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 .
Response to Arguments
Applicant has cancelled Claim 2 and therefore the 35 USC 101 rejection as applied in the Non-Final Rejection dated 9/23/2025 no longer applies.
Applicant's arguments filed 1/20/2026 with respect to the 35 USC 112(a) and 102 rejections have been fully considered but they are not persuasive.
Regarding the 35 USC 112(a) rejection of Claims 5, 11-14, 17 and 18, Applicant argues:
“The Examiner's position effectively imposes an ‘algorithm disclosure’ requirement that is not demanded by 12(a) for claim language of this type. In particular, claim 5 does not invoke means-plus-function treatment under §112(f), and therefore the Applicant is not required to provide a specific step-by-step algorithm or source code implementation in order to demonstrate possession of the claimed ‘numerical model.’”
The Examiner respectfully disagrees. MPEP §2161.01 discusses computer implemented inventions and is not solely limited to means-plus-function limitations under §112(f) as argued. The limitations of claims 5, 11-14, 17 and 18 are concerned with a “central processing unit” that “generates a numerical model”, and the use of that model to control the potion and/or orientation of the laser cutting device. In other words, Applicant is claiming a computer implemented function that generates a model and uses that model for device control. As noted in MPEP §2161.01, “Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. “ The Examiner maintains Applicant has not provided sufficient detail regarding how the model operates or how he data disclose din the specification is particularly used/organized to create said model (see par. [0120, 0126, 0131, 0136] of PGPBU 2024/0225730, which is the publication of the present application.)
Applicant further argues “Moreover, the generation of such numerical models from known categories of data is well within the ordinary skill in the art, and the corresponding algorithms form part of the state of the art and are therefore routine and conventional for the skilled person.” First, the Examiner notes, “ It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)”, MPEP §2161.01. Secondly, the Examiner notes that a generic numerical model is not being claimed here. Applicant is claiming a specific model that describes the shape of the empty inner space; coordinates of the first plurality of fiducial markers with respect to the reference coordinate system and the relationship of coordinates and orientation between the empty inner space of the main body of the surgical access port and the first plurality of fiducial markers; and the coordinates of the second plurality of fiducial markers. The rejection is maintained.
Applicant’s arguments regarding the 35 USC 102 rejection have been considered and are not persuasive. The added features of a third plurality of fiducial markers having a fixing element configured to be affixed to the patient is disclosed by Richmond et al. (2018/0055578). Specifically, Richmond discloses applying tracking markers to the patient (such as over the head, torso etc. to establish safety zones (par. [0076]).
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.
Claims 5, 11-14, 17 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding computer-implemented functional limitations, MPEP §2161.01 states:
“Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
Claim 5 includes the processor implemented function of “generat[ing] a numerical model”. However, the claims and specification only provide the types of data used to create the model but fail to provide any particular details or algorithms indicating how the model operates or how this data is particular used/organized to create said model (see par. [0120, 0126, 0131, 0136] of PGPUB 2024/0225730, which is the publication of the present application.). Accordingly, Claim 5 lacks adequate written description support of the claimed numerical model.
Claims 11-14, 17 and 18 are rejected due to their dependence on Claim 5.
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 3-18 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 3, as amended, include the limitation “a surgical access port according suitable for surgical interventions…” (emphasis added). The meaning of this is unclear. The Examiner suggests amending the claim to remove the word “according”.
Claim 3 recites the limitation "”a main body…open at the ends of the tubular conduit”. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending the claim to read “open at ends of the tubular conduit.”
Claim 3 recites the limitation "”a tracking device adapted for establishing the three-dimensional pose…”. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending the claim to read “establishing a three-dimensional pose.”
Claim 3 recites the limitation "”determining at least the three-dimensional pose of the empty inner space…”. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending the claim to read “determining at least a three-dimensional pose…”.
Claim 3 recites the limitation "the tracking device is further adapted for establishing the three-dimensional pose…for tracking the movements of the patient”. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending the claim to read “”…establishing a three-dimensional pose…for tracking movements of the patient.”
Claims 4-18 are rejected due to their dependence on indefinite claim 3.
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 (i.e., changing from AIA to pre-AIA ) 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 3-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Richmond et al. (2018/0055578).
Regarding Claims 3, 6, 7 and 11, Richmond discloses a surgical access port 100 having a main body configured having a cylindrical conduit with an empty inner space therein and open at the ends of the tubular conduit (Fig. 4E, 6A; par. [0038]); and a first plurality of fiducial markers 206 (two of the four markers shown) spaced from one another and fixed to the main body in a rigid manner (Fig. 4E; par. [0061]). Richmond further discloses a tracking device 113 that obtains 3D coordinates; registers these coordinates within a common coordinate frame and stores the spatial position and pose of the port as well as a desired position of an end effector and automated robotic arm with respect to the port and stores this information in memory (par. [0058-0061]). Additionally, Richmond discloses using the tracking data to align the robotic arm and end effector with the port such that the end effector is aligned with the center of the port to have direct access to the surgical site at the bottom of the port (par. [0130-0140]) and notes the end effecter can be a laser ablation device for excising tissue(par. [0040-0042]). Lastly, Richmond discloses using a third set of fiducial markers affixable to the patient (such as over the head or torso) to establish safety zones and control the system to avoid entering into or cutting within the establish safety zones (pat. [0076]).
In regard to Claim 4, Richmond discloses four fiducial markers 206, wherein two of them could be considered a first plurality of markers and the other two could be considered the second plurality of markers (Fig. 4E). Richmond discloses the tracking device 113 that obtains 3D coordinates from each plurality of markers 206 ; registers these coordinates within a common coordinate frame and stores the spatial position and pose of the port as well as a desired position of an end effector and automated robotic arm with respect to the port and stores this information in memory (par. [0058-0061]).
With regard to Claims 5 and 12-14, Richmond discloses providing numerical data/relationships of the port; its dimensions; and it’s relative spatial position and pose to the robotic arm and end effector by using the fiducial markers 206 (Fig. 8B; par. [0091-0095]).
In regard to Claim 8, Richmond discloses the surgical robot has a viewing optic, such as a wide field camera or other imaging instruments in addition to the laser ablation device (par. [0042, 0100]).
Regarding Claim 9, Richmond discloses the device tracking is continuous and in real-time (par. [0093]).
In regard to Claim 10, Richmond discloses the positioning/orientation can also be intermittent, such as on-demand (par. [0087, 0091] and also implicitly disclosed by “if…the imaging sensor is to be continuously… in par. [0093]).
With regard to Claims 15-18, Richmond discloses two sets of three fiducial parkers associated with the surgical port (see 815) and another set of markers used for tracking movement of the patient (see 805 in Fig. 8B), wherein the tracking system accounts for end effector movement and position; port pose and position and patient pose and position (Fig. 8B; par. [0091-0095]).
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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