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 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: “imaging system for acquiring images of the target region and/or the non-target region” in claims 8 - 11.
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 § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1 - 19 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 13 have been amended to recite limitations directed towards “based on the comparison, computationally updating the values of at least some of the ultrasound parameters during the sonication” and “wherein steps (c)-(f) are performed during a single sonication of the target region so that the ultrasound parameters are dynamically adjusted throughout the ultrasound procedure”.
The specification does not disclose “updating the values of … the ultrasound parameters during the sonication”. In contrast, the ‘optimization’ step 240 is performed after ‘treatment and monitoring’ step 230 (see steps 230 and 240 in fig. 2 and corresponding description in [0042] - [0044]). Similarly, steps (d), (e), and (f) are not disclosed as being ‘performed during a single sonication’. In contrast, the ‘comparing’ and ‘computational updating’ are part of ‘optimization’ step 240 ([0042], fig. 2), which occurs after ‘treatment and monitoring’ step 230 ([0042] - [0044] and fig. 2). Moreover, the optimization/updating accounts for the deactivation of the transducer elements between short sonications ([0037], [0039]), thus further reflecting that the updated parameters are applied during subsequent sonications, rather than an initial “single” sonication. There does not appear to be any portion of the specification that suggests that the ultrasound parameters are updated during active emission of ultrasound energy from the transducer elements (i.e., “during the sonication” or during a “single sonication”).
Claims 1, 13, and all claims depending therefrom, thus introduce new matter.
Claim 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 1 - 19 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.
Claim 1 is indefinite for the following reasons:
There is unclear antecedent basis for “a single sonication” (last paragraph). It is unclear if this is the sonication in step (b).
It is unclear what is intended by “a single sonication”. It is unclear if this refers to emission of a single ultrasound wave, a series of ultrasound waves applied to a specific focal zone, a series of ultrasound waves only within a specific timeframe, or if some other meaning is intended.
There is insufficient antecedent basis for “the ultrasound procedure” (last paragraph). It is unclear if this is the sonication in step (b).
It is unclear how the values of the ultrasound parameters are updated during the sonication” and how “steps (c)-(f) are performed during a single sonication of the target region …” As explained in the 112(a) rejections above, the specification does not disclose the claimed subject matter.
It is unclear how “steps (c)-(f) are performed during a single sonication of the target region so that the ultrasound parameters are dynamically adjusted throughout the ultrasound procedure”, as an ultrasound procedure is understood to encompass multiple sonications, rather than a “single sonication”, such that updating parameters during a single sonication as claimed would not result in the claimed effect (i.e., dynamic adjustment throughout the procedure). It is unclear if the claim intends to require repetition of steps (c)-(f) throughout the ultrasound procedure.
Claim 5 is indefinite because it is unclear how the claimed repetition relates to performing steps (c)-(f) “so that the ultrasound parameters are dynamically adjusted throughout the ultrasound procedure”, as recited in claim 1. It is unclear if these are two different features or not.
Claim 13 is indefinite for the following reasons:
There is unclear antecedent basis for “a single sonication” (last paragraph). It is unclear if this is the sonication in step (b).
It is unclear what is intended by “a single sonication”. It is unclear if this refers to emission of a single ultrasound wave, a series of ultrasound waves applied to a specific focal zone, a series of ultrasound waves only within a specific timeframe, or if some other meaning is intended.
There is insufficient antecedent basis for “the ultrasound procedure” (last paragraph). It is unclear if this is the sonication in step (b).
It is unclear how the values of the ultrasound parameters are updated during the sonication” and how “steps (c)-(f) are performed during a single sonication of the target region …” As explained in the 112(a) rejections above, the specification does not disclose the claimed subject matter.
It is unclear how “steps (c)-(f) are performed during a single sonication of the target region so that the ultrasound parameters are dynamically adjusted throughout the ultrasound procedure”, as an ultrasound procedure is understood to encompass multiple sonications, rather than a “single sonication”, such that updating parameters during a single sonication as claimed would not result in the claimed effect (i.e., dynamic adjustment throughout the procedure). It is unclear if the claim intends to require repetition of steps (c)-(f) throughout the ultrasound procedure.
Claim 14 is indefinite because it is unclear how the claimed repetition relates to performing steps (c)-(f) “so that the ultrasound parameters are dynamically adjusted throughout the ultrasound procedure”, as recited in claim 13. It is unclear if these are two different features or not.
Dependent claims that are listed in the rejection header above as being rejected while not having been specifically addressed are rejected by virtue of dependency.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 - 2, 5 - 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2015/359603, of record) in view of Vahala et al. (US 2012/0296197).
Regarding claims 1 and 13, Levy shows a system and method for delivering ultrasound energy to a target region (focused-ultrasound procedures, [0002]). The system comprises an ultrasound transducer comprising a plurality of transducer elements (“ultrasound transducer 302 …elements 304”, [0045] and fig. 3) for generating a focal zone of acoustic energy at the target region, and a controller (“computational facility …computer 312”, [0046] and fig. 3) that is used to:
(a) computationally determine values of ultrasound parameters associated with the transducer elements and predict the treatment effects at the target region and/or the non-target region (“treatment planner determines treatment profile parameters for the sonications at each focal point…”, [0031] “simulation of the sonications … effect on the tissue …” [0033]; steps 114 and 116 in fig. 1);
(b) execute a sonication by operating the ultrasound transducer based on the determined values to deliver ultrasound energy to the target region (“commence actual treatment of the instant region, i.e., execute the plan”, [0039] and step 130 in fig. 1; “using a treatment device to conduct a first portion of the treatment”, claim 2);
(c) obtain from a measurement system an actual treatment effect measured in real-time (“[t]reatment of a region … monitored .., e.g., using MRI thermometry or direct temperature sampling”, [0040] and step 132 of fig. 1; “monitoring the effect of the conducted treatment”, claim 2);
(d) compare the measured actual treatment effect against the predicted treatment effects (“…measured temperature distribution … compared with the predicted temperature distribution”, [0040]; “comparing the experimentally monitored treatment effect with the predicted treatment effect”, claim 2);
(e) based on the comparison, computationally update the values of at least some of the ultrasound parameters (“ … update the treatment plan”, [0040] - [0042]; “revising the treatment plan based on the adjusted model”, claim 2); and
(f) operate the ultrasound transducer based on the updated values during the treatment (“conducting a second portion of the treatment in accordance with the revised treatment plan”, [0016]; [0040] - [0041]; “… updated treatment plan on the fly…”, [0042] and step 130 on fig. 1; “conducting a second portion of the treatment in accordance with the revised treatment plan”, claim 2).
Levy is not specific to the measurement, updating, and operation steps being performed during the sonication.
Vahala discloses high intensity focused ultrasound guided by magnetic resonance imaging. Vahala teaches measurement, updating, and operation steps being performed during a sonication (“thermometry data acquired during the sonication may be used to modify the treatment plan during sonication”, [0006]; [0014]; “modification of the treatment plan occurs during sonication of the target volume … while ultrasound energy is applied to the transducer of the high-intensity focused ultrasound system”, [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Levy to have the measurement, updating, and operation steps be performed during the sonication, as taught by Vahala, in order to lead to better and more efficient treatments than if the treatment plan were adjusted after a sonication is finished, as suggested by Vahala ([0015]).
Examiner note: the prior art is interpreted as meeting the claim as best understood in light of the written description and clarity deficiencies discussed in the 112(a) and 112(b) rejections above.
Regarding claims 2 and 15, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows that the measurement system comprises a magnetic resonance imaging device that is used to measure the treatment effects (“MRI apparatus 310 (or other imaging device)”, [0043] and fig. 3), as explained above.
Regarding claims 5 and 14, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows repeating steps (c)-(f) ([0040] - [0042] and iterative steps 128, 130, and 132 in fig. 1).
Regarding claim 6, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows the ultrasound parameters comprise a power, a frequency, a phase, a position and an activation pattern ([0031] and step 112 in fig. 1).
Regarding claims 7 and 19, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows the treatment effects comprise temperature (“…measured temperature distribution … compared with the predicted temperature distribution”, [0040]), as explained above.
Regarding claim 8, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows an imaging system for acquiring images of the target region and/or the non-target region (“MR images … MR thermometry”, [0035]).
Regarding claim 9, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows the controller is configured to analyze the acquired images for determining an anatomic characteristic and/or material characteristic of tissue in the target region and/or the non-target region (“material properties or other physical quantities”, [0033]; “experimental model, derived from measurements … is used either in lieu of or supplementing a physical model …, tissue densities or other physiological properties …MR images”, [0035]).
Regarding claim 10, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows the anatomic characteristic comprises a density (“ … tissue densities or other physiological properties …”, [0035]) associated with the issue.
Regarding claim 11, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows the material characteristic comprises a speed of sound (“ … speed of sound …”, [0033]).
Regarding claim 12, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows the ultrasound transducer is a phased-array transducer (‘ … transducer elements 304 form a “phased array” capable of steering the ultrasound beam in a desired direction …’, [0045]).
Claims 3 - 4 and 16 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over Levy and Vahala as applied to claims 2 and 13 above, and further in view of Hutchinson et al. (US 6,135,971, of record).
Regarding claims 3 - 4 and 16 - 17, the combined invention of Levy and Vahala discloses the claimed invention substantially as noted above. Levy further shows computing deviations of the measured actual treatment effects from the predicted treatment effects (“measured temperature distribution may … discrepancies … used to update the treatment plan”, [0040]) and defining a metric defined based on the deviations, and simultaneously and iteratively updating values of some of the ultrasound parameters (“ … adjust … set of parameters … re-computation of the treatment effect based on adjustments to the initially selected parameter(s) … decrease the discrepancy satisfactorily” [0040]) until a value of the metric is minimized or below a predetermined threshold (“… fitting the model to the measurements … fitting is based on measured iso-surfaces corresponding to respective constant temperatures or thermal doses … bounded by pre-set limits”, [0041] - at least the ‘fit’ to the model is a ‘metric’).
However, Levy does not specifically state that the metric is a cost function.
Hutchinson discloses devices for ultrasound deposition in body tissue for use in medical treatment. Hutchinson teaches a metric that is a cost function (“ … algorithm minimizes a cost function …”, col. 8, lines 52 - 67 ).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the combined invention of Levy and Vahala to have the metric be a cost function, as taught by Hutchinson, in order to use conventional and well-understood mathematical operations to ensure that the temperature distribution is as close to a desired value as possible.
Examiner note: applicant discloses no criticality of the use of a cost function, as parameter optimization may be achieved in the instant invention using other techniques instead, as explained in [0045] of the instant published specification.
Regarding claim 18, the combined invention of Levy, Vahala, and Hutchinson discloses the claimed invention substantially as noted above. Levy further shows the ultrasound parameters comprise a power, a frequency, a phase, a position and an activation pattern ([0031] and step 112 in fig. 1).
Response to Arguments
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive or are moot in view new grounds of rejection.
Applicant asserts on page 6 that support for the claim amendments may be found in [0009], [0034], [0042] - [0044] and fig. 2.
Examiner respectfully disagrees for reasons explained in the 112(a) rejections above.
Applicant’s arguments regarding the art rejections are moot, as Vahala is introduced to address the amended features.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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