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
Election/Restrictions
Applicant’s election without traverse of Group I readable on Claims 1-6, 11-13, 23, 26-32 and 35-38 in the reply filed on 05 January 2026 is acknowledged.
Claims 40, 61 and 62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 January 2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 September 2023, 05 January 2024, 20 February 2024 and 05 January 2026 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-6, 11-13, 23, 26-32 and 35-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1 (and dependent claims 2-6, 11-13, 23, 26-32 and 35-38) recite “A method for calibrating at least one solid-state sensor coupled to an elongate body comprising an expandable member, the method comprising: advancing the expandable member to a target location in a blood vessel of a patient; injecting a fluid calibration bolus into the expandable member; obtaining, using a controller, a first sensor data from an expandable member sensor, the first sensor data representing pressure in the expandable member; obtaining, using the controller, a second sensor data from the at least one solid-state sensor; and adjusting the second sensor data based on the first sensor data.”
Claims 1-6, 11-13, 23, 26-32 and 35-38, in view of the claim limitations, recite the abstract idea of “advancing the expandable member to a target location in a blood vessel of a patient; injecting a fluid calibration bolus into the expandable member; obtaining, using a controller, a first sensor data from an expandable member sensor, the first sensor data representing pressure in the expandable member; obtaining, using the controller, a second sensor data from the at least one solid-state sensor; and adjusting the second sensor data based on the first sensor data.”
As a whole, in view of the claim limitations, but for the computer components and systems performing the claimed functions, the broadest reasonable interpretation of the recited “advancing the expandable member to a target location in a blood vessel of a patient; injecting a fluid calibration bolus into the expandable member; obtaining, using a controller, a first sensor data from an expandable member sensor, the first sensor data representing pressure in the expandable member; obtaining, using the controller, a second sensor data from the at least one solid-state sensor; and adjusting the second sensor data based on the first sensor data.”; therefore, the claims recite mental processes. Accordingly, the claims recite a mental process, and thus, the claims recite an abstract idea under the first prong of Step 2A.
This judicial exception is not integrated into a practical application under the second prong of Step 2A. In particular, the claims recite the additional elements beyond the recited abstract idea of“[a] computer- implemented method” and “the method is carried out by one or more physical processors configured by machine-readable instructions” as recited in claim 1, individually and when viewed as an ordered combination, and pursuant to the broadest reasonable interpretation, each of the additional elements are computing elements recited at high level of generality implementing the abstract idea on a computer (i.e. apply it), and thus, are no more than applying the abstract idea with generic computer components. Moreover, aside from the aforementioned additional elements, the remaining elements of dependent claims 2-6, 11-13, 23, 26-32 and 35-38 do not integrate the abstract idea into a practical application because these claims merely recite further limitations that provide no more than simply narrowing the recited abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception under Step 2B. As noted above, the aforementioned additional elements beyond the recited abstract idea, as an order combination, are no more than mere instructions to implement the idea using generic computer components (i.e. apply it), and further, generally link the abstract idea to a field of use, which is not sufficient to amount to significantly more than an abstract idea; therefore, the additional elements are not sufficient to amount to significantly more than an abstract idea. Additionally, these recitations as an ordered combination, simply append the abstract idea to recitations of generic computer structure performing generic computer functions that are well-understood, routine, and conventional in the field as evinced by Applicant’s Specification at [0159] (describing that the disclosure is not limited to the disclosed implementations, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims). Furthermore, as an ordered combination, these elements amount to generic computer components performing repetitive calculations, receiving or transmitting data over a network, which, as held by the courts, are well-understood, routine, and conventional. See MPEP 2106.05(d); July 2015 Update, p. 7. Moreover, aside from the aforementioned additional elements, the remaining elements of dependent claims 2-6, 11-13, 23, 26-32 and 35-38 do not transform the recited abstract idea into a patent eligible invention because these claims merely recite further limitations that provide no more than simply narrowing the recited abstract idea. Looking at these limitations as an ordered combination adds nothing additional that is sufficient to amount to significantly more than the recited abstract idea because they simply provide instructions to use a generic arrangement of generic computer components and recitations of generic computer structure that perform well-understood, routine, and conventional computer functions that are used to “apply” the recited abstract idea. Thus, the elements of the claims, considered both individually and as an ordered combination, are not sufficient to ensure that the claim as a whole amounts to significantly more than the abstract idea itself. Since there are no limitations in these claims that transform the exception into a patent eligible application such that these claims amount to significantly more than the exception itself, claims 1-6, 11-13, 23, 26-32 and 35-38 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 11-13, 23, 26-32 and 35-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al (US 2020/0046364).
Johnson et al disclose the following claimed features:
Regarding claim 1, a method (Figures 1 and 2) for calibrating at least one solid-state sensor (300) coupled to an elongate body (catheter) comprising an expandable member (200), the method comprising: advancing the expandable member (200) to a target location in a blood vessel of a patient (paragraph [0056]); injecting (408) a fluid calibration bolus into the expandable member (paragraphs [0061], [0063]); obtaining, using a controller (400), a first sensor data from an expandable member sensor, the first sensor data representing pressure in the expandable member; obtaining, using the controller (400), a second sensor data from the at least one solid-state sensor (paragraphs [0046], [0047]); and adjusting the second sensor data based on the first sensor data (paragraphs [0046], [0047]).
Regarding claim 2, wherein adjusting the second sensor data comprises shifting at least one of a calibration curve and a calibration constant of the at least one solid-state sensor (paragraphs [0046], [0047]).
Regarding claim 3, wherein adjusting the second sensor data further comprises: determining a first mean of the first sensor data; determining a second mean of the second sensor data; and adjusting the second mean based on the first mean (Figures 11A-11C).
Regarding claim 4, wherein the first sensor data includes a first waveform and the second sensor data includes a second waveform, and wherein adjusting the second sensor data comprises adjusting the second waveform based on the first waveform (paragraphs [0043], [0054]).
Regarding claim 5, wherein the second sensor data and the first sensor data comprises data from the at least one solid-state sensor and data from the expandable member sensor respectively at a point in time (paragraphs [0046], [0047]).
Regarding claim 6, wherein the pressure in the expandable member is indicative of pressure at the target location in the blood vessel (paragraphs [0020], [0022], [0024]).
Regarding claim 11, wherein the volume of the fluid calibration bolus is between about 1 ml and about 1.5 ml (TABLE 3).
Regarding claim 12, wherein the volume of the fluid calibration bolus is less than 5% of a volume of the expandable member (TABLE 3).
Regarding claim 13, wherein the volume of the fluid calibration bolus does not distend the expandable member (paragraphs [0046], [0047]).
Regarding claim 23, wherein the second sensor data from the at least one solid-state sensor includes a first waveform, the method further comprising determining, based at least in part on the first waveform, whether a volume of the fluid calibration bolus is a non-disruptive volume of fluid (paragraphs [0043], [0054]).
Regarding claim 26, wherein the at least one solid-state sensor includes a first pressure sensor proximal to the expandable member and a second pressure sensor distal to the expandable member (paragraphs [0022], [0023]).
Regarding claim 27, wherein adjusting the second sensor data includes: adjusting sensor data from the second pressure sensor based on the first sensor data; and adjusting sensor data from the first pressure sensor based on the first sensor data (paragraphs [0046], [0047]).
Regarding claim 28, wherein the second sensor data includes third sensor data from the first pressure sensor and fourth sensor data from the second pressure sensor, and wherein adjusting the second sensor data includes: adjusting fourth sensor data from the second pressure sensor based on the first sensor data; and adjusting third sensor data from the first pressure sensor based on the fourth sensor data (paragraphs [0046], [0047], [0054]).
Regarding claim 29, further comprising one or more calibration safeguards (paragraph [0057]).
Regarding claim 30, wherein the one or more calibration safeguards comprises applying negative pressure to the expandable member prior to injecting the fluid calibration bolus (paragraphs [0046], [0047], [0050], [0057]).
Regarding claim 31, wherein the negative pressure is applied using a syringe pump (408).
Regarding claim 32, wherein the syringe pump (408) is also used to inject the fluid calibration bolus into the expandable member (paragraphs [0061], [0063]).
Regarding claim 35, wherein the one or more calibration safeguards comprises measuring the pressure in the expandable member after injecting the fluid calibration bolus (paragraphs [0046], [0047], [0050], [0057]).
Regarding claim 36, further comprising repeating injection of the fluid calibration bolus if the measured pressure in the expandable member is negative (paragraphs [0046], [0047], [0050], [0057]).
Regarding claim 37, wherein the elongate body (catheter) and the expandable member (200) are used to control blood flow in a patient (paragraphs [0020]-[0022]).
Regarding claim 38, wherein controlling blood flow is used to treat one or more types of shock selected from the group consisting of neurogenic shock, hemorrhagic shock, hypovolemic shock, and septic shock (paragraphs [0005], [0041]).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Glover et al (US 12,402,797) disclose A system comprising a multi-sensor catheter for monitoring a cardiac hemodynamic condition, e.g. heart failure. The multi-sensor catheter comprises multi-lumen catheter tubing, first and second optical pressure sensors, and respective optical fibers and connectors. For right heart and pulmonary artery catheterization, a flow-directed multi-sensor catheter comprises a guidewire lumen, inflatable balloon tip, and sensor locations are configured for placement of a sensor in each of the right atrium and pulmonary artery, for measurement of central venous pressure in the right atrium and a pulmonary artery pressure. An optical fiber for oximetry may be included. McKinney et al (US 11,672,457) disclose a catheter insertable into a patient for monitoring pressure having an expandable outer balloon. An expandable inner balloon is positioned within the lumen of the catheter and has having a second outer wall and forms a gas chamber to monitor pressure within the patient. Wright et al (US 11,559,213) disclose a pressure sensing guidewire includes a tubular member having a proximal region and a housing region. An optical fiber may be disposed within the tubular member and extend to the housing region. The optical fiber may have a distal end region with a cavity formed therein. A polymeric member disposed within the cavity. A reflective surface disposed along the polymeric member.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AN H DO whose telephone number is (571)272-2143. The examiner can normally be reached on M-F 7:00am-4:00pm.
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, Ricardo Magallanes can be reached on 571-272-5960. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AN H DO/Primary Examiner, Art Unit 2853
Prosecution Insights