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 a preliminary amendment filed on 1/19/2026. As directed by the amendment, claims 59 and 65 were amended, claims 1-58 were cancelled, and new claims 69-76 were added. Thus, claims 59-76 are presently pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: the reference numerals “490” and “460” in fig. 41, “1195” in figs. 132-133, “1260” in fig. 139, and “1520” and “1510” in fig. 141 are missing from the specification.
Furthermore, the drawings are objected to because figs. 33, 70, 79, 90, 99, and 112 contain an assembly having a plurality of parts that are disconnected, some form of connection to indicate that all of the parts are part of the same assembly is missing. A connecting axis or bracket is needed to show that the plurality of parts are part of the same assembly. If the plurality of parts are not part of the same assembly, then each part should be on a separate figure. See 37 C.F.R. 1.84(h)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 59, 69 and 72-76 are objected to because of the following informalities:
In claim 59, line 3, the term “the occluded body passage” is suggested to be changed to --the body passage-- or --the body passage comprising the calcified tissue occlusion-- in order to provide consistency.
In claim 59, line 5, the term “an acoustic wave emitter coupled to the elongate body adjacent to the distal end of the elongate body” is suggested to be changed to --an acoustic wave emitter coupled to the elongate body and is adjacent to the distal end of the elongate body-- in order to clarify the claim. In claim 69, line 3, the term “the occluded body passage” is suggested to be changed to --the body passage-- or --the body passage comprising the calcified tissue occlusion-- in order to provide consistency.
In claim 69, line 5, the term “an acoustic wave emitter coupled to the elongate body adjacent to the distal end of the elongate body” is suggested to be changed to --an acoustic wave emitter coupled to the elongate body and is adjacent to the distal end of the elongate body-- in order to clarify the claim.
In claim 72 (second occurrence, page 4, line 12) is suggested to be renumbered to --73--; current claim 73, renumbered to --74--; current claim 74 renumbered to --75--; current claim 75 renumbered to --76--; and current claim 76 renumbered to --77-- in order to correct the numbering of the claims.
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.
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.
Claims 59-76 are 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 pre-AIA the applicant regards as the invention.
Regarding claim 59, the limitation “a distal end” (line 8) is unclear if the distal end in line 8 is the same as or different from “a distal end” being claimed in claim 59, line 4. If they are different, suggest to amend to --a second distal end--, if they are the same, suggest to amend to --the distal end--. Furthermore, if they are different, then the limitation “the distal end of the elongate medical device” (line 13) is unclear if the distal end of the elongate medical device in line 13 is referring to the distal end in line 8 or line 4. It is noted that “a distal end” (line 4) of the elongate body that is part of a medical device is also a distal end of the medical device (in reference to the distal end in line 4).
Regarding claim 59, the limitation “the elongate medical device” (lines 13-14) is unclear if the intention is to claim the elongated body or the medical device, if the intent is to claim the medical device, it is unclear if the claim is trying to redefine the medical device as an elongate medical device. A medical device comprising an elongate body does not necessarily make the medical device an elongate medical device, therefore, by claiming “the elongate medical device” for the first time, it is not clear if the claim is trying to claim the elongate body, the medical device, or defining the medical device as elongate.
Regarding claims 60-68 and 70-76, the limitation “The method” (line 1) lacks proper antecedent basis. Furthermore, it is unclear if the applicant is trying to claim a method claim or an apparatus, claims 59 and 69 claim a “medical device” while claims 60-68 and 70-76 claim “The method”. For examination purposes, the limitation “The method” is being interpreted as --The medical device--.
Regarding claim 69, the limitation “a distal end” (line 8) is unclear if the distal end in line 8 is the same as or different from “a distal end” being claimed in claim 69, line 4. If they are different, suggest to amend to --a second distal end--, if they are the same, suggest to amend to --the distal end--. Furthermore, if they are different, then the limitation “the distal end of the elongate medical device” (line 13) is unclear if the distal end of the elongate medical device in line 13 is referring to the distal end in line 8 or line 4. It is noted that “a distal end” (line 4) of the elongate body that is part of a medical device is also a distal end of the medical device (in reference to the distal end in line 4).
Regarding claim 69, the limitation “the elongate medical device” (lines 13-14) is unclear if the intention is to claim the elongated body or the medical device, if the intent is to claim the medical device, it is unclear if the claim is trying to redefine the medical device as an elongate medical device. A medical device comprising an elongate body does not necessarily make the medical device an elongate medical device, therefore, by claiming “the elongate medical device” for the first time, it is not clear if the claim is trying to claim the elongate body, the medical device, or defining the medical device as elongate.
Regarding claim 72 (second occurrence), the limitation “The method of claim 72” (line 1) is unclear as to which claim 72 (second occurrence) is being depended on, the 72 of the first occurrence or the second occurrence, if the second occurrence, it is unclear how a claim can be dependent on itself.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 59-67 and 69-75 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nguyen (US 2011/0137298).
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Regarding claim 59, Nguyen discloses a medical device (see entire device in embodiment in figs. 7-14, paragraphs 0057-0067) for treating a calcified tissue occlusion of a body passage of a subject (it is noted that the limitation “for treating a calcified tissue occlusion of a body passage of a subject” is intended use, the medical device of Nguyen is capable of being used for treating a calcified tissue occlusion of a body passage of a subject, Nguyen discloses in figs. 9 and 13 and paragraphs 0063-0066 that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to treat calcified tissue), the medical device comprising an elongate body (122, fig. 7, paragraph 0058) configured to be inserted into the occluded body passage (the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, would be capable of being inserted into occluded body passage, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073), the elongate body comprising a distal end (distal end is the end of 122 that is attached to 138, figs. 7, 9 and 13, see the annotated-Nguyen fig. 9 above), an acoustic wave emitter (160, 138 and 154, figs. 7, 9 and 13, paragraphs 0059, 0063, 0065, 0066) coupled to the elongate body adjacent to the distal end of the elongate body (see fig. 13), wherein the acoustic wave emitter includes an emitter enclosure (138, figs. 7, 9 and 13, paragraphs 0059, 0061 and 0063-0067), and an acoustic wave generator (160, figs. 7 and 13, paragraphs 0059, 0063, 0065, 0066) received in the emitter enclosure; and a distal tip (distal tip of 180, see the annotated-Nguyen fig. 9 above) coupled to the acoustic wave emitter, wherein the distal tip defines a distal end of the medical device (see the annotated-Nguyen fig. 9 above), wherein the acoustic wave generator is configured to generate acoustic waves inside the emitter enclosure, wherein the acoustic wave emitter is configured to enable the generated acoustic waves to propagate distally through the emitter enclosure and distal of the distal end of the elongate medical device in use so that the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate body (Nguyen discloses in figs. 9 and 13 and paragraphs 0056-0076, that the ultrasound transducer is for producing a vibration for ablating tissue and is configured to be inserted into a blood vessel, which would be able to modify calcified tissue).
Regarding claim 60, Nguyen discloses that the acoustic wave emitter is configured to generate acoustic waves propagating spherically to the calcified tissue that is distal of the distal end of the elongate body (see paragraphs 0072 and 0075, Nguyen discloses that the ablation transducer 160 in fig. 9 emit ultrasonic energy around the circumference, from the shape of the transducer 160 and the disclosure of the ultrasonic energy being emitted around the circumference, as the waves travel, the shape would be propagating spherically, and is therefore, capable of propagating spherically to the calcified tissue that is at the distal of the distal end of the elongate body, furthermore, see fig. 10 for the circular cross section of transducer 160, alternatively, the waves is traveling/propagating through a spherical body 138, therefore, the waves would propagate spherically to the calcified tissue).
Regarding claim 61, Nguyen discloses an external power source configured to supply power to the acoustic generator to generate the acoustic waves (see paragraphs 0065-0066, Nguyen discloses an ultrasound generator 152 that comprises electrical wires for controlling transducer 160, therefore, would require a power source, the power source would be external relative to a body that is external from the power source).
Regarding claim 62, Nguyen discloses that the acoustic wave generator comprises a ring shape member (160 is ring shape as shown in fig. 10, see figs. 9 and 13 for reference, see paragraphs 0065-0066 and 0071, alternatively, 184 and 182 can be considered to be part of the acoustic wave generator, and would have the ring shape formed by 180 as shown in figs. 7, 9 and 13).
Regarding claim 63, Nguyen discloses that the emitter enclosure (138) is filled with an acoustic material, wherein the acoustic waves propagate through the acoustic material (see paragraphs 0063-0064, Nguyen discloses that the ablation is then carried out by energy that is emitted from the ultrasound transducer 160 through the inflation media (e.g., fluid, saline, contrast media or mixture) inside the balloon 138).
Regarding claim 64, Nguyen discloses that the acoustic material is saline (see paragraphs 0063-0064, Nguyen discloses that the ablation is then carried out by energy that is emitted from the ultrasound transducer 160 through the inflation media (e.g., fluid, saline, contrast media or mixture) inside the balloon 138).
Regarding claim 65, Nguyen discloses that the body passage is a blood vessel (the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, would be capable of being inserted into occluded body passage, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073).
Regarding claim 66, Nguyen discloses that the acoustic emitter is configured to widen the occluded body passage (see paragraphs 0063 and 0064, Nguyen discloses that the ultrasound transducer 160 will emit energy to ablate tissue that extend radially from the position of the balloon 138, to ablate tissue that extends radially from the position of the balloon 138 would widen the occluded body passage to a certain extent or is capable of widening the occluded body passage, alternatively, 180 can be considered as being part of the acoustic emitter, 180 can be pushed again an occluded passage to widen the occluded passage due to the size of 180 relative to the occluded passage).
Regarding claim 67, Nguyen discloses the medical device is configured to be distally advanced into the modified calcified tissue (the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, is capable of being distally advanced into the modified calcified tissue, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073).
Regarding claim 69, Nguyen discloses a medical device (see entire device in embodiment in figs. 7-14, paragraphs 0057-0067) for treating a calcified tissue occlusion of a blood vessel of a subject (it is noted that the limitation “for treating a calcified tissue occlusion of a blood vessel of a subject” is intended use, the medical device of Nguyen is capable of being used for treating a calcified tissue occlusion of a blood vessel of a subject, Nguyen discloses in figs. 9 and 13 and paragraphs 0063-0066 that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to treat calcified tissue), the medical device comprising an elongate body (122, fig. 7, paragraph 0058) configured to be inserted into the occluded blood vessel (the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, would be capable of being inserted into occluded body passage, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073, furthermore, the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, would be capable of being inserted into occluded body passage, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073), the elongate body comprising a distal end (distal end is the end of 122 that is attached to 138, figs. 7, 9 and 13, see the annotated-Nguyen fig. 9 above), an acoustic wave emitter (160, 138 and 154, figs. 7, 9 and 13, paragraphs 0059, 0063, 0065, 0066) coupled to the elongate body adjacent to the distal end of the elongate body (see fig. 13), wherein the acoustic wave emitter includes an emitter enclosure (138, figs. 7, 9 and 13, paragraphs 0059, 0061 and 0063-0067), and an acoustic wave generator (160, figs. 7 and 13, paragraphs 0059, 0063, 0065, 0066) received in the emitter enclosure; and a distal tip (distal tip of 180, see the annotated-Nguyen fig. 9 above) coupled to the acoustic wave emitter, wherein the distal tip defines a distal end of the medical device (see the annotated-Nguyen fig. 9 above), wherein the acoustic wave generator is configured to generate acoustic waves inside the emitter enclosure, wherein the acoustic wave emitter is configured to enable the generated acoustic waves to propagate distally through the emitter enclosure and distal of the distal end of the elongate medical device in use so that the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate body (Nguyen discloses in figs. 9 and 13 and paragraphs 0056-0076, that the ultrasound transducer is for producing a vibration for ablating tissue and is configured to be inserted into a blood vessel, which would be able to modify calcified tissue).
Regarding claim 70, Nguyen discloses that the acoustic wave emitter is configured to generate acoustic waves propagating spherically to the calcified tissue that is distal of the distal end of the elongate body (see paragraphs 0072 and 0075, Nguyen discloses that the ablation transducer 160 in fig. 9 emit ultrasonic energy around the circumference, from the shape of the transducer 160 and the disclosure of the ultrasonic energy being emitted around the circumference, as the waves travel, the shape would be propagating spherically, and is therefore, capable of propagating spherically to the calcified tissue that is at the distal of the distal end of the elongate body, furthermore, see fig. 10 for the circular cross section of transducer 160, alternatively, the waves is traveling/propagating through a spherical body 138, therefore, the waves would propagate spherically to the calcified tissue).
Regarding claim 71, Nguyen discloses an external power source configured to supply power to the acoustic generator to generate the acoustic waves (see paragraphs 0065-0066, Nguyen discloses an ultrasound generator 152 that comprises electrical wires for controlling transducer 160, therefore, would require a power source, the power source would be external relative to a body that is external from the power source).
Regarding claim 72, Nguyen discloses that the acoustic wave generator comprises a ring shape member (160 is ring shape as shown in fig. 10, see figs. 9 and 13 for reference, see paragraphs 0065-0066 and 0071, alternatively, 184 and 182 can be considered to be part of the acoustic wave generator, and would have the ring shape formed by 180 as shown in figs. 7, 9 and 13).
Regarding claim 72 (second occurrence and being reference to as claim 73 in the index of claims), Nguyen discloses that the emitter enclosure (138) is filled with an acoustic material, wherein the acoustic waves propagate through the acoustic material (see paragraphs 0063-0064, Nguyen discloses that the ablation is then carried out by energy that is emitted from the ultrasound transducer 160 through the inflation media (e.g., fluid, saline, contrast media or mixture) inside the balloon 138).
Regarding claim 73 (being reference to as claim 74 in the index of claims), Nguyen discloses that the acoustic material is saline (see paragraphs 0063-0064, Nguyen discloses that the ablation is then carried out by energy that is emitted from the ultrasound transducer 160 through the inflation media (e.g., fluid, saline, contrast media or mixture) inside the balloon 138).
Regarding claim 74 (being reference to as claim 75 in the index of claims), Nguyen discloses that the acoustic emitter is configured to widen the occluded body passage (see paragraphs 0063 and 0064, Nguyen discloses that the ultrasound transducer 160 will emit energy to ablate tissue that extend radially from the position of the balloon 138, to ablate tissue that extends radially from the position of the balloon 138 would widen the occluded body passage to a certain extent or is capable of widening the occluded body passage, alternatively, 180 can be considered as being part of the acoustic emitter, 180 can be pushed again an occluded passage to widen the occluded passage due to the size of 180 relative to the occluded passage).
Regarding claim 75 (being reference to as claim 76 in the index of claims), Nguyen discloses the medical device is configured to be distally advanced into the modified calcified tissue (the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, is capable of being distally advanced into the modified calcified tissue, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073).
Claims 59, 68-69 and 76 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by NGUYEN et al. (US 2011/0137298).
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Regarding claim 59, Nguyen discloses a medical device (entire device shown in figs. 1-5, paragraphs 0038-0055) for treating a calcified tissue occlusion of a body passage of a subject (it is noted that the limitation “for treating a calcified tissue occlusion of a body passage of a subject” is intended use, the medical device of Nguyen is capable of being used for treating a calcified tissue occlusion of a body passage of a subject, Nguyen discloses in paragraphs 0038-0055 that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to treat calcified tissue), the medical device comprising an elongate body (22, figs. 1-6, paragraphs 0040-0041) configured to be inserted into the occluded body passage (the device is disclosed as being inserted into blood vessel, paragraphs 0005, 0052 and 0055), the elongate body comprising a distal end (distal end is the end of 22 that is directly connected to 62, see the annotated-Nguyen fig. 3 above), an acoustic wave emitter (62 and 60, figs. 1-3 and paragraphs 0041-0043 and 0047-0050) coupled to the elongate body adjacent to the distal end of the elongate body (see figs. 1-6), wherein the acoustic wave emitter includes an emitter enclosure (62, fig. 3), and an acoustic wave generator (60 that is within 62, see paragraphs 0041-0043 and 0047-0050) received in the emitter enclosure; and a distal tip (distal tip is the distal tip of 102 that is accommodated within opening 94 in the distal tip 92, see paragraphs 0041 and 0044 and see the annotated-Nguyen fig. 3 above) coupled to the acoustic wave emitter, wherein the distal tip defines a distal end of the medical device (see the annotated-Nguyen fig. 9 above), wherein the acoustic wave generator is configured to generate acoustic waves inside the emitter enclosure, wherein the acoustic wave emitter is configured to enable the generated acoustic waves to propagate distally through the emitter enclosure and distal of the distal end of the elongate medical device in use so that the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate body (Nguyen discloses in figs. 1-5 and paragraphs 0038-0055, that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to modify calcified tissue).
Regarding claim 68, Nguyen discloses that the emitter enclosure is non-expandable (the emitter enclosure 62 is disclosed in paragraphs 0038-0055, which is a non-expandable embodiment, specifically see paragraph 0041, Nguyen discloses a non-compliant and non-porous tubular cap 62).
Regarding claim 69, Nguyen discloses a medical device (entire device shown in figs. 1-5, paragraphs 0038-0055) for treating a calcified tissue occlusion of a blood vessel of a subject (it is noted that the limitation “for treating a calcified tissue occlusion of a blood vessel of a subject” is intended use, the medical device of Nguyen is capable of being used for treating a calcified tissue occlusion of a blood vessel of a subject, Nguyen discloses in paragraphs 0038-0055 that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to treat calcified tissue, Nguyen further discloses that the device is configured to be inserted into blood vessel, paragraphs 0005, 0052 and 0055), the medical device comprising an elongate body (22, figs. 1-6, paragraphs 0040-0041) configured to be inserted into the occluded blood vessel (the device is disclosed as being inserted into blood vessel, paragraphs 0005, 0052 and 0055), the elongate body comprising a distal end (distal end is the end of 22 that is directly connected to 62, see the annotated-Nguyen fig. 3 above), an acoustic wave emitter (62 and 60, figs. 1-3 and paragraphs 0041-0043 and 0047-0050) coupled to the elongate body adjacent to the distal end of the elongate body (see figs. 1-6), wherein the acoustic wave emitter includes an emitter enclosure (62, fig. 3), and an acoustic wave generator (60 that is within 62, see paragraphs 0041-0043 and 0047-0050) received in the emitter enclosure; and a distal tip (distal tip is the distal tip of 102 that is accommodated within opening 94 in the distal tip 92, see paragraphs 0041 and 0044 and see the annotated-Nguyen fig. 3 above) coupled to the acoustic wave emitter, wherein the distal tip defines a distal end of the medical device (see the annotated-Nguyen fig. 9 above), wherein the acoustic wave generator is configured to generate acoustic waves inside the emitter enclosure, wherein the acoustic wave emitter is configured to enable the generated acoustic waves to propagate distally through the emitter enclosure and distal of the distal end of the elongate medical device in use so that the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate body (Nguyen discloses in figs. 1-5 and paragraphs 0038-0055, that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to modify calcified tissue).
Regarding claim 76 (being reference to as claim 77 in the index of claims), Nguyen discloses that the emitter enclosure is non-expandable (the emitter enclosure 62 is disclosed in paragraphs 0038-0055, which is a non-expandable embodiment, specifically see paragraph 0041, Nguyen discloses a non-compliant and non-porous tubular cap 62).
Remarks
Applicant is advised that should claim 69 be found allowable, claim 65 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cox (6,083,232) is cited to show a vibrating stent for treating calcified lesions.
Delaney (3,352,303) is cited to show a device comprising an elongate body for transmitting vibration to the patient’s body.
Rontal (2006/0224103) is cited to show an ultrasonic cleaning device used to treat sinuses or lungs.
DonMicheal (4,870,953) is cited to show an ultrasonic device for breaking up calcified plaque.
Schaer (US 2004/0082859) is cited to show a medical device comprising an ultrasonic transducer.
Sterzer (4,924,863) is cited to show a device for treating calcified plaque.
Maguire (6,607,502) is cited to show a guiding cannula and a catheter comprising a balloon having an ultrasonic transducer.
Ishitsu (5,042,976) is cited to show an outer cannula for a catheter.
Zadno-Azizi (2002/0065507) is cited to show a catheter having an inflatable element and a cannula.
Harhen (WO 0205720) is cited to show a catheter comprising a balloon having an ultrasonic transducer.
Keidar (2005/0021015) is cited to show an ablation device having a balloon comprising an ultrasonic transducer.
McDaniel (2008/0086073) is cited to show a guiding cannula and a catheter comprising a balloon having an ultrasonic transducer.
Acker (6,669,655) is cited to show a balloon comprising an ultrasonic transducer.
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/TU A VO/Primary Examiner, Art Unit 3785