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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 15, 2026 has been entered.
Response to Amendment
This Office action is responsive to the amendment filed with request for continued examination noted above. As directed by the amendment, claims 40 and 57 have been amended and the specification has been amended.
Claims 1-22, 40, 57, 84 and 85 remain pending.
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: "administration device for introducing a transient acoustic reflector” in claim 10.
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
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 40 and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by previously Vitek et al. US 2006058671 A1 hereinafter “Vitek” in view of Levy et al., US 20150359603 A1 hereinafter “Levy”.
Regarding claims 40 and 57, Vitek discloses a system and associated method (Figs. 1, 5, [0019]) comprising: an ultrasound transducer (“10” [0019]) comprising a plurality of transducer elements (“12” [0020]) for providing a series of sonications to at least one target region associated with treatment (“6”); and a controller (“18” [0019]) configured to: for the at least one target region associated with treatment, determine a phase value (Fig. 4 @ 308 [0038]: in this step it is determined that a phase of the transducer is to be adjusted) associated with a first one of the transducer elements (“12”) to be adjusted for generating a focus at the at least one target region (“6” examiner’s note: a focus is necessarily generated); predict, using a physical model or an imager, a therapeutic or acoustic change (Fig.4 @ 306a [0037] temperature or energy intensity change is predicted, [0042] measuring temperatures and energy intensities at target tissue comprises capturing temperature sensitive images, “The temperature sensitive image will illustrate the actual thermal dose distribution resulting from the application of the acoustic wave energy” i.e., an imager is used to predict temperature change which is a therapeutic or acoustic change) in the at least one target region (“6”) resulting from adjustment of the phase value (Fig. 4 @308); and if the predicted therapeutic or dynamic change exceeds a maximum allowable change or causes the therapeutic or acoustic dynamic change in the at least one target region to exceed a target value ([0038], Fig. 4 - prescribed target threshold), (i) determine (Fig. 4, repeat step 306a) at least one of a power level, an ultrasound frequency or an energy level associated with the first one of the transducer elements and/or a second one of the transducer elements for reducing the predicted therapeutic or acoustic change, and (ii) activate the ultrasound transducer (“10”) (examiner’s note: determined treatment parameters in [0041] will necessarily be used to activate the transducer “10”), based at least in part on at least one of the determined phase value, power level, ultrasound frequency or energy level (paragraph 41: determined operational parameters).
Vitex does not explicitly disclose that the therapeutic or acoustic change includes at least one selected from among a pressure change, a mechanical index change, a cavitation activity change, a tissue sensitization change, a blood brain barrier disruption change, an acoustic radiation force change, a tumor ablation change, a drug-delivery change, a clot lysis change and a tissue ablation change.
Levy, in the same field of ultrasound treatment discloses in [0011-0012] that treatment effect or constraints such as temperature, power or energy, associated with acoustic energy for ultrasound treatment may be described or characterized in terms of “… pressures, forces, mechanical index, or mechanical stresses … local concentration of drug… tissue ablation or coagulation…. cavitation (which can have several effects on the surrounding tissue, including, e.g., opening physiological barriers such as the blood brain barrier), neuromodulation (e.g., neurological stimulation or neurological inhibition), targeted drug delivery (e.g., via activation of drugs or disruption of barriers, such as the blood brain barrier, to increase drug uptake)”. In view of these, at the time of filing the claimed invention, inasmuch as the teachings of Levy show that treatment effects associated with temperature, power or energy may be described/characterized as described above (i.e., pressures, forces, mechanical index, or mechanical stresses … local concentration of drug, tissue ablation or coagulation, cavitation , neuromodulation, drug delivery), it would have been obvious to one having ordinary skill in the art to have substituted one for the other, i.e., considered the therapeutic or acoustic change in terms of a pressure change, a mechanical index change, a cavitation activity change, a tissue sensitization change, a blood brain barrier disruption change, an acoustic radiation force change, a tumor ablation change, a drug-delivery change, a clot lysis change and/or a tissue ablation change, as these are known terms or parameters known to characterized an effect of acoustic power or energy for ultrasound treatment, and a change in these terms would be expected to reflect a change in treatment effect or constraints of temperature, power or energy during monitoring of treatment.
Response to Arguments
Applicant's arguments filed June 15, 2026 have been fully considered but are moot in light of new ground of rejection, further in view of Levy as set forth supra . Allowable Subject Matter
Claims 1-15, 17-20, 22, 84 and 85 are allowed, see previous Office action of February 13, 2025 for reasons for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached on (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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