DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed October 13, 2025. As directed by the amendment: claims 1, 3, 7 and 15 have been amended and claim 4 has been cancelled. With claims 2, 6 and 8 being previously cancelled, claims 1, 3, 5, 7 and 9-15 are presently pending in this application.
The amendment to claims 7 and 11 and cancellation of claim 4 are sufficient to overcome the 35 U.S.C 112(b) rejections from the previous Office action. Those rejections are hereby withdrawn.
Claim Objections
Claim 3 is objected to because of the following informalities: the phrase “introducing energy” should be amended to “applying energy” to be consistent with previous recitation in claim 1. 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:
a production device for applying a first portion of energy at a focal point in or at an object and for producing bubbles away from the focal point by applying a second portion of energy (claim 11/15);
a control device configured for detecting and identifying bubbles, for recording a movement of the bubbles and for obtaining an estimated value for the movement of the object from the movement of the bubbles (claim 11);
an imaging device configured for creating images of the object (claim 14).
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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
New ground of Rejection necessitated by amendments
Claims 1, 7, 9 and 10 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over previously cited Slayton et al., US 20140243713 A1 (“Slayton”) in view of previous cited Gertner US 20160114194 A1.
Regarding claim 1, Slayton discloses a method comprising: producing bubbles in or at an object by applying energy at a first power density in a first phase for producing the bubbles away from a focal point (Fig. 2 and [0059] delivering first energy 4 or second energy 6 to ROI 12, either or both the first and second energy are used to produce thermal bubbles 8 marker or boundary, [0057] “ROI 12 may consist of or comprise of one or more organs or a combination of tissues or subcutaneous tissues, which are either superficial or located deep within the body” [0070] teaches applying focused energy for treatment within the at least a portion of ROI 12,examiner note: the bubbles are created in a first phase and treatment occurs in a second phase after the bubbles form the boundary, as per [0034], a cell, tissue, gland, fiber or tumor that acoustic energy is applied for treatment forms a focal point that is located within the boundary, it follows that the bubbles that form or mark the boundary are produced away from the focal point) and applying energy at a second power density in a second phase at the focal point ([0070] focused energy for treatment within at least a portion of ROI 12), wherein the first power density is less than the second power density ([0056] regarding high intensity focused beams for ablative effects, the power density of defocused or unfocused first power density for producing bubbles is of less power density compared to the ablative focused energy for treatment), wherein the applied energy at the first power density is without a therapeutic effect (the bubbles as marker or boundary are produced by non-ablative energy with no therapeutic effect); detecting the bubbles ([0014] “imaging thermal bubbles” and [0043] “locating the plurality of thermal bubbles” involves detection of the bubbles via imaging); recording a movement of the bubbles ([0043] “locating the plurality of thermal bubbles” and [0053] “monitoring of bubble activity comprising imaging” would record a movement of the bubbles.
Slayton does not explicitly disclose obtaining an estimated value for the movement of the object from the movement of the bubbles.
Gertner discloses in [0094] “… tracker, detector and monitor are computer algorithms configured to identify and track a [. ..] movement and/or feature of a region of an anatomical structure [. ..] a monitor may use both a tracker and detector to identify and track micro air bubbles, examiner note: the micro bubbles are located on the object, tracking of the bubbles would correlate to movement of the object and thus infer or estimate a movement of the object. In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention to have modified the method of Slayton to estimate a value of the movement of the object based as inferred from movement of the bubbles, so as to track the boundary of the object and ensure that treatment is targeted within the boundary during treatment as required by Slayton in [0034] wherein the bubbles act as boundaries for ultrasound therapy.
Regarding claim 3, Slayton further discloses applying energy includes ultrasound waves ([0058] acoustic transducer to provide the energy).
Regarding claim 5, Slayton in view of Gertner discloses the method of claim 1, Slayton further discloses in [0049] concomitant use of micro-bubble based formulations, emulsifiers, saponificants and/or emulsion to maximize bubble response and use of other chemical moieties infer use of chemical reactions to generate the bubbles.
Regarding claim 7 and 10, these limitations will flow in Slayton as modified by Gertner as discussed in claim 1 above as focal point will be repositioned or switched on/off based on tracking of the boundary which would be according to the estimated value of movement of the object, so as to maintain the focal point within the boundary and to protect tissue without the boundary from the effects of the treatment energy, wherein in the event the treatment energy source is an ultrasound apparatus (see [0070] of Slayton “Ultrasound treatment”), then it follows that the ultrasound apparatus will be controlled, i.e., turned on/off according to the estimated movement.
Regarding claim 9, Slayton in view of Gertner discloses the method of claim 1, Slayton exemplifies in Fig. 2 and associated discussion e.g., in [0059] that the energy used to produce bubbles (e.g., at a first phase) at a location demarcated by the boundary is defocused (“6” in Fig. 2 to produce bubbles), the energy for treatment will be focused at the defined location for treatment purposes as Slayton teaches in [0070] focused energy for treatment.
Maintained Rejections
Claims 11-14 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over Gertner in view of Slayton.
Regarding claim 11, Gertner discloses a recording apparatus (Fig. 1A) comprising: a production device for producing bubbles in or at the object ([0092] therapy energy delivery system 107 is an equivalent thereof production device [0094] for producing bubbles as a result of cavitation. i.e., micro air bubbles are generated); and a control device configured for detecting and identifying the bubbles ([0094] tracker and detector to identify and track micro air bubbles involves detecting the bubbles, the tracker and detector are an equivalent thereof control device), for recording a movement of the bubbles ([0094], tracker and detector to identify and track micro air bubbles involves recording a movement of the bubbles by the imaging module); and for obtaining an estimated value for the movement of the object from the movement of the bubbles ([0094] The tracker, detector and monitor are computer algorithms configured to identify and track a [. ..] movement and/or feature of a region of an anatomical structure [. ..] a monitor may use both a tracker and detector to identify and track micro air bubbles – the micro bubbles are located on the object, tracking of the bubbles would correlate to movement of the object and thus infer or estimate a movement of the object).
Accordingly, Gertner teaches the aspect of determining movement of an object, by producing bubbles on or at the object, detecting and recording movement of bubbles to determine movement of the object.
Gertner does not explicitly disclose applying a first portion of energy at a focal point in or at the object and for producing bubbles away from the focal point by applying a second portion of the energy that differs from the first portion, wherein the second portion of the energy is without a therapeutic effect.
However, Slayton discloses in Fig. 2 and [0059] a first portion of energy (“4” in Fig. 2) is focused at a focal point in or at an object, and a second portion of the energy (“6” in Fig. 2) that differs from the first portion, produces bubbles at another site from the focal point without therapeutic effect (“Either […] of first energy 4 and second energy 6 may be used to produce thermal bubbles 8” – in this case , energy portion “6” is used to produce the bubbles as marker or boundary, hence no therapeutic effect). In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the production device of Gertner to apply a first portion of energy at a focal point in or at the object and a second portion of energy that differs with the first portion to produce bubbles at another site (boundary) away from the focal point without therapeutic effect, so as to track a boundary onto which the first energy is applied and to protect tissue downstream of the boundary from the effects of the first portion of energy.
Regarding claim 12-14, Gertner in view of Slayton discloses the invention of claim 11 as discussed above, Gertner further discloses in [0094] a component of a therapy apparatus i.e., the therapy energy delivery system 107 (a lithotripsy apparatus) is controlled according to an estimated movement of the object such that therapy may be delivered substantially continuously to the target as discussed above, and an imaging device (imaging transducer “105” and image acquisition subsystem 103 [0091] as an imaging module “101” in Fig. 1A) are disclosed for generating images of the object.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited Cathignol US 5219401 in view of Slayton.
Regarding claim 15, Cathignol discloses a method comprising: producing bubbles in or at the object by applying energy at a first power density in a first phase for producing the bubbles and applying energy at a second power density in a second phase, wherein the first power density is less than the second power density, wherein the first power density is without a therapeutic effect [col. 7: 30-31, 41-48] “… gas bubbles can be brought in situ by many different ways … the generator will work at low power to pass, in a second stage, to the 4emission of high power waves capable of imploding the gas bubbles created by the cavitation phenomena caused by the low power waves” - generator is an equivalent thereof production device);
detecting the bubbles; recording a movement of the bubbles(e.g., Fig. 1, tracking means “32”, [col. 5: 9-11], [col. 6: 37-55], [col. 7: 7-10] and illustration Fig. 1 – tracking means 32 would record a movement of the bubbles via tracking); and obtaining an estimated value for the movement of the object from the movement of the bubbles (see illustration Fig. 1 and [col. 6: 37-55], the bubbles are located on the object, it follows that tracking of the bubbles would track movement of the object and thus infer movement of the object from the bubbles) -- overlapping subject matter from claim 9 from previous Office action.
Cathingol further discloses a central control device 42 for collecting information and controlling an implosion means 24 as a function of the collected information ([col. 6: 45-55]), Cathingol does not explicitly disclose a non-transitory computer readable medium with instructions which are executed by at least one processor to perform the method steps in claim 9. However, Slayton teaches that a control system may comprise a system processor and various digital control logic, such as one or more of microcontrollers, microprocessors, field-programmable gate arrays, computer boards, and associated components, including firmware and control software ([0083]). In view of these, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have implemented the method of Cathingol on a non-transitory computer readable medium with instructions which are executed by at least one processor, as this is notorious and common practice to implement a method on a control system as exemplified by Slayton.
Response to Arguments
Applicant’s arguments directed to the prior art rejections of the pending claims have been considered and are each addressed as follows:
As to arguments directed to claims 1, 5, 7, 9 and 10, these arguments are moot in light of new ground of rejection necessitated by the amendments to the claims. Examiner does address arguments directed to claim 15 (see page 8 refers to arguments above i.e., arguments directed to claim 1 in page 5 to 7 of the response). In page 6, second full paragraph, Applicant acknowledges that Cathingol refers to tracking and locating the bubbles using ultrasonic imaging, tracking and locating would record a movement of the bubbles, Applicant argument that “Cathingol does not teach or suggest recording bubble movement such as trajectories, analyzing displacement over time or deriving quantitative movement or velocity information” is not commensurate in scope with recitation in the claims as the features upon which applicant relies (i.e., bubble movement such as trajectories, analyzing displacement over time or deriving quantitative movement or velocity information) are not recited in the rejected claim(s). Applicant argument in paragraph bridging page 6-7 of the response is directed towards recitations in amended claim 1 of the bubbles relative to a focal point, recitations that find no counterpart in claim 15 and therefore not applicable to claim 15. Applicant argument in page 7 first full paragraph is not persuasive for reason noted above, i.e., tracking would record movement of the bubbles, and Applicant does not rebut the position taken by the Office action that “the bubbles are located on the object, it follows that tracking of the bubbles would track movement of the object and thus infer movement of the object from the bubbles”, which would be recognized by those of ordinary skill in the art.
As to arguments directed to claims Examiner further notes that while limitations of claim 8 have been incorporated in claim 1, certain significant limitations in claim 1 have also been deleted, as such, previously presented claim 8 is not of the same scope as current claim 1.
Next in arguments directed to claim 11 in paragraph bridging page 7-8, the argument directed to Slayton is unpersuasive because Slayton specifically teaches an aspect of generating bubbles to form bubbles at a boundary that surrounds a focal point, hence away from the focal point. Applicant arguments are also not commensurate with the scope of the claims, as the claims do not recite away from a therapeutic region/zone, rather away from a focal point. The Office action does not rely on the bubbles generated by Gertner to teach aspect of bubbles away from a focal point, as such this argument is moot. In response to using the tracker of Gertner to track movement of bubbles and estimate value of movement of object, it is noted that the Office action applies an obviousness rationale to use the tracker of Gertner for estimating movement of the object. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 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 at (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