; “… finger 12 protruding … respective complementary opening 32 …”, [0064]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Van Beek, Daon, and Finley as applied to claim 16 above, and further in view of Onativia Bravo et al. (US 2020/0129264, of record).
Regarding claim 17, the combined invention of Van Beek, Daon, and Finley discloses the claimed invention substantially as noted above.
Van Beek fails to show that the sigmoid mounting arm is radiotransparent.
Onativia Bravo discloses a surgical clamp. Onativia Bravo teaches a sigmoid mounting arm (figs. 1A - 1B and fig. 3: a curved half of clamp 1) that is radiotransparent (“clamp can be made of carbon fiber reinforced ceramic material that has the advantage of being radiolucent,” [0024]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Van Beek, Daon, and Finley to have the sigmoid mounting arm be radiotransparent, as taught by Onativia Bravo, in order to provide the advantage of being radiolucent, as suggested by Onativia Bravo ([0024]), such as improving image quality by ensuring that the sigmoid mounting arm does not obscure the patient’s anatomy, as is understood in the art.
Claims 25, 27 - 28, and 30 - 32 are rejected under 35 U.S.C. 103 as being unpatentable over Van Beek et al. (US 2018/0311011,of record) in view of Finley (US 2018/0092699, of record).
Regarding claim 25, Van Beek shows a method comprising:
attaching a support structure (base 10, [0088] and fig. 11) to a bone of a patient (“base is fixed to the bone”, [0088]; “base is rigidly attached to the bone”, [0092] and step 101 in figs. 12 - 13), the support structure comprising an upper surface (see upper surface of base 10 in fig. 11);
connecting (“registration phantom is attached to the base using the reproducible fixation means,” [0093] and step 102 of figs. 12 and 13) a first end (bottom portion of elongated member 34 in fig. 11) of a sigmoid mounting arm (elongated member 34, [0088] and fig. 11) to the support structure, with a lower surface of the first end of the sigmoid mounting arm engaging the upper surface of the support structure (see this arrangement in fig. 11) and with at least one of the upper surface or the lower surface comprising a protrusion extending therefrom that engages a hole in the other of the upper surface or the lower surface to align the first end of the sigmoid mounting arm with the support structure (fixation system [0020] - [0023]; cooperating fixation means 12, 32, [0062]; “… finger 12 protruding … respective complementary opening 32 …”, [0064]), the sigmoid mounting arm having a second end fixedly connected to a radiotransparent (“registration phantom 30 is made of a radiotransparent material,” [0059]) plate (registration phantom 30, [0087] - [0088] and figs. 10 - 11) that comprises a plurality of radiopaque elements (radiopaque fiducials 31, [0059] - [0060]; [0088] and figs. 10 - 11) embedded therein in a predefined pattern (“known position,” [0059] - [0060]), and wherein the sigmoid mounting arm has a mechanical offset between the first end and the second end (“…elongated member 26, 34 that allows placing the and/or the registration phantom in an offset position relative to the base …”, [0088]), wherein the offset is known (i.e., at least by the manufacturer, as one non-limiting example);
fluoroscopically scanning the radiotransparent plate, the sigmoid mounting arm, and the support structure to form a fluoroscopic scan (“… intraoperatively acquired fluoroscopic images”, [0003]; fluoro-navigation, [0040]; [0060]; “acquires images of the patient in the region of the bone”, [0094] and step 103 in figs. 12 - 13); and
causing a processing system to determine a spatial transformation between the patient and the support structure to register a frame of reference of the patient with a frame of reference of the support structure (registration, [0095] - [0096]).
Van Beek fails to show that the support structure comprises a surgical clamp.
Finley discloses surgical navigation for spine surgery. Finley teaches a support structure that comprises a surgical clamp (“spinous clamp 124 serves to secure the array 38 with the anatomic feature 4 by clamping onto the feature 4 and providing an interface for releasably securing the array 38,” [0096] and figs. 8D - 8E).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Van Beek to have the support structure comprise a surgical clamp, as taught by Finley, in order to secure the marking device to an anatomic feature by clamping onto the feature and to provide an interface for releasably securing the marking device, as suggested by Finley ([0096]), when the surgeon deems that clamping is a more appropriate attachment technique for the patient’s needs. It is noted that Finley demonstrates that spine pins and spine clamps are suitably equivalent (“spine pin or a spine clamp,” abstract, [0011]), and conventionally selected as needed by those in the art.
Regarding claim 27, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the sigmoid mounting arm comprises a first curved section connected to a second curved section by a straight section, as the elongated member 34 positions the registration phantom near the center of the imaged region, in an offset position relative to the base ([0088] and fig. 11). As a matter of logic, it follows that the elongated member 34 is not completely straight, and thus necessarily comprises at least two microscopic portions that are curved and connected therebetween by at least a microscopic portion that is straight.
Regarding claim 28, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the sigmoid mounting arm comprises a first curved section connected directly to a second curved section, as the elongated member 34 positions the registration phantom near the center of the imaged region, in an offset position relative to the base ([0088] and fig. 11). As a matter of logic, it follows that the elongated member 34 is not completely straight, and thus necessarily comprises at least a first microscopic portion that is curved and connected directly to at least a microscopic portion that is straight.
Regarding claim 30, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above.
Van Beek does not explicitly discuss display, and thus fails to show in response to the registration, presenting to a professional performing surgery on the patient a stored image of the patient aligned with the patient.
Finley discloses surgical navigation for spine surgery. Finley teaches in response to a registration, presenting to a professional performing surgery on the patient a stored image of the patient aligned with the patient (“… display different view of the surgical site…”, [0124] and figs. 21 - 22, 26 - 28, and 31 - 39).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Van Beek to include, in response to the registration, presenting to a professional performing surgery on the patient a stored image of the patient aligned with the patient, as taught by Finley, in order improved surgeon visualization, as suggested by Finley ([0009]).
Regarding claim 31, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the predefined pattern and the predetermined mechanical offset are in a one-to-one correspondence, at least because only one predefined pattern and mechanical offset are used at a time.
Regarding claim 32, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above. Van Beek further shows that the protrusion comprises a stud extending from the upper surface of the support structure (fixation system [0020] - [0023]; cooperating fixation means 12, 32, [0062]; “… finger 12 protruding … respective complementary opening 32 …”, [0064]). In the combined invention of the prior art, the support structure is the clamp, as discussed above.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable Van Beek and Finley as applied to claim 25 above, and further in view of Onativia Bravo et al. (US 2020/0129264, of record).
Regarding claim 26, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above.
Van Beek fails to show that the sigmoid mounting arm is radiotransparent.
Onativia Bravo discloses a surgical clamp. Onativia Bravo teaches a sigmoid mounting arm (figs. 1A - 1B and fig. 3: a curved half of clamp 1) that is radiotransparent (“clamp can be made of carbon fiber reinforced ceramic material that has the advantage of being radiolucent,” [0024]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Van Beek and Finley to have the sigmoid mounting arm be radiotransparent, as taught by Onativia Bravo, in order to provide the advantage of being radiolucent, as suggested by Onativia Bravo ([0024]), such as improving image quality by ensuring that the sigmoid mounting arm does not obscure the patient’s anatomy, as is understood in the art.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Van Beek and Finley as applied to claim 25 above, and further in view of Daon et al. (US 2015/0150641).
Regarding claim 29, the combined invention of Van Beek and Finley discloses the claimed invention substantially as noted above.
Van Beek fails to show that the predefined pattern has no axis of symmetry and no plane of symmetry.
Daon discloses determining 3D location and orientation of identification markers. Daon teaches a predefined pattern that has no axis of symmetry and no plane of symmetry (asymmetry, abstract; [0079] - [0080]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Van Beek and Finley to have the predefined pattern have no axis of symmetry and no plane of symmetry, as taught by Daon, in order to ensure that the pose of the device may be uniquely determined from the scan data obtained of the surgical site with the device attached to the surgical site at the time of the scan, as suggested by Daon ([0079]).
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive or are moot.
Applicant's comments regarding the double patenting rejections are acknowledged. The double patenting rejections are deemed proper for reasons discussed above, and are therefore maintained.
Applicant’s arguments with respect to the art rejections have been 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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