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 .
Response to Amendment
The rejection under 35 U.S.C. 103 of Claim 5 has been withdrawn in light of the arguments filed on 20 January 2026.
Claim Rejections - 35 USC § 112(a)
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 5 & 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for “a flexible bladder containing an acoustic coupling medium for positioning between the transducer and the exterior surface of the organ” as recited in parent Claim 1, does not reasonably provide enablement for “wherein the transducer is external to the flexible bladder” as recited in Claim 5. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In particular, the instant specification discloses in ¶ [0270] that transducer 2176 is external to bladder 598 and relies on an acoustic mirror 2188 to reflect and direct the ultrasound mechanical waves to organ surface 34. However, according to the instant specification, more specifically FIG. 36A, the acoustic coupling medium is no longer between the transducer and the exterior surface of the organ. Accordingly, the instant specification does not teach those skilled in the art how to use the full scope of the claimed invention without undue experimentation; therefore, the instant specification is not commensurate with the scope of protection sought by the claims.
Claim 17 recites similar limitations and are rejected under the same rationale as Claim 5.
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 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.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Makin et al. (US PGPUB 20050261586; hereinafter "Makin").
With regards to Claim 1, Makin discloses an organ surface ultrasound probe (ultrasound medical system 110; see Makin ¶ [0018] & FIG. 2) comprising:
a head (end effector 112; see Makin ¶ [0018] & FIG. 2) comprising:
a transducer (ultrasound transducer 114; see Makin ¶ [0018] & FIG. 2);
a housing supporting the transducer (sheath 134 which supports the shaft 140 upon which the transducer 114 is disposed; see Makin ¶ [0028] & FIG. 2); and
a flexible bladder (expandable acoustic window 126; see Makin ¶ [0021] & FIG. 2) containing an acoustic coupling medium (acoustic coupling medium 116; see Makin ¶ [0021] & FIG. 2) for positioning between the transducer and the exterior surface of the organ (altering the pressure of the acoustic coupling medium 116 against an inner surface 128 of the expandable acoustic window 126 to bias the said window against tissue 124; see Makin ¶ [0021] & FIG. 2); and
a pump (pump for circulating coupling medium for altering the pressure to change the shape of the acoustic window; see Makin ¶ [0035]); and
a controller to output control signals causing the pump to inflate the flexible bladder to different inflation states (the controller 132 controls the end effector 112 to change the shape {i.e. different inflation states} of the acoustic window 126, by changing (directly or indirectly) the pressure exerted by the acoustic coupling medium 116 against the acoustic window 126; see Makin ¶ [0029] & FIG. 2), wherein the different inflation states comprise a first inflation state in which the flexible bladder is (Makin illustrates in FIG. 2 that the ends of the expandable acoustic window 126 are flush with the surface of the sheath 134, one of ordinary skill in the art would understand that the acoustic window is/can be partially retracted within the housing {i.e. sheath 134}) and a second inflation state in which the flexible bladder protrudes from the housing (Makin illustrates in FIG. 2 that the acoustic window 126 clearly protrudes from sheath 134).
While Makin illustrates in FIG. 2 that the ends of the expandable acoustic window 126 are flush with the surface of the sheath 134, Makin does not explicitly teach of the flexible bladder being fully retracted within the housing. However, one of ordinary skill in the art would understand that when the expandable acoustic window 126 is an unexpanded state the entirety of the expandable acoustic window 126 would be retracted within the housing defined by the sheath 134 because the exterior surface 130 of the acoustic window 126 would be parallel to the adjacent surface of the sheath.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makin to provide at least a first inflation state in which the flexible bladder is fully retracted within the housing. Doing so would amount to amount to simple substitution of one known element for another to obtain predictable results, i.e. non-expanded acoustic window 126.
With regards to Claim 21, modified Makin teaches of an actuator to move the transducer relative to the housing (the shaft 140 which supports transducer 114 is rotatable relative to sheath 134 which is supported by handpiece 138; see Makin ¶ [0030]).
With regards to Claim 31, modified Makin teaches of wherein the pump is fluidly coupled to an interior of the flexible bladder to circulate fluid through the flexible bladder (pump for circulating coupling medium for altering the pressure to change the shape of the acoustic window; see Makin ¶ [0035]).
With regards to Claim 41, modified Makin teaches of wherein the transducer is contained within the flexible bladder (FIG. 2 of Makin illustrates that the transducer 114 is in fluid communication with the interior surface 128 of the acoustic window 126, one of ordinary skill in the art would interpret FIG. 2 as the transducer being contained within cavity defined by the sheath 134 and acoustic window 126 and thus is within the flexible bladder; it should be appreciated that the claim does not limit the entirety of the bladder to be flexible).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over modified Makin as applied to claim 1 above, and further in view of Gijsbers et al. (US PGPUB 20200383661; hereinafter "Gijsbers").
With regards to Claim 101, while modified Makin teaches all of the limitations of intervening Claim 1 as shown above , it appears that modified Makin may be silent to: wherein the head comprises:
a first retractable and extendable wing supporting the transducer and the flexible bladder; and
a second retractable and extendable wing supporting a second transducer and a second flexible bladder containing a second acoustic coupling medium.
However, Gijsbers teaches of an ablation catheter 100 with folding ultrasound transducer arrays 106 {i.e. first and second retractable and extendable wings} which, when in a folded configuration, are positioned against the catheter shaft 102 and the transducer arrays 106, when in the deployed configuration, are separated at least 90 degrees away from shaft 102 (Gijsbers Abstract & FIGS. 3-4).
Makin and Gijsbers are both considered to be analogous to the claimed invention because they are in the same field of in vivo ultrasound devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Makin to incorporate the above teachings of Gijsbers to provide at least first & second retractable and extendable wings supporting the first and second transducers and the first flexible bladder. Doing so would aid in assessment of the patient tissue and effective guidance in a deployed configuration and patient safety with a smaller form factor that allows easy insertion in a folded configuration (see Gijsbers ¶ [0045 & 0048]).
While modified Makin teaches of a plurality of folding ultrasound transducer arrays 106, it appears that modified Makin may be silent to a plurality of corresponding flexible bladders. However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Makin to provide at least a second flexible bladder containing a second acoustic coupling medium. Doing so would amount to a duplication of parts because the Makin transducer 114 requires the corresponding expandable acoustic window 126, thus the modified Makin having a plurality of ultrasound transducer 106 each with an imaging transducer 114 would require the corresponding expandable acoustic window in order to maintain contact with the tissue.
Claims 14 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over modified Makin as applied to claim 1 above, and further in view of Burdette (US PGPUB 20160030773)
With regards to Claim 14, while modified Makin teaches of all of the limitations of intervening claim 1 as shown above, it appears that modified Makin may be silent to wherein the flexible bladder comprises independently inflatable compartments. However, Burdette teaches of treatment catheter 3210 which includes a chambered balloon 3260 {i.e. flexible bladder} proximate to transducers 230 which is divided into chambers 3261 which are independently controlled via water pump to inflate various combinations of different chambers utilizing various levels of inflation each sub-chamber independently in order to help control the position of the transducers 230 for treatment (see Burdette ¶ [0070 & 0203-0205]).
Modified Makin and Burdette are both considered to be analogous to the claimed invention because they are in the same field of ultrasound balloon transducers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Makin to incorporate the above teachings of Burdette to provide at least a flexible bladder with independently inflatable compartments. Doing so would aid in positioning the transducers for treatment (see Burdette ¶ [0205]).
Claim 18 recite similar limitations and are rejected under the same rationale as Claim 14 with the addition of a pump to inflate balloons (see Burdette 0070).
Allowable Subject Matter
Claim 5 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to Claims 5 & 17, while modified Makin teaches that transducer 114 is spaced from flexible acoustic window 126, the transducer 114 is in fluid communication with the acoustic coupling medium 116 within said compartment and, thus, cannot be external to the flexible bladder.
Previously cited Maini (US PGPUB 20210085384) teaches of a plurality of independently controlled balloons 314 to position transducers 326 against the tissue as illustrated in FIG. 3B (see also Maini ¶ [0063]); however, balloons 314 are not disposed between the transducer the organ surface, i.e. acoustic coupling fluid within the balloon disposed between the transducer the inspection region. Therefore, Maini cannot teach of the limitation of Claim 5.
Shulze et al. (see IDS of 13 February 2024) teaches, with respect to FIG. 8, a concave support element 212 which creates a hydraulic vacuum against the organ surface (see Shulze et al. ¶ [0064]). While Shulze et al. teaches of energy transfer element 202 {i.e. ultrasound transducer} being external {i.e. not in fluid communication with coupling fluid 108} to concave support element 212 as illustrated in FIG. 8, the concave support element 212 is open on side 213 and, thus, one of ordinary skill in the art would not recognize said concave support element 212 as a flexible bladder.
The search prior art teaches of transducer elements disposed within an acoustic fluid containing balloon and is silent to a transducer external to a flexible bladder while also being disposed between the transducer and a surface of an organ.
Response to Arguments
With regards to the rejection under 35 U.S.C. 112(a), Applicant contends that the rejection is improper and in support cites FIG. 28B which “clearly illustrates the transducer 276 external to the flexible bladder with the flexible bladder containing an acoustic coupling medium that is between the transducer and the external surface of the organ.” However, the embodiment of FIGS. 28A & 28B clearly illustrate repositioning actuator 584 which controls the retracted {i.e. first position} and extended position {i.e. second position} of both the transducer 276 and acoustic coupler 1080 (see FIGS. 15-28 along with ¶ [0198-0202]). More specifically, the actuator 584 of FIGS. 28A-28B controls whether the flexible bladder is in the in first state or second state and not the inflation state of bladder 1780. While ¶ [0244] discloses that “Bladder 1780 supports transducer 276 and is similar to bladder 598 except that bladder 1780 comprises internal baffles or walls 1701, 1702…,” the instant specification is silent to a combination of the embodiments of FIGS. 28A-28B, as described directly above, and the claimed embodiment of a controller to control the inflation state of the flexible bladder to one of a first inflation state, which is fully retracted, and a second inflation state, which is protruding. For example, the inflation state of 1703-3 of FIG. 28A is virtually identical to the inflation state of 1703-3 of FIG. 28B, but the flexible bladder 1780 of FIG. 28B is protruding regardless of the inflation state. For at least reason, Applicant’s arguments are not persuasive.
With regards to 35 U.S.C. 103 rejection of Claim 1, Applicant's arguments filed 20 January 2026 have been fully considered but they are not persuasive.
In particular, Applicant contends that Makin does not obviate Claim 1 as currently amended. In support, Applicant argues that:
“nowhere does Makin ever disclose that the expandable acoustic window 126 is ever in such an unexpanded state. Nowhere does Makin even remotely suggest a controller that would necessarily output control signals deflating the expandable acoustic window to the degree necessary to fully retracted the expandable acoustic window 126 within the housing. The assertion that the probe of Makin could or might be deflated to such a state, when Makin says absolutely nothing about the expandable acoustic window 126 ever being deflated to such a state and fails to articulate ANY reason for doing so, is based upon pure impermissible hindsight reasoning, insufficient to establish a prima facie case of obviousness.”
The Office disagrees. According to MPEP § 2112, “The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995).” For example, in FIG. 2, Makin clearly illustrates that the expandable window 126 is an expanded state established by increasing the pressure of the acoustic coupling medium 116: “FIG. 2 is a schematic cross-sectional view of the end effector of the ultrasound medical system of FIG. 1, wherein the adaptation of the end effector is shown and includes a movable piston which exerts pressure on the acoustic coupling medium,”(emphasis added) (see Makin ¶ [0011-0012]). Furthermore, “expandable” inherently establishes two states: an expanded state and an unexpanded state. Moreover, one of ordinary skill in the art of elastomers would recognize polyurethane as having elastomeric properties, i.e. elastic (see Makin ¶ [0032]). Based on the foregoing, the illustrated acoustic window in FIG. 2 is in a state in which the piston 142 is exerting pressure onto the acoustic coupling medium 116 which in turn is exerting pressure on to the polyurethane acoustic window 126 to change the shape, such as the curvature, of the polyurethane acoustic window 126 (see Makin ¶ [0019 & 0033]). One of ordinary skill in the art would recognize that in order to change the shape of the polyurethane window 126 back into an unexpanded state, which is inherent to an expandable elastomer, the piston 142 must not exert pressure on to the acoustic coupling medium 116 such that the acoustic coupling medium 116 does not exert pressure onto the elastomeric polyurethane acoustic window 126. Since Makin discloses that the state of illustrated FIG. 2 is shown to be exerting pressure onto the acoustic coupling medium 116 {i.e. expanded state}, then the disclosed ability to change the pressure of the acoustic coupling medium 116 would inherently involve changing from the illustrated expanded state back to an unexpanded state. Therefore, Makin clearly discloses changing the shape of the elastomeric acoustic window 126 by changing the pressure of the acoustic coupling medium 116 via actuation of piston 142. For at least this reason, Applicant’s argument is not persuasive
Applicant also argues that:
“That deflating the expandable acoustic window to such extent that the window 126 is fully retracted within the housing would amount to "simple substitution of one known element for another". (Office Action, page 6). However, the rejection fails to withstand scrutiny as there is nothing being substituted. What is being claimed is a controller that causes a specific state that is never taught or suggested in Makin” (emphasis added).
Firstly, the Office disagrees. Secondly, it appears that Applicant is suggesting that the claimed controller is only capable of causing a single “specific state” and not the two states as claimed, i.e. fully retracted and protruding. For at least this reason, Applicant’s argument is not persuasive. Arguendo, Applicant fails to recognize the Office’s explicit substitution of a non-expanded state. More specifically, when the elastomeric window 126 of FIG. 2 is in an expanded state, when not in an expanded state one of ordinary skill in the art would recognize that elastomeric window 126 would return to its unexpanded state is established by the curved ends of the elastomeric expandable acoustic window 126, reproduced below for ease of reference.
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One of ordinary skill in the art would readily recognize that a polyurethane based elastomer, in such a configuration where is ends are connected to a sheath using opposing butt joints, when not under pressure, would relax to its unexpanded which is informed by the ends such that its curvature would change to a surface that is substantially parallel to the proximate surfaces adjacent to the annotated ends. Accordingly, not only does Makin does teach and suggest both states, but it would be obvious to substitute the expanded state, as illustrated, with the inherent unexpanded as recognized by one of ordinary skill in the art. For at least this reason, Applicant’s argument is not persuasive.
With regards to 35 U.S.C. 103 rejection of Claim 2, Applicant contends that Makin does not obviate “an actuator to move the transducer relative to the housing.” In support, Applicant argues that “shaft 140 is what actually supports the transducer 114. Now here does Makin disclose that the transducer 114 is somehow movable relative to shaft 140. Even assuming, arguendo, that sheath 134 could be properly characterized as the "housing" which supports the transducer , nowhere does Makin disclose that shaft 140 (and the transducer 114) are necessarily rotatable relative to sheath 134.” The Office disagrees. Makin clearly discloses a circumferential acoustic window in ¶ [0021]. It makes no logical sense to one of ordinary skill in the art to incorporate a rotatable shaft if the acoustic window 126 is not circumferential because there is no diagnostic value in imaging the inner surface sheath when it is not acoustically transparent. Therefore, in Makin’s embodiment of a rotatable shaft 140, the acoustic window 126 is inherently circumferential. Arguendo, if the rotatable shaft 140 is to rotate in concert with sheath 134, as Applicant suggest, then it makes no logical sense to disclose a circumferential acoustic window 126 because the transducer 114 would always be oriented at the portion of the circumferential window 126. Applicant is again reminded that express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims. The Office contends that even one not having ordinary skill in the art would recognize shaft 140 rotates relative to sheath 134 in order to image circumferentially, as disclosed by Applicant, when paired with a circumferential acoustic window 126. Moreover, the claims do not precluded interpreting the Makin’s handpiece as part of a housing because Makin explicitly discloses that “the shaft 140 supports the medical ultrasound transducer 114 and is operatively connected to the handpiece 138” which one of ordinary skill in the art would readily recognize as a analogous housing. For at least this reason, Applicant’s argument is not persuasive.
With regards to 35 U.S.C. 103 of Claim 10, Applicant' s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, the Office introduces Gijsbers as detailed above. More specifically, Gijsbers teaches of an ablation catheter with folding ultrasound transducer arrays 106 which, when in a folded configuration, are position against the catheter shaft 102 and the transducer arrays 106, when in the deployed configuration, are separated at least 90 degrees away from shaft 102.
With regards to 35 U.S.C. 103 rejection of Claim 5, Applicant's arguments have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of Claim 5 has been withdrawn. In particular, Applicants contend that neither Makin nor Maini, alone or in combination, discloses “acoustic coupling medium be between the transducer and the exterior surface of the organ” while the transducer is a external to a flexible bladder. The Office agrees and the corresponding rejection is withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sinelnikov et al. (US 20160374710) – FIG. 43C shows balloon {i.e. flexible bladder } with a fully retracted position in which splines 655 of the membrane material 656 are pulled snugly against to the side of catheter, and FIG. 43D which shows an extended position in which the splines 566 are bent in order to expand the membrane 656 to an extended state;
Barnes et al. (US PGPUB 20170105792) – tissue dilation apparatus 510 includes expansion devices 502 {i.e. flexible bladder or balloon} which, when in a collapsed configuration, said expansion devices are fully retracted within housing 504 and, when in an expanded configuration, protrude from housing 504; and
Borody et al. (US PGPUB 20220233209) – wide beam ultrasound emitters 8 which are pivotably lifted between 1-90 degrees and kept in a closed position via anchors 33.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith M. Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798