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
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 1-17 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.
Claims 1, 9-10 and 17 recites a method, image processing apparatus, a treatment system and a learning apparatus (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: “estimate a target object”. 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/estimation, and the Supreme Court has explicitly characterized mathematical relationships/formulas as abstract ideas (Federal Register, Vol. 79, No. 241, December 16, 2014 at 74622, column 2). 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 limitations of an “processor” for processing data, a “display” for display images and an “energy treatment instrument” for treating a living body. The additional elements are recited at a high level of generality and are recited as performing generic computer functions routinely used in computer applications. Generic computer components (processor) 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, these additional elements do 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 ultrasound probe is well-known and generic to the ultrasound 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 medical treatment or condition. It is merely processing signal 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 2-3, 5-8, 11 and 16 are merely claiming using mathematical/algorithmic function. The dependent claims do not claim any particular medical treatment or condition to be considered practical application. Thus, claims 1-17 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.
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 1-17 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. The specification does not sufficiently disclose how to estimate a target object using a learned model. A learn model is like a black box.
No art rejection.
Response to Arguments
Applicant's arguments filed 11/18/25 have been fully considered but they are not persuasive. Applicant argues the claims do not recite an abstract idea under the 2019 Revised Guidance because the amended claims cannot be performed in the human mind, the claims are not analogous to the cited case law and the claims recite operations performed during active medical treatment. Applicant’s argument is not persuasive because the claims are just claiming using images as input then use algorithm/mathematic (learning model) to estimate distal end (target object). The claims do not claim any treatment. Recite operations performed during active medical treatment such as distal end of the energy treatment, supply power to the energy treatment instrument, treatment time by the energy treatment instrument, etc. is not a positively claiming performing a treatment. Applicant argues the claims recite a practical application. Applicant’s argument is not persuasive because using images as input then use algorithm/mathematic (learning model) to estimate distal end (target object) is not a practical application. It is just an estimation/algorithmic/mathematical operation. Applicant argues the claims improve the functioning of the surgical system. Applicant’s argument is not persuasive because the improvement is not in the claim. Applicant argues the amended claims improve the functioning of endoscopic surgical systems by enabling continuous operation despite degraded visibility; the system as presently claimed solves this problem by automatically detecting turbidity, selecting appropriate learned models based on real-time instrument characteristics, estimating instrument position through the turbidity, and providing visual guidance to enable continued treatment. Applicant’s argument is not persuasive because applicant argument is not in the claim. There nothing in the claim mention improvement and treatment operation. Applicant argues examiner has cited no prior art, no technical documents, no publication that the claims elements are well-understood, routine and conventional. Applicant’s argument is not persuasive because as examiner listed that the ultrasound probe as conventional device and the prior art made of record and not relied upon is considered pertinent to applicant's disclosure disclose ultrasound probe. Further, algorithmic turbidity detection, conditional selection of machine learning models are a mathematical operations therefore the claims are being rejected under 101. Applicant argues the claims require dual-imaging system capture both visible and infrared image. Applicant’s argument is not persuasive because this is not in the claims. Applicant argues the claim solve the problem of maintaining surgical guidance during procedure that generate visibility-degrading turbidity. Applicant’s argument is not persuasive because this is not in the claims. Regarding rejection 101 of claim 10 applicant argue examiner has provided no evidence that parameterizing machine learning model for surgical tracking based on real-time electrical measurement from the instrument represents convention activity. Applicant’s argument is not persuasive because claim 10 claims a processor the process information to identify target which is an algorithmic operation without any practical application. Claim 10 is just a processor that perform algorithmic process. Examiner suggests cancel claim 10 and its dependents. Claim 10 does not integration with medical hardware during active treatment. A practical application would involve a medical device/apparatus/system and method that perform a medical treatment/procedure. Applicant argues the amended claims do not recite an abstract idea but rather recite operations that cannot be performed in the human mind, require integration with medical hardware during active treatment, and solve a problem in endoscopic surgery. Applicant’s argument is not persuasive because the claims do not claim any endoscopic surgery or treatment step.
Examiner withdraw enablement and indefinite rejection because the amended claims overcome the rejection. Applicant does not address 112 written description therefore examiner maintain 112 written description rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2022/0378514; US 2019/0254754; US 2019/0129162; US 2018/0367797; US 11/881017 (turbidity determination with machine learning) and US 11/737,434 (turbidity determination with machine learning).
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.
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, Keith Raymond can be reached at (571)270-1790. 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 3793