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 an amendment filed on 8/5/2026. As directed by the amendment, claims 59 and 79 are amended, claims 1-58, 60, and 68-78 were cancelled, and new claims 89-92 were added. Thus, claims 59, 61-67 and 79-92 are presently pending in this application.
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.
Presently, no limitation(s) is/are being interpreted under 112(f).
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.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 59, 61-67, 79, and 81-92 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Cioanta (2011/0034832) or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Cioanta (2011/0034832) in view of Uebelacker (2008/0146971).
PNG
media_image1.png
805
1203
media_image1.png
Greyscale
Regarding claim 59, Cioanta discloses a medical device (entire device shown in fig. 53A, see fig. 35 for reference) for treating a calcified tissue of a body passage (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures) of a subject, the medical device comprising: an elongate body (elongate body is tubular structure that comprises 366, see the annotated-Cioanta fig. 54A above) configured to be inserted into the body passage (fig. 54A with reference to figs. 1-17, 36A-41 and 53, Cioanta discloses a body passage 15 comprising occlusion 20, paragraphs 0203, 0206-0208, and 0211), the elongate body comprising a distal end (see the annotated-Cioanta fig. 54A above); and an acoustic wave emitter (541, 542, 544, 340, and 90, fig. 54A, paragraphs 0539-0544) coupled to the elongate body and disposed adjacent to the distal end of the elongate body (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave emitter includes a non-expandable emitter enclosure (340, the emitter enclosure is 340 and the generator is 544 and 542 and throughout the disclosure of Cioanta, 340 is not expandable in the same manner as the balloon enclosure 541, see full disclosure of Cioanta), and an acoustic wave generator (544 and 542 or alternatively the acoustic wave generator can be considered as 544, 542 and 90, see the annotated-Cioanta fig. 54A above) received in the non-expandable emitter enclosure (see the annotated-Cioanta fig. 54A above), Cioanta discloses a distal tip coupled to a distal end of the acoustic wave emitter (see the annotated-Cioanta fig. 54A above, the distal end of the acoustic wave emitter can be formed by the end of 542 or the distal end of the acoustic wave emitter can be formed by ring member of 340 or the distal end of the acoustic wave emitter can be formed by end of 541, alternatively, a tip of 90 is the distal tip, the distal tip is a tip portion of 90 which is coupled to a distal end of the acoustic wave emitter also formed by 90), wherein the acoustic wave generator is configured to generate spherical waves inside the non-expandable emitter enclosure (see fig. 54A and paragraph 0540, Cioanta discloses electrodes for creating a discharge 546 which creates radial waves, since the radial waves start from a point source, the radial waves form spherical waves), and wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure to selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Furthermore, Cioanta discloses that electrodes (544 and 542, fig. 54a, paragraph 0540) of the acoustic wave generator configured to produce the spherical acoustic waves (see the explanation above). However, if there is any doubt that Cioanta discloses that the acoustic wave generator is for generating spherical waves.
Uebelacker teaches electrodes forming an acoustic wave generator configured to generate spherical acoustic waves (see fig. 2, as shown, electrodes 2’ and 3’ produce a point source which generate spherical acoustic waves, see paragraph 0074).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the electrodes of the acoustic wave generator of Cioanta to produce spherical waves as taught by Uebelacker for the purpose of providing an alternative shockwave generator that would be capable of generating shockwave that would propagate from a point source and outward to treat the patient.
Regarding claim 61, Cioanta or the modified Cioanta discloses an external power source configured to supply power to the acoustic wave generator to generate acoustic waves (see paragraph 0540 of Cioanta, connected via electrical wire 432 to a voltage source, the source is in the other direction, therefore, is external to the electrodes 542 and 544).
Regarding claim 62, Cioanta or the modified Cioanta discloses that the acoustic wave generator comprises a ring-shaped member (see the annotated-Cioanta fig. 54a above, the ring member is formed by 90 of the acoustic wave generator).
Regarding claim 63, Cioanta or the modified Cioanta discloses that the emitter enclosure is filled with an acoustic material, wherein the acoustic waves propagate through the acoustic material (see paragraphs 0539-0542 and fig. 54A of Cioanta, see saline).
Regarding claim 64, Cioanta or the modified Cioanta discloses that the acoustic material is saline (see paragraphs 0539-0542 and fig. 54A of Cioanta, see saline).
Regarding claim 65, Cioanta or the modified Cioanta discloses that the body passage is a blood vessel (fig. 54A with reference to figs. 1-17, 36A-41 and 53, Cioanta discloses a body passage 15, paragraphs 0203 and 0206-0208).
Regarding claim 66, Cioanta or the modified Cioanta discloses that the acoustic emitter is configured to widen the body passage (see figs. 47A-47C, and 49C-53 of Cioanta for reference, the invention of Cioanta is to break up calcified tissue or fat cells formed by occlusion 20, therefore, would widen the body passage, 0002-0003, 0175, 0211 and 0516 of Cioanta).
Regarding claim 67, Cioanta or the modified Cioanta discloses that the medical device is configured to be distally advanced into the modified calcified tissue (see figs. 53 and 54A and paragraphs 0232-0234, 0414 of Cioanta, the medical device is capable of being distally advanced into the modified calcified tissue, furthermore, Cioanta discloses advancing of the medical device into the blood vessel 15).
Regarding claim 79, Cioanta or the modified Cioanta discloses a method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures); and activating the acoustic wave generator to generate spherical waves inside the emitter enclosure (see paragraphs 053-0542 of Cioanta or alternatively, see the modification with Uebelacker), wherein the spherical acoustic waves propagate through the emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Regarding claim 81, Cioanta or the modified Cioanta discloses irrigating the body passage to remove broken up calcified tissue from the body passage (see paragraph 0430 of Cioanta, Cioanta discloses that after the intracorporeal pressure shock wave catheter 340 is removed from the treatment area, allowing a larger lumen to be used for suction, see fig. 37 for reference, furthermore, see paragraphs 0209, 0229, 0282-0285, 0426-0430 of Cioanta for reference into the suctioning of the debris being done during treatment or after treatment when the catheter 340 is removed).
Regarding claim 82, Cioanta or the modified Cioanta discloses supplying power from an external power source to the acoustic wave generator to generate the acoustic waves (see paragraph 0540 of Cioanta, connected via electrical wire 432 to a voltage source, the source is in the other direction, therefore, is external to the electrode 542 and 544).
Regarding claim 83, Cioanta or the modified Cioanta discloses that the body passage is a blood vessel (fig. 54A with reference to figs. 1-17, 36A-41 and 53, Cioanta discloses a body passage 15, paragraphs 0203 and 0206-0208).
Regarding claim 84, Cioanta or the modified Cioanta discloses activating the acoustic wave generator widens the body passage (see figs. 47A-47C, and 49C-53 of Cioanta for reference, the invention of Cioanta is to break up calcified tissue or fat cells formed by occlusion 20, therefore, would widen the body passage, 0002-0003, 0175, 0211 and 0516 of Cioanta).
Regarding claim 85, Cioanta or the modified Cioanta discloses adjusting an energy signal supplied to the acoustic wave generator based on a material characteristic of the calcified tissue (see paragraphs 0271, 0402-0405, 0440, 0456 and 0536 of Cioanta, Cioanta discusses different energy settings for different types of treatment).
Regarding claim 86, Cioanta or the modified Cioanta discloses that the material characteristic includes at least one of mechanical resonance, density or modulus of elasticity (see paragraphs 0271, 0402-0405, 0440, 0456 and 0536 of Cioanta, Cioanta discusses different energy settings for different types of treatments, all of the different types of treatments against different types of tissues inherently comprise mechanical resonance, density or modulus of elasticity, therefore, relatively, the setting for the different tissues being treated is “based” on material characteristics that would include density, elasticity or mechanical resonance).
Regarding claim 87, Cioanta or the modified Cioanta discloses that the emitter enclosure (340 of Cioanta) is filled with an acoustic material, and wherein the spherical acoustic waves propagate through the acoustic material before reaching the calcified tissue (see paragraphs 0539-0542 and fig. 54A of Cioanta, see saline).
Regarding claim 88, Cioanta or the modified Cioanta discloses positioning the elongate body through a canula having a longitudinal passage, wherein the cannula shield at least a portion of the body passage from the acoustic wave (the cannula is 340, see the annotated-Cioanta fig. 54A above, the cannula has a length that is long (see fig. 35 of Cioanta for reference), therefore, would relatively shield at least a portion of the body passage from acoustic wave to a certain degree, alternatively, when a suction source is used, the cannula can be interpreted as 92, see figs. 37 and 45 for reference, paragraphs 0491-0501 of Cioanta).
Regarding claim 89, the modified Cioanta discloses that the spherical acoustic waves propagate distally beyond the distal tip (see the annotated-Cioanta fig. 54A above, as shown, the location where the spherical acoustic waves propagate to would be distally beyond the distal tip relative to the distal tip, since the waves are away from the distal tip).
Regarding claim 90, the modified Cioanta discloses that the calcified tissue is located distally of the distal tip (see the annotated-Cioanta fig. 54A above relative to figs. 37-41 and 51-53, as shown, the location where the spherical acoustic waves propagate to which would have the calcified tissue, which would be distally beyond the distal tip relative to the distal tip, since the calcified tissues are away from the distal tip).
Regarding claim 91, the modified Cioanta discloses that the spherical acoustic waves propagate distally beyond the distal tip (see the annotated-Cioanta fig. 54A above, as shown, the location where the spherical acoustic waves propagate to would be distally beyond the distal tip relative to the distal tip, since the waves are away from the distal tip).
Regarding claim 92, the modified Cioanta discloses that the modified Cioanta discloses that the calcified tissue is located distally of the distal tip (see the annotated-Cioanta fig. 54A above relative to figs. 37-41 and 51-53, as shown, the location where the spherical acoustic waves propagate to which would have the calcified tissue, which would be distally beyond the distal tip relative to the distal tip, since the calcified tissues are away from the distal tip).
Claim 80 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cioanta (2011/0034832) or Cioanta (2011/0034832) in view of Uebelacker (2008/0146971) as applied to claim 79 above, and further in view of Janssen (2005/0283148).
Regarding claim 80, Cioanta or the modified Cioanta discloses advancing the elongate body distally into the body passage (see paragraphs 0414, 0432-0433, 0457-0476 and 0481 of Cioanta, Cioanta discloses advancing the intracorporeal pressure shock wave catheter 340 through vasculatures to reach the treatment area, and positioning of the intracorporeal pressure shock wave catheter 340 to treat the occlusion), but fails to disclose advancing as the calcified tissue is broken up by the acoustic waves.
However, Janssen teaches advancing ablation with the active tip while ablating in the successive zones (see paragraph 0054).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the method of Cioanta or the modified Cioanta to advance the elongate body distally into the body passage while the acoustic wave generator of Cioanta or the modified Cioanta to be active as taught by Janssen for the purpose of providing an efficient method of removing calcified tissue by moving the tip further into the calcified tissue while actively breaking up calcified tissue.
However, if there is any doubt that it would be obvious to modify with Janssen. The feature of choosing to advance as the calcified tissue is broken up by the acoustic waves is considered as an obvious treatment design choice since it is up to the doctor and the condition of the patient to advance into the modified calcified tissue to further pulverize additional calcified tissue as the calcified tissue is broken up by the acoustic waves.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 79-80, 82-84, 87, and 91-92 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over co-pending claims 2, 4-11, and 13-21 of Application No. 19/455,540 in view of Cioanta (2011/0034832) and alternatively in view of Uebelacker (2008/0146971).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the co-pending claims are minor and obvious from each other. For example, the instant claims 79-80, 82-84, 87, and 91-92 are a broader version of the co-pending claims 2, 4-11, and 13-21 (i.e., the instant claims 79-80, 82-84, 87, and 91-92do not include the method of treating an occluded body passage or an elongated medical device as in the co-pending claims 2, 4-11, and 13-21). In the instant claims 79-80, 82-84, 87, and 91-92, the method is included in the co-pending claims 2, 4-11, and 13-21. Any infringement over the co-pending claims would also infringe over the instant claim. Therefore, the instant claims 79-80, 82-84, 87, and 91-92 do not differ in scope from the co-pending claims 2, 4-11, and 13-21. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding the instant application claim 79, the following comparison between the co-pending claim 2 and the instant application claim, see underlined features in the co-pending claim, show what elements have been excluded in the presentation of the instant application claim and co-pending claim.
Application claim 79
Co-pending claim 2
59. (for reference) A medical device for treating a calcified tissue of a body passage of a subject, the medical device comprising: an elongate body configured to be inserted into the body passage, the elongate body comprising a distal end; and an acoustic wave emitter coupled to the elongate body and disposed adjacent to the distal end of the elongate body, wherein the acoustic wave emitter includes a non-expandable emitter enclosure, and an acoustic wave generator received in the a non-expandable emitter enclosure, and a distal tip coupled to a distal end of the acoustic wave emitter, wherein the acoustic wave generator is configured to generate spherical acoustic waves inside the non-expandable emitter enclosure, and wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure to selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
79. A method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue; and activating the acoustic wave generator to generate spherical acoustic waves inside the non-expandable emitter enclosure, wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
2. A method of treating an occluded body passage of a subject, the method comprising: inserting an elongate medical device into the occluded body passage, wherein the elongate medical device has a distal end; positioning an acoustic wave emitter of the elongate medical device in the occluded body passage so that the distal end of the elongate medical device faces a calcified tissue occlusion of the occluded body passage, wherein the acoustic wave emitter is adjacent the distal end of the elongate medical device and includes a non-expandable emitter enclosure, and an acoustic wave generator received in the emitter enclosure; generating acoustic waves inside the emitter enclosure using the acoustic wave generator, wherein the generated acoustic waves propagate spherically and distally through acoustic material within the non-expandable emitter enclosure, and through the emitter enclosure and distal of the distal end of the elongate medical device, wherein the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate medical device.
Regarding the additional limitations in the instant application claim 79, the co-pending claims 2, 4-11, and 13-21 fail to disclose that the spherical acoustic waves selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
Cioanta teaches a medical device (entire device shown in fig. 53A) for treating a calcified tissue of a body passage (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures) of a subject, the medical device comprising: an elongate body (elongate body is tubular structure that comprises 366, see the annotated-Cioanta fig. 54A above) configured to be inserted into the body passage (fig. 54A with reference to figs. 1-17, 36A-41 and 53, Cioanta discloses a body passage 15 comprising occlusion 20, paragraphs 0203, 0206-0208, and 0211), the elongate body comprising a distal end (see the annotated-Cioanta fig. 54A above); and an acoustic wave emitter (541, 542, 544, 340, and 90, fig. 54A, paragraphs 0539-0544) coupled to the elongate body and disposed adjacent to the distal end of the elongate body (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave emitter includes an emitter enclosure (541, fig. 54A), and an acoustic wave generator (portion of 340 and 544 and 542, see the annotated-Cioanta fig. 54A above) received in the emitter enclosure (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave generator is configured to generate spherical waves inside the emitter enclosure (see fig. 54A and paragraph 0540, Cioanta discloses electrodes for creating a discharge 546 which creates radial waves, since the radial waves start from a point source, the radial waves form spherical waves), wherein the acoustic wave emitter is configured to enable the generated spherical acoustic waves to propagate through the emitter enclosure so that the propagated acoustic waves selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Cioanta teaches a method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures); and activating the acoustic wave generator to generate spherical waves inside the emitter enclosure (see paragraphs 053-0542 of Cioanta or alternatively, see the modification with Uebelacker), wherein the spherical acoustic waves propagate through the emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the co-pending claims 2, 4-11, and 13-21 to use the medical device comprising the acoustic wave generator is configured to generate spherical acoustic waves that selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue as taught by Cioanta for the purpose of utilizing an alternative acoustic generating medical device that is capable of treating calcified tissues of an occluded body.
Furthermore, regarding the additional limitation of a distal tip coupled to a distal end, the acoustic wave emitter would be three dimensional, therefore, has a tip that can be sectioned into a tip and an end.
The instant claim 79 is being rejected by the modified co-pending claims 2, 4-11, and 13-21.
The instant claim 80 is being rejected by the modified co-pending claim 11.
The instant claim 82 is being rejected by the modified co-pending claim 4.
The instant claim 83 is being rejected by the modified co-pending claims 9 and 14.
The instant claim 84 is being rejected by the modified co-pending claims 10 and 15-19.
The instant claim 87 is being rejected by the modified co-pending claims 7-8 and 16-17.
The instant claim 91 is being rejected by the modified co-pending claims 2, 4-11, and 13-21.
The instant claim 92 is being rejected by the modified co-pending claims 2, 4-11, and 13-21.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim 81 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over co-pending claims 2, 4-11, and 13-21 of Application No. 19/455,540 in view of Cioanta (2011/0034832) and alternatively in view of Uebelacker (2008/0146971).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claim and the co-pending claims are minor and obvious from each other. For example, the instant claim 81 is a broader version of the co-pending claims 2, 4-11, and 13-21 (i.e., the instant claim 81 does not include the method of treating an occluded body passage or an elongated medical device as in the co-pending claims 2, 4-11, and 13-21). In the instant claim 81, the method is included in the co-pending claims 2, 4-11, and 13-21. Any infringement over the co-pending claims would also infringe over the instant claim. Therefore, the instant claim 81 does not differ in scope from the co-pending claims 2, 4-11, and 13-21. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding the instant application claim 81, the following comparison between the co-pending claim 2 and the instant application claim, see underlined features in the co-pending claim, show what elements have been excluded in the presentation of the instant application claim and co-pending claim.
Application claim 81
Co-pending claim 2
59. (for reference) A medical device for treating a calcified tissue of a body passage of a subject, the medical device comprising: an elongate body configured to be inserted into the body passage, the elongate body comprising a distal end; and an acoustic wave emitter coupled to the elongate body and disposed adjacent to the distal end of the elongate body, wherein the acoustic wave emitter includes a non-expandable emitter enclosure, and an acoustic wave generator received in the a non-expandable emitter enclosure, and a distal tip coupled to a distal end of the acoustic wave emitter, wherein the acoustic wave generator is configured to generate spherical acoustic waves inside the non-expandable emitter enclosure, and wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure to selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
79. A method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue; and activating the acoustic wave generator to generate spherical acoustic waves inside the non-expandable emitter enclosure, wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
81. The method of claim 79, further comprising irrigating the body passage to remove broken up calcified tissue from the body passage.
2. A method of treating an occluded body passage of a subject, the method comprising: inserting an elongate medical device into the occluded body passage, wherein the elongate medical device has a distal end; positioning an acoustic wave emitter of the elongate medical device in the occluded body passage so that the distal end of the elongate medical device faces a calcified tissue occlusion of the occluded body passage, wherein the acoustic wave emitter is adjacent the distal end of the elongate medical device and includes a non-expandable emitter enclosure, and an acoustic wave generator received in the emitter enclosure; generating acoustic waves inside the emitter enclosure using the acoustic wave generator, wherein the generated acoustic waves propagate spherically and distally through acoustic material within the non-expandable emitter enclosure, and through the emitter enclosure and distal of the distal end of the elongate medical device, wherein the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate medical device.
Regarding the additional limitations in the instant application claim 81, the co-pending claims 2, 4-11, and 13-21 fail to disclose that the spherical acoustic waves selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
Cioanta teaches a medical device (entire device shown in fig. 53A) for treating a calcified tissue of a body passage (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures) of a subject, the medical device comprising: an elongate body (elongate body is tubular structure that comprises 366, see the annotated-Cioanta fig. 54A above) configured to be inserted into the body passage (fig. 54A with reference to figs. 1-17, 36A-41 and 53, Cioanta discloses a body passage 15 comprising occlusion 20, paragraphs 0203, 0206-0208, and 0211), the elongate body comprising a distal end (see the annotated-Cioanta fig. 54A above); and an acoustic wave emitter (541, 542, 544, 340, and 90, fig. 54A, paragraphs 0539-0544) coupled to the elongate body and disposed adjacent to the distal end of the elongate body (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave emitter includes an emitter enclosure (541, fig. 54A), and an acoustic wave generator (portion of 340 and 544 and 542, see the annotated-Cioanta fig. 54A above) received in the emitter enclosure (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave generator is configured to generate spherical waves inside the emitter enclosure (see fig. 54A and paragraph 0540, Cioanta discloses electrodes for creating a discharge 546 which creates radial waves, since the radial waves start from a point source, the radial waves form spherical waves), wherein the acoustic wave emitter is configured to enable the generated spherical acoustic waves to propagate through the emitter enclosure so that the propagated acoustic waves selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Cioanta teaches a method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures); and activating the acoustic wave generator to generate spherical waves inside the emitter enclosure (see paragraphs 053-0542 of Cioanta or alternatively, see the modification with Uebelacker), wherein the spherical acoustic waves propagate through the emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the co-pending claims 2, 4-11, and 13-21 to use the medical device comprising the acoustic wave generator is configured to generate spherical acoustic waves that selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue as taught by Cioanta for the purpose of utilizing an alternative acoustic generating medical device that is capable of treating calcified tissues of an occluded body.
Regarding the additional limitation in the instant application claim 81, the co-pending claims 2, 4-11, and 13-21 fail to disclose irrigating the body passage to remove broken up calcified tissue from the body passage.
Cioanta teaches irrigating the body passage to remove broken up calcified tissue from the body passage (see paragraph 0430 of Cioanta, Cioanta discloses that after the intracorporeal pressure shock wave catheter 340 is removed from the treatment area, allowing a larger lumen to be used for suction, see fig. 37 for reference, furthermore, see paragraphs 0209, 0229, 0282-0285, 0426-0430 of Cioanta for reference into the suctioning of the debris being done during treatment or after treatment when the catheter 340 is removed).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the modified co-pending claims 2, 4-11, and 13-21 to have the step of irrigating the body passage to remove broken up calcified tissue from the body passage as taught by Cioanta for the purpose of providing safety to the patient by removing the broken up calcified tissues from the patient’s body.
Furthermore, regarding the additional limitation of a distal tip coupled to a distal end, the acoustic wave emitter would be three dimensional, therefore, has a tip that can be sectioned into a tip and an end.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 85-86 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over co-pending claims 2, 4-11, and 13-21 of Application No. 19/455,540 in view of Cioanta (2011/0034832) and alternatively in view of Uebelacker (2008/0146971).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the co-pending claims are minor and obvious from each other. For example, the instant claims 85-86 are a broader version of the co-pending claims 2, 4-11, and 13-21 (i.e., the instant claims 85-86 do not include the method of treating an occluded body passage or an elongated medical device as in the co-pending claims 2, 4-11, and 13-21). In the instant claims 85-86, the method is included in the co-pending claims 2, 4-11, and 13-21. Any infringement over the co-pending claims would also infringe over the instant claim. Therefore, the instant claims 85-86 do not differ in scope from the co-pending claims 2, 4-11, and 13-21. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding the instant application claims 85-86, the following comparison between the co-pending claim 2 and the instant application claim, see underlined features in the co-pending claim, show what elements have been excluded in the presentation of the instant application claim and co-pending claim.
Application claims 85-86
Co-pending claim 2
59. (for reference) A medical device for treating a calcified tissue of a body passage of a subject, the medical device comprising: an elongate body configured to be inserted into the body passage, the elongate body comprising a distal end; and an acoustic wave emitter coupled to the elongate body and disposed adjacent to the distal end of the elongate body, wherein the acoustic wave emitter includes a non-expandable emitter enclosure, and an acoustic wave generator received in the a non-expandable emitter enclosure, and a distal tip coupled to a distal end of the acoustic wave emitter, wherein the acoustic wave generator is configured to generate spherical acoustic waves inside the non-expandable emitter enclosure, and wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure to selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
79. A method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue; and activating the acoustic wave generator to generate spherical acoustic waves inside the non-expandable emitter enclosure, wherein the spherical acoustic waves propagate through the non-expandable emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue.
85. The method of claim 79, further comprising adjusting an energy signal supplied to the acoustic wave generator based on a material characteristic of the calcified tissue.
86. The method of claim 85, wherein the material characteristic includes at least one of mechanical resonance, density, or modulus of elasticity.
2. A method of treating an occluded body passage of a subject, the method comprising: inserting an elongate medical device into the occluded body passage, wherein the elongate medical device has a distal end; positioning an acoustic wave emitter of the elongate medical device in the occluded body passage so that the distal end of the elongate medical device faces a calcified tissue occlusion of the occluded body passage, wherein the acoustic wave emitter is adjacent the distal end of the elongate medical device and includes a non-expandable emitter enclosure, and an acoustic wave generator received in the emitter enclosure; generating acoustic waves inside the emitter enclosure using the acoustic wave generator, wherein the generated acoustic waves propagate spherically and distally through acoustic material within the non-expandable emitter enclosure, and through the emitter enclosure and distal of the distal end of the elongate medical device, wherein the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate medical device.
Regarding the additional limitations in the instant application claims 85-86, the co-pending claims 2, 4-11, and 13-21 fail to disclose that propagated acoustic waves selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue, and adjusting an energy signal supplied to the acoustic wave generator based on a material characteristic of the calcified tissue, the material characteristic includes at least one of mechanical resonance, density, or modulus of elasticity.
Cioanta teaches a medical device (entire device shown in fig. 53A) for treating a calcified tissue of a body passage (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures) of a subject, the medical device comprising: an elongate body (elongate body is tubular structure that comprises 366, see the annotated-Cioanta fig. 54A above) configured to be inserted into the body passage (fig. 54A with reference to figs. 1-17, 36A-41 and 53, Cioanta discloses a body passage 15 comprising occlusion 20, paragraphs 0203, 0206-0208, and 0211), the elongate body comprising a distal end (see the annotated-Cioanta fig. 54A above); and an acoustic wave emitter (541, 542, 544, 340, and 90, fig. 54A, paragraphs 0539-0544) coupled to the elongate body and disposed adjacent to the distal end of the elongate body (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave emitter includes an emitter enclosure (541, fig. 54A), and an acoustic wave generator (portion of 340 and 544 and 542, see the annotated-Cioanta fig. 54A above) received in the emitter enclosure (see the annotated-Cioanta fig. 54A above), wherein the acoustic wave generator is configured to generate spherical waves inside the emitter enclosure (see fig. 54A and paragraph 0540, Cioanta discloses electrodes for creating a discharge 546 which creates radial waves, since the radial waves start from a point source, the radial waves form spherical waves), wherein the acoustic wave emitter is configured to enable the generated spherical acoustic waves to propagate through the emitter enclosure so that the propagated acoustic waves selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Cioanta teaches a method of using the medical device of claim 59, the method comprising: positioning the elongate body in the body passage such that the acoustic wave emitter is adjacent to calcified tissue (paragraphs 0002-0003, 0141-0175, 0211 and 0539-0540, fig. 54A, Cioanta discloses destruction of unwanted hard tissues including calcification, furthermore, see paragraphs 0413-0415 regarding intracorporeal catheter shockwave being used to treat plaques 130 (stenotic plaques or vulnerable plaques), furthermore, Cioanta discloses in paragraph 0211 and figs. 47A and 50D the medical device being used to treat occlusion 20 comprising solid calcifications structures); and activating the acoustic wave generator to generate spherical waves inside the emitter enclosure (see paragraphs 053-0542 of Cioanta or alternatively, see the modification with Uebelacker), wherein the spherical acoustic waves propagate through the emitter enclosure and selectively break up the calcified tissue while preserving adjacent non-calcified tissue based on a difference in at least one of density or modulus of elasticity between the calcified tissue and the non-calcified tissue (see paragraphs 0505 and paragraphs 0141-0175 and 0211, Cioanta discloses that the shockwave is capable of destroying calcified tissue while avoiding damage to the healthy tissue, Cioanta discloses “cavitation bubbles produced by special tailored pressure shock waves collapses with microjets powerful enough to penetrate the hyperplastic, benign or malignant cells membrane and thus destroying their integrity. This represents a ‘normal body temperature ablation’ process not employing high or low temperatures used by existing ablation technologies and targets only the hyperplastic, benign or malignant cells without having damaging influences on the healthy adjacent tissue”, therefore, would be based on a difference in a density or modulus of elasticity between the calcified tissue and the surrounding non-calcified tissue, furthermore, see paragraph 0002-0003 regarding cavitation caused by shockwave being used to destroy calcified tissue and plaque).
Cioanta teaches adjusting an energy signal supplied to the acoustic wave generator based on a material characteristic of the calcified tissue (see paragraphs 0271, 0402-0405, 0440, 0456 and 0536 of Cioanta, Cioanta discusses different energy settings for different types of treatments). Cioanta teaches that the material characteristic includes at least one of mechanical resonance, density or modulus of elasticity (see paragraphs 0271, 0402-0405, 0440, 0456 and 0536 of Cioanta, Cioanta discusses different energy settings for different types of treatments, all of the different types of treatments against different types of tissues inherently comprise mechanical resonance, density or modulus of elasticity, therefore, relatively, the setting for the different tissues being treated is “based” on material characteristics that would include density, elasticity or mechanical resonance).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the co-pending claims 2, 4-11, and 13-21 to use the medical device comprising the acoustic wave generator is configured to generate spherical acoustic waves that selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue as taught by Cioanta for the purpose of utilizing an alternative acoustic generating medical device that is capable of treating calcified tissues of an occluded body.
Furthermore, regarding the additional limitation of a distal tip coupled to a distal end, the acoustic wave emitter would be three dimensional, therefore, has a tip that can be sectioned into a tip and an end.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
The arguments to the newly added claim limitations in claims 2, 4-11, and 13-21 has been addressed in the above rejection.
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 TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TU A VO/Primary Examiner, Art Unit 3785
Prosecution Insights