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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 06/16/26 is acknowledged.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 recites a system (Step 1: Yes). In this case, the judicial exception relied upon by the instantly claimed invention is an abstract idea (Step 2A: Yes), and the limitation(s) that set(s) forth or describe(s) the abstract idea(s) is/are: “generate an average surgical corridor based on the…” and “generate a model indicative of the average surgical corridor…”. The reason(s) that the limitation(s) are considered an abstract idea is because they are directed to functionally-described algorithmic processes that require performing mathematical calculations, and the Supreme Court has explicitly characterized mathematical relationships/formulas/calculation as abstract ideas (Federal Register, Vol. 79, No. 241, December 16, 2014 at 74622, column 2). The claim is basically just a processor that perform some calculations. The instantly claimed invention is also similar to claims already found to be directed to an abstract idea and patent ineligible. See at least the following court decisions:
• SmartGene, Inc. v Advanced Biological Labs., 555 Fed. Appx. 950 (Fed. Cir. 2014), directed to systems, methods and computer program products for guiding the selection of therapeutic treatment regimens (ineligible)
• TLI Communications LLC v. A. V. Automotive, LLC (Fed. Cir. May 17, 2016) directed to generalized steps for recording, administration and archiving of digital images, and classifying and storing digital images in an organized manner (ineligible)
• Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)., directed to a method of non-invasive prenatal diagnosis (ineligible)
• Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014), directed to methods of payment of intellectual property royalties by interposed sponsor over a telecommunications network (ineligible)
• Digitech Image Techs., LLC v Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014), drawn to device profiles for use in a digital image processing system (ineligible)
The claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The claim recites the additional limitation of a “processor” for receiving query and running instructions. The claim also recites the additional limitation of a “display” for displaying the model. The additional element is recited at a high level of generality and are recited as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Thus, taken alone, this additional element does not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. The processor is well-known and generic to the computational field. For prong 1 of Step 2A the claim is an abstract idea as stated above. For prong 2 of Step 2A, the claims do not integrate into practical application because the claims do not claim any particular improvement to a medical application. It is merely some calculation, generating or computation using a computer.
With regards to the instantly rejected dependent claim(s), these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. For example, claims 2-10 are merely claiming more calculation and some generic components. The dependent claims do not claim any particular medical treatment or condition to be considered practical application. Thus, claims 1-10 as a whole do not amount to significantly more than the exception itself (Step 2B: No).
Applicant is reminded that additional steps/elements may be enough to qualify as “significantly more” if they meaningfully limit the judicial exception, improve the technology or technical field, improve the functioning of a computer itself, or add a specific limitation other than what is well-understood, routine, conventional activity in the field or unconventional steps that confine the claim to a particular useful application.
For additional guidance, applicant is directed generally to MPEP 2106 and to the USPTO's Guidance on Subject Matter Eligibility (October 2019 Update). This information can be found at: http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0.
Examiner suggests amend claim 1 to include claims 2 and 8 claim a complete medical system that perform specific transformative steps of medical application to overcome 101 abstract rejection. The claims need to include applicant specific inventive steps that perform the medical application in order to overcome abstract idea.
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 6-10 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. Limitation “generate an average surgical corridor based on the plurality of selected datasets, wherein each selected dataset of the plurality of datasets includes a set of measured data points indicative of a shape of a surgical corridor” is unclear because there is no meet and bound define for “a set of measured data point”. As see in Fig. 3, elements 210 to 250 generate average surgical corridor using very specific data point such as translate data from first 3d coordinate system to standardized second 3d coordinate system, corridor intersection points and equidistant radial vector. The claim does not limit the type of data point. Not every set of data points are used to generate average surgical corridor as see in Fig. 3. The data sets are being perform on by a series of steps and certain points are chosen to generate an average surgical corridor.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et al. (US 2016/0070436).
Addressing claim 1, Thomas discloses a system, comprising:
a processor in communication with a memory, the memory including instructions, which, when executed, cause the processor to: receive, at a user interface in communication with the processor, a query including procedural information and patient-specific information regarding a procedure to be performed (see Figs. 1, 5, abstract and [0015]; receiving inputs of procedural information and patient-specific information such as images; procedural information are brain surgery);
identify a plurality of selected datasets of a plurality of datasets stored within a database in communication with the processor based on the procedural information and the patient-specific information (see [0090], [0093] and Fig. 5; select features (selected datasets) from patient specific pre-operation 3D images; define region, define targets, identify engagement points are selected datasets for brain surgery procedure)
generate an average surgical corridor based on the plurality of selected datasets, wherein each selected dataset of the plurality of datasets includes a set of measured data points indicative of a shape of a surgical corridor (see [0091], [0093] and [0116]; register with average image and generate surgical path with average damage is the average surgical corridor;
generate a model indicative of the average surgical corridor (see Figs. 1, 5 and [0179]; create brain model, surgical tool model then generate surgical path and export to navigation system is a model);
display, at a display device, the model indicative of the average surgical corridor with respect to patient imaging (see [0021]).
Addressing claims 6-10, Thomas discloses:
addressing claim 6, wherein the memory includes instructions, which, when executed, further cause the processor to: align, at the processor, the model indicative of the average surgical corridor over patient imaging (see [0134], [0206] and Figs. 8-10; display virtual surgical tool with entry point and surgical path to target over patient image).
addressing claim 7, wherein the memory includes instructions, which, when executed, further cause the processor to: generate, at the processor, a 3D model indicative of the average surgical corridor (see [0058]; surgical path on a 3d image/space is the 3d model of average surgical corridor).
addressing claim 8, an image-guided surgical planning system in operative communication with the display device and the processor and/or the memory, the image-guided surgical planning system being configured to: receive one or more parameters of the average surgical corridor as input; and display, at the display device, the model indicative of the average surgical corridor over patient imaging, wherein the model is indicative of a volumetric trajectory of a surgical approach (see abstract, [0134], [0206] and Figs. 2, 6, 8-10; planning, navigation and simulation system that generate surgical paths using images is the image-guided surgical planning system; display virtual surgical tool with entry point and surgical path to target over patient image).
address claim 9, a stereotactic navigation system in operative communication with the display device and the processor and/or the memory, the stereotactic navigation system being configured to: receive one or more parameters of the average surgical corridor as input; and display, at the display device, the model indicative of the average surgical corridor over patient imaging, wherein the model is indicative of a volumetric trajectory of a surgical approach (see abstract, [0134], [0206] and Figs. 2, 6, 8-10; stereotactic is relating to techniques for surgical treatment that permit the accurate position of probes inside the brain; the planning, navigation and simulation system; the guidance system 11 is the stereotactic navigation system that provide simulate surgical path to accurately position surgical tool inside the brain).
addressing claim 10, a robotic surgical system in operative communication with the display device and the processor and/or the memory, the robotic surgical system being configured to: receive the model of the average surgical corridor as input, the model being indicative of a volumetric trajectory of a surgical approach (see abstract, [0134], [0185], [0187], [0206] and Figs. 2, 6, 8-10; especially [0185] and [0187]; robotic system perform surgery using simulated surgical path in 3d space; surgical path in 3d space is volumetric trajectory of a surgical approach).
No art rejection for claims 2-5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
Prosecution Insights