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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 18, 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 10-12, 16, 40 and 57 have been amended.
Claims 1-22, 40, 57, 84 and 85 remain pending.
Response to Arguments
Applicant's arguments filed February 18, 2025 have been fully considered but they are not persuasive. In response to the argument in paragraph bridging page 9-10 of the response, Applicant acknowledges that Vitek “… also discloses separately adjusting parameters when the value exceeds a safety threshold, but this configuration is only applied to sensitive tissue which is a tissue to be protected”, however, Applicant goes on to argue that “Vitek does not reduce the predicted therapeutic or acoustic energy change for the target tissue”. This argument must fail because a person of ordinary skill in the art would readily recognize that the same energy intensity from the same transducer elements would affect both the target tissue “6” and the sensitive tissue “60” simultaneously, as such, when the safety threshold of sensitive tissue “60” is exceeded, the same adjustment of operational parameters would directly affect the target tissue, i.e., the predicted therapeutic or acoustic energy at the target tissue would be simultaneously reduced. For example, in the event that the target tissue “6” needs to be maintained above the prescribed threshold and the sensitive tissue “60” happens to be above the prescribed safety threshold at the same time (see Fig. 4a and associated discussion in [0037-0039]), the adjustment to adjust operational parameters to keep the sensitive tissue “60” below the prescribed safety threshold would necessarily reduce the predicted therapeutic or acoustic energy change at the target tissue “6”. In view of the foregoing, the current rejections of claims 40 and 57 cannot be withdrawn at this time , subject to any clarification noted above.
Specification
The disclosure is objected to because of the following informalities: in [0022-0024] and [0067] as filed, the word or phrase “administration device” should be amended to “administration system” so as to be consistent throughout the specification and claims.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the phrase “therapeutic or acoustic dynamic change” lacks antecedence basis in the speciation as a new word “dynamic” has been added to the claims that lacks a counterpart in the specification.
Appropriate correction is required.
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 § 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 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”.
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 (“6”); and a controller (“18” [0019]) configured to: 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 dynamic 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), this change is dynamic as the temperature change varies; 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).
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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797