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 .
Specification
The amendment filed on May 29th, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the European Patent Application No. 21 212 048.9 filed on December 2nd, 2021 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of the associated PCT, which in this case is November 10th, 2022, see MPEP 1893.03(b). Therefore, the specification amendment of May 29th, 2024 to include the incorporation by reference is new matter, per MPEP 608.01(p). In order to overcome the objection, Examiner suggests that the Applicant file an amendment to their specification that removes the statement “the disclosures of which are incorporated herein by reference in their entireties”.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1 currently recites “the patient’s thorax” in line 6, but should read “a thorax of the patient”
Claim 1 currently recites “the set” in line 13, but should read “the predetermined set”
Claim 11 currently recites “the patient’s thorax” in lines 5-6, but should read “a thorax of the patient”
Claim 11 currently recites “the set” in line 12, but should read “the predetermined set”
Appropriate correction is required.
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 1-17 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.
Claim 1 recites “that set” in line 7. It is unclear as to what exactly this limitation is referring to, as Claim 1 had previously recited “at least two different sets” in line 4.
Claim 1 recites “that aortic state” in lines 11-12. It is unclear as to what exactly this limitation is referring to, as Claim 1 previously recited “a predetermined set of aortic states” in line 10.
Claim 1 recites “which surrogate model” in line 12. It is unclear as to what exactly this limitation is referring to, as it could be referring to the previously recited “surrogate model” from line 11 of Claim 1, or another surrogate model associated with “that aortic state”. Clarification is requested.
Claim 1 recites “each of which” in line 14. It is unclear as to what exactly this limitation is modifying, as it could be referring to an aortic state of the set, a similarity value, a product, or a probability function. Clarification is requested.
Claim 1 recites “a respective set” in line 15. It is unclear as to what exactly this limitation is referring to, as it could be referring to the previously recited “at least two different sets” from line 4 of Claim 1, “that set” from line 7 of Claim 1, or a separate element. Clarification is requested.
Claim 1 recites the limitation "the same set" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the highest computed similarity value" in lines 18-19. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the sensing by the jth set" in line 9. There is insufficient antecedent basis for this limitation in the claim.
The term “healthy” in claim 4 is a relative term which renders the claim indefinite. The term “healthy” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 4 recites the limitation "the aortic parameters of a healthy aortic state" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the aortic parameters of a dissected aortic state" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “a method for measuring an aortic state of a patient” in line 1. It is unclear as to whether the limitation of “an aortic state of a patient” is referring to the previously introduced “aortic state of a patient” from Claim 1, or a separate element.
Claim 11 recites “configured to receive from at least two different sets of impedance cardiography (ICG) electrodes” in lines 3-4. It is unclear as to whether the ICG electrodes are part of the claimed invention or not, as the current limitations only require that the memory receives the sensed impedance from the impedance cardiography electrodes. Examiner notes that Claim 15 later recites “A measuring system comprising the processing device according to claim 11 and said at least two different sets of ICG electrodes” in lines 1-3. Therefore, as best understood, Claim 15 seems to be reciting that the ICG electrodes as a separate component from the processing device. Clarification is requested.
Claim 11 recites “that set” in line 6. It is unclear as to what exactly this limitation is referring to, as Claim 11 had previously recited “at least two different sets” in line 3.
Claim 11 recites “that aortic state” in line 9. It is unclear as to what exactly this limitation is referring to, as Claim 11 had previously recited “a predetermined set of aortic states” in line 7.
Claim 11 recites “which surrogate model” in line 9. It is unclear as to what exactly this limitation is referring to, as it could be referring to the previously recited “surrogate model” from line 8 of Claim 11, or another surrogate model associated with “that aortic state”. Clarification is requested.
Claim 11 recites “each of which” in line 13. It is unclear as to what exactly this limitation is modifying, as it could be referring to an aortic state of the set, a similarity value, a product, or a probability function. Clarification is requested.
Claim 11 recites “a respective set” in lines 13-14. It is unclear as to what exactly this limitation is referring to, as it could be referring to the previously recited “at least two different sets” from line 3 of Claim 11, “that set” from line 6 of Claim 11, or a separate element. Clarification is requested.
Claim 11 recites the limitation "the same set" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the highest computed similarity value" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the sensing by the jth set" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the sensing by the jth set" in line 15. There is insufficient antecedent basis for this limitation in the claim.
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. Each of Claims 1-17 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-10 recite a series of steps or acts for determining an aortic state of a patient. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Claims 11-17 recite a device for determining an aortic state of a patient. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-17 recites at least one step or instruction for determining an aortic state of a patient, which is grouped as a mental process under the 2019 PEG. Both Claims 1 and 11 recite abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Determining an aortic state of the patient using similarity values are assessments that may be performed by a human. This applies for all claims dependent on claims 1 and 11.
Furthermore, Claims 1-17 recite claim limitations that constitute an abstract idea that is part of the Mathematical Concepts group. “A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of computing and determining recite mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations), and dependent claims 2, 6-7, 9, 13-14, and 16-17 clearly claim mathematical formulas and equations to fulfill the claimed computation limitations. Accordingly, each of Claims 1-17 recites an abstract idea.
Specifically, Claim 1 recites the abstract idea of “computing, by means of the processor, for each aortic state of the set, a similarity value…and determining, by means of the processor, the aortic state with the highest computed similarity values as the patient’s aortic state”. Specifically, Claim 11 recites the abstract idea of “configured to compute for each aortic state of the set, a similarity value…and to determine the aortic state with the highest computed similarity values as the patient’s aortic state”.
Examiner notes that the other steps of receiving, sensing, and storing are not part of the abstract idea. Rather, they are considered as insignificant extra-solution activity in the form of data-gathering and/or performing generic computer functions. Further, dependent Claims 2-10 and 12-17 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed. Accordingly, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 and 11 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “processing device”, “processor”, “memory”, and “impedance cardiography (ICG) electrodes” are generically recited computer elements or data-gathering elements in independent Claims 1 and 11 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1 and 11 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical concept) using rules (e.g., computer instructions) executed by a computer (e.g., “processing device”, “processor”, and “memory” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 11 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 and 11 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-17 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “processing device”, “processor”, “memory”, and “impedance cardiography (ICG) electrodes”. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks or considered data-gathering elements. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by: Applicant’s specification (e.g. paragraphs [0037]-[0042]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. computing and determining) that are well-understood, routine, and conventional activities previously known to the pertinent industry; the Applicant’s Background in the specification; and the non-patent literature of record in the application. Specifically, NPL Badeli (Badeli, Vahid, et al. "Electrode positioning to investigate the changes of the thoracic bioimpedance caused by aortic dissection–a simulation study." Journal of Electrical Bioimpedance 11.1 (2020): 38.; cited by Applicant) and NPL Mansouri (Mansouri, Sofienne, et al. "Impedance cardiography: recent applications and developments." Biomedical Research 29.19 (2018): 3542-3552.; cited by Applicant) teaches wherein ICG electrodes and their tetra-polar electrode configuration are well-understood, routine, and conventional, previously known to the pertinent industry, as they are commonly used to record thoracic impedance changes during the cardiac cycle (NPL Badeli Page 41 and NPL Mansouri Page 3542).
Accordingly, in light of Applicant’s specification, the claimed terms “processing device”, “processor”, and “memory” are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “processing device”, “processor”, “memory”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-17 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and apparatus of Claims 1-17 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-17 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 11 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-17 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of Claims 1-17 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-17 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NPL Badeli (Badeli, Vahid, et al. "Electrode positioning to investigate the changes of the thoracic bioimpedance caused by aortic dissection–a simulation study." Journal of Electrical Bioimpedance 11.1 (2020): 38.; cited by Applicant) teaches using impedance cardiography electrodes, in a tetra-polar configuration, to evaluate several cardiodynamic parameters by measuring the cardiac synchronous changes in the dynamic transthoracic electrical impedance. ICG allows for the identification and quantification of conductivity changes inside the thorax by measuring the impedance on the thorax during a cardiac cycle. Pathologic changes in the aorta, such as aortic dissection, will alter the aortic shape as well as the blood flow and consequently, the impedance cardiogram. Therefore, ICG is useful in the process of identifying aortic pathology. Results showed that the remarkable pathological changes in the aorta caused by aortic dissection alters the impedance cardiogram significantly (NPL Badeli Pages 38-46).
NPL Mansouri (Mansouri, Sofienne, et al. "Impedance cardiography: recent applications and developments." Biomedical Research 29.19 (2018): 3542-3552.; cited by Applicant) teaches wherein impedance cardiography electrodes were arranged in a four-band spot configuration in order to ameliorate and facilitate measurements to record hemodynamic parameters, using several signal processing algorithms to accurately and easily detect the main characteristic points on the ICG traces (NPL Mansouri Pages 3542-3543).
Manera et al (U.S. Publication No. 2006/0111641) teaches an impedance cardiography control system for improved performance and improved reporting of the hemodynamic parameters obtained during an Impedance Cardiography (ICG) session (Abstract), including several sets of electrodes for use on the neck and thorax of the patient, a current source, an ECG monitor, and a computer to control the operation of the system and record system parameters and hemodynamic parameters ([0008]). When the ICG control system is used, impedance waveforms, ECG Waveforms, and hemodynamic parameters are recorded continuously for each session. The parameters and/or pictorial representations are stored in a computer memory for recall, and the parameters may be recalled in formats particularly conducive to assessing and managing a patient's hemodynamic status. Since a complete ICG session or multiple ICG sessions is recorded for the patient or multiple patients in a database, the ICG control system can evaluate trends found in the ECG and ICG parameters of the patient occurring over time using a trend analysis feature ([0034]).
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/CHANEL J YOON/Examiner, Art Unit 3791
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