DETAILED ACTION
Summary
Claims 1-18 are pending in the application. Claim 12 is rejected under 35 USC 112(b). Claim 18 is rejected under 35 USC 112(d). Claims 1-7, and 9-18 are rejected under 35 USC 103.
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 Objections
Claim 12 objected to because of the following informalities:
Claim 12 recites “either the inside or outside of the handle”. It should recite “either inside or outside of the handle”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 12 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 12 recites the limitation "the outside" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is not clear what “the outside” is referring to (e.g. outside the device, outside the handle, outside the distal end space, etc.). For the purposes of examination, outside will be referring to outside the device.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 is identical to claim 15, upon which it depends, and therefore fails to further limit claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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: “fastening member” in claims 4-5.
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.
The claim limitation will be interpreted as follows:
A “fastening member” will be interpreted as fastening tape 35, and equivalents thereof, as shows in Fig. 7-8 and discussed on pages 13-14.
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 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.
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, 9-10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (U.S PGPub 2021/0387024 A1) in view of Sela et a. (U.S PGPub 2021/0267679 A1).
Regarding Claim 1, Cho teaches an intracavitary ultrasound device (Abstract) comprising:
a support bar extending in a longitudinal direction (Fig. 2, 20) [0038]+[0040]+[0042];
an ultrasound probe (Fig. 2, 30) supported by the support bar and configured to be insertable into a body cavity [0038]+[0041]-[0042];
a sealing cover (Fig. 2, 50) [0038] configured to surround at least a portion of the ultrasound probe [0049]-[0050] and the support bar [0052]; and
an ultrasound transmission medium supply tube (Fig. 2, 72) configured to supply an ultrasound transmission medium to a space in which the ultrasound probe is disposed, [0059]-[0060]
wherein the ultrasound transmission medium supply tube is configured to supply the ultrasound transmission medium [0059]-[0060].
Cho fails to explicitly teach supplying the medium past the ultrasound probe to a distal end space of the sealing cover.
Sela teaches an intracavity ultrasound ablation system (Abstract). This system supplied transmission medium past the ultrasound probe to a distal space of the sealing cover (Fig. 1B, 156) [0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Cho to supply transmission fluid past the ultrasound probe, as taught by Sela, because this allows the system to keeps the probe cooler, thereby increasing the safety of the procedure, as recognized by Sela [0041].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Cho further teaches an ultrasound transmission medium discharge tube (Fig. 2, 71) configured to discharge the ultrasound transmission medium from the space in which the ultrasound probe is disposed [0060]-[0061].
Regarding Claim 10, the combination of references teaches the inventions substantially as claimed. Cho further teaches wherein the ultrasound probe includes a housing (Fig. 2, 31) [0042] and an ultrasound piezoelectric element fixed to the housing (Fig. 2, 33) [0042],
wherein the housing includes a pair of recessed grooves (Fig. 6, 71+72 are in grooves) [0061], and
wherein the ultrasound transmission medium supply tube and the ultrasound transmission medium discharge tube are respectively inserted into the pair of recessed grooves (Fig. 6, 71+72) [0060]-[0061].
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Cho further teaches wherein the sealing cover (Fig. 2, 37 “sealing structure” is considered part of the sealing cover) [0051] comprises an ultrasound transmission medium inlet passage for the inflow of the ultrasound transmission medium (Fig. 2, 371) [0063], and an ultrasound transmission medium outlet passage for the discharge of the ultrasound transmission medium (Fig. 2, 372) [0063].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Cho further teaches a handle to which the support bar is connected (Fig. 1, 10) [0009]+[0040], wherein the sealing cover is configured to be detachable from the handle [0038] (separable sealing cover).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Sela as applied to claim 1 above, and further in view of Just et al. (U.S PGPub 2009/0254078 A1).
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Cho further teaches wherein the ultrasound probe comprises a housing (Fig. 2, 31) [0042], and an ultrasound piezoelectric element fixed to the housing (Fig. 2, 33) [0042], and wherein the ultrasound transmission medium supply tube is configured such that an end thereof passes through the housing (Fig. 6, 72) [0061].
Cho fails to explicitly teach the end is exposed to an inner space of the sealing cover.
Just teaches an intrabody probe for applying energy to the body (Abstract). This system can be used with focused ultrasound [0082]. This system used conduits to supply fluid to the tip of the device (Fig. 10, 80) [0085]. This system has the conduit extend through the housing of the energy applicator (Fig, 20-21, 80) to face an inner space of the sealing cover (Fig. 21, 20) [0075]+[0090].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the supply tube exposed to an inner space of the sealing cover, as taught by Just, because this allows for effective cooling of the device, thereby increasing the safety and efficacy of the treatment, as recognized by Just [0085]-[0086].
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Cho further teaches wherein the housing comprises a recessed groove (Fig. 6, groove 72 is in) [0061], and
wherein the ultrasound transmission medium supply tube is inserted into the recessed groove (Fig. 6, groove 72 is in) [0061]+[0063].
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Cho further teaches further comprising a fastening member that connects the housing and the ultrasound transmission medium supply tube to each other so as to prevent the ultrasound transmission medium supply tube from disengaging from the recessed groove of the housing (Fig. 6, 51) [0060]-[0061] (one of ordinary skill would recognize that, as the sealing member surrounds the indent in which the tube is located, it would act as a fastening member connecting the housing and the tube and would prevent the tube from disengaging from the groove) (furthermore, 51 comprises tape, and can be interpreted as “fastening tape”, consistent with the interpretation under 35 USC 112(f)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Sela and Just as applied to claim 4 above, and further in view of Sinelnikov et al. (U.S PGPub 2016/0374710 A1).
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Cho further teaches wherein the fastening member is configured to fasten the housing and the ultrasound transmission medium supply tube to each other (Fig. 6, 51) [0060]-[0061] while preventing the ultrasound transmission medium supply tube from detaching from the housing (Fig. 6, 51) [0060]-[0061].
Cho fails to explicitly teach such that relative movement between the housing and the ultrasound transmission medium supply tube is allowed.
Sinelnikov teaches an intrabody ultrasound treatment device (Abstract). This system allows for relative movement between the ultrasound probe housing and an supply tube (Fig. 12C 523 and 524) [0193] (the ultrasound moves through lumen 524, and thus has relative movement to the supply tube).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to allow for relative movement between the housing and the tube, as taught by Sinelnikov, because this allows for colling the transducer, thereby reducing the risk of injury, as recognized by Sinelnikov [0148].
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Sela as applied to claim 1 above, and further in view of Driscoll, Jr. et al. (U.S Patent 5,882,302).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the ultrasound probe is disposed within the sealing cover in a linearly movable state.
Driscoll Jr teaches a system for ultrasonic procedures (Abstract). This system has an ultrasound probe within a cover which is able to move linearly (Fig. 3, 28 moves linearly) (Col 8, lines 26-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date to linearly move the ultrasound, as taught by Driscoll Jr, because this provides an effective method for accurately targeting the ultrasound for treatment, thereby allowing for more effective treatment, as recognized by Driscoll Jr. (Col 1, lines 17-31)+(Col 8, lines 26-39).
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Cho fails to explicitly teach wherein the ultrasound probe is configured to linearly move together with the support bar.
Driscoll Jr. teaches that the positioning mechanism moves the ultrasound transducer member in a linear motion (Col 8, lines 26-39). As shown in Fig. 3, 28, the motion is relayed to the radiation surfaces using a support bar (Fig. 3, 28), which suggests the transducer and the bar move together.
It would have been obvious to one of ordinary skill in the art before the effective filing date to linearly move the ultrasound using a support bar, as taught y Driscoll Jr, because this provides an effective method for accurately targeting the ultrasound for treatment, thereby allowing for more effective treatment, as recognized by Driscoll Jr. (Col 1, lines 17-31)+(Col 8, lines 26-39).
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Cho further teaches a handle to which the support bar is connected [0040].
Cho fails to explicitly teach wherein the ultrasound probe and the support bar are configured to move relative to the handle.
Driscoll Jr. further teaches wherein the ultrasound probe and the support bar are configured to move relative to the handle (Col 8, lines 26-39). As shown in Fig. 3, 28, the motion is relayed to the radiation surfaces using a support bar (Fig. 3, 28) using the positioner 34 in the handle 32 (Col 9, lines 26-39), which suggests the transducer and the bar move together relative to the handle.
It would have been obvious to one of ordinary skill in the art before the effective filing date to linearly move the ultrasound using a support bar, as taught by Driscoll Jr, because this provides an effective method for accurately targeting the ultrasound for treatment, thereby allowing for more effective treatment, as recognized by Driscoll Jr. (Col 1, lines 17-31)+(Col 8, lines 26-39).
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Cho further teaches wherein the ultrasound transmission medium supplied into the sealing cover through the ultrasound transmission medium supply tube [0059]-[0060] is configured to be discharged to the outside via either the inside or outside of the handle [0060]+[0064]+[0068].
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Sela and Just as applied to claim 2 above, and further in view of Driscoll, Jr. et al. (U.S Patent 5,882,302).
Regarding Claims 15 and 18, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the ultrasound probe is disposed within the sealing cover in a linearly movable state.
Driscoll Jr teaches a system for ultrasonic procedures (Abstract). This system has an ultrasound probe within a cover which is able to move linearly (Fig. 3, 28 moves linearly) (Col 8, lines 26-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date to linearly move the ultrasound, as taught y Driscoll Jr, because this provides an effective method for accurately targeting the ultrasound for treatment, thereby allowing for more effective treatment, as recognized by Driscoll Jr. (Col 1, lines 17-31)+(Col 8, lines 26-39).
Regarding Claims 16, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the ultrasound probe is disposed within the sealing cover in a linearly movable state.
Driscoll Jr teaches a system for ultrasonic procedures (Abstract). This system has an ultrasound probe within a cover which is able to move linearly (Fig. 3, 28 moves linearly) (Col 8, lines 26-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date to linearly move the ultrasound, as taught y Driscoll Jr, because this provides an effective method for accurately targeting the ultrasound for treatment, thereby allowing for more effective treatment, as recognized by Driscoll Jr. (Col 1, lines 17-31)+(Col 8, lines 26-39).
Regarding Claims 17, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the ultrasound probe is disposed within the sealing cover in a linearly movable state.
Driscoll Jr teaches a system for ultrasonic procedures (Abstract). This system has an ultrasound probe within a cover which is able to move linearly (Fig. 3, 28 moves linearly) (Col 8, lines 26-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date to linearly move the ultrasound, as taught by Driscoll Jr, because this provides an effective method for accurately targeting the ultrasound for treatment, thereby allowing for more effective treatment, as recognized by Driscoll Jr. (Col 1, lines 17-31)+(Col 8, lines 26-39).
Allowable Subject Matter
Claim 8 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 8 recites “wherein the ultrasound transmission medium supply tube is configured to maintain a predetermined position during linear movement of the ultrasound probe and to function as a guide for the linear movement of the ultrasound probe”. This, in combination with the limitations of the base and intervening claims, is not taught by the prior art without the benefit of improper hindsight.
Neither Cho, Sela, nor Just teach linear motion of the ultrasound probe, and therefore cannot teach “to maintain a predetermined position during linear movement of the ultrasound probe and to function as a guide for the linear movement of the ultrasound probe”. Driscoll Jr. teaches a linear motion of the ultrasound probe. However, Driscoll Jr. does not teach an ultrasound medium supply tube and does not teach the ultrasound transmission medium supply tube is configured to maintain a predetermined position during linear movement of the ultrasound probe and to function as a guide for the linear movement of the ultrasound probe. Sinelnikov teaches an ultrasound probe that can be linearly moved. However, Sinelnikov does not teach that the ultrasound transmission supply tube functions as a guide for the linear movement of the ultrasound probe.
McCaffrey (U.S PGPub 2026/0174497 A1) teaches an ultrasound transducer around a guidewire that supplies a cooling medium (Fig. 2) [0061]. However, the system does not teach a linear movement of the ultrasound probe, and therefore does not teach the invention as claimed. Lee (KR 10-2020-0069055 A1) teaches a linear movement of the ultrasound probe. However, Lee does not teach a ultrasound transmission medium supply tube is configured to maintain a predetermined position during linear movement of the ultrasound probe and to function as a guide for the linear movement of the ultrasound probe. Claim 8 is therefore non-obvious over the prior art, and would be allowable If rewritten in independent form.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee (KR 10-2020-0069055 A1), which teaches an ultrasound probe which linearly moves within a sealing member.
McCaffrey (U.S PGPub 2026/0174497 A1), which teaches an ultrasound transducer catheter.
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/SEAN D MATTSON/ Primary Examiner, Art Unit 3798
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