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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21, 23-34 and 41 are rejected under 35 U.S.C. 101 because the claimed invention, while directed to a statutory category of invention (a method or process), falls within a judicial exception thereof without reciting significantly more.
Regarding independent claim 21, The claim recites a method of planning involving steps that can be carried out as mental steps and/or with pen and paper using math. For example, the step of receiving a surgical plan can be satisfied by having the idea of how one desires the screws to be placed (e.g., position and orientation) to achieve a target curvature of the subject’s spine. Calculating a rod shape can be accomplished with pen and paper using math. Determining, using a path planning algorithm, robotic motions for inserting a rod into the heads of the plurality of screws can be satisfied by following a flowchart, protocol or mental process involving determining bending, translation and rotation motions that would need to be carried out whether manually or by a robot. Determining whether the motions (robotic or manual) fall within a predetermined threshold of acceptable insertion motion procedures comprising maximum lateral forces that insertion of the rod is predicted to exert on the subject’s tissues again can be carried out via mental steps or with pen and paper using math. This judicial exception is not integrated into a practical application because the claim does not recite any technological implementation of the planning steps. Moreover, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, for example, no particular control system and/or particular surgical bending robot is claimed.
Dependent claims 23-29 and 41 likewise can each be accomplished using mental steps and/or with pen and paper using math, without reciting significantly more, in the same manner as with independent claim 21. It is noted that dependent claim 23 recites generating instructions to cause a robot to insert the rod using the robotic motions when the robotic motions fall within the predetermined threshold of acceptable insertion motion procedures, but still does not execute the instructions and does not require a particular control system and/or particular surgical bending robot to merely generate instructions.
Regarding independent claim 30, the claim recites a method of planning involving steps that can be carried out as mental steps and/or with pen and paper using math. For example, the step of receiving a surgical plan can be satisfied by having the idea of how one desires the screws to be placed (e.g., position and orientation) to achieve a target curvature of the subject’s spine. Calculating a rod shape can be accomplished with pen and paper using math. Determining, using a path planning algorithm, robotic motions for inserting a rod into the heads of the plurality of screws can be satisfied by following a flowchart, protocol or mental process involving determining bending, translation and rotation motions that would need to be carried out whether manually or by a robot. Determining whether the motions (robotic or manual) fall within a predetermined threshold of acceptable insertion motion procedures comprising maximum lateral forces that insertion of the rod is predicted to exert on the subject’s tissues can be carried out via mental steps or with pen and paper using math. This judicial exception is not integrated into a practical application because the claims do not recite any technological implementation of the planning steps. Further, the additional step of determining at least one adjustment to the surgical plan may involve recalculating the surgical plan using mental steps or pen and paper using math. Moreover, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no particular control system and/or bending mechanism is claimed.
Dependent claims 31-34 likewise can each be accomplished using mental steps and/or with pen and paper using math and do not recite significantly more, in the same manner as with independent claim 30. It is noted that dependent claim 34 recites generating instructions to cause a robot to insert the rod using the robotic motions and the updated screw configuration and corresponding recalculated rod shape, but still does not execute the instructions and does not require a particular control system and/or particular surgical bending robot to merely generate instructions.
Double Patenting
The double patenting rejection set forth in the Office action mailed 28 August 2025 has been withdrawn in light of Applicant’s amendments to the claims adding limitations not found in U.S. Pat. No. 10,849,691.
Allowable Subject Matter
Claims 35, 37-40 and 42 are allowed.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claims 21, 23-34 and 41 in the instant application are not allowed (see rejection under 35 U.S.C. 101 above), but have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations recited in independent claims 21 and 30. In particular, none of the cited references teach or suggest a method including determining whether the robotic motions fall within a predetermined threshold of acceptable insertion motion procedures, wherein the predetermined threshold of acceptable insertion motion procedures comprises maximum lateral forces that the insertion of the rod is predicted to exert on the subject's tissues, as required by independent claims 21 and 30.
Claims 35, 37-40 and 42 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations recited in independent claim 35. In particular, none of the cited references teach or suggest a control system configured to determine whether the robotic motions fall within a predetermined threshold of acceptable insertion motion procedures, wherein the predetermined threshold of acceptable insertion motion procedures comprises maximum lateral forces that the insertion of the rod is predicted to exert on the subject's tissues, as required by independent claim 35.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments regarding the rejections under 35 U.S.C. 112 and corrective amendments are acknowledged. Accordingly, the rejections under 35 U.S.C. 112 have been withdrawn.
It is also noted that Applicant’s amendments to the claims present subject matter not found in U.S. Pat. No. 10,849,691. Therefore, the outstanding double patenting rejection has been withdrawn.
Upon further consideration, the indicated allowability of claims 22 and 33, if rewritten in independent form including all the features of the base claim and any intervening claims, as set forth in the Office action mailed 28 August 2025, has been withdrawn. The method claims are subject to new grounds of rejection under 35 U.S.C. 101, as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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