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 .
Status of Claims
Claims 21-40 are pending. Claims 21-27 are examined. Claims 28-40 remain withdrawn as being directed towards a non-elected invention.
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.
Claims 21-27 are 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.
Regarding Claim 21, line 8, “determine an orientation” is indefinite because a frame of reference is unclear. While the claim has been amended to recite “an orientation…relative to a plane of the body”, it is unclear if this plane is the previously defined “simulated first plane” (line 11), “simulated second plane” (line 11), “a plane of the body” (line 8), or a different plane. During examination, it is assumed to be the same as the line 8 “plane of the body”.
Further regarding Claim 21, two lines from the end, “the insertion angle orientation” lacks antecedent basis. Should this be “the insertion angle”?
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160235481 to Dorman (published August 18, 2016).
Regarding Claim 21, Dorman discloses an apparatus for positioning a medical device in a body (shown in Figures 3A, 7, par. 0037), the apparatus comprising:
an electronic device (apparatus 300, Figure 3A; electronic device used in steps 502, 503, 508, 509, 511 of Figure 5A) configured to display an image of at least a portion of the body adjacent to where the medical device will be positioned (as shown in Figure 7, the apparatus 300 provides real-time measurement and display of the orientation of the attached medical equipment 702, par. 0038), the electronic device comprising:
an orientation sensor (gyroscope 332, Figure 3A; step 509, Figure 5A, par. 0049); and
one or more processors (processor 350, Figure 3A) configured to:
simulate a positioning of the medical device relative to the image to determine an insertion angle of the medical device relative to a plane of the body, the insertion angle of the medical device having an orientation, wherein the simulation of the position of the medical device comprises aligning a simulated medical device between a simulated first plane of a first vertebral body and a simulated second plane of a second vertebral body (step 502, Figure 5A as shown in Figure 6C by the target 633 on the image 635, par. 0063; specifically in Figure 5B the sagittal plane in a vertebrae is used, Figure 5C the traverse plane in a vertebrae is used, and Figure 5D the coronal plane of a vertebrae is used as simulated planes for the simulated surgical hardware alignment);
determine an orientation of the electronic device relative to a plane of the body using the orientation sensor (step 509, Figure 5A; Nav mode, Figure 6D, orientation of the apparatus 300, par. 0064); and
output a notification when the orientation of the electronic device is such that the electronic device is positioned at the insertion angle/orientation of the medical device relative to the plane of the body (step 511, Figure 5A; Nav mode, Figure 6D, when the probe is within a threshold of 20 degrees from the target orientation, it changes to yellow, at 5 degrees, it changes to green, and when it is within 1 degree, a green line extends outward, par. 0064).
Regarding Claim 22, Dorman further discloses wherein the medical device is any medical hardware that includes one or more from a group that includes an interbody cage, a pedicle screw, a steel rod, a stent, a bone graft, or other implant (par. 0059, pedicle screw).
Regarding Claim 23, Dorman further discloses wherein the image of at least a portion of the body is one or more portions of the body from a group that includes a spine, a joint, a rib cage, a cranium, an artery, a lung, or other portion of the body to receive the medical device (spine is shown in at least Figure 7 as the guidance image).
Regarding Claim 24, Dorman further discloses wherein the one or more processors are configured to simulate the positioning of the medical device relative to the image by aligning at least one axis of the medical device with at least one plane of the body (as shown in Figures 5B, 5C, 5D, all three planes are utilized for the simulated positioning, i.e. transverse, coronal, sagittal planes; sagittal viewplane is shown in Figure 6C).
Regarding Claim 25, Dorman further discloses wherein the medical device is configured to be positioned between vertebral bodies (intended use of the pedicle screw implant, par. 0059).
Regarding Claim 26, Dorman does not specify that the medical device is an interbody cage. Instead, Dorman teaches pedicle screw as the implant and also suggests other instruments may be selected (par. 0059, 0069). As such, Dorman is capable of being used with an interbody cage as the medical device. Further, the system of Dorman is capable of aligning an interbody cage in the simulation to align a first side of the interbody cage with a first surface of a first vertebral body and a second side of the interbody cage opposite the first side with a second surface of a second vertebral body. For example, the user would select the desired target trajectory to be between the first and second vertebral surfaces in the transverse viewplane using the process outlined in Figure 5B. Examiner notes that the claim does not directly include the medical device as part of the claimed apparatus. Rather, the claim includes the medical device in the preamble of claim 21. As such, the claim requires an electronic device that is intended to be used with the medical device and structurally capable of being used with such medical device. However, specifying the medical device as an interbody cage does not change the structure of Dorman’s device, since it is already structurally configured for use with such an implant (similar to the pedicle screw). See MPEP 2111.02.
Regarding Claim 27, Dorman does not teach a threaded opening configured to threadedly couple to a surgical instrument. However, Dorman teaches pedicle screw as the implant and also suggests other instruments may be selected (par. 0059, 0069). As such, Dorman is capable of being used with the medical device including a threaded opening configured to threadedly couple to a surgical instrument. Examiner notes that the claim does not directly include the medical device or the surgical instrument as part of the claimed apparatus. Rather, the claim includes the medical device in the preamble of claim 21. As such, the claim requires an electronic device that is intended to be used with the medical device and structurally capable of being used with such medical device. However, specifying the medical device as having a threaded opening configured to threadedly couple to a surgical instrument does not change the structure of Dorman’s device, since it is already structurally configured for use with such a medical device (for example, to engage the pedicle screw). See MPEP 2111.02.
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 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12440279 in view of US 20160235481 to Dorman. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are narrower in scope than the instant claims and therefore necessarily anticipate the claimed invention for the claim 21 features of an orientation sensor, and processor configured to simulate, determine an orientation, and output a notification. In particular, patent claim 1 maps to instant claim 21, except for the feature of being configured to “display an image”. Dorman teaches an identical device to that claimed (as described in the USC 102 rejection above) and clearly teaches a display of image guidance (e.g. Figure 7). As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine a guidance display of Dorman in the claimed invention of 12440279 to provide an intuitive display for guiding the implant to the target location. Patent claim 5 includes a pedicle screw as the implant, thereby implicitly teaching the instant dependent claims since the context is spinal surgery. The features of the dependent claims are also taught by Dorman, as indicated in the USC 102 rejection above.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11737828. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are narrower in scope than the instant claims and therefore necessarily anticipate the claimed invention. Patent claim 1 teaches “insertion angle” instead of the instant claim “orientation”; however, “insertion angle” is a subtype of broader “orientation”. Patent claim 6 includes a pedicle screw as the implant, thereby implicitly teaching the instant dependent claims since the context is spinal surgery.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11000335 in view of US 20160235481 to Dorman. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are narrower in scope than the instant claims and therefore necessarily anticipate the claimed invention. Patent claim 1 teaches “display a representation of the bone” instead of the instant claim “image”; however, “representation of the bone” is a subtype of broader “image”. The features of the dependent claims are taught by Dorman, as indicated in the USC 102 rejection above. While patent claim 6 includes a “screw” as the implant, Dorman’s teachings make it clear this is a pedicle screw, thereby giving the context of spinal surgery lacking from the 11000335 claims.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10123840 in view of US 20160235481 to Dorman. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are narrower in scope than the instant claims and therefore necessarily anticipate the claimed invention for the claim 21 features of an orientation sensor, and processor configured to simulate, determine an orientation, and output a notification. In particular, patent claim 1 maps to instant claim 21, except for the feature of being configured to “display an image”. Dorman teaches an identical device to that claimed (as described in the USC 102 rejection above) and clearly teaches a display of image guidance (e.g. Figure 7). As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine a guidance display of Dorman in the claimed invention of 10123840 to provide an intuitive display for guiding the implant to the target location. Patent claim 8 includes a vertebra as the body location and claim 7 teaches “screw” as the implant, thereby implicitly teaching the instant dependent claims since the context is spinal surgery. The features of the dependent claims are also taught by Dorman, as indicated in the USC 102 rejection above.
Claims 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19028765 (reference application, published as US 20250160959). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are commensurate in scope than the instant claims and therefore necessarily anticipate the claimed invention. Conflicting claim 6 includes a pedicle screw as the implant, thereby implicitly teaching the instant dependent claims since the context is spinal surgery.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed April 20, 2026 have been fully considered but they are not persuasive. Applicant generally argues that Dorman does not anticipate the claimed invention and all issues are resolved by the amendments. However, specific reasoning is not provided. Examiner finds that Dorman still anticipates the claimed invention because the simulated planes alignment is performed with at least sagittal, tranverse, and coronal planes of a vertebrae in Figures 5B, 5C, 5D of Dorman. Examiner notes that the figures in Dorman are identical to the instant figures and seem to be directed towards the same invention.
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights