DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 05/04/26 have been fully considered but they are not persuasive.
On pages 9-10 Applicant argues drawings need not show the claimed subject matter because it would not be necessary for understanding the subject matter. Applicant argues figure 2 shows a plot with cross-hairs, and so a person of ordinary skill would understand “the center of the cross-hair alignment guide corresponding to the implant plan, the angular reference planes being associated with the azimuth and elevation differences, the global references, the direction of gravity, and the direction of a user accessing the alignment guide”. Applicant also argues that since figure 6 has a text representation of the step of displaying cross-hair alignment guides, all the claimed subject matter need not be shown.
The Examiner respectfully disagrees and notes that a text box and a generic display of cross-hairs are not sufficient to show all the missing features of the claim, which must be shown in order to understand the invention properly.
On pages 10-11 regarding 112a rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully disagrees, noting amendments have not removed the new matter from the claims. This is accordingly maintained.
On pages 11-12 regarding 112b rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully agrees and withdraws the 112b rejections of record.
On pages 12-13 Applicant argues Greenan fails to teach the centers of the cross-hair alignment guide as conveying specific angular difference information as claim 21 requires.
The Examiner respectfully points out that this argument appears to analyze Greenan alone, as opposed to modifying Sati in view of Greenan. Sati already teaches tracking the planned location and orientation of the prosthetic component. Greenan is simply provided to indicate it is known within implant tracking to track via cross-hair alignment guides.
Further, on page 13, Applicant argues Howard teaches concentric rings as opposed to cross-hair alignment guides.
The Examiner respectfully points out again that Applicant is analyzing Howard alone, as opposed to within the context of the rejection. The other prior art teaches those elements Applicant indicates is missing, making this argument unpersuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. See MPEP 2145(IV).
On page 14 Applicant argues further that the differences between the implant positioning device and implant would not be seen within the Combination.
The Examiner respectfully disagrees, pointing out again that Sati already teaches this limitation, making this argument unpersuasive.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the center of the cross-hair alignment guide corresponding to the planned location and orientation of the prosthetic acetabular cup, the angular reference planes being associated with the azimuth and elevation differences, the global references, the direction of gravity, and the direction of a user accessing the alignment guide must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21, 23, 43-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 is rejected for claiming “a center of the cross-hair alignment guide corresponds to the planned location and orientation of the prosthetic acetabular cup” but this is considered to be new matter. The originally filed description (specification [0077]) states that “a cross-hair alignment display can correspond to the azimuth and elevation of the implant positioning device in a spherical coordinate system” which is “aligned to the implant plan”, but this differs in many ways to what is claimed. The specification also states that the “center of the XY plot corresponds to the implant plan”, but this is also distinct from what is claimed. This is accordingly new matter.
Remaining claims are rejected for depending on a claim with new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21, 23, 43-44 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sati et al. (US 20050203384 A1) hereinafter known as Sati in view of Pedicini (US 20130161050 A1), and further in view of Greenan et al. (US 20080171934 A1) hereinafter known as Greenan and Howard (US 5585813 A).
Regarding claim 21, Sati discloses a method of positioning an implant comprising:
attaching a first tracking marker to anatomy of an implant host ([0030] positions of the patient is monitored by a plurality of positional sensors or patient trackers);
attaching a second tracking marker to an implant positioning device ([0033] position and orientation of the operative instruments are monitored with positional sensors; [0026] the medical practitioner places the implants using the instruments)
identifying, by a tracking device, a first location of the first tracker ([0030] the location of the patient is displayed on images to allow real-time tracking);
identifying, by the tracking device, a second location of the second marker ([0033] the position of the instrument is tracked virtually represented by images while performing the procedure);
obtaining, by a control device in operable communication with the tracking device (27), an implant plan for positioning a prosthetic acetabular cup ([0059]) attached to the positioning device into an acetabulum of the implant host ([0063] the acetabular cup is guided to gain access to the acetabulum; [0026] the medical practitioner places the implant using the instruments), wherein the plan comprises a virtual implant host model and a planned location and planned orientation of the cup within the implant host ([0012]; [0039] the optimum position and configuration of the images are maneuvered; [0030] the images (models) on screen are displayed throughout surgery ([0055]) and both position and orientation are also displayed);
registering, by the control device, the implant host and implant positioning device within a coordinate system based on the identified first and second locations ([0037], [0029]);
aligning, by the control device, the virtual implant host model with the registered implant host ([0030]-[0031]);
generating, by the control device, a visualization based on the registration, wherein the visualization comprises the virtual implant host model, an indication of the planned location and orientation, and a representation of the cup ([0036]-[0039], [0048]),
wherein the representation of the cup is located in the visualization based on the identified second location ([0033] position of the operative instruments are monitored with positional sensors; [0026] the medical practitioner places the implants using the instruments; [0063] the acetabular cup is guided by the instrument which places the implant and has the sensors); and
outputting, by the control device, the visualization to a display device to facilitate implantation of the cup ([0027], [0012]),
but is silent with regards to the implant positioning device including one or more actuators and a positioning arm with a proximal fixed portion and a distal moveable portion coupled to an end effector,
the implant being attached to the end effector,
and the actuators on the distal moveable portion imparting linear motion to implant the implant,
and the control device generating the cross-hair alignment guide, and the alignment guide being indicative of azimuth and elevation differences in the implant positioning device and the implant plan, the center of the alignment guide corresponding to the planned location and orientation of the prosthetic acetabular cup.
However, regarding claim 21 Pedicini teaches an implant positioning device (abstract: orthopedic impacting tool; [0048] force is directed to adapter 1 which is attached to the prosthesis) which comprises one or more actuators (Figure 1 item 8) and a positioning arm having a proximal fixed portion (e.g. the right half of the device of Figure 1) and a distal moveable portion (e.g. a left half of the device of Figure 1 that includes moveable part 24) coupled to an end effector (1),
the end effector attached to an implant ([0048] the adapter 1 is attached to the implant),
to facilitate implantation of the implant via linear motion ([0010]) imparted by one or more actuators on the distal moveable portion ([0042]). Sati and Pedicini are involved in the same field of endeavor, namely implanting orthopedic implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Sati by utilizing an implant positioning device as is taught by Pedicini, since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C).
Further, regarding claim 21 Greenan teaches that a cross-hair alignment guide can be generated in a visualization by a control device based on a location of an implant, tool, or part of the body, wherein the cross-hair alignment guide comprises two dimensions indicative of differences ([0066]-[0067], Figure 5 shows the center of the guide “corresponding” to the display of the implant plan.), and Howard teaches alignment guides in two dimensions can be indicative of azimuth and elevation differences between two objects (Column 1 lines 21-26; Column 2 lines 1-10; Column 4 line 65 – Column 5 line 8). Sati, Greenan, and Howard are involved in the same field of endeavor, namely surgical or implant positioning. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Sati Pedicini Combination so that the control device generates a cross-hair alignment guide based on the location of either the implant, implantation tools, or the person into which the implant is located as is taught by Greenan, and into any known coordinate system as is taught by Howard, in order to help the implanting physician with alignment of the various elements during implantation. As regards the center of the alignment guide corresponding to the planned location and orientation of the prosthetic acetabular cup, the Examiner notes that when the Sati Pedcini Combination is modified in view of Greenan, which teaches the use of the cross-hair alignment guide, the person of ordinary skill would understand that the planned location and orientation (as is already discussed as being displayed by Sati [0036]-[0039], [0048]), should correspond to the center of the cross-hairs, since this is the accepted way that cross-hair alignment guides are intended to work, with the center indicating the target.
Regarding claim 23, the Sati Pedicini Greenan Howard Combination teaches the method of claim 21 substantially as is claimed,
wherein Sati further discloses the visualization further comprises a 3d representation of the implant host, implant positioning device, and the cup, wherein the 3d representation provides real-time feedback to assist with alignment of the cup with the implant host ([0030], [0033], [0036], [0055], [0029], [0038] the Examiner notes that the 3d image is presented to the processor, which illustrates the implant host, positioning device (and other devices), and implants where the 3d image is transferred to a 3d image before it provides real-time feedback to the physician).
Regarding claim 43, the Sati Pedicini Greenan Howard Combination teaches the method of claim 21 substantially as is claimed,
wherein Howard further teaches angular reference planes associated with the azimuth and elevation differences are aligned to global references (Column 2 lines 1-10).
Regarding claim 44, the Sati Pedicini Greenan Howard Combination teaches the method of claim 43 substantially as is claimed,
wherein Howard further teaches the global references are one of: a direction of gravity or a facing direction of a user accessing the cross-hair alignment guide (Column 2 lines 1-5).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/13/26
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