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, 3-10 and 12-15 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 recites a computer-implemented method (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: “determining a first measure of a flow velocity of the blood in the blood vessel of the subject using the first ultrasound data”, “determining a first measure of a diameter of the blood vessel using the first ultrasound data”, “determining a second measure of the flow velocity of the blood in the blood vessel of the subject using the second ultrasound data”, “determining a second measure of the diameter of the blood vessel using the second ultrasound data” “determining a first ratio of blood velocity to blood vessel diameter, or a correlate thereof, using the first blood velocity measure and first blood vessel diameter measure”, “determining a second ratio of blood velocity to blood vessel diameter, or a correlate thereof, using the second blood velocity measure and second blood vessel diameter measure”, deriving an index of fluid responsiveness of the subject based on a comparison between the first ratio and second ratio”. 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 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 “receiving first ultrasound data”, “receiving second ultrasound data” and “generating a data output”. 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 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. The computer just receives and generate data. 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. Receiving and generate data is well-known in the computer 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 received and generate data 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 a 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 2-15 are merely claiming using mathematical calculation, type of data and how the data are obtain. The dependent claims do not claim any particular medical treatment or condition to be considered practical application. Thus, claims 1-15 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 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, 3-10 and 12-15 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 “wherein the second control instructions are generated so as to cause the ultrasound acquisition apparatus to acquire second ultrasound data at a time determined based on the said user input;… generating second control instructions for communication to the ultrasound acquisition apparatus to cause the apparatus to acquire second ultrasound data” is unclear. Are the two second control instructions the same? It appears the claim repeat it self and it should be rewritten that combine the limitation into one limitation and using just one second control instructions. Further, “wherein the second control instructions are generated so as to cause the ultrasound acquisition apparatus to acquire second ultrasound data at a time determined based on the said user input” should be “wherein a second control instructions are generated…” because “the second control instructions are generated” lack antecedent basis. Limitation “deriving an index of fluid responsiveness of the subject based on one of a third ratio of the first ratio to the second ratio and a difference between the first and second ratio” is unclear. Is applicant trying to claim the third ratio is determine by calculating a difference between the first and second ratio? Is deriving index of fluid responsiveness of the subject based on a difference between the first and second ratio?
No art rejection
Response to Arguments
Applicant's arguments filed 06/15/26 have been fully considered but they are not persuasive. Applicant argues claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, such as when the human mind is not equipped to perform the claim limitations. Applicant’s argument is not persuasive because measurements of diameter and flow velocity can be done with paper, pencil and in human mind. Also determine the ratio and determine the difference between the first and second ratio can be done in the human mind. All the steps of generating instructions to acquire ultrasound data are generic computer steps. Applicant argues amended claim 1 provide an improvement to the technological field of assessing fluid responsiveness in critically ill patients in for example cardio-genic shock or hemorrhagic shock. Applicant claim 1 does not claim assessing fluid responsiveness in critically ill patients in for example cardio-genic shock or hemorrhagic shock. Calculate the difference between the first and second ratio and generate output indicative of the index of fluid responsiveness does not tie to any practical medical application or tie to any improvement to any practical medical application. Index of fluid responsiveness is not a practical medical field. Applicant need to tie the index of fluid responsiveness to a practical medical condition/problem/field.
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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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