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 .
Information Disclosure Statement
An IDS has not been filed in the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of US application 63/345560 filed 5/25/2022 is acknowledged.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 recites dependency from “claim 36” and should recite “claim 16.” Appropriate correction is required.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-7 are drawn to a system comprising a robotic device and computer, so a machine.
Claims 8-19 are drawn to non-transitory computer readable medium with instructions, so a manufacture.
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s):
1. generating a first data set, the first data set comprises one or more preoperative virtual models of the target anatomy, as in claims 1 and 8.
This step can be performed by the human mind by analyzing anatomical images and generating a model with the aid of paper/pen or with an extra solution activity of displaying on a computer. The step is therefore an abstract idea.
2. calculating one or more selected surgical measurements from the one or more preoperative virtual models of the target anatomy to create a second data set, as in claims 1 and 8.
The step can be performed by the human mind by analyzing an image of an anatomical part or with math. The step is therefore an abstract idea, as in claims 1 and 8.
3. creating a preoperative plan by analyzing the one or more preoperative virtual models, as in claims 1 and 8.
This step can be performed by the human mind by planning surgery. The step is therefore an abstract idea.
Dependent claims 2-4 and 9-18 further recite analysis that is part of the abstract idea, and are therefore also a judicial exception.
Step 2A Prong Two: Consideration of Practical Application
The claims result in creating a preoperative plan by analyzing a virtual model. This is an abstract idea and not a practical application. The claims do not recite any additional elements that integrate the abstract idea into a practical application.
Instead, claim 1 recites a robotic device configured to be controlled by a computer however the abstract idea is not integrated with the control of the robotic device so as to integrate the surgical plan with, or in conjunction with, a particular machine or manufacture that is integral to the claim. The claims also do not integrate the abstract idea with administering a particular treatment, such as a particular surgery.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
1. a robotic device having a plurality of joints and actuators that is configured to be controlled by a computer, as in claim 1.
2. a computer in communication with a robotic device, as in claim 1.
3. a camera and display, as in claims 5 and 7.
4. the robotic device comprising an arm to move a guide in at least two degrees of freedom, as in claim 6.
5. a non-transitory computer readable medium with instructions, cloud storage and workstation, as in claims 8, 18 and 19.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because computer assisted robotic surgery wherein a camera images a patient anatomy or model, displays the images for the surgeon and a robotic arm that assists in the surgery is routine, conventional and well understood as of the instant filing date.
Other elements of the method include a computer to execute model analysis (claim 1) and computer readable medium to store instructions (claim 8) which are a recitation of generic computer structures that serve to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112-2nd paragraph
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.
Claim 6 is 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 pre-AIA the applicant regards as the invention.
Claim 6 recites, “said guide.” There is lack of antecedent basis for this limitation in the claim. Claim 1, from which claim 6 depends, does not recite a guide.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-9 and 14-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bleunven et al. (US 2022/0296302).
Bleunven et al. teach robotic systems for assisting a surgeon in surgical procedures (par. 0001 and 0006) including a computer-assisted robot that enhances the skill of the surgeon (par. 0008)(i.e. a robotic device and a computer in communication with said robot), as in claim 1.
Bleunven et al. teach the robotic system with joints (Figure 6), as in claim 1.
Bleunven et al. teach a computer which is a control unit as having actuators (par. 0241), however Bleunven et al. do not specifically teach that the robotic device has actuators (i.e. robotic device with actuators), as in claim 1.
Bleunven et al. teach creating a digital model of the patient from preoperative data obtained from medical imaging of the patient (par. 0003)(i.e. accessing one or more preoperative images of a targeted anatomy of a patient; generating a first data set, the first data set comprises a preoperative virtual models; the model may contain three-dimensional localizers (par. 0003)(i.e. the one or more virtual models including identification of anatomical landmarks), as in claims 1 and 8.
Bleunven et al. teach (par. 0021) calculating a transformation between a virtual referential and a target referential and a transformation between an acquisition referential of a 3D imaging sensor and the target referential by registration of a digital model of the target (i.e. preoperative virtual models of the target anatomy) with a portion of the target in the 3D image (i.e. calculating one or more surgical measurements from the preoperative virtual models of the target anatomy to create a second data set); Bleunven et al. also teach determining a “machining plan” for a surgical action such as cutting bone (par. 0134 and 0234) (i.e. calculating one or more surgical measurements from the preoperative virtual models of the target anatomy to create a second data set), as in claims 1 and 8.
Bleunven et al. teach generating a surgical plan from the digital patient model (par. 0004) and that the first step of the pre-operative surgical planning is to establish a 3D digital model of the target bones (par. 0234); Bleunven et al. teach that from the model a machining plan is prepared (par. 0134, 0234) based on machining planes P1 through P6 (i.e. creating a preoperative plan by analyzing one or more preoperative virtual models and the one or more surgical measurements), as in claims 1 and 8.
Bleunven et al. teach computer guided surgery for the navigation of a robotic system (par. 0007) and computer assisted robotic surgery (par. 0008)(i.e. wherein the robotic device is configured to be controlled by said computer), as in claim 1.
As set forth above, Bleunven et al. teach computer surgery with a computer guided robotic system. Bleunven et al. teach that the control unit which is a computer has actuators (par. 0241). Bleunven et al. do not specifically teach that the robotic device has actuators.
However it would be obvious for one of ordinary skill in the art to combine the computerized robotic system of Bleunven et al. with the actuators on the control unit also taught by Bleunven et al. Since an actuator is a machine component that converts energy into physical movement such as force, torque or displacement, one of ordinary skill would be motivated to combine the control unit with actuators with the robotic system so that the robotic system could be movement controlled by the control unit. Such is an obvious combination of known elements that would yield a predictable result.
Regarding dependent claims 1-9 and 14-19
Bleunven et al. teach creating digital representation of bones by using medical imaging such as computed tomography, X-rays, MRI, fluoroscopy, ultrasound or other imaging means (par. 0234) which suggests that the medical images are received by a computer; the patient’s “region of interest” comprising the surgical target is then registered to the digital model (par. 0173), as in claim 2.
Bleunven et al. teach a kinematic chain of imaging the surgical target (par. 0180) where 3D images of a current time step is registered with the image taken at a previous time stamp (i.e. registering a preoperative image data set with an intraoperative image data set), as in claim 3.
Bleunven et al. teach (par. 0010) markers placed on bone and surgical instruments, combined with an optical tracking system to ensure that real and digital reference points are matched knowing the exact position of bones and surgical instruments in space (i.e. define the target area relative to the virtual representation of the patient’s anatomy and register the virtual representation to the patient’s anatomy), as in claim 4.
Bleunven et al. teach a camera (par. 0103) and marker-based tracking by following the position and spatial orientation of an object between successive images of a stream (par. 0112); Bleunven et al. teach (par. 0010) an optical tracking system to ensure that real (i.e. trackable markers attached to patient’s anatomy) and digital reference points are matched, as in claim 5.
Bleunven et al. teach a robotic arm (Figure 6) with a guide that can move up/down and horizontally (i.e. as least two degrees of freedom), as in claim 6.
Bleunven et al. teach well known implementations of a display (par. 0005, 0191, 0231) in surgical procedure and operation of the surgical plan (par. 0242), as in claim 7.
Bleunven et al. teach computer readable storage medium (par. 0067) and devices for storing instructions (par. 0252 and 0253) and display (par. 0231), as in claim 9.
Bleunven et al. teach medical imaging such as CT scan, MRI, x-rays (i.e. raw images) and segmentation treatment of each image (par. 0116)(i.e. modified preoperative images), as in claim 14.
Bleunven et al. teach registering 3D images against digital model of the target which suggests that the model is 2D or 3D, as in claim 15.
Bleunven et al. teach (par. 0025-0027) image data (i.e. first data set) and defining regio of interest and registering the region of interest to the digital model of the target to define a transformation CTA (i.e. second data comprising numerical data)(par. 0027 and Figure 2), as in claim 16.
Bleunven et al. teach that each point in the digital model of the target has a known position in the target referential (par. 0174)(i.e. numerical data comprises surgical measurements), as in claim 17.
Bleunven et al. teach various storage mediums include software websites (par. 0252-0253) wherein cloud bases storage is well known to those of ordinary skill, as in claim 18.
Bleunven et al. teach navigation systems (par. 0001) and workstation navigation systems (Figure 6), as in claim 19.
Claims 10-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bleunven et al. (US 2022/0296302) as applied to claims 1-9 and 14-19 above and further in view of Goyette et al. (US 2021/0177526).
Bleunven et al. teach claims 1-9 and 14-19 as set forth above.
Bleunven et al. do not teach claims 10-13.
Goyette et al. teach computer assisted surgery of the spine (Abstract) including imaging the spine and determining a referential image (i.e. target anatomy comprises spine segment of a spine), and generating 3D models and preoperative models of the spine (par. 0031), as in claim 10.
Goyette et al. teach spine tracking in computer assisted surgery (par. 0005); Goyette et al. teach imagine the spinal column comprising a plurality of vertebrae where each vertebrae has two pedicles (par. 0029)(i.e. first and second spine segment in a spine region), as in claim 11.
Goyette et al. teach a spine column and multiple vertebrae (par. 0029) and therefore the spine regions along the spine are different, as in claim 12.
Goyette et al. teach imaging the spinal column (par. 0029) for surgery which would include the cervical, thoracic, lumbar region and sacral region (Figure 5, box including item 100/308A), as in claim 13.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Bleunven et al. for computer assisted surgical planning involving anatomical imaging, modeling and registration with the teachings of Goyette et al. for computer assisted surgery of the spine. Goyette et al. provide motivation by teaching that imaging guided surgery and navigation reduces the invasiveness of spinal surgery (par. 0003). One of skill in the art would have had a reasonable expectation of success at combining Bleunven et al. and Goyette et al. because both teach surgical imaging and modeling to assist in surgery.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-7035. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights