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 .
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 1-20 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) determining, using a computational processing system, a PCWP measurement from the blood pressure measurement from the wedge position; and determining, using the computational processing system, a quality assessment for the PCWP measurement using a machine-learning model configured to provide a quality assessment for the PCWP measurement based on the blood pressure measurement acquired from the pulmonary artery position and the blood pressure measurement acquired from the wedge position.
The abstract idea is part of the Mathematical Concepts and Mental Process group(s) identified in the Ninth Edition, Revision 10.2019 (revised June 2020) of the Manual of Patent Examination Procedure (MPEP). This judicial exception is not integrated into a practical application because they amount to simply implementing the abstract idea on a computer; data-gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity; there is no improvement to a computer or other technology; does not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition; does not apply the abstract idea with, or by use of, a particular machine. The additional elements are identified as follows: a computational processing system (processor, display and memory) and a pulmonary artery catheter with inflatable balloon. The claim(s) does/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 a whole, do not amount to significantly more than the abstract idea. The additional computer and data-gathering elements, which are recited at a high level of generality, provide conventional computer and data-gathering functions that do not add meaningful limitations to practicing the abstract idea.
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 Johnson et al. (Room for improvement in pulmonary capillary wedge pressure reporting: a review of hemodynamic tracings at a large academic medical center; Pulmonary Circulation 2020; 10(4) 1–7) as well as Schlesinger et al. (A Deep Learning Model for Inferring Elevated Pulmonary Capillary Wedge Pressures From the 12-Lead Electrocardiogram; JACC:ADVANCES, VOL. 1, NO. 1, 2022 MARCH 2022) as well as Bootsma et al. (The contemporary pulmonary artery catheter. Part 1: placement and waveform analysis; Journal of Clinical Monitoring and Computing (2022) 36:5–15) as well as Fetanat et al. (Fully Elman Neural Network: A Novel Deep Recurrent Neural Network Optimized by an Improved Harris Hawks Algorithm for Classification of Pulmonary Arterial Wedge Pressure; IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 69, NO. 5, MAY 2022) Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
When considered in combination, the additional elements (generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. The Federal Circuit has held that combining additional elements for data-gathering with abstract ideas does not make a claim patent-eligible. Looking at the claim limitations as a whole 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.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data gathering that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known data-gathering equipment/functions is not significantly more than the abstract idea.
Allowable Subject Matter
Claim 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior arts of record (Boostma; Fetanat and Garrett et al. (US 2020/0205739 A1)) teach the combination of a pulmonary artery catheter, a computational processing system and a quality assessment but fail to specifically teach determining a quality assessment for a PCWP measurement using a machine learning algorithm based on blood pressure measures acquired from both the pulmonary artery position as well as the wedge position. None of the prior art considered, alone or in combination, teaches that particular feature combined with the other limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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, Jennifer Robertson can be reached at 571-272-5001. 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.
JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
Prosecution Insights