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 .
Status of Claims
Claims 1, 5, 7, 8, and 11 have been amended.
Claim 6 has been cancelled. Claims 3, 9, 10, 15, 16, 18, and 19 were previously cancelled.
Claims 1-2, 4-5, 7-8, 11-14, 17, and 20-24 are pending.
The Section 112(b) rejection of claims 1, 2, 4-8, 11-14, 17, and 20-24 is maintained as discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities. Examiner recommends amending the claim as shown below. Similar changes may be necessary for claim 11:
…
set a three-dimensional coordinate system that forms x-, y-, and z-axes of a three- dimensional high-resolution image acquired by a user, wherein the three-dimensional high-resolution image represents a human organ to be targeted for medical procedure, and set a point where the medical tool is to be inserted into the organ, wherein the point is determined as a reference point of the three-dimensional coordinate system;
set the reference point as a start point of three-dimensional shape data of the medical tool;
identify, on the three-dimensional high-resolution image, a portion of the organ that maintains a substantially straight shape from the reference point to a distance h1, and a curvature occurrence point on the three-dimensional high-resolution image located after the distance h1 from the reference point, wherein the distance h1 is a distance from the reference point to the curvature occurrence point on the three-dimensional high-resolution image;
detect, as a trigger, an onset of curvature in the three-dimensional shape data during insertion, and determine a distance h2 from the reference point to a curvature occurrence point on the three-dimensional shape data corresponding to the detected onset of curvature, wherein the distance h2 is a distance from the reference point to the curvature occurrence point on the three-dimensional shape data;
compare a stretchability parameter acquired by the user to a predetermined threshold, and based on the comparison, determine the distance h2 such that when the stretchability parameter is greater than the predetermined threshold, h2 is determined to be near h1, and when the stretchability parameter is less than the predetermined threshold, h2 is determined to be shorter than h1….
Claims 20-24 are objected to because of the following informalities:
Claims 20-24 each appear to be written in an independent form, yet also refers back to the other independent claims (i.e., respectively claims 11, 12, 13, 14, and 17). In an interpretation, each of claims 20-24 may be construed as an independent claim; and in another interpretation each may also be construed as a dependent claim. In order to prevent any ambiguity, it is suggested to bring the entirety of the claim from which each of claims 20-24 depend added to the respective claim (e.g., claim 11 subject matter added to claim 20) to have the claim construed as a proper independent claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-2, 4-5, 7-8, 11-14, 17, and 20-24 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
“Stretchability parameter”
Claims 1 and 11 require comparing a stretchability parameter acquired by the user to a predetermined threshold. While the specification refers to “stretchability” and other physical properties (see, e.g., page 20, lines 14-21, which correspond to [0103] and [0104] of the published application US 2024/0285349 A1), the application does not define “stretchability parameter.” The specification uses the term “stretchability” at three locations. First, “the registration unit 130 may predict, through physical properties (stretchability, hardness, length, etc.) of the human organ, a change in a shape of the organ in a portion of the human organ in which the medical tool is inserted after the medical tool is inserted….” (see, e.g., page 19, lines 9-14, which correspond to [0097] of the published application US 2024/0285349 A1). Second, the specification provides two high-level examples to demonstrate how a stretched distance “h” might be different if the organ has a “high stretchability” or “low stretchability.” (see, e.g., page 20, lines 14-21, which correspond to [0103] and [0104] of the published application US 2024/0285349 A1). However, the specification does not describe what is meant by a high stretchability, a low stretchability, or any other level of stretchability. Moreover, the term “parameter” could include a numerical value, a dynamic variable, or a model.
Moreover, in the context of surgical navigation, it is clear that there is not a common or standard definition of “stretchability” used by those having ordinary skill in the art applied to organs. (see, e.g., Zhang et al. "Deformable models for surgical simulation: a survey," IEEE reviews in biomedical engineering 11 (2017) (143-164) (hereinafter “ZHANG”). ZHANG notes that “[m]ost biological soft tissues exhibit anisotropic and heterogeneous stiffness and are nearly incompressible, leading to ill-conditioned problems during simulation.” (Id., p.1, bottom left column). ZHANG surveys several deformable models and divides them into different categories and examines common considerations, such as “linear and nonlinear deformable modeling, model internal forces, and numerical time integrations, together with modeling of soft tissue anisotropy, viscoelasticity, and compressibility.” (Abstract). ZHANG finds that “[a]mong various deformable models proposed for modeling of soft tissue deformation, it is obvious that there is no single deformable model that can address both requirements of realistic and real-time surgical simulation.” (Id, p.15, Discussion, first paragraph).
It is also not clear if the meaning “stretchability parameter” considers the physical properties of the organ only or if it also considers properties of the tool being inserted through the organ. As demonstrated by CHOPRA '869 (discussed below), when determining how much a tissue is displaced, one should consider not only the physical properties of the organ but also the properties of the tool. (see, e.g., CHOPRA '869 at Figure 9 and [0084]-[0089]). For example, if the tool is more rigid, the organ will stretch when pushed by the tool. But if the tool is less rigid, the organ will resist stretching.
Without a clear definition from the specification for “stretchability parameter,” it is not clear what would be compared to a predetermined threshold. Moreover, it is not clear if the claims require any consideration to the tool’s physical properties. As such, a person of ordinary skill in the art cannot interpret the metes and bounds of the claims. “If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate.” (MPEP 2173.02, II).
“Acquired by the user”
Each of claims 1 and 11 also recite that the stretchability parameter is “acquired by the user.” The claims and specification do not describe how the stretchability parameter is acquired by the user. The phrase could mean “acquired from the user” or “provided by the user” as suggested by Applicant, but it could also mean that the stretchability parameter was “acquired by the user,” (i.e., the user received the parameter from a source or determined the parameter). The specification does not suggest any of the above suggested meanings.
“Near h1” and “shorter than h1” overlap one another
Each of claims 1 and 11 also recites “when the stretchability is greater than the predetermined threshold, h2 is determined to be near h1,and when the stretchability is less than the predetermined threshold, h2 is determined to be shorter than h1.” It is not clear how one having ordinary skill in the art could distinguish the differences between “near h1” and “shorter than h1.” For example, near h1 could by 2.0 millimeters (mm) above or below h1 (i.e., ±2.0 mm). However, shorter than h1 would include 0.1-2.0 mm below h1. To provide one example, if h1 is 20 mm then near h1 could be 18-22 mm and shorter than h1 could be 18-20 mm. Thus, “near h1” and “shorter than h1” have overlapping meanings such that “greater than the predetermined threshold” and “less than the predetermined threshold” could result in the same determination for h2.
As all other claims depend directly or indirectly from claim 1 or from claim 11, all claims (i.e., claims 1, 2, 4-8, 11-14, 17, and 20-24) are rejected for being indefinite.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-2, 4-5, 7-8, 11-14, 17, and 20-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 each recite comparing “a stretchability parameter acquired by the user with a predetermined threshold….” Applicant’s disclosure does not adequately support this claim limitation such that the disclosure reasonably conveys to one skilled in the relevant art that the inventors had possession of the claimed invention.
The above claim limitation appears to be derived from page 20, lines 14-24, of the disclosure which provides two high-level examples to demonstrate how a stretched distance “h” might be different if the organ has a “high stretchability” or “low stretchability.” (see, e.g., page 20, lines 14-21, which correspond to [0103]-[0105] of the published application US 2024/0285349 A1).
For example, when the human organ has high stretchability, since the organ may be stretched by a distance distant to a distance ‘h’ depending on the physical properties of the stretchable human organ when the insertion of the medical tool results in curvature, the portion C where the bend occurs may be predicted to remain near ‘h’ as illustrated in FIG. 10D.
For example, when the human organ has low stretchability, since the organ is unlikely to be stretched depending on the physical properties of the low-stretchable human organ when the insertion of the medical tool results in curvature, the portion C where the curvature occurs may be predicted to occur at a shorter distance than ‘h’ as illustrated in FIG. 10E.
As described above, after the change in the shape of the organ is predicted in consideration of the physical properties of the human organ, the three-dimensional high-resolution image may be converted based on the predicted change in the shape of the organ.
Notably, the term “stretchability parameter” is not used nor is the term “predetermined threshold.” As best understood by the Examiner, the predetermined threshold is being inferred from “consideration of the physical properties of the human organ.”
As all other claims depend directly or indirectly from claim 1 or from claim 11, all claims (i.e., claims 1, 2, 4-8, 11-14, 17, and 20-24) are rejected for lacking written description.
Accordingly, the disclosure does not reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention.
Claims 1-2, 4-5, 7-8, 11-14, 17, and 20-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification provides:
For example, when the human organ has high stretchability, since the organ may be stretched by a distance distant to a distance ‘h’ depending on the physical properties of the stretchable human organ when the insertion of the medical tool results in curvature, the portion C where the bend occurs may be predicted to remain near ‘h’ as illustrated in FIG. 10D.
For example, when the human organ has low stretchability, since the organ is unlikely to be stretched depending on the physical properties of the low-stretchable human organ when the insertion of the medical tool results in curvature, the portion C where the curvature occurs may be predicted to occur at a shorter distance than ‘h’ as illustrated in FIG. 10E.
With both “near h1” and “shorter than h1” possibly meaning the same distance when the stretchability is high and when the stretchability is low, one having ordinary skill in the art could not make or use the invention from the disclosure coupled with information known in the art without undue experimentation.
It is not clear how one having ordinary skill in the art could distinguish the differences between “near h1” and “shorter than h1.” For example, near h1 could by 2.0 millimeters (mm) above or below h1 (i.e., ±2.0 mm). However, shorter than h1 would include 0.1-2.0 mm below h1. To provide one example, if h1 is 20 mm then near h1 could be 18-22 mm and shorter than h1 could be 18-20 mm. Thus, “near h1” and “shorter than h1” have overlapping meanings such that “greater than the predetermined threshold” and “less than the predetermined threshold” could result in the same determination for h2.
As all other claims depend directly or indirectly from claim 1 or from claim 11, all claims (i.e., claims 1, 2, 4-8, 11-14, 17, and 20-24) are rejected for not enabling one skilled in the art.
Accordingly, the disclosure does not enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant argues that the term “stretchability” or “stretchability parameter” is not indefinite because the claims recite that the “stretchability parameter” is a value of the organ that is provided by the user. (see page 11 of Applicant’s Response dated February 2, 2026). The “’stretchability’ is a value of the organ that is provided by the user…, thereby constraining the term to a specific input parameter.” Applicant also alleges that stretchability “is no longer an indeterminate characteristic left to subjective interpretation; rather, it is expressly limited to an organ stretchability value provided by the user.” First, the claims do not recite “stretchability value provided by the user.” Instead, the claims recite a “stretchability parameter acquired by the user.” If Applicant intends for “acquired by the user” to mean “provided by the user,” then Examiner recommends amending the claims as such. However, the phrase “provided by the user” is not supported by the disclosure.
Second, the claims do not recite a stretchability “value” but a stretchability “parameter.” The term parameter can be construed more broadly than value. For example, a parameter can mean dynamic variables, equations, or models. The disclosure does not suggest either interpretation because neither “value” nor “parameter” is used in the specification.
While the claim does recite comparing the parameter to a “predetermined threshold,” the predetermined threshold is not limited to being a numerical value. Likewise, Applicant’s disclosure does not use the term threshold. Instead, the disclosure discusses circumstances “when the human organ has high stretchability” and “when the human organ has low stretchability.” ([0103], [0104]).
As such, even if Applicant successfully argues that a “stretchability parameter acquired by the user” is adequately supported by the disclosure it is not clear what is meant by stretchability parameter. Furthermore, as explained above, it is clear that there is not a common or standard definition of “stretchability” that is used by those having ordinary skill in the art applied to organs in the context of surgical navigation. It is also not clear if “stretchability parameter” considers the physical properties of the organ only or if it also considers properties of the tool being inserted through the organ.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2011/0319815 A1 (“ROELLE”) teaches systems that use shape data to improve control or steering of an instrument. ROELLE teaches situations in which the instrument comes into contact with the environment or an obstruction. “If the bending stiffness of a section is known or has been adapted before coming in contact with an obstruction (49), the deviation between a predicted shape and an actual shape as measured can reveal where the instrument (1) makes contact and the degree of force with the environment or obstruction (49). If the estimate of bending stiffness, calculated simply from tendon positions and shape, were to rapidly change in conjunction with commanded movement, the device could be assumed to have come into contact with its environment.” ([0291]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON P GROSS whose telephone number is (571)272-1386. The examiner can normally be reached Monday-Friday 9:00-5:00CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-5284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797