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 .
Priority
Receipt is acknowledged that application claims priority to foreign application with application number KR10-2024-0024252 dated 02/20/2024. Copies of certified papers required by 37 CFR 1.55 have been received. Priority is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Specification
The abstract of the disclosure is objected to because the abstract is too long in length, it is currently 161 words long, the limit is 150 words in length. Additionally, any acronyms used should be described before the acronym is used (for example Particle Image Velocimetry (PIV)) to ensure clarity. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
5, 13, 17 are referenced in the description of Figure 4, but they do not appear in Figure 4.
E1 and E2 are present in the specification ¶0118 in reference to Figure 2 but they are not shown in Figure 2.
F1 and F2 are present in the specification ¶0124 in reference to a figure but are not present in any figure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 and 9 is/are objected to because of the following informalities:
Claim 1 and Claim 9 both reference the acronym “PIV” on Line 1 and do not define the acronym. If the acronym is to be used in the claim language it needs to be described for example “Particle Image Velocimetry (PIV)” to ensure clarity.
Claim(s) 2-8 and 10-18 depend either directly or indirectly from the objection of claim(s) 1 and 9, therefore they are also objected.
Appropriate correction is required.
Claim(s) 3 and 11 is/are objected to because of the following informalities:
Claim 3 and Claim 11 both reference the acronym “FFT” on Line 1 and do not define the acronym. If the acronym is to be used in the claim language it needs to be described for example “Fast Fourier Transform (FFT)” to ensure clarity.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"a cardiac organoid image conversion unit" in claim 9, in the specification “conversion unit” is defined as “A cardiac organoid image conversion unit 210 receives a cardiac organoid contraction video I and converts it into an image sequence.” In ¶0061.
"a PIV setting unit " in claim 9, in the specification “PIV setting unit” is defined as “The PIV setting unit 220 sets an interrogation window size and a step size for the PIV algorithm.” in ¶0064.
"a cardiac organoid setting unit" in claim 9, in the specification “a cardiac organoid setting unit” is not defined.
"a deformation velocity calculation unit" in claim 9, in the specification “deformation velocity calculation unit” is defined as “A deformation velocity calculation unit 240 calculates the deformation velocity of the cardiac organoid using the setting values of the interrogation window size and the step size, information on the cardiac organoid, and the PIV algorithm.” In ¶0071.
"a postprocessing unit" in claim 9, in the specification “postprocessing unit” is defined as “A postprocessing unit 250 provides a real-time interactive tool for postprocessing of the deformation velocity.” In ¶0081.
"a multiple parameter calculation unit" in claim 9, in the specification “a multiple parameter calculation unit” is defined as “A multiple parameter calculation unit 260 calculates multiple parameters for assessing contractility of the cardiac organoid on the basis of the profile of the postprocessed deformation velocity.” In ¶0084.
"an output unit" in claim 9, in the specification “an output unit” is defined as “ The output unit 270 outputs visual data and multiple parameters used for analyzing contractility of the cardiac organoid.” In ¶0086.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The claims in this application are given their broadest reasonable interpretation 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 broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification.
Under MPEP 2143.03, "All words in a claim must be considered in judging the patentability of that claim against the prior art." In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970). As a general matter, the grammar and ordinary meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009).
Claim 4 and 12 recite “at least any one or more” then listing “a noise threshold, removing noise, smoothing, deleting noise peak points, and selecting or deselecting start, peak, and end points of contraction and relaxation”. Since “at least any one or more” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 5 and 13 recite “at least any one or more” then listing “a maximum contraction force and a maximum relaxation force”. Since “at least any one or more” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 6 and 14 recite “at least any one or more” then listing “decay times of 90%, 50%, and 10% levels”. Since “at least any one or more” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim Rejections - 35 USC § 112
Claim limitation “a cardiac organoid setting unit” in claim 9 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is silent on what structure or hardware makes up the output unit or how it performs its functions, the only context given is in the claim itself which states that “for setting information on the cardiac organoid” which does not convey structure to perform the task. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 8 and 16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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. The Examiner strongly suggested that appropriate corrections be made to clarify the claim scope.
With respect to Claims 8 and 16 , the claim recites the following, each of which renders the claim indefinite:
“ the image of the cardiac organoid ” on line 2 (unclear antecedent basis as there is no reference to “the image of the cardiac organoid” in the parent claim, only reference to an “video of the cardiac organoid” and a “converted image sequence” it cannot be determined which of these “the image” is referring to).
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 therefore, 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 17 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows. Claim 17 and 18 defines a “computer-readable recording 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 “computer program product ” 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 recording medium” and adding the limitation ”non-transitory ” 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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 8-9, 13, and 16-18 are rejected under 35 U.S.C. 103 as unpatentable over Kheradvar et al (US Patent Publication US 2024/0020841 Al, hereafter referred to as Kheradvar) in view of Kim et al (US Patent Publication US 2023/0087578 A1, hereafter referred to as Kim).
Regarding Claim 1, Kheradvar teaches a PIV-based cardiac organoid contractility assessment method (Kheradvar ¶0016, ¶0017, ¶0021 discloses using PIV imaging for management of heart diseases including the incompressible flow which shows the state of contractility in the right ventricle of the heart)
setting an interrogation window size and a step size for a PIV algorithm to a first value (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber)
configuring information on the cardiac organoid (Kheradvar ¶0025, ¶0029 and Fig 2A disclose the data of the flow field images including information flow through the heart chamber);
calculating a deformation velocity of the cardiac organoid (Kheradvar ¶0024, ¶0051, and Fig 6 discloses the determination of the kinetic energy and dissipation rate by considering the rate of deformation of the blood flow due to shear forces within the RV) using the first value (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber), information on the cardiac organoid (Kheradvar ¶0025, ¶0029 and Fig 2A disclose the data of the flow field images including information flow through the heart chamber), and the PIV algorithm (Kheradvar ¶0016, ¶0017, ¶0021 discloses using PIV imaging for management of heart diseases including the incompressible flow which shows the state of contractility in the right ventricle of the heart);
providing a real-time interactive tool (Kheradvar ¶0027, ¶0047 ¶0003, ¶0050 discloses an user input output device with a GUI based on real time blood flow) for postprocessing of the deformation velocity (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow);
calculating multiple parameters that assess contractility of the cardiac organoid on the basis of a profile of the postprocessed deformation velocity (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow); and
outputting visual data (Kherdvar ¶0047-¶0048, Fig 2C disclose outputting a visualization of the flow field) and the multiple parameters (Kheradvar ¶0017 discloses all of the parameters that can be output based on the PIV algorithm) used for analyzing contractility of the cardiac organoid (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow), wherein the first value is reset to a second value (Kherdvar ¶0026, ¶0032 discloses the scanning area being adjusted based on the area of interest or patient parameters) considering continuity and calculation time of a deformation velocity vector field (Kherdvar ¶0026, ¶0032 discloses the scanning area being adjusted based on the area of interest or patient parameters and ¶0059, ¶0077 discloses data correction of the flow field being adjusted based on the time derivative of the calculation) being imaged calculated at the step of calculating the deformation velocity of the cardiac organoid (Kheradvar ¶0024, ¶0051, and Fig 6 discloses the determination of the kinetic energy and dissipation rate by considering the rate of deformation of the blood flow due to shear forces within the RV).
Kheradvar does not explicitly disclose converting a captured video of a cardiac organoid into an image sequence, for each of the converted image sequences.
Kim is in the same field of analysis of biomedical tissue flow. Further, Kim teaches converting a captured video of a cardiac organoid into an image sequence (Kim ¶0128, ¶0039, Fig 14A-D, ¶0096, and ¶0118 discloses assessing contractile function using videos of the cells that are broken down into 4-5 contractions and 3-5 fields of view and that the reference frames are divided) for each of the converted image sequences (Kim ¶0128, ¶0039, Fig 14A-D, ¶0096, and ¶0118 discloses assessing contractile function using videos of the cells that are broken down into 4-5 contractions and 3-5 fields of view and that the reference frames are divided).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar by incorporating the converted video images and contraction and relaxation characteristics of the observed organoid tissues as taught by Kim; to make an invention that can accurately determine the functionality of the cardiac organoid tissue from a video; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need as accurately model and observe vascular tissues such as the vasculature or chambers of the heart, since they often possess curved surfaces and hollow lumens that are difficult to recapitulate given their anisotropic architecture as disclosed by Kim in ¶0056.
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.
Regarding Claim 5, Kheradvar in view of Kim teaches the method according to claim 1, wherein the multiple parameters (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow) include at least any one or more among a maximum contraction force and a maximum relaxation force (Kim ¶0135-¶0137 discloses the relaxation and contraction patterns being modeled and the base and apex of the force being modeled which the examiner is interpreting as the maximum and minimum forces). See Claim 1 for rationale, its parent claim.
Regarding Claim 8, Kheradvar in view of Kim teaches the method according to claim 1, wherein the image of the cardiac organoid (Kim ¶0128, ¶0039, Fig 14A-D, ¶0096, and ¶0118 discloses assessing contractile function using videos of the cells that are broken down into 4-5 contractions and 3-5 fields of view and that the reference frames are divided) is captured using a standard imaging device having a frame rate of 10 to 60 frames per second (Kim ¶0128, discloses the videos were taken at 60fps, it would be obvious to one skilled in the art that any camera or device having the function of 60 fps could complete this task). See Claim 1 for rationale, its parent claim.
Regarding Claim 9, Kheradvar teaches a PIV-based cardiac organoid contractility assessment system (Kheradvar ¶0016, ¶0017, ¶0021 discloses using PIV imaging for management of heart diseases including the incompressible flow which shows the state of contractility in the right ventricle of the heart) comprising:
a PIV setting unit for setting an interrogation window size and a step size for a PIV algorithm to a first value (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber)
a cardiac organoid setting unit for setting information on the cardiac organoid (Kheradvar ¶0025, ¶0029 and Fig 2A disclose the data of the flow field images including information flow through the heart chamber);
a deformation velocity calculation unit for calculating a deformation velocity of the cardiac organoid (Kheradvar ¶0024, ¶0051, and Fig 6 discloses the determination of the kinetic energy and dissipation rate by considering the rate of deformation of the blood flow due to shear forces within the RV) using the first value (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber), information on the cardiac organoid (Kheradvar ¶0025, ¶0029 and Fig 2A disclose the data of the flow field images including information flow through the heart chamber), and the PIV algorithm (Kheradvar ¶0016, ¶0017, ¶0021 discloses using PIV imaging for management of heart diseases including the incompressible flow which shows the state of contractility in the right ventricle of the heart);
a multiple parameter calculation unit for calculating multiple parameters that assess contractility of the cardiac organoid on the basis of a profile of the postprocessed deformation velocity (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow);
an output unit for outputting visual data (Kherdvar ¶0047-¶0048, Fig 2C disclose outputting a visualization of the flow field) and the multiple parameters (Kheradvar ¶0017 discloses all of the parameters that can be output based on the PIV algorithm) used for analyzing contractility of the cardiac organoid (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow), wherein the first value is reset to a second value (Kherdvar ¶0026, ¶0032 discloses the scanning area being adjusted based on the area of interest or patient parameters) considering continuity and calculation time of a deformation velocity vector field (Kherdvar ¶0026, ¶0032 discloses the scanning area being adjusted based on the area of interest or patient parameters and ¶0059, ¶0077 discloses data correction of the flow field being adjusted based on the time derivative of the calculation) being imaged calculated at the step of calculating the deformation velocity of the cardiac organoid (Kheradvar ¶0024, ¶0051, and Fig 6 discloses the determination of the kinetic energy and dissipation rate by considering the rate of deformation of the blood flow due to shear forces within the RV).
Kheradvar does not explicitly disclose a cardiac organoid image conversion unit for converting a captured image of a cardiac organoid into an image sequence, for each of the converted image sequences.
Kim is in the same field of analysis of biomedical tissue flow. Further, Kim teaches a cardiac organoid image conversion unit for converting a captured image of a cardiac organoid into an image sequence (Kim ¶0128, ¶0039, Fig 14A-D, ¶0096, and ¶0118 discloses assessing contractile function using videos of the cells that are broken down into 4-5 contractions and 3-5 fields of view and that the reference frames are divided);
for each of the converted image sequences (Kim ¶0128, ¶0039, Fig 14A-D, ¶0096, and ¶0118 discloses assessing contractile function using videos of the cells that are broken down into 4-5 contractions and 3-5 fields of view and that the reference frames are divided).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar by incorporating the converted video images and contraction and relaxation characteristics of the observed organoid tissues as taught by Kim; to make an invention that can accurately determine the functionality of the cardiac organoid tissue from a video; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need as accurately model and observe vascular tissues such as the vasculature or chambers of the heart, since they often possess curved surfaces and hollow lumens that are difficult to recapitulate given their anisotropic architecture as disclosed by Kim in ¶0056.
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.
Regarding Claim 13, Kheradvar in view of Kim teaches the system according to claim 9, wherein the multiple parameters (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow) include at least any one or more among a maximum contraction force and a maximum relaxation force (Kim ¶0135-¶0137 discloses the relaxation and contraction patterns being modeled and the base and apex of the force being modeled which the examiner is interpreting as the maximum and minimum forces). See Claim 9 for rationale, its parent claim.
Regarding Claim 16, Kheradvar in view of Kim teaches the system according to claim 9, wherein the image of the cardiac organoid (Kim ¶0128, ¶0039, Fig 14A-D, ¶0096, and ¶0118 discloses assessing contractile function using videos of the cells that are broken down into 4-5 contractions and 3-5 fields of view and that the reference frames are divided) is captured using a standard imaging device having a frame rate of 10 to 60 frames per second (Kim ¶0128, discloses the videos were taken at 60fps, it would be obvious to one skilled in the art that any camera or device having the function of 60 fps could complete this task). See Claim 9 for rationale, its parent claim.
Regarding Claim 17, Kheradvar in view of Kim teaches a computer program stored in a computer-readable recording medium (Kheradvar ¶0098 discloses a computer program product, embodied in a computer readable medium, including computer-executable instructions such as program code, executed by computers I networked environments), the computer program for executing the contractility assessment method (Kheradvar ¶0016, ¶0017, ¶0021 discloses using PIV imaging for management of heart diseases including the incompressible flow which shows the state of contractility in the right ventricle of the heart) according to claims 1. See Claim 1 for rationale, its parent claim.
Regarding Claim 18, Kheradvar in view of Kim teaches a computer-readable recording medium storing computer programs, in which a computer program for executing (Kheradvar ¶0098 discloses a computer program product, embodied in a computer readable medium, including computer-executable instructions such as program code, executed by computers I networked environments) the contractility assessment method according (Kheradvar ¶0016, ¶0017, ¶0021 discloses using PIV imaging for management of heart diseases including the incompressible flow which shows the state of contractility in the right ventricle of the heart) to claims 1 is recorded. See Claim 1 for rationale, its parent claim.
Claims 2-4, 6-7, 10-12, and 14-15 are rejected under 35 U.S.C. 103 as unpatentable over Kheradvar in view of Kim in further view of Wang et al (Wang, Hongping, Guowei He, and Shizhao Wang. "Globally optimized cross-correlation for particle image velocimetry." Experiments in Fluids 61.11 (2020): 228, hereafter referred to as Wang)
Regarding Claim 2, Kheradvar in view of Kim teaches the method according to claim 1, wherein as the second value (Kherdvar ¶0026, ¶0032 discloses the scanning area being adjusted based on the area of interest or patient parameters), the PIV interrogation window size (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber).
Kheradvar in view of Kim does not explicitly disclose is set to 32 pixels and the step size is set to 8 pixels.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches is set to 32 pixels (Wang Pg 13 Col 1 ¶02 discloses the interrogation window size being 32 pixels), and the step size is set to 8 pixels (Wang Pg 13 Col 2 ¶02 discloses the step size being set to 8 pixels).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the specific PIV window size and step as taught by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches including window control size; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 3, Kheradvar in view of Kim teaches the method according to claim 1, with interrogation windows in the PIV algorithm (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber).
Kheradvar in view of Kim does not explicitly disclose wherein an FFT algorithm is used to perform cross-correlation.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches wherein an FFT algorithm is used to perform cross-correlation (Wang Pg 7 Col 1 ¶01 and Abstract discloses a FFT-based cross correlation).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the FFT algorithm as taught by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 4, Kheradvar in view of Kim teaches the method according to claim 1, wherein the postprocessing (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow).
Kheradvar in view of Kim does not explicitly disclose includes at least any one or more among setting a noise threshold, removing noise, smoothing, deleting noise peak points, and selecting or deselecting start, peak, and end points of contraction and relaxation.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches includes at least any one or more among setting a noise threshold, removing noise (Wang Abstract and Pg 2 Col 1, ¶01 discloses using IW size to help with image noise on velocity measurements), smoothing (Wang Pg 2 Col 1, ¶01 discloses applying smoothing methods), deleting noise peak points, and selecting or deselecting start, peak, and end points of contraction and relaxation (Wang Fig 2 and Pg 4 Col 2 ¶01, discloses selecting or isolating certain peaks using window size to obtain a less noisy velocity).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the noise reduction techniques by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 6, Kheradvar in view of Kim in view of Wang teaches the method according to claim 4, wherein the multiple parameters (Kheradvar ¶0017 discloses all of the parameters that can be output based on the PIV algorithm) further include at least any one or more among decay times of 90%, 50%, and 10% levels (Wang Fig 8a and Pg 10 Col 1 ¶01 disclose the decay as 0.0. to 0.2 which contains the 10% level). See Claim 4 for rationale, its parent claim.
Regarding Claim 7, Kheradvar in view of Kim teaches the method according to claim 1, wherein the visual data (Kherdvar ¶0047-¶0048, Fig 2C disclose outputting a visualization of the flow field) includes a contraction-relaxation velocity profile (Kim ¶0135-¶0137 discloses the relaxation and contraction patterns being modeled and the base and apex of the force being modeled which the examiner is interpreting as the maximum and minimum forces) linked to an input image in real time (Kheradvar ¶0027, ¶0047 ¶0003, ¶0050 discloses an user input output device with a GUI based on real time blood flow), a beating image overlaid with the vector field of the deformation velocity (Kim Figs 12A-12F and ¶0037 disclose cardiac tissue contractions with motion vectors overlayed demonstrating unidirectional motion of aligned 4-layer cardiac tissues during contraction).
Kheradvar in view of Kim does not explicitly disclose and a beating image of a heatmap form.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches and a beating image of a heatmap form (Wang Abstract and graphical abstract show the beating image in heatmap form).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the heatmap representation as taught by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 10, Kheradvar in view of Kim teaches the system according to claim 9, wherein as the second value (Kherdvar ¶0026, ¶0032 discloses the scanning area being adjusted based on the area of interest or patient parameters), the PIV interrogation window size (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber).
Kheradvar in view of Kim does not explicitly disclose is set to 32 pixels and the step size is set to 8 pixels.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches is set to 32 pixels (Wang Pg 13 Col 1 ¶02 discloses the interrogation window size being 32 pixels), and the step size is set to 8 pixels (Wang Pg 13 Col 2 ¶02 discloses the step size being set to 8 pixels).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the specific PIV window size and step as taught by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 11, Kheradvar in view of Kim teaches the system according to claim 9, with interrogation windows in the PIV algorithm (Kheradvar ¶0026, ¶0032, ¶0062, and Example A6 discloses setting the scanning parameters for the PIV imaging for the heart chamber).
Kheradvar in view of Kim does not explicitly disclose wherein an FFT algorithm is used to perform cross-correlation.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches wherein an FFT algorithm is used to perform cross-correlation (Wang Pg 7 Col 1 ¶01 and Abstract discloses a FFT-based cross correlation).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the FFT algorithm as taught by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 12, Kheradvar in view of Kim teaches the system according to claim 9, wherein the postprocessing (Kheradvar ¶0051 and Fig 6 disclose that kinetic energy was calculated from velocity magnitude and dissipation rate was computed accordingly by considering the rate of deformation of blood flow due to shear forces within the RV, the examiner determines that both calculations can be seen as post processing as they are based on the deformation rate of the blood flow).
Kheradvar in view of Kim does not explicitly disclose includes at least any one or more among setting a noise threshold, removing noise, smoothing, deleting noise peak points, and selecting or deselecting start, peak, and end points of contraction and relaxation.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches includes at least any one or more among setting a noise threshold, removing noise (Wang Abstract and Pg 2 Col 1, ¶01 discloses using IW size to help with image noise on velocity measurements), smoothing (Wang Pg 2 Col 1, ¶01 discloses applying smoothing methods), deleting noise peak points, and selecting or deselecting start, peak, and end points of contraction and relaxation (Wang Fig 2 and Pg 4 Col 2 ¶01, discloses selecting or isolating certain peaks using window size to obtain a less noisy velocity).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the noise reduction techniques by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 14, Kheradvar in view of Kim teaches the system according to claim 13, wherein the multiple parameters (Kheradvar ¶0017 discloses all of the parameters that can be output based on the PIV algorithm).
Kheradvar in view of Kim does not explicitly disclose further include at least any one or more among decay times of 90%, 50%, and 10% levels.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches further include at least any one or more among decay times of 90%, 50%, and 10% levels (Wang Fig 8a and Pg 10 Col 1 ¶01 disclose the decay as 0.0. to 0.2 which contains the 10% level).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the noise reduction techniques by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Regarding Claim 15, Kheradvar in view of Kim teaches the system according to claim 9, wherein the visual data (Kherdvar ¶0047-¶0048, Fig 2C disclose outputting a visualization of the flow field) includes a contraction-relaxation velocity profile (Kim ¶0135-¶0137 discloses the relaxation and contraction patterns being modeled and the base and apex of the force being modeled which the examiner is interpreting as the maximum and minimum forces) linked to an input image in real time (Kheradvar ¶0027, ¶0047 ¶0003, ¶0050 discloses an user input output device with a GUI based on real time blood flow), a beating image overlaid with the vector field of the deformation velocity (Kim Figs 12A-12F and ¶0037 disclose cardiac tissue contractions with motion vectors overlayed demonstrating unidirectional motion of aligned 4-layer cardiac tissues during contraction).
Kheradvar in view of Kim does not explicitly disclose and a beating image of a heatmap form.
Wang is in the same field of image analysis of particle image velocimetry. Further, Wang teaches and a beating image of a heatmap form (Wang Abstract and graphical abstract show the beating image in heatmap form).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kheradvar in view of Kim by incorporating the heatmap representation as taught by Wang; to make an invention that can reduce the noise associated with PIV techniques using different approaches; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to consider the influences of the IW size, particle concentration, particle image diameter, large displacements and image noise on the velocity measurements. Error analysis indicates that GOCCPIV outperforms FFTCCPIV in resolving small-scale vortices and reducing the measurement error as disclosed by Wang in Abstract.
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.
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Sala, Luca, et al. "MUSCLEMOTION: a versatile open software tool to quantify cardiomyocyte and cardiac muscle contraction in vitro and in vivo." Circulation research 122.3 (2018): e5-e16.to Sala et al. discloses method for processing video recordings, for reliable pharmacological data and measures of cardiac disease phenotype in experimental cell, animal, and human models.
Conclusion
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/RACHEL L ROBERTS/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674
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