DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-18 are pending.
Claims 19-20 are cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Response to Arguments
Applicant’s argument has been fully considered but it is moot in light of a new ground of rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 10-11, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg et al. (US 20200405399 A1, 2020-12-31) (hereinafter “Steinberg”) in view of McDonald et al. (US 20140148816 A1, 2014-05-29) (hereinafter “McDonald”).
Regarding claims 1, 3, 10-11, 14, and 18-20, Steinberg teaches A surgical robotic system, comprising: a robotic arm including a surgical instrument coupled thereto (e.g., [0016], [0386]-[0387]); a computer configured to calculate port placement locations based on an image of a patient and a type of procedure to be performed ([0017]-[0022]); and a printing device configured to print a template of the port placement locations on a transparent substrate for placement on the patient based on the port placement locations calculated by the computer (e.g., Figs. 5A-5D, [0248]-[0262]) (as recited in claim 1); wherein at least a portion of an underside of the transparent substrate includes an adhesive layer for adhering the transparent substrate to the patient (e.g., [0050], [0244]) (as recited in claim 3); further comprising capturing the image of the patient with an imaging device (as recited in claim 11); wherein printing the template of the port placement locations on the transparent substrate includes printing the template of the port placement locations on a transparent film having an adhesive disposed on an underside thereof (as recited in claim 14); a surgical accessory for aiding in access port placement, the surgical accessory comprising: a transparent substrate formed from a polyester film; an adhesive layer disposed on a tissue contacting surface of the transparent substrate; and at least one marking designating access port insertion disposed on the transparent substrate (as recited in claim 18).
Note that Steinberg teaches the following:
Steinberg teaches computer-guided insertion of surgical tools (via “ports”) into different anatomical parts of a patient. See, e.g., [0237] (“. . . the term “tool” should be interpreted as including any tool or implant that is inserted into any portion of the skeletal anatomy during a procedure that is performed upon the skeletal anatomy.”); [0572] (“For some applications, the navigation systems comprise the use of augmented reality, or virtual reality, or robotic manipulation of tools, or any combination thereof.”) Note that claim 1 recites “the port placement locations [are] calculated by the computer.” This limitation is construed simply as computer-guided insertions given the context of the previous limitation (i.e., “a computer configured to calculate port placement locations based on an image of a patient and a type of procedure to be performed . . . ”). In other words, the claim is not narrowly construed to mean that the template themselves (e.g., their shapes) are calculated/generated by the computer based on calculated port placement locations.
Steinberg teaches placing a template (or marker) directly on a patient. See, e.g., [0244] (“Typically, sets 50 of markers 52 are attached, e.g., by an adhesive disposed on a surface of the marker, e.g., an adhesive disposed on support 53, to a surface of the subject in a vicinity of a site, e.g., skeletal portion, at which an intervention is to be performed, and such that at least some of the markers appear in 2D radiographic images that are acquired of the intervention site from typical imaging views for such an intervention. For example, for a procedure that is performed on the subject's vertebra(e) and particularly within one or more vertebral bodies, the markers are typically placed on the subject's back in a vicinity of the site of the spinal intervention, such that at least some of the markers appear in 2D radiographic images that are acquired of the intervention site from AP imaging views, and potentially from additional imaging views as well. For some applications, the markers are placed on the subject's side in a vicinity of the site of the spinal intervention, such that at least some of the markers appear in 2D radiographic images that are acquired of the intervention site from a lateral imaging view. For some applications, the markers are placed on the subject's back, such that at least some of the markers are level with the subject's sacrum.”).
Steinberg also teaches printing such templates (or markers) on a substrate. See, e.g., [0250] (“Typically, such foldable arrangement also facilitates manufacturing the markers by printing radiopaque ink on support 53, e.g., a flat surface or sheet.”); [0251] (“For some applications, such as is shown in FIG. 5B, radiopaque marker set 50 comprises elements that may be converted (for example by folding) from 2D (for example a flat printed marker) to 3D such that in the 3D form an element is identifiable concurrently from multiple angles.”).
Steinberg also teaches that the markers themselves may be radiopaque or radio-transparent. See, e.g., [0297] (“It is noted that in FIG. 8B the alphanumeric markers appear as white in the image. In general, the markers may appear as generally white or generally black, depending on (a) the contrast settings of the image (e.g., do radiopaque portions appear as white on a black background, or vice versa), and (b) whether the markers are themselves radiopaque, or the markers constitute cut-outs from a radiopaque backing material, as is the case, in accordance with some applications of the present invention.”). Note that for the transparent case, the marker just is the (radio-)transparent substrate (i.e., cut-out).
Because Steinberg teaches (1), (2), (3), and (4), Steinberg teaches a printing device configured to print a
template of the port placement locations (3) on a transparent substrate (4) for placement on the patient (2)
based on the port placement locations calculated by the computer (1).
Note further that Steinberg teaches usage of markers or modules that is patient-specific and/or treatment-specific. See, e.g., [0257] (“For some applications, a first marker set 50a and a second marker set 50b are each modular. For example, a marker in the form of a notched ruler, may comprise several ruler-like modules. Typically, the number of modules to be actually applied to the subject's body is related to the overall size of the subject, to the location of the targeted vertebra(e) relative to the anatomical reference point (e.g., sacrum) at which placement of the marker sets begins, or to a combination thereof. For example, a target vertebra in the lumbar spine may require one module, a target vertebra in the lower thoracic spine may require two modules, a target vertebra in the upper thoracic spine may require three modules, etc.”); [0259] (“For some applications, the sets of markers as shown in FIG. 5C are used in open-surgery procedures where a large central incision is made along the applicable portion of the spine. For such procedures, a relatively large central window is required for performing the procedure between the two sets of markers. For some applications, the sets of markers as shown in FIG. 5C are used in less invasive, or minimally invasive, surgery as well.”). See also, e.g., [0261]-[0272].
McDonald teaches determining and indicating patient-specific port placement. See, e.g., [0009]-[0012].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of McDonald with the invention taught by Steinberg such that the invention further comprises a printing device configured to print a patient-specific template of the port placement locations on a transparent substrate for placement on the patient, wherein the printing device is configured to print the template subsequent to the computer calculating the port placement locations (as recited in claim 1); a method for mapping port placement locations comprising: calculating port placement locations based on an image of a patient and a type of procedure to be performed; and printing a template of the port placement locations on a transparent substrate for placement on the patient based on the port placement locations calculated (as recited in claim 10); wherein the at least one marking corresponds to a port placement location calculated based on an image of a patient (as recited in claim 18) in order to ensure that the port placement locations are accurate for a specific patient.
Claims 2, 4-7, 12, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg in view of McDonald.
Regarding claims 2, 4-7, 12, 13, and 15, Steinberg does not teach the specific limitations recited in the claims. However, Steinberg teaches distinctive and identifiable markers that are easily manufacturable and robust (e.g., [0243]-[0244], [0246]-[0252]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate what is well known in the art at the time of the invention with the invention taught by Steinberg such that wherein the transparent substrate is a polyester film (as recited in claim 2); wherein the printing device is configured to print the template of port placement locations on the transparent substrate by engraving the port placement locations through the transparent substrate (as recited in claim 4); further comprising a transparent substrate configured to be engraved by the printing device, wherein the transparent substrate includes at least one preformed cutout extending through a thickness thereof (as recited in claim 5); wherein the template of port placement locations printed on the transparent substrate includes port placement locations designated for at least one of a right arm, a left arm, a reserve arm, and a camera arm (as recited in claim 6); further comprising an imaging device configured to capture an image of the patient (as recited in claim 7); wherein printing the template of the port placement locations on the transparent substrate includes engraving the port placement locations through the transparent substrate (as recited in claim 12); wherein printing the template of the port placement locations on the transparent substrate includes printing the template of the port placement locations on a polyester film (as recited in claim 13); wherein printing the template of the port placement locations on the transparent substrate includes printing port placement locations designated for at least one of a right arm, a left arm, a reserve arm, and a camera arm wherein printing the template of the port placement locations on the transparent substrate includes printing the template of the port placement locations on a transparent film having an adhesive disposed on an underside thereof (as recited in claim 15) in order to improve the usability of the invention for a particular surgical procedure.
Claims 8-9 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg in view of McDonald, and further in view of Goldman et al. (US 20150305673 A1, 2015-10-29) (hereinafter “Goldman”).
Regarding claims 8-9 and 16-17, Steinberg does not teach use of a projector. Goldman teaches use of a projector (e.g., [0100]-[0101], [0168]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate teachings of Goldman with the invention taught by Steinberg (in view of McDonald) such that further comprising a projector configured to project a projection of the template of port placement locations on the patient (as recited in claim 8); wherein the projector is adjustable to resize or move the projection of the template of port placement locations on the patient (as recited in claim 9); further comprising projecting an image of the template of the port placement locations on the patient using a projector (as recited in claim 16); further comprising adjusting the projector to resize or move the image of the template of the port placement locations (as recited in claim 17) in order to minimize the intrusiveness of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792