DETAILED ACTION
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: image acquisition device, spatial registration portion, object separation portion, path generating portion, and coordinate determining portion in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
Referring to the specifications as filed, the image acquisition device corresponds to pg. 18 “The 2D image may be obtained by the 2D image acquisition device, for example, a so-called C-arm device having an X-ray source and a detector”, and the spatial registration portion, object separation portion, path generating portion, and coordinate determining portion correspond to Fig. 17 & pg. 18 “a spatial registration portion, an object separation portion, a path generating portion, and a coordinate determining portion may be functionally included in the devices described above, and the spatial registration portion, etc. may be included in the navigation system 400”. The navigation system 400 is interpreted as a computer.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1 and 8 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.
Claims 1 and 8 recite “a target point or terminating point…”. It is unclear whether “target point” and “terminating point” refer to different points or to the same point. As written, it seems as though the “target point” and “terminating point” are different/alternate points. However, the specification on pg. 15 wherein “FIG. 14 shows a set coordinate of a target point T or a terminating point of a surgical screw on the screw path on the y-z plane” seems to describe these points as the same point. Appropriate correction is required.
Claims 1 and 8 recites the limitation "an entry point and a target point" as features located in the second image: "...determining a 3D coordinate for insertion of a surgical screw in the surgical space by setting, based on the first screw path, an entry point and a target point ... on a second screw path corresponding to the first screw path, in the second pedicle region of the second image."
Claims 3-5 (each depending from claim 1), and claims 10-12 (each depending from claim 8) then refer to "the entry point" and "the target point" as if they were antecedently established as features of the first image: Claim 3: "...the entry point is located on or adjacent to the outer edge of the first pedicle region, and the target point is located within the first vertebral body region.”
The specification (e.g., p. 12-15, operations S6-S7, Figs. 10-14) makes clear that the applicant intends the entry point (E) and target point (T) to be calculated first on the first-image y-z plane (as coordinates E(y,z) and T(y,z)) and only afterward projected into the second image to obtain the missing x-coordinate. But claim 1 and 8, the sole antecedent basis available to claims 3-5 and 10-12, locates "an entry point and a target point" exclusively "in the second pedicle region of the second image." Claim 1 and 8 never establishes an entry point or target point in the first image at all.
The result is that claims 3-5 and 10-12 depend on and purport to further limit "the entry point" and "the target point" of claim 1 and 8, yet describe those same points as being located in regions (first pedicle region outer edge; first vertebral body region) that claim 1 and 8 never associates with them. The examiner cannot determine with reasonable certainty whether: (i) claims 3-5 and 10-12 are describing the same entry/target point recited in claim 1 and 8 (in which case claim 1/8 and claim 3/10 directly contradict each other as to where that point is located, e.g. second image vs. first image), or (ii) claims 3-5 and 10-12 are silently introducing a new, different first-image entry/target point with no antecedent basis of its own, or (iii) claim 1 and 8 are missing an intervening step (locating a first entry/target point on the first screw path) that the specification discloses but the claim omits.
Claim 2 and 9 compounds the problem, as it introduces "a screw entry point and a screw target point" set "on the first screw path" using the indefinite article, suggesting new claim elements, and in the very same sentence refers back to "the entry point or the target point in the first image" using the definite article, as though these had already been established. It is unclear whether the claim's "the entry point... in the first image" refers to (a) the newly-introduced "screw entry point" of the claims itself, or (b) the entry point of claim 1 and 8 (which claim 1 and 8 places in the second image, not the first).
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) limitations that fall under the grouping of abstract idea of “Certain Methods of Organizing Human Activity”, e.g. Concepts Relating To Managing Human Behavior (Step 2A, Prong One) ,“Mental Processes”, e.g. concepts performed in the human mind (such as observation, evaluation and judgement) and “Mathematical Concepts”, such as mathematical relationships and algorithms (step 2A, prong one). The claim limitations merely recite various steps of human activity. Specifically, the claim recites steps can be performed in the human mind or with pen and paper such as acquiring images, defining a 3D space, extracting regions, setting screw paths, and recites the mathematical concept of computing a trajectory (a line in 3D space) from geometric relationships among segmented regions in two images.
Under step 2A, prong two, this judicial exception is not integrated into a practical application. The claim merely recite generic hardware in support of the abstract idea without reciting any specific improvements to computer functionality or a particular technological solution. The components recited such as the image acquisition device and “portions” of claim 8 are described at a high level without technological specificity or unconventional architecture. Thus, the claims are direct to an abstract idea implemented on a generic computing system.
Critically, independent claims 1 and 8 both terminate at the calculation of a 3D coordinate: "determining a 3D coordinate for insertion of a surgical screw in the surgical space" (claim 1) / "a coordinate determining portion configured to determine a 3D coordinate for insertion of a screw" (claim 8). Neither independent claim recites any step that uses that coordinate, e.g., displaying it as an overlay for navigation, transmitting it to a robot controller, driving a robot arm or end effector to the coordinate, or otherwise causing a physical result. This is analogous to the "collecting information, analyzing it, and displaying certain results of the collection and analysis" pattern held ineligible in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016), and to SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161 (Fed. Cir. 2018) (claims to selecting, manipulating, and mathematically transforming data, without more, are not saved by a specific mathematical technique). While the specification's system embodiment (Fig. 17; spec pp. 18–19) discloses a robot arm, controller, and navigation display that use the surgical plan, these elements are not recited in independent claims 1 or 8, and thus cannot support eligibility of those claims as presently drafted.
Under step 2B, the claims does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d). The claims do not include an inventive concept that is sufficient to transform the abstract idea into a patent-eligible application.
The dependent claims are also rejected under 35 U.S.C. 101 for the same reasons as discussed above. Claims 2-5 merely further define the mathematical and geometric relationships used to determine the entry point, target point, and screw path. These limitations refine the abstract mathematical determinations recited in claim 1 by specifying particular geometric constraints and placement of points, but do not integrate the judicial exception into a practical application or amount to significantly more than the abstract idea.
Claims 6-7 and 17-20 recite additional limitations of calculating an angle based on detecting the posture of an image acquisition portion using an optical tracking system, and registering images using the calculated angle, but this merely add data gathering and additional mathematical processing to the abstract idea recited in claim 1. These limitations constitute insignificant extra-solution activity and do not improve the functioning of the optical tracking system or any other technology.
Claims 8-12 recites the abstract idea in the form of a system comprising an image acquisition device, registration portion, object separation portion, path generating portion, and coordinate determining portion merely implements the same abstract mathematical determinations using generic computing components. The additional limitations do not integrate the judicial exception into a practical application or provide significantly more than the abstract idea. Claims 13-16 recite additional limitations of utilizing an optical tracking system to calculate an acquisition angle and register images using the calculated angle, but this merely add data collection and mathematical processing to the abstract idea implemented by the system of claim 8. These additional elements do not improve the functioning of the optical tracking system, the image acquisition device, or any other technology, and therefore do not amount to significantly more than the judicial exception.
Examiner’s Comments
The Office has established numerous rejections under 35 U.S.C. 112(a) and/or 35 U.S.C. 112(b) and/or 35 U.S.C. 101 with regard to claims 1-20. The scope of claims 1-20 cannot be determined because of the identified issues presented above. The numerous rejections to claims 1-20 under 35 U.S.C. 112(a) and/or 35 U.S.C. 112(b) render applicant's claims as being so incomprehensible as to preclude a reasonably detailed search of the prior art by the examiner. The examiner has attempted to identify all grounds for rejection under35 U.S.C. 112(a) and/or 35 U.S.C. 112(b). However, the number of issues with regard to claims 1-20 is so numerous that the scope of the claims cannot be ascertained. The examiner suggests that the applicant carefully review the claims in order to fix any and all issues that have and have not been highlighted by this office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN KY whose telephone number is (571)272-7648. The examiner can normally be reached Monday-Friday 9-5PM.
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/KEVIN KY/ Primary Examiner, Art Unit 2671
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