DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 20 September 2024 has been entered. Claims 1-44 have been canceled. New claims 45-64 have been added, and are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
Claim Objections
Claims 52 and 59 are objected to because of the following informalities: each occurrence of "wherein calculating the first time constant from the first set of time series pressure values comprises a determining relationship τ […]" should be amended/corrected to "wherein calculating the first time constant from the first set of time series pressure values comprises [[a]] determining a relationship τ […]."
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 52, 59 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 52, claim 59 and claims dependent thereon, "where Area(P-R)12 is an area between (i) a first time series of pressure values from the first portion of the heart and (ii) a second time series of pressure values from the cardiovascular region adjacent to the first portion of the heart, and between a first time and a second time" is indefinite. Applicant discloses determining an area or space bounded/defined by a particular arrangement/representation of the time series data, i.e., a graphical representation of the first time series of pressure values (e.g., left ventricular pressure curve) presumably time-aligned (¶ [0195]; Fig. 20; etc.) with a graphical representation of the second time series of pressure values (e.g., aortic pressure curve) (e.g., area 2013 of Fig. 20). However, a "time series of pressure values" as recited by the pending claims reasonably encompasses a series of respective pressure and timestamp pair values, i.e., mere data points, therefore having no inherent spatial/geometric properties. Similarly, the time series acquired from a first portion of the heart and the time series acquired from a second portion adjacent the first portion have no inherent relative spatial/geometric relationship, or any such relationship recited in the pending claims. Accordingly, it is unclear to what "an area between (i) a first time series of pressure values from the first portion of the heart and (ii) a second time series of pressure values from the cardiovascular region adjacent to the first portion of the heart, and between a first time and a second time" refers. To the best of the examiner's understanding, the above-noted area refers to the area or space similarly bounded/defined by a particular representation of the time series data arranged in a particular relationship to each other (i.e., comparable to Fig. 20). Amendments commensurate in scope with this understanding would overcome this rejection.
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.
Claim(s) 45-64 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 45-64 recite the steps of calculating a first time constant and a first regurgitation index from a first set of time series pressure values; calculating a second time constant and a second regurgitation index from a second set of time series pressure values; determining a time constant difference value based at least in part on the first time constant and the second time constant, such as subtracting one of the first time constant and the second time constant from the other of the first time constant and the second time constant; and determining a regurgitation difference value based at least in part on the second regurgitation index and the first regurgitation index.
These limitations encompass and/or recite mathematical formulas or equations (e.g., claims 48, 52-54, 59-61), and are therefore fall within the mathematical concept grouping of abstract ideas. Alternatively/Additionally, these limitations are a process that, under a broadest reasonable interpretation (BRI) thereof, covers performance of the limitations in the mind but for the recitation of generic computer components, where present. That is, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the "by a processor" language, where present, calculating time constants and regurgitation indices encompasses a user visually/mentally observing pressure waveforms acquired before and after a procedure, and formulating an estimation for each of the parameters and/or inputting observed features into a pre-defined equation. Calculating difference values encompasses the user mentally or manually subtracting pre-procedure parameter values from post-procedure parameters value (or vice versa). The pending method claims do not recite that a computer/processor is necessary for performing these steps, apparently indicating the use of a computer/processor is not required. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites at least one abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional elements of steps for determining a first, pre-procedure set of time series pressure values and a second, post-procedure set of time series pressure values from first and second pressure sensors; using a processor(s) and associated programming to perform the above-noted steps based on the determined first and second sets of time series pressure values; tagging a calculated values; causing a generic presentation of a result of performing the abstract idea(s) (difference values) in a user interface; and an indication of the first sensor type from which data is received, and the type of heart procedure for which the system or method may be used.
The processor, steps of receiving the first and second sets of time series pressure values; and causing a generic presentation of a result of performing the abstract idea(s) (difference values) in a user interface are recited at a high-level of generality (i.e., as a generic processor performing generic computer functions of receiving data, performing calculations, tagging data and outputting results), such that it amounts no more than mere instructions to apply the exception using a generic computer component (i.e., invoke a computer as a tool to execute the abstract idea(s), e.g., using of software to tailor information and provide it to a user on a generic computer, see MPEP 2106.05(f)). Further, the steps of receiving the pressure data from sensors and causing a generic presentation of information calculated from said received pressure data are comparable to steps that have been identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), performing clinical tests to obtain input for an equation, printing generated menus, etc.). Lastly, the limiting the abstract idea to data obtained by/received from a type of sensor, or the heart procedure to a transcatheter aortic valve replacement procedure merely indicates a field of use or technological environment in which to apply a judicial exception (see MPEP 2106.05(h), particularly discussion of claims in Electric Power Group). In view of the above, the additional elements of the claims merely include instructions to implement an abstract idea on a computer, or use a computer as a tool to perform an abstract idea; add insignificant extra-solution activity to the judicial exception; and/or generally linking the use of a judicial exception to a particular technological environment or field of use, and therefore do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(d)(I). Accordingly, the claims are directed to an abstract idea(s).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of receiving pressure data; using a processor as a tool to perform the abstract idea(s); tagging calculated data; and outputting said calculated data amounts to no more than mere instructions to apply the exception using a generic computer. Further, the courts have recognized such functions as receiving or transmitting data over a network, performing repetitive calculations, storing and retrieving information in memory, etc. as well‐understood, routine, and conventional computer functions when claimed in a merely generic manner (see MPEP 2106.05(d)(II)). Mere instructions to apply an exception using a generic computer component; simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception; adding insignificant extra-solution activity to the judicial exception; and/or generally linking the user of the judicial exception to a particular technological environment or field of use cannot provide an inventive concept (see MPEP 2106.05(I)(A)). Therefore, claims 45-64 are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 45-47, 49-51, 56-58 and 63-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0390350 A1 (Glawdel) in view of US 2020/0375473 A1 (Johnson) and US 2021/0275816 A1 (Cuchiara).
Regarding claims 45, 50, 57 and 64, Glawdel discloses/suggests a system comprising:
a non-transitory computer storage medium configured to at least store computer-executable instructions; and one or more hardware processors m communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions (e.g., ¶ [0031]) to perform a method, the method comprising:
before a heart procedure, determining a first set of time series pressure values from (i) a first pressure sensor positioned in a first portion of a heart, and (ii) a second pressure sensor positioned in a cardiovascular region adjacent to the first portion of the heart (e.g., ¶ [0028] measurements of transvalvular pressure gradients before deployment of a prosthetic heart valve; ¶ [0101] measurements of transvalvular pressure gradient comprises concurrent blood pressure measurements in the ascending aorta and in the left ventricle, e.g., pressure waveforms of Fig. 12), wherein the heart procedure comprises a transcatheter aortic valve replacement procedure (e.g., ¶ [0028] TVT procedures, such as TAVR);
calculating a first parameter from the first set of time series pressure values (¶ [0030] computing a parameter/index from acquired pressure data, such as aortic regurgitation index (ARi));
after the heart procedure, determining a second set of time series pressure values from (i) the first pressure sensor positioned in the first portion of the heart, and (ii) the second pressure sensor positioned in the cardiovascular region adjacent to the first portion of the heart (e.g., ¶ [0028] measurements of transvalvular pressure gradients after deployment of a prosthetic heart valve); and
calculating a second parameter from the second set of time series pressure values (¶ [0030] computing a parameter and/or index from the acquired pressure data).
Glawdel does not expressly disclose the method further comprises determining a parameter difference value based at least in part on the first parameter and the second parameter; and causing presentation of the parameter difference value in a user interface. However, Glawdel discloses the method may comprise displaying, on a graphical user interface, pressure waveforms and numeric data relating to selected hemodynamic parameters and indexes (e.g., ¶ [0031]), and discloses the heart procedure is expected to yield a change, i.e., difference, between the first, pre-procedure parameter and the second, post-procedure parameter (e.g., ¶ [0110]).
Johnson discloses/suggests a method comprising, before a heart procedure, calculating a first parameter; after the heart procedure, calculating a second parameter; determining a parameter difference value based on the first and second parameters (Fig. 9; ¶¶ [0060]-[0061] comparing a post-TAVI prosthetic cardiac valve function parameter, SAVI, to a SAVI computed prior to the TAVI); and causing presentation of the parameter difference value in a user interface (e.g., ¶ [0064] where said method/steps may be performed by a computer, thereby indicating and/or suggesting the calculated difference is at least generically output to a user via a computer interface, e.g., display).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Glawdel to comprise determining a parameter difference value based at least in part on the first parameter and the second parameter; and causing presentation of the parameter difference value in a user interface as taught/suggested by Johnson in order to enable a user (e.g., clinician) to readily assess the effect(s) of the procedure (Glawdel, ¶ [0110]; Johnson, ¶ [0006]).
Glawdel as modified does not disclose the first and second parameters respectively comprise a first and second time constant, such that the parameter difference value is a time constant difference value.
Cuchiara discloses/suggests a method comprising determining a set of time series pressure values from a first pressure sensor positioned in a first portion of a heart (¶ [0017] LV pressure), and a second pressure sensor positioned in a cardiovascular region adjacent to the first portion of the heart (¶ [0017] arterial pressure); and calculating a time constant from the set of time series pressure values (¶ [0017] time constant of LV isovolumetric relaxation in diastole; time constant of ABP isovolumetric relaxation in diastole; etc.) in order to assess an impact of therapy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Glawdel with the first and second parameters respectively comprising a first and second time constant, such that the parameter difference value is a time constant difference value, as taught/suggested by Cuchiara in order to enable the user to readily assess the effect of the procedure, particularly on left ventricular relaxation (Cuchiara, ¶ [0017]).
Regarding claims 46, 51, and 58, Glawdel as modified discloses/suggests the first portion of the heart includes at least a left ventricle and the cardiovascular region adjacent to the first portion includes at least an aorta (Abstract, ¶ [0101], etc.).
Regarding claim 47, Glawdel as modified discloses/suggests the first pressure sensor comprises a diagnostic catheter, a guiding catheter, a pigtail catheter, or a pressure guidewire (e.g., ¶ [0020]).
Regarding claims 49, 56, and 63, Glawdel as modified discloses/suggests the method further comprises calculating a first regurgitation index from the first set of time series pressure values (¶ [0008] assessment of aortic valve regurgitation before a TAVR procedure; ¶ [0030] ARi); calculating a second regurgitation index from the second set of time series pressure values (¶ [0008] assessment of aortic valve regurgitation after a TAVR procedure; ¶ [0030] ARi); determining a regurgitation difference value based at least in part on the second regurgitation index and the first regurgitation index; and causing presentation of the regurgitation difference value in the user interface (see discussion of independent claims above).
Claim(s) 48, 54 and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glawdel in view of Johnson and Cuchiara as applied to claim(s) 45, 50 and 57 above, and further in view of US 2020/0210917 A1 (Kotake).
Regarding claims 48, 54 and 61, Glawdel as modified discloses/suggests the limitations of claims 45, 50 and 57, as discussed above, but does not expressly disclose determining the time constant difference value comprises subtracting (i) one of the first time constant and the second time constant from (ii) a different one of the first time constant and the second time constant. However, one of ordinary skill in the art would readily appreciate subtraction of one number from another as a suitable method for determining a difference between said numbers. Alternatively or additionally, Kotake expressly discloses a value difference indicative of variation before and after an intervention may be obtained by subtraction of a pre-intervention value from a post-intervention value, or vice versa (e.g., ¶ [0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Glawdel with determining the time constant difference value by subtracting one of the first time constant and the second time constant from a different one of the first time constant and the second time constant as taught/suggested by Kotake in order to employ a well-known means/method for calculating the difference or variation between the first and second parameters, e.g., time constants.
Claim(s) 55 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glawdel in view of Johnson and Cuchiara as applied to claim(s) 50 and 57 above, and further in view of "SmartFlow™ Integrated Lumen Physiology" (Florence Medical).
Regarding claims 55 and 62, Glawdel as modified discloses/suggests the limitations of claims 50 and 57, as discussed above, but does not disclose the method further comprises receiving a user selection that tags the first time constant.
Florence Medical discloses a system comprising a processor(s) (Fig. 1, PC-based system) configured to execute further computer-executable instructions (pgs. 10-12) for receiving a user selection that tags acquired/calculated data (e.g., pg. 40, after measurements are made, the program will prompt a user to select a condition according to procedure stage, such as pre-treatment (base line), post-treatment (post-PTCA, post-stent, etc.); pg. 26, status selection is made via a displayed status selection window; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Glawdel to comprise receiving a user selection that tags the first time constant as taught/suggested by Florence Medical in order to facilitate saving the first time constant with an indication of procedure stage/status (Florence Medical, pg. 26), thereby ensuring the correct values are utilized in evaluating the treatment based on changes in the time constant before and after said treatment (Florence Medical, pg. 6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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