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. On page 1, the status of copending applications, which have since issued as patents, must be updated.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because it appears to be incomplete, i.e. does not end in a period.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12167870.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claim of the present application and the patented claims is that the patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claim of the present application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claim of the present application are anticipated by the patented claims, it is not patentably distinct from the patented claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable claim 13 of U.S. Patent No. 11376045.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claim of the present application and the patented claims is that the patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claim of the present application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claim of the present application are anticipated by the patented claims, it is not patentably distinct from the patented claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The preamble of claim 1 recites “..intra-operatively assessing and adjusting a patient..” However, the body of the claim does not recite how the steps enable assessing and adjusting the patient. Claim 1 also appears to be incomplete (see claim objection in this Office Action).
In claim 1, the recitation “determining a target value for a patient which represents a desired clinical outcome..” renders the claim vague and indefinite because it is unclear what the target value is and how it represents a desired clinical outcome. Applicant’s disclosure describes “target spinal parameter measurements may then be optionally adjusted the [sic] user in accordance with a surgical plan.” It is suggested that Applicant use alternate language, for e.g. “determining target values of pelvic incidence angle and sacral slope to enable surgical correction of the patient’s spine.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Foley et al. (US RE42226) in view of Peultier et al. (US 20140249591 A1).
Foley et al. disclose a method for use during spinal deformity correction including the steps of:
displaying a medical image of the patient in a first position on a screen (col. 6, lines 18-53: “A computer assisted image-guided surgery system, indicated generally at 10, generates an image for display on a monitor 106 representing the position of one or more body elements, such as spinal elements fixedly held in a stabilizing frame or device such as a spinal surgery frame 125 commonly used for spinal surgery.” “The system includes an apparatus such as a digitizer or other Position Sensing Unit (PSU), such as for example sensor array 110 on support 112 for identifying, during the procedure, the relative position of each of the reference points to be displayed by tracking the position of emitters 122 on arc 120. The system also includes a processor 114 such as a PC or other suitable workstation processor associated with controller 108 for modifying the image data set according to the identified relative position of each of the reference points during the procedure, as identified by digitizer 110. The processor 114 can then, for example, generate an image data set representing the position of the body elements during the procedure for display on monitor 106.”).
receiving user input of known points on the displayed medical image (col. 9, lines 61-67 and col. 10, lines 1-28: “On the image 105 provided by monitor 106, the surgeon can see the clamp 30 or screw 42 and fiducial array 170 and also the additional screws 250, wires 260 or other imageable devices. When screws 250 or other devices are used, these screws 250 (as depicted in FIG. 7) may contain a divot 256 or other specially shaped interface on the head 255 so that a pointer probe 130 can be used to point to the head 255 of the screw 250 (or wire) and indicate the orientation of the screw 250 or wire 260 to the surgical navigation system by communicating to the controller 114 or by emission from LEDs 195 on probe 130 to digitizer 110. The image of these additional screws 250 also appear in the scan. Once the patient is then moved to the operating facility, rather than the scanning area, the image of the screw 250 can be compared to the actual position of the screw 250 as indicated by the pointer probe 130 that is touched to the head 255 of the screw 250 or wire 260. If necessary, the operator can manipulate the position of the patient to move the spinal element and thus the location of the screw 250 or wire 260 to realign the spinal elements with the earlier image of the spine. Alternatively, the operator can manipulate the image mean to correspond to the current position of the spinal segments.”).
Foley et al. disclose manipulation of spinal segments utilizing image-guided technology during the spinal procedure. Foley et al. disclose a method that enables a user to change the position of spinal vertebrae segments and provide a method to realign the spinal vertebrae (Figs. 1 and 1A and cols. 6-11).
Foley et al. disclose all elements of the claimed invention except for: 1) determining a pelvic incidence angle (PI) of the patient; 2) measuring a sacral slope (SS) of the patient from the displayed medical image: and 3) comparing the spinal parameters (pelvic incidence angle and sacral slope) with desired values (desired clinical outcome) during the spinal surgical procedure.
It is well known to use a pelvic goniometer to measure the pelvic incidence and the sacral slope corresponding to a measured pelvic incidence wherein correcting lumbar lordosis includes an angle of pelvic incidence plus 10 degrees (target value), as evidenced by Peultier et al. Peultier et al. also disclose the pelvic goniometer to be configured to measure the parameters pelvic incidence and sacral slope on medical imaging and provide various instrumentation to correct a spinal deformity (paras [0019]-[0020] and [0077]-[0079]).
It would have been obvious to one having ordinary skill in the art to have utilized measurements of the pelvic incidence angle and sacral slope while executing the method steps disclosed by Foley, as taught by Peultier et al., since it was well known to use these parameters to control and adjust the type of correction applied during treatment of a spinal deformity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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February 5, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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