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 .
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.
The USPTO “Interim Guidelines for Examination of Patent Applications for Patent Subject Matter Eligibility” (Official Gazette notice of 23 February 2010), Annex IV, reads as follows:
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" to the claim. Cf. Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473(Fed. Cir. 1998).
Claim(s) 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows. Claim 9 defines a “storage medium” embodying functional descriptive material. However, the claim does not define a non-transitory computer-readable medium or memory and is thus non-statutory for that reason (i.e., “examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In see Official Gazette Notice 1351 OG212, February 23,2010). That is, the scope of the presently claimed “storage medium non-transiently storing a program ” typically covers forms of non-transitory tangible media and transitory propagating signals per se. The examiner suggests amending the claim to embody the program on a “computer readable medium” and adding the limitation ”non-transitory instead of non-transiently” to the claim or equivalent in order to make the claim statutory. Any amendment to the claim should be commensurate with its corresponding disclosure.
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 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. When reviewing independent claim 8 and based upon consideration of all of the relevant factors with respect to the claim as a whole, claim(s) 8 are held to claim an abstract idea without reciting elements that amount to significantly more than the abstract idea and is/are therefore rejected as ineligible subject matter under 35 U.S.C. 101.
The claimed invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below. The following two step analysis is used to evaluate these criteria.
Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
When examining the claim under 35 U.S.C. 101, the Examiner interprets that the claims is related to a process since the claim is directed to a method to acquire medical images
Step 2a, Prong 1: Does the claim wholly embrace a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception?
The Examiner interprets that the judicial exception applies since Claim 8 limitation of “acquiring first feature data related to a structure of interest on the basis of the first medical image data and second feature data related to the structure of interest on the basis of the second medical image data; estimating third feature data by estimating the structure of interest at the second timing by simulation on the basis of the first feature data; calculating, from the second feature data and the third feature data, a first feature value, and a second feature value that is a feature value more local than the first feature value; specifying a plurality of parameter sets related to the simulation on the basis of optimization calculation having a loss function including the first feature value “is/are directed to an [laws of nature, physical phenomena, or abstract idea]. The claim is related to mathematical concept . If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two.
Step 2a, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The Examiner interprets that Claim 8 limitation does not provide additional elements or combination of additional elements to a practical application since the claim/s is/are [adding the words of “applying it” with more instructions to implement an abstract idea on a computer. See MPEP 2106.05(f). or insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g). or Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h).] See, MPEP §2106.04(a), Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). OR Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B. If there are no additional elements in the claim, then it cannot be eligible. In such a case, after making the appropriate rejection (see MPEP § 2106.07 for more information on formulating a rejection for lack of eligibility), it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim.
Step 2b: If a judicial exception into a practical application is not recited in the claim, the Examiner must interpret if the claim recites additional elements that amount to significantly more than the judicial exception.
The Examiner interprets that the Claims do not amount to significantly more since the Claim/s is/state
Furthermore, the generic computer components of the processor recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system.
Thus, Claim 8 recite the abstract idea and therefore are not drawn to the eligible subject matter as they are directed to the abstract idea without significantly more.
Therefore, the Examiner interprets that the claims are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-6,8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ionasec et al (US 2014/0052001) in view of Sipiorski et al (US 2016/0246938)
As to claim 1, Ionasec et al teaches the A medical image processing apparatus comprising processing circuitry configured to: acquire first medical image data and second medical image data scanned (one or more sets of data are obtained by scanning. One or more sets represent the cardiac region at a same phase of the cardiac cycle (e.g., end-diastole or end-systole), paragraph [0028])at least at a first timing and at a second timing different from the first timing (determining motion between samples from different times using correlation, paragraph [0030]);
acquire first feature data related to a structure of interest on the basis of the first medical image data and second feature data related to the structure of interest on the basis of the second medical image data (To detect the mitral valve, tissue and fluid features are calculated in act 36. The features are not specific cardiac or mitral valve anatomy or jet features, but are features for input to a classifier. Anatomy or jet features may be used on input features for the classifier. Other features, such as the B-mode data and flow data or values derived there from, may be used, paragraph [0033]); estimate third feature data by estimating the structure of interest at the second timing by simulation on the basis of the first feature data ( a patient-specific mitral valve model is obtained based on the detected mitral regurgitation and mitral valve locations. The anatomical structure is visualized to assist therapy planning and procedure simulation, paragraph [0019][0074-0075]);
calculate, from the second feature data and the third feature data, a first feature value, and a second feature value that is a feature value more local than the first feature value (applies the feature values from both the B-mode data and the flow data to a second machine-learnt classifier, the second machine learnt classifier indicating a regurgitant orifice, the regurgitant orifice constrained to be within the global region of the mitral valve, (c) identifies a mitral annulus and closure line as a function of a third machine-learnt classifier and orientation and scale of the global region, and (d) transforms a statistical shape model as a function of the mitral annulus and closure line, paragraph [0007]).While Ionesec teaches the limitation above.Ionesec fails to teach “ specify a plurality of parameter sets related to the simulation on the basis of optimization calculation having a loss function including the first feature value;
and determine a parameter set of interest from the plurality of parameter sets on the basis of the second feature value.” However, Sipiorski et al teaches Clinical data from one or more clinical databases or other sources 270 is also, according to an embodiment, inputted to the valve clip prediction processor 210 for use in generating the simulation of the blood flow for the mitral valve 100. The clinical data may include data or parameters collected by prior computational fluid dynamics (CFD) simulations. In an embodiment, CFD simulation data is obtained from formerly-collected clinical data regarding the valve 100. The valve clip prediction processor 210 may be uploaded with prior calculations and parameters based on the prior CFD simulations ( paragraph [0028]).Sipiorski et al clearly teaches the prediction model to re-conduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result, wherein the reconducting is performed until the acceptable simulation result is accomplished as determined by a comparison of the results of the re-conducting simulation with the defined one or more clinical data from one or more clinical databases may be used and may include data or parameters collected by prior computational fluid dynamics simulations; contributing parameters may include, but are not limited to, calcification details, information from 3D or 4D model of valve i.e. actually measured data, and prior flow simulation, which are used in a simulation of the blood flow for the mitral valve i.e. loss function; paragraph [0037]). It would have been obvious to one skilled in the art before filing of the claimed invention to use uset he prediction model of Sipiorski et al in order to replace the trial and error process, and to provide the cardiologist with a preferred location for the valve clip to be placed, along with the preferred clip type to be used in the placement. Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
As to claim 2, Ionasec et al teaches the medical image processing apparatus according to claim 1, wherein the first feature value is a feature value of the entire structure of interest (FIG. 4 shows an example sampling of features based on orientation. The image on the left shows nine planes defined relative to the orientation of the bounding box. Any number of planes with equal or non-equal spacing may be used. Other plane orientations relative to the valve orientation may be used. Starting from a plane at the anterior commissure, a sequence of any number (e.g., 30) constrained sub-volumes Vi for the anterior (FIG. 4—upper row) and the posterior (FIG. 4—bottom row) annulus and closure line are used to calculate the input features. The directional features are aligned with the direction of the sampling plane. From each volume Vi, pre-aligned 3D Haar-like features are computed, paragraph[0069-0071]).
As to claim 3, Sipiorski et al teaches the medical image processing apparatus according to claim 1, wherein the processing circuitry is configured to specify a plurality of parameter sets on the basis of the first feature value calculated by the loss function from a parameter set group obtained on the basis of the multi-start optimization calculation (paragraph [0024], [0026]) (contributing parameters may include, but are not limited to, calcification details, information from a 3D or 4D model of the valve, valve clip properties, and prior flow simulations; The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets of the valve, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest. Doppler information may also include location and size specifics of the valve and valve leaflets)), and Estimates estimating the state of the biological organ in the predetermined time phase at the - second timing based on the parameter indicating at least one of the above items and the estimated data in the predetermined time phase ((Sipiorski et al., [0006]) (conduct the simulation of the blood flow for the mitral valve based on one or more of the one or more received parameters; compare results of the simulation with the defined one or more metrics; reconduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result)).
As to claim 4, Sipiorski et al teaches the medical image processing apparatus according to claim 3, wherein the processing circuitry is configured to specify a plurality of parameter sets in which the first feature value is relatively small (the one or more metrics may be based on the clinical situation and may be entered by a physician, lab technician, user, or the like, and transmitted to the valve clip predictor processor; This iterative process of checking the simulation results at and cycling through may be repeated until the accepted criteria, as defined by the one or more metrics, are met; paragraph [0031]).
As to claim 5, Ionasec et al teaches the medical image processing apparatus according to claim 1, wherein the processing circuitry is configured to determine a parameter set in which the corresponding second feature value is relatively small among the plurality of parameter sets as the parameter set of interest (Since the view angle and other scan parameters may vary from scan to scan, all of the calculated input features may be used.
The global position of the mitral valve is located by a classifier. The feature values are input to the classifier, and the classifier outputs the bounding box, parameter values, or other indicator of the global position of the mitral valve, paragraph [0043-0044]).
As to claim 6, Ionasec et al teaches the medical image processing apparatus according to claim 1, wherein the processing circuitry is configured to acquire first medical image data and second medical image data scanned at least during systole and diastole of a heart ( one or more sets of data are obtained by scanning. One or more sets represent the cardiac region at a same phase of the cardiac cycle (e.g., end-diastole or end-systole), paragraph [0028]).
The limitation of claim 8-9 has been addressed above.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY BITAR whose telephone number is (571)270-1041. The examiner can normally be reached Mon-Friday from 8:00 am to 5:00 p.m..
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NANCY . BITAR
Examiner
Art Unit 2664
/NANCY BITAR/Primary Examiner, Art Unit 2664