DETAILED ACTION
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 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.
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 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 when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 control unit is configured to in clams 14 and 15.
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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 – 9, and 11 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Takeshi (Publication: WO 2021/153721 A1) in view of Andreas et al. (Publication: WO 2022/022994 A1), WATANABE ET AL. (PUBLICATION: US 2008/0085043 A1).
Regarding claim 1, Takeshi discloses computer implemented method for adjusting a morphology of a heart valve model segmented from a 3D or 4D volume data set, the method comprising (Page 1, paragraph 1 - Fig. 19, This word representation device comprises a storage unit and a word representation generation unit to present its data to the display 30.
Page 3 paragraph 1 - The blood flow vector drawn in this cross section should be a projection of the 3D blood flow vector onto the 2D cross section, but the component of the in-plane vector is larger than the component passing through the cross section.
Morphology is the study of form and structure. ):
providing a 3D visualisation of a segmented heart valvePage 4 paragraph 4 - They cause flow detachment as the inflow blood flow through the mitral valve during diastole, resulting in a larger radius vortex around the wide anterior leaflet of the valve belly. A torus-shaped vortex is generated three-dimensionally, “3D visualization”),
wherein the heart valve is segmented from the 3D or 4D volume data set (Page 3 paragraph 1 - The blood flow vector drawn in this cross section should be a projection of the 3D blood flow vector onto the 2D cross section. As for the eddy current of the left chamber blood flow, it is assumed that the vector and orbit of the flow in this cross section well capture the characteristics of the three-dimensional left chamber flow of a heart.
Page 21 paragraph last - The display unit 30 displays the topological data structure extracted from the flow pattern. ),
creating a topology-based 2D model
Page 3 paragraph 1 - The blood flow vector drawn in this cross section should be a projection of the 3D blood flow vector onto the 2D cross section. As for the eddy current of the left chamber blood flow, it is assumed that the vector and orbit of the flow in this cross section well capture the characteristics of the three-dimensional left chamber flow of a heart valve.
Page 27 paragraph last - FIG. 27 (c) is a typical intra-section two-dimensional flow failure pattern often seen in late left ventricular dilatation, which is referred to as “pattern D”. First, pattern B in FIG. 27 (a) is a situation in which a uniform flow flows from bottom to top in the region of interest, “topology-based 2D model”.
Page 21 paragraph last - The display unit 30 may further show the flow pattern itself in the region of interest by displaying the streamline extracted from the original image of the flow and its singular point, “, “topology-based 2D model”. ).
displaying the 2D modelPage 21 paragraph last - The display unit 30 displays the topological data structure extracted from the blood flow pattern.)
adjusting the 2D model
Page 21 paragraph last - The display unit 30 displays the topological data structure extracted from the blood flow pattern.
Page 33 paragraph last 2 - a display unit for displaying a topological data structure extracted from the flow pattern. The streamline structure of the given flow pattern is extracted, characters are added to the extracted streamline structure based on the correspondence stored in the storage unit, and the extracted streamline structure is added.).
Takeshi does not however Andreas discloses
receiving user input data for adjusting via the user interface (Page 17 paragraph 2 - the rotation marker 54 may comprise three markings, such as lines, that are visible to an operator and each aligned with commissural posts 35a-c of a prosthesis 30 when the prosthesis 30 is collapsed inside the intervention device. Lines are made up of points on the display. ) .
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea with receiving user input data for adjusting via the user interface as taught by Andrea. The motivation for doing is to improve patient outcome.
Takeshi in view of Andrea do not disclose however Wantanabe discloses
Model including a heart valve annulus, and wherein the model is characterized by valve leaflets ([0050] - The annulus and leaflet of the mitral valve are manually marked for each plane image “2D” obtained through scanning during the contraction phase of the heart. A image of the annulus and leaflet of the mitral valve is reconstructed from these data.).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea with Model including a heart valve annulus, and wherein the model is characterized by valve leaflets as taught by Wantanabe. The motivation for doing is to have a more detailed image thus improve diagnosis of the heart.
Regarding claim 2, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 1.
Takeshi discloses created by mapping the segmented heart valve
Page 3 paragraph 1 - The blood flow vector drawn in this cross section should be a projection of the 3D blood flow vector onto the 2D cross section. As for the eddy current of the left chamber blood flow, it is assumed that the vector and orbit of the flow in this cross section well capture the characteristics of the three-dimensional left chamber flow, “mapping the segmented … to scale onto a plane”.
Page 30 paragraph last 2 - FIG. 28 is a streamline visualization of the left ventricular intracardiac blood flow in the phase between the early and middle contractions analyzed by ultrasonic VFM (vector flow mapping), that is, the phase in which the aortic valve begins to be released. ).
Regarding claim 3, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 1.
Takeshi discloses displayed on the user interface of the segmented heart valve (Page 21 paragraph last - The display unit 30 displays the topological data structure extracted from the flow pattern.
Page 30 paragraph last 2 - FIG. 28 is a streamline visualization of the left ventricular intracardiac blood flow in the phase between the early and middle contractions analyzed by ultrasonic VFM (vector flow mapping), that is, the phase in which the aortic valve begins to be released.
Page 2 paragraph 1 - regarding the blood flow in the heart, the blood flow velocity distribution in the heart is acquired by the technique of acquiring the blood flow velocity distribution from the ultrasonic measurement cross section and displaying the streamline (see Patent Document 3), and the cardiac MRI. , A technique for displaying a streamline in a lumen or a cross section (see Patent Document 4) is disclosed.).
Andrea discloses 2D model is displayed on the user interface next to the 3D (Fig. 10 and Fig. 11 - Page 39 Paragraph 4 - The GUI further comprises an implantation plane display 82. This is a 2D simulation of the implantation plane of the aortic root 17, for example, as it might appear on a 2D fluoroscopy image. Such an image may be computed from the 3D anatomical model data, for example. The anatomical representation in the implantation plane display 82 is geometrically registered to the 3D anatomical model data used to generate the vascular route display 81.
Page 40 Paragraph 2 - Optionally, a ray-based projection algorithm may be used to generate a prediction 85 of the appearance of the traces of the radiopaque markers in the 2D fluoroscopy view of the implantation plane display 82 based on the projected location of the prosthesis in the 3D anatomical model data. The rotation of the prosthesis 30 relative to the 3D anatomical model may be generated using an algorithm according to the first aspect, with the prior knowledge of the desired optimal prosthesis rotation angle at the deployment location, thus “2D is displayed next to the 3D”.).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with 2D model is displayed on the user interface next to the 3D as taught by Andrea. The motivation for doing is to improve patient outcome.
Regarding claim 4, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 1.
Takeshi discloses includes commissure pointsIt is cut along the anterior-posterior axis so as Page 4 paragraph 2 - to cross the commissure of the mitral valve, and becomes an exit, and the cross section is cut line-symmetrically at the center of the anterior-posterior valve apex of the mitral valve on the posterior wall side to form a boundary line, “separating line between at least two leaflets”.
It is knows that mitral valve is considered a two-leaflet heart valve.).
Regarding claim 5, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 4.
Takeshi discloses comprises instructions to [[modify a position]] of at least one commissure point
Page 4 paragraph 2 - to cross the commissure of the mitral valve, and becomes an exit, and the cross section is cut line-symmetrically at the center of the anterior-posterior valve apex of the mitral valve on the posterior wall side to form a boundary line. At these boundaries, the mitral valve is a source boundary during diastole and the aortic valve is a sink boundary during systole.
Display, Page 30 paragraph last 2 - FIG. 28 is a streamline visualization of the left ventricular intracardiac blood flow, in which the aortic valve begins to be released.
Page 27 paragraph last - FIG. 27 (c) is a typical intra-section two-dimensional flow failure pattern often seen in late left ventricular dilatation, which is referred to as “pattern D”. First, pattern B in FIG. 27 (a) is a situation in which a uniform flow flows from bottom to top in the region of interest, “topology-based 2D model”.
Page 21 paragraph last - The display unit 30 may further show the flow pattern itself in the region of interest by displaying the streamline extracted from the original image of the flow and its singular point, “, “topology-based 2D model”.).
Andrea discloses instructions to modify a position of at least one point (
Page 40 Paragraph 2 - Optionally, a ray-based projection algorithm may be used to generate a prediction 85 of the appearance of the traces of the radiopaque markers in the 2D fluoroscopy view of the implantation plane display 82 based on the projected location of the prosthesis in the 3D anatomical model data. The rotation of the prosthesis 30 relative to the 3D anatomical model may be generated using an algorithm according to the first aspect, with the prior knowledge of the desired optimal prosthesis rotation angle at the deployment location, thus rotation changes position.).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with instructions to modify a position of at least one point as taught by Andrea. The motivation for doing is to improve patient outcome.
Regarding claim 6, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 4.
Takeshi discloses wherein the on both the topology-based 2D model
Page 4 paragraph 4 - They cause flow detachment as the inflow blood flow through the mitral valve during diastole, resulting in a larger radius vortex around the wide anterior leaflet of the valve belly. A torus-shaped vortex is generated three-dimensionally, “3D visualization”
Page 27 paragraph last - FIG. 27 (c) is a typical intra-section two-dimensional flow failure pattern often seen in late left ventricular dilatation, which is referred to as “pattern D”. First, pattern B in FIG. 27 (a) is a situation in which a uniform flow flows from bottom to top in the region of interest, “topology-based 2D model”.
Page 21 paragraph last - The display unit 30 may further show the flow pattern itself in the region of interest by displaying the streamline extracted from the original image of the flow and its singular point. ).
Andreas discloses the commissure points Page 17 paragraph 2 - the rotation marker 54 may comprise three markings, such as lines, that are visible to an operator and each aligned with commissural posts 35a-c of a prosthesis 30 when the prosthesis 30 is collapsed inside the intervention device. Lines are made up of points on the display. ) .
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with the commissure points
Regarding claim 7, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 4.
Takeshi discloses add a new [[point]] and/or to delete a [[point]] (Page 1 paragraph 1 - deleting the extracted streamline structure, until the route is reached. The COT representation generation means converts the tree representation configured).
Andreas discloses commissure point (Page 17 paragraph 2 - the rotation marker 54 may comprise three markings, such as lines, that are visible to an operator and each aligned with commissural posts 35a-c of a prosthesis 30 when the prosthesis 30 is collapsed inside the intervention device. Lines are made up of points on the display. )
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with commissure point as taught by Andrea. The motivation for doing is to improve patient outcome.
Regarding claim 8, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 4.
Takeshi discloses includes the plurality of leaflets
Page 4 paragraph 2 - cut along the anterior-posterior axis so as to cross the commissure of the mitral valve, and becomes an exit, and the cross section is cut line-symmetrically at the center of the anterior-posterior valve apex of the mitral valve on the posterior wall side to form a boundary line. At these boundaries, the mitral valve is a source boundary during diastole and the aortic valve is a sink boundary during systole, unless valve regurgitation is present.
It is knows that mitral valve is considered a two-leaflet heart valve.)
Andreas discloses labelling [[the plurality of leaflets]] (Page 17 paragraph 2 - the rotation marker 54 may comprise three markings, such as lines, that are visible to an operator and each aligned with commissural posts 35a-c of a prosthesis 30 when the prosthesis 30 is collapsed inside the intervention device. Lines are made up of points on the display. )
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with labelling [[the plurality of leaflets]] as taught by Andrea. The motivation for doing is to improve patient outcome.
Regarding claim 9, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 1.
Takeshi discloses includes a structure surrounding the heart valve (
Page 21 paragraph last - The display unit 30 displays the topological data structure extracted from the blood flow pattern.
Page 2 paragraph 5 - FIG. 1 shows the periodic movements of blood flow, blood pressure, and heart valve associated with contraction / expansion of the heart (left ventricle) in normal dissection (visceral orientation, atrioventricular connection, large vessel connection orientation). Normally, in the left ventricle, the mitral valve, which is the atrioventricular valve at the entrance of blood flow, and the aortic valve, which is the semilunar valve, which is the exit of blood flow, repeatedly open and close, and the following four phases are displayed.).
Regarding claim 11, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 1.
Takeshi discloses projecting a flow phenomenonPage 21 paragraph last - The display unit 30 displays the topological data structure extracted from the flow pattern.
Page 3 paragraph 1 - The blood flow vector drawn in this cross section should be a projection of the 3D blood flow vector onto the 2D cross section. As for the eddy current of the left chamber blood flow, it is assumed that the vector and orbit of the flow in this cross section well capture the characteristics of the three-dimensional left chamber flow of a heart.),
identifying a location on the topology-based 2D modelPage 21 paragraph last - The display unit 30 displays the topological data structure extracted from the flow pattern, “based 2D model”. Page 21 paragraph last - The display unit 30 may further display the COT expression generated by the COT expression generation means 23 in addition to the topological data structure. The display unit 30 may further fill and display the eddy current region corresponding to the COT expression. Page 21 paragraph last - The display unit 30 may further show the flow pattern itself in the region of interest by displaying the streamline extracted from the original image of the flow and its singular point. Further, when the flow pattern is a flow pattern of intraventricular blood flow, the display unit 30 may further display an ultrasonic VFM (vector flow mapping) image or a blood flow velocity vector. );
and providing a marker at the identified location (Page 24 paragraph 1 - After assigning the COT representation, remove the structure from the orbital structure and replace it with the label . By replacing the label in this way, it is possible to express that the structure "does not have" inside, and it is possible to convert the upper structure including the extracted structure into the innermost structure. This operation is continued until all 0-dimensional structures are exhausted, “providing a marker”.
Page 21 paragraph last - The display unit 30 may further display the COT expression generated by the COT expression generation means 23 in addition to the topological data structure.
Page 25 paragraph 2 - (Step 2) Next, the innermost (that is, labeled as without a structure inside) one-dimensional structure and two-dimensional structure are searched from the ss-saddle connection diagram in the region of interest Ω, “identified location”.).
Regarding claim 12, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 11.
Takeshi discloses includes a computer graphical representation of flow phenomenonPage 21 paragraph last - The display unit 30 may further show the flow pattern itself in the region of interest by displaying the streamline extracted from the original image of the flow and its singular point. Further, when the flow pattern is a flow pattern of intraventricular blood flow, the display unit 30 may further display an ultrasonic VFM (vector flow mapping) image or a blood flow velocity vector.).
Regarding claim 13, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 11.
Takeshi discloses receiving indicative of a location on the model in which no marker should be displayed (
Page 24 paragraph 1 - After assigning the COT representation, remove the structure from the orbital structure and replace it with the label . By replacing the label in this way, it is possible to express that the structure "does not have" inside, and it is possible to convert the upper structure including the extracted structure into the innermost structure. This operation is continued until all 0-dimensional structures are exhausted, “no marker should be displayed”.
Page 21 paragraph last - The display unit 30 may further display the COT expression generated by the COT expression generation means 23 in addition to the topological data structure.
Page 25 paragraph 2 - (Step 2) Next, the innermost (that is, labeled as without a structure inside) one-dimensional structure and two-dimensional structure are searched from the ss-saddle connection diagram in the region of interest Ω, “indicative of a location”.
).
Andreas discloses receiving user input (Page 17 paragraph 2 - the rotation marker 54 may comprise three markings, such as lines, that are visible to an operator and each aligned with commissural posts 35a-c of a prosthesis 30 when the prosthesis 30 is collapsed inside the intervention device. Lines are made up of points on the display. )
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with receiving user input as taught by Andrea. The motivation for doing is to improve patient outcome.
Regarding claim 14, see rejection on claim 1.
Regarding claim 15, see rejection on claim 1.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Takeshi (Publication: WO 2021/153721 A1) in view of Andreas et al. (Publication: WO 2022/022994 A1), WATANABE ET AL. (PUBLICATION: US 2008/0085043 A1) and Langeland (Publication; US 2020/0098125 A1).
Regarding claim 10, Takeshi in view of Andrea, Wantanabe disclose all the limitation of claim 1.
Takeshi discloses wherein the visualisation of a segmented heart valve is a [[dynamical 4D visualization]] of the heart valve (
Page 21 paragraph last - The display unit 30 displays the topological data structure extracted from the blood flow pattern.
Page 2 paragraph 5 - FIG. 1 shows the periodic movements of blood flow, blood pressure, and heart valve associated with contraction / expansion of the heart (left ventricle) in normal dissection (visceral orientation, atrioventricular connection, large vessel connection orientation). Normally, in the left ventricle, the mitral valve, which is the atrioventricular valve at the entrance of blood flow, and the aortic valve, which is the semilunar valve, which is the exit of blood flow, repeatedly open and close, and the four phases are displayed.).
Takeshi in view Andreas do not however Langeland discloses
dynamical 4D visualisation of the heart valve ([0039] - may automatically superimpose a marker on a mitral valve of the heart detected in 4D volume renderings presented at the display system 134 based on the coordinates identifying the mitral valve associated with the volume renderings by the structure recognition module 160.).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Takeshi in view of Andrea, Wantanabes with dynamical 4D visualisation of the heart valve as taught by Langeland. The motivation for doing is to improve efficiency.
Response to Arguments
Claim Rejection Under 35 U.S.C. 103
The applicant asserts “35 U.S.C. § 103 Rejections Claims 1 --- 9, and 11 --- 15 are rejected under 35 U.S.C. 103 as being unpatentable over Takeshi (Publication: WO 2021/153721 Al) in view of Andreas et al. (Publication: WO 2022/022994 A1). Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Takeshi (Publication: WO 2021/153721 Al) in view of Andreas et al. (Publication: \VO 2022/022994 Al) and Langeland (Publication; US 2020/0098125 Al)_ Applicant respectfully traverses. Independent claim l has been amended to recite "creating a topology-based 2D model of the heart valve, wherein the topology-based 2D model is a simplified visualisation of the characteristics of the heart valve including a heart valve annulus, and wherein the topology-based 2D model is characterized by valve leaflets." Support for this amendment may be found in, for example, paragraph [0023] of the current specification. The cited references Takeshi in view of Andreas do not teach or suggest the subject matter amended into amended claim 1.”
The argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Watanabe reference.
During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. See MPEP § 2111. Further, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See also MPEP § 2145(VI).
Regarding claims 2 – 13, the Applicant asserts that they are not obvious over based on their dependency from independent claim 1. The examiner cannot concur with the Applicant respectfully from same reason noted in the examiner’s response to argument asserted from claim 1.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ming Wu whose telephone number is (571) 270-0724. The examiner can normally be reached on Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devona Faulk can be reached on 571-272-7515. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ming Wu/
Primary Examiner, Art Unit 2618
Prosecution Insights