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 .
Response to Arguments
Regarding the amendment to overcome the 35USC112(f) interpretations, the Examiner suggests amending the claims back to their original format. These were properly invoked and changing them does not mitigate the other related issues in which the Examiner will address now. The majority of the previous 35USC112(a)’s are withdrawn. The Examiner believes that the specification has sufficient disclosure for most of the “unit”’s at issue. The Examiner still is concerned whether or not the “stroke volume calculation unit…” has sufficient disclosure. There appears to not be sufficient disclosure of the “stroke volume calculation module”. The Applicant argues “…calculate[ing]… has been finally verified” which does not appear to describe anything about the algorithm, only that data is inputted. Please note for comparison, the stroke volume calculation model gives specifics to an error range and recalculating when an error range is met.
Regarding the arguments to the 35USC112(b) rejections, the arguments and amendments are persuasive in overcoming the 35USC112(b) rejections.
Regarding the arguments to the 35USC102 and 103 rejections, the arguments and amendments are persuasive in overcoming the rejections.
Applicant's arguments filed against the 35USC101 rejection have been fully considered but they are not persuasive.
The applicant argues that the data processing of the APCO and TDCO results in an improvement in how stroke volume is calculated from arterial blood pressure waveform data. Firstly, the improvement is solely within the judicial exception as there is nothing practically done with the data processing. Secondly, the argument that the various limitations cannot be performed mentally or are not mathematical calculations comes down to the disclosure which appears to admit that at least some of the processes are well known algorithms that are used conventionally or lacks the specific disclosure (e.g. in the instance of how the stroke volume is calculated). This also comes down to the metes and bounds of the claim. The applicant argues that the function is performed in real time however the claim does not include such a limitation. Further, how quickly is real time under BRI (i.e. every second, minute, hour, day?). It is noted that the data gathering may take place and the processing could be performed later. Further, mathematical abstract ideas are not subject to mental processing, so any potential mathematical formula/algorithm used is not subject to such constraints. Applicant is further arguing that the claims are integrated into practical application. This appears to not be the case since the claims merely calculate a value as is admitted by the applicant. It is also reiterated how the stroke volume is achieved is not disclosed by the applicant. Finally, regarding the arguments directed towards step 2B, the arguments are directed towards the signal processing of self-admitted conventional and commercially available equipment (general purpose computer performing machine learning, APCO equipment, and TDCO equipment). Applicant argues that the signal processing performed on the conventional equipment is new. However, under step 2B, the only question is whether or not the combination of additional elements were well understood, routine, and conventional. Applicant further argues that the process is improved which is an argument under step 2A, prong 2. The Examiner re-asserts that the improvement cannot be solely within the judicial exception.
Applicant should clearly point out the algorithm that governs the calculation of the stroke volume to overcome the 112(a) rejection and further look to examples 47-49 to help overcome the 35USC101 rejection.
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.
Claims 1-7 and 9-15 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 amendments to all of the “unit”’s previously claimed (e.g. filtering unit [Wingdings font/0xE0] filter) are instances of new matter. For example, a filter is not in the disclosure. Applicant should return the claims to that format.
Regarding claims 1 and 9, the “stroke volume calculation unit/calculator” appears to lack sufficient disclosure in the specification. The specification does not convey possession of an algorithm because the specification supplies no formula, algorithmic steps to achieve such algorithm and associated result. See MPEP § 2161.01(I).
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 1-7 and 9-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s):
configured to pre-train a first stroke volume calculation model which calculates a stroke volume based on the arterial blood pressure value, by using third data filtered from the first data;
to transfer learn the first stroke volume calculation model, which, by using fourth data filtered from the second data, thus to generate a second stroke volume calculation model;
to extract arterial blood pressure values and corresponding stroke volumes from a predetermined time before a first time point to the first time point, from each of the first data and the second data, wherein the first time point is a time point where the change of the stroke volume waveform reaches or exceeds a predetermined slope value.
These limitations describe a mathematical calculation and/or recite a mental process as the skilled artisan is capable of looking at the obtained data and making a mental assessment thereafter or with the aid of a pen and paper.
This judicial exception is not integrated into a practical application because the additional elements (e.g. implied computer/processor, APCO equipment, and TDCO equipment) do not integrate the judicial exception into practical application. The equipment/sensors are generic sensing elements that fall into the category of insignificant extra solution activity because they’re merely gathering data. The generally recited computer does not integrate into practical application do not improve the functioning of the computer or any other technological field.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following reasons.
These claims require the additional elements of a filtering unit, a pretrainer, a transfer learner, a stroke volume calculator, a data storage, a data extractor, a data verifier, a data processor, a stroke volume calculator, arterial pressure-based cardiac output equipment, and thermodilution-based cardiac output (TDCO) equipment as recited in independent Claims 1 and 9 and their dependent claims.
The above-identified additional elements are generically claimed computer or machine components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. 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.
The arterial pressure-based cardiac output equipment is functionally described without detailed structure or drawings to calculate the stroke volume as a more accurate value using the arterial blood pressure of the specific patient measured by existing commercial equipment (Paragraph 38, thus admitting conventionality); the thermodilution cardiac output equipment is described to include a catheter (Paragraph 2) with an example being Vigilance II of Edwards Lifesciences (Paragraph 97).
The recitation of the above-identified additional limitations in Claims 1-7 and 9-15 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.
For at least the above reasons, the system and method of Claims 1-7 and 9-15 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 1-7 and 9-15 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.
The dependent claims further limit the abstract idea and/or add additional elements that are well understood-routine, and conventional.
Therefore, none of the Claims 1-7 and 9-15 amounts to significantly more than the abstract
idea itself. Accordingly, Claims 1-7 and 9-15 are not patent eligible and rejected under 35 U.S.C.
101.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX M VALVIS whose telephone number is (571)272-4233. The examiner can normally be reached 9:00-5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ALEX M. VALVIS
Supervisory Patent Examiner
Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791