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 .
Drawings
The drawings filed on October 30, 2024 are accepted.
Election/Restrictions
Applicant’s election without traverse of Invention 1, claims 1-13 and 19-20 in the reply filed on July 20, 2026 is acknowledged. Claims 14-18 are withdrawn. Claims 1-13 and 19-20 are under examination in this Office action.
Claim Objections
Claims 19-20 are objected to because of the following informalities:
Claim19 is identical to claim 11 and both claims depend on claim 1.
Claim 20 is identical to claim 10 and both claims depend on claim 1.
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
Claim 1: the claim limitation of “computer-readable program instructions executable by the processing unit for tracking a surgical tool…; identifying from the tracking a trigger orientation; …switching the tracking to a second mode…;…identifying a signal…;…recording surfacic data…; and generating and outputting a 3D model…” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “tracking/identifying/switching/recording/generating/outputting” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: “a processing unit” does not have structural information disclosed in the specification. For examination purpose, it is interpreted as a processor, along with the instructions/algorithm for performing the corresponding functions as described in the specification.
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim 1 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, yet neither the claim nor the specification provides the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claim 1: Claim limitation “computer-readable program instructions executable by the processing unit for tracking a surgical tool…; identifying from the tracking a trigger orientation; …switching the tracking to a second mode…;…identifying a signal…;…recording surfacic data…; and generating and outputting a 3D model…”.
The specification, PG Pub US 2025/0134594 A1, [0006], [0019], [0047], [0054], [0071] and [0072], as aforementioned, discloses the functions performed by these limitations. However, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality.
These limitations fail to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
Further because claims including a 112(f)-invoking term are interpreted as requiring the disclosed corresponding structure for that term, absent the disclosure of any such corresponding structure, the written description is insufficient to show that Applicant was in possession of the invention as claimed at the time of the invention, and such a claim must be rejected under 35 USC 112(a). (MPEP 2181.IV).
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.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph:
Claim 1: the limitations of “a processing unit”.
A claim with a 112(f)-invoking term must be construed as requiring the corresponding structure for that term, or its equivalents. Consequently, absent the disclosure of such corresponding structure, the metes and bounds of the claim cannot be determined, and the claim must be rejected under 112(b) as being indefinite. (MPEP 2181.III)
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-13 an 19-20 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.
Claim 1 recites in line 8 “identifying from the tracking a trigger orientation” that renders the scope of the claim indefinite. (1) It is unclear what object the “orientation” refers to. (2) It is unclear what the “trigger” refers to. It is unclear whether the orientation refers to an orientation that triggers some events. For examination purpose, the most technically reasonable interpretation that Examiner could make is that, the trigger orientation is interpreted to be an orientation of the surgical tool that, upon being identified, triggers a switch from the tracking mode (the first mode) to the recording mode (the second mode). However, this interpretation
Claim 1 recites in line 10 “surfacic data is ready to be recorded from the tracking”. It is unclear what object the “surfacic data” refers to. According to the specification, [0060] discloses that “the surfacic data is representative of the position and orientation of working end of the surgical tool”. Hence the claim is interpreted as that.
Claim 1 recites in line 13 “in response to said switching the tracking to the second mode, identifying a signal representative of the surgical tool being in a recording position”. It is unclear if the tracking continues after being switched to the second mode. If Yes it is unclear what the purpose of switching is (i.e., before and after switching the tracking continues anyway). If No it is unclear how, without the tracking function, the position of the surgical tool may be determined to be a recording position. Further, it is unclear whether the recording occurs prior to the mode being switched to the second mode. It is unclear that if there is no recording, how can the tracking data be reviewed in order for the trigger orientation to be identified.
Claim 1 recites in line 14 “surfacic data”. It is unclear if it refers to the same as the identical term recited in line 10.
Claim 1 recites in lines 16-17 “generating and outputting a 3D model of the anatomical feature using the surfacic data” that renders the scope of the claim indefinite. The surfacic data refers to the position and orientation of the surgical tool, and the surfacic data is recorded from the tracking. The claim does not recite that the anatomical feature participates at all in the tracking and recording. Hence the surfacic data and the anatomical feature as recited appears to be two independent features. It is hence unclear how the 3D model may be generated using the surfacic data.
Claim 8 and claim 13 recite “surfacic data”. It is unclear if they refer to the same as the identical term recited in claim 1, line 10.
Applicant is requested to clarify what is being tracked and recorded, what the surfacic data refers to, how the anatomical feature involves in the tracking and recording such that the 3D model of the anatomical feature may be generated from the tracking and the recorded surfacic data.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6-11 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gullotti et al., US 2020/0405395 A1, hereinafter Gullotti.
Claim 1. Gullotti teaches in FIG.1 a system for generating a 3D anatomical feature surface comprising:
a processing unit; and a non-transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit ([0048]: a system comprising…a processor and a memory coupled to the processor, where the memory stores instructions executed by the processor) for:
tracking a surgical tool ([0725]: an optical-tracking system that can be used in surgical navigation…which tracks tools or objects; and [0898]: each mobile component of the surgical tool that is used, requires 3D-tracking relative to each of the other components within said tool) configured for contacting an anatomical feature surface, in a first mode ([0986]: bone-mounted fiducial markers with one or more anatomical landmarks of interest, triggering of tracked mobile stray markers attached to 3D-tracked tool);
identifying from the tracking a trigger orientation ([1325]: a 3D-tracked probe registers the unique 3D location and orientation of the bone-mounted fiducial device with a probe tip that can features a complementary mating interface);
in response to the trigger orientation being identified, switching the tracking to a second mode in which surfacic data is ready to be recorded from the tracking of the surgical tool ([1325]: the 3D-tracked probe is fully mated with the female bon-mounted fiducial and the trigger button actuated the TMSM 11737 into an active state, which signals to the computer to record the current 3D location and orientation of the bone-mounted fiducial) – the fully mated orientation is the “trigger orientation” as claimed;
in response to said switching the tracking to the second mode, identifying a signal representative of the surgical tool being in a recording position ([1325]: the trigger button actuated the TMSM 11737 into an active state, which signals to the computer to record the current 3D location and orientation of the bone-mounted fiducial) – the signal to the computer upon actuating the trigger button to start the recording is the “signal representative of the surgical tool being in a recording position” as claimed;
in response of the signal being identified, recording surfacic data from the tracking of the surgical tool ([1325]: signals to the computer to record the current 3D location and orientation of the bone-mounted fiducial) – the current 3D location and orientation is the “surfacic data from the tracking of the surgical tool” as claimed; and
generating and outputting a 3D model of the anatomical feature using the surfacic data (Abstract: the systems, assemblies and/or methods can output localized anatomical analyses and therapeutic device contouring data and/or imagery on a display; [0878]: each tool is equipped with a unique tracked DRF to enable tracking of the device’s location and pose in 3D space by a 3D-tracking camera…when the assessment devices are activated, their relative 3D angles can be calculated, and projected onto anatomical reference planes. In FIG.40A, the angle between handles shown is 10 degrees, which can be displayed to a user as the maximum limit of spine flexion).
Claim 4. Gullotti further teaches that
identifying the signal includes receiving an input signal provided by a user ([0004]: at least one user-actuation trigger).
Claim 6. Gullotti further teaches that
said tracking is performed using optical tracking ([0725]: an optical-tracking system that can be used in surgical navigation…which tracks tools or objects).
Claim 7. Gullotti further teaches that
tracking the surgical tool configured for contacting an anatomical feature surface includes tracking the surgical tool configured for contacting a bone (FIGS.40 and 42).
Claim 8. Gullotti further teaches that
in response to the trigger orientation being identified, displaying graphically at least one region of at least the anatomical feature surface for which surfacic data is to be recorded (Abstract: the systems, assemblies and/or methods can output localized anatomical analyses and therapeutic device contouring data and/or imagery on a display; FIGS.4E and 4F: a sample X-ray image of a spine-fiducial pair including annotated vectors; and [0036]: the memory stores instructions executable by the processor to track 3D coordinates of one or more of trackable markers, and output on a display an anatomical imaging analysis of at least a portion of a patient, and one or more anatomical landmarks and representation of at least a portion of the assembly based on the 3D coordinates).
Claim 9. Gullotti further teaches that
displaying graphically the at least one region includes updating a graphical display as surfacic data is recorded for the at least one region (Abstract: the systems, assemblies and/or methods can output localized anatomical analyses and therapeutic device contouring data and/or imagery on a display; [0036]: the memory stores instructions executable by the processor to track 3D coordinates of one or more of trackable markers, and output on a display an anatomical imaging analysis of at least a portion of a patient, and one or more anatomical landmarks and representation of at least a portion of the assembly based on the 3D coordinates; and [0955]: once the bone-mounted fiducial is registered in both the X-ray imaging system and the 3D-tracking acquisition system, every time the user returns to register the updated location and orientation, the relative relationship between its current position and that of the prior registration are calculated and applied via a rigid transformation to calcite the most accurate location of the anatomical landmark of interest as they currently exist in relation to the fiducial marker in 3D space).
Claims 10 and 20. Gullotti further teaches that
retrieving the trigger orientation programmed in the non-transitory computer-readable memory (FIG.1 shows the software algorithm, i.e., the instructions stored in the memory and executed by the processor; [01348: a bone-mounted fiducial device with an internal protrusion is registered via a 3D-tracked probe with self-triggering mechanism that automatically activates upon fully engaging and mating with the mating features between the fiducial and the probe tip) – since the triggering is automated, the trigger orientation of fully engaging and mating is preprogrammed and stored in the memory.
Claim 11 and 19. Gullotti further teaches that
defining a referential system for the anatomical surface feature prior to said tracking ([0036]: the memory stores instructions executable by the processor to track 3D coordinates of one or more of trackable markers, and output on a display an anatomical imaging analysis of at least a portion of a patient, and one or more anatomical landmarks and representation of at least a portion of the assembly based on the 3D coordinates) – the 3D coordinates is the “referential system” as claimed.
Allowable Subject Matter
Claims 2-3, 5 and 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The reference Gullotti that the rejection to claim 1 is relied upon teaches the triggering orientation to be a fully mated orientation between the 3D-tracked probe and the fiducial marker that is mounted on the bone. Since the fiducial marker contacts the anatomy via a mounting on the bone, and the mating does not affect the mounting, there would not be a motivation to modify the configuration of Gullotti (bone-mounted fiducial marker mated with a 3D-tracked probe) to a tool that does not require the bone-mounting configuration (such that it may contact, or not contact, or have an upward orientation, it may constitute a continuous movement of the tool on the anatomical feature surface). Further, the “fully mated” orientation is the only trigger orientation for recording so there would not be or need another trigger orientation.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Soriano et al., US 2021/0361360 A1. This reference discloses a system comprises an orientation module that records an orientation of the image-capture device. The recordation may be triggered by a user such as via a button or switch direction on the tracking system. During tracking, the orientation of the image-capture device is constantly verified to identify any angular variation from the initial orientation recorded.
Li et al., US 2021/0251711 A1. This reference discloses a method and system for registration of a bone and a trackable element. It is configured to obtain a mark point information which can be obtained from a certain operation performed by a distal end of the trackable element on a surface of the bone when a switch of the trackable element meets a setting condition corresponding to the operation. The switch is configured to trigger the control device to record an information of first position of the trackable element when the trackable element performs the puncture operation at the selected point on the surface of the cartilage and when a first setting condition is met. However, it does not teach that the setting condition is associated with any trigger orientation.
Sawyer et al., US 2005/0033108 A1. This reference discloses an optical tracking system (OTS) program executed by the processor operates the surgical instrument and sensing unit to generate data indicating the location and orientation of the tip of the instrument with respect to its coordinate system. This instrument position data is produced on a real time continuous basis, so that as the surgical instrument is moved, its position and orientation are continuously tracked and recorded by the sensing unit. Position and orientation data are produced whenever a push button switch on the instrument is depressed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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