DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: image processing means and means for calculating in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinott et al., Pub. No. US 2020/0166593 (hereinafter “Rinott”).
Regarding claim 1, Rinott discloses an assembly for heat treatment of a target region of biological tissue (paragraphs [0033 ]-[0044]; figure 1, (100)), comprising:
a heat energy generator (implicit);
an energy applicator coupled to said generator and designed to deposit the heat energy into the target region so as to induce a change in temperature (104);
an assembly for heat treatment of a target region of biological tissue (paragraphs [0033 ]-[0044]; figure 1, (100)), comprising:
a heat energy generator (implicit);
an energy applicator coupled to said generator and designed to deposit the heat energy into said target region so as to induce a change in temperature (104);
an MRI image capturing device designed to generate at least one anatomical MRI image and at least one MRI phase image ((102) and [40]);
an MRI image capturing device designed to generate at least one anatomical MRI image and at least one MRI phase image ((102) and [40]);
a planning unit (paragraphs [0045 ]-[0051]; figures 2a and 3a-c, (210)) comprising a means for processing MRI images which is designed to define the target region Re ({46] and (210)), a region Rp to be preserved ({[49] and [60]) and a neutral region Rn on said at least one anatomical MRI image ({49] and [60]), said means for processing MRI images also being designed to assign a heat treatment setpoint to each of the three regions (The heat treatment setpoints of Rp and Rn must not be different. In paragraph [60], three regions are implicitly defined with different heat treatment setpoints) and to assign an acceptable temperature measurement uncertainty to each of the three regions ({60]: "In addition, the predetermined threshold(s) for deciding whether the temperature increase in a thermal map results from a tissue response to the thermal treatment or some extraneous artifacts (described in steps 216, 222, 256, 258) … For example, because the target tissue is to be ablated in ultrasound treatment, the thresholds of temperature increase corresponding to the target tissue may be larger than those corresponding to the non-target tissue. In addition, if the non-target tissue next to the target region is a sensitive and/or important organ, the risk of damaging the non-target organ is high, and the need for protecting the sensitive/important non-target organ is heightened. Consequently, in this situation, the predetermined thresholds corresponding to the temperature increase in the non-target tissue may be smaller than for the situation where non-sensitive and/or clinically unimportant non-target tissue surrounds the target region.");
a unit for monitoring the progression of the heat treatment status (implicit), which is designed to receive data from the planning unit ((2/4): implicit from "predicted thermal map") and data from the MRI image capturing device in real time during a heat treatment phase (2/4), the monitoring unit comprising a means for generating temperature images on the basis of said at least one MRI phase image (212), and a means for calculating an indicator of the reliability of the change in temperature indicated on the temperature image ((2/6) and (222); see also figures 3a-c) and a means for calculating an indicator of the heat treatment status in each of the three regions (the imaged temperature of the regions is an indicator of the heat treatment status. In addition, automatically terminating the treatment when a predefined parameter reaches a threshold value cannot be considered inventive; see for example WO 2019/069135, paragraphs [0057] and [0062 ]), wherein the means for calculating a quantitative indicator of the heat treatment status being designed to:
spatially correlate the anatomical MRI image with the temperature images generated during the heat treatment ([45]-[46]);
compare the temperature and/or the heat dose associated with each pixel in the three regions with the predefined heat treatment setpoint in each of the three regions;
determine the number of pixels which satisfy the predefined heat treatment setpoint for each of the three regions, said number corresponding to the quantitative indicator of the heat treatment status in real time;<strikethrough] - generate signals in real time which indicate the heat treatment status and the temporal progression of the quantitative indicators in the three regions ((212), (222)).
Regarding claim 2 and 3, Rinott paragraphs [0012] and [0053]: the prediction may use a CT image. The recalibration means is therefore implicit.
Regarding Claim 4: Rinott, paragraph [0063]; figure 6 and paragraphs [0049]-[0050]; figures 3a-c: D1 does not indicate that the number of pixels has to be used for the result. As such, this method does not have a technical effect because the usefulness of the response depends on the number of pixels in each region. The criterion of D1 or a calculation of the percentage of pixels has a technical effect.
Regarding claim 9, Rinott paragraph [0050]: the thermal therapy applicator delivers a beam of energy (e.g., ultrasonic energy) along a beam 412 having a nominal direction.
Regarding claim 10, Rinott paragraph [0037], Figure 1: the image data may then be displayed on a monitor 126, such as a computer CRT, LCD display or other suitable display.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 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.
Claim 11 is 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.
Claim 11 recites the limitation "the status of heat treatment" in line. There is insufficient antecedent basis for this limitation in the claim. Thus, this limitation renders indefinite claim 11 and dependent claim 12-14. Appropriate correction is required.
Allowable Subject Matter
Claims 5-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED M FARAH whose telephone number is (571)272-4765. The examiner can normally be reached Mon - Fri. 9:30AM -10:30 PM.
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/AHMED M FARAH/Primary Examiner, Art Unit 3792