DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 4, and 14 are objected to because of the following informalities:
Claim 1, line 10: “its cavity” should be “the cavity of the acceleration tube”.
Claim 4, line 2: “at least one proximal openings or openings” should read “at least one proximal opening”.
Claim 4, line 3: “the distal opening or openings” should read “at least one distal opening”.
Claim 14, line 8: “its cavity” should be “the cavity of the acceleration tube”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 9-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the first closure element" in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be read as “a first closure element”.
Claim 9 recites the limitation "the second cylindrical portion” and “the second end portion” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim. For examination purposes, the limitations will be read as "a second cylindrical portion” and “a second end portion”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 6-7, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt et al. (US 6,264,660).
Regarding claim 1, an invention relating to lithotripsy, Schmidt discloses (Fig. 4b) a lithotripsy device for breaking up calculi (Abstract), wherein the lithotripsy device comprises a carrier unit [i.e. the housing and everything disposed inside] (Col. 3, lines 60-62), a guide tube (1), an acceleration tube [i.e. portion of element 8 inside element 1] with an axial direction, a cavity [i.e. hollow in element 8] (Col. 4, lines 61-63), a proximal end and a distal end (see annotated figure below), a movable projectile (3), and a proximal stop element and a distal stop element for the movable projectile (see annotated figure below), wherein the acceleration tube is at least partially surrounded by the guide tube (Fig. 4b) and the acceleration tube has at least one proximal opening (4) and at least one distal opening (5) for the inflow and/or outflow of a pressure medium into and/or out of its cavity, for the back and forth movement of the projectile between the proximal stop element and the distal stop element, and the lithotripsy device can is configured to be assigned a drive device [i.e. compressed air source] for supplying and/or discharging the pressure medium, and can is configured to be assigned a probe [i.e. portion of element 8 outside element 1], wherein the probe can be connected directly or indirectly to the carrier unit at a carrier unit proximal end and can be excited to vibrate by a mechanical impact of the projectile on the distal stop element, wherein the acceleration tube is arranged to be movable in the axial direction internally at an acceleration tube proximal end portion by means of the proximal stop element and at an acceleration tube distal end portion by means of the distal stop element, so that the acceleration tube is displaceable in a distal direction and in a proximal direction relative to the guide tube (Col. 3, lines 10-14; Col 4, lines 1-22, 61-67; Col. 5, lines 1-10).
PNG
media_image1.png
254
714
media_image1.png
Greyscale
Regarding claim 4, Schmidt discloses a lithotripsy device according to claim 1. Schmidt further discloses wherein the at least one proximal opening or openings and the distal opening or openings are arranged in a peripheral surface of the acceleration tube, axially symmetrical to a longitudinal center axis of the acceleration tube and/or all around the circumference (Fig. 4b).
Regarding claim 6, Schmidt discloses a lithotripsy device according to claim 1. Schmidt further discloses wherein the proximal stop element has a first end portion as a stop on the proximal end of the acceleration tube and the distal stop element has a second end portion as a stop on the distal end of the acceleration tube (see annotate figure below).
PNG
media_image2.png
254
714
media_image2.png
Greyscale
Regarding claim 7, Schmidt discloses a lithotripsy device according to claim 1. Schmidt further discloses (Fig. 4b) wherein a first spring element (9) for repulsing the projectile is arranged proximally in relation to the first closure element (10).
Regarding claim 11, Schmidt discloses a lithotripsy device according to claim 1. Schmidt further discloses (Fig. 4b) wherein a chamber (2) for conveying pressure medium to and/or from the at least one proximal opening or the proximal openings and/or the at least one distal opening or the distal openings is/are arranged between an outer surface of the guide tube and an inner surface of the carrier unit (Col. 3, lines 63-67 & Col. 4, lines 1-10).
Regarding claim 12, Schmidt discloses a lithotripsy device according to claim 1. Schmidt further discloses (Fig. 4b) wherein the lithotripsy device has a connection port (4) for connecting to the drive device and for continuously supplying or discharging the pressure medium (Col. 4, lines 1-10).
Regarding claim 13, Schmidt discloses a lithotripsy device according to claim 1. Schmidt further discloses wherein, by means of the drive device, a negative pressure and/or an overpressure can be applied to the cavity or a part of the cavity of the acceleration tube (Col. 4, lines 1-10).
Claims 1, 4, 6-7, and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leibersperger et al. (US 5,951,570).
Regarding claim 1, an invention relating to lithotripsy, Leibersperger discloses (Fig. 4b) a lithotripsy device for breaking up calculi (Abstract), wherein the lithotripsy device comprises a carrier unit [i.e. the housing and everything disposed inside] (Col. 3, lines 60-62), a guide tube (1), an acceleration tube [i.e. portion of element 8 inside element 1] with an axial direction, a cavity [i.e. hollow in element 8] (Col. 4, lines 61-63), a proximal end and a distal end (see annotated figure below), a movable projectile (3), and a proximal stop element and a distal stop element for the movable projectile (see annotated figure below), wherein the acceleration tube is at least partially surrounded by the guide tube (Fig. 4b) and the acceleration tube has at least one proximal opening (4) and at least one distal opening (5) for the inflow and/or outflow of a pressure medium into and/or out of its cavity, for the back and forth movement of the projectile between the proximal stop element and the distal stop element, and the lithotripsy device can is configured to be assigned a drive device [i.e. compressed air source] for supplying and/or discharging the pressure medium, and can is configured to be assigned a probe [i.e. portion of element 8 outside element 1], wherein the probe can be connected directly or indirectly to the carrier unit at a carrier unit proximal end and can be excited to vibrate by a mechanical impact of the projectile on the distal stop element, wherein the acceleration tube is arranged to be movable in the axial direction internally at an acceleration tube proximal end portion by means of the proximal stop element and at an acceleration tube distal end portion by means of the distal stop element, so that the acceleration tube is displaceable in a distal direction and in a proximal direction relative to the guide tube (Col. 3, lines 10-14; Col 4, lines 1-22, 61-67; Col. 5, lines 1-10).
PNG
media_image1.png
254
714
media_image1.png
Greyscale
Regarding claim 4, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses wherein the at least one proximal opening or openings and the distal opening or openings are arranged in a peripheral surface of the acceleration tube, axially symmetrical to a longitudinal center axis of the acceleration tube and/or all around the circumference (Fig. 4b).
Regarding claim 6, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses wherein the proximal stop element has a first end portion as a stop on the proximal end of the acceleration tube and the distal stop element has a second end portion as a stop on the distal end of the acceleration tube (see annotate figure below).
PNG
media_image2.png
254
714
media_image2.png
Greyscale
Regarding claim 7, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses (Fig. 4b) wherein a first spring element (9) for repulsing the projectile is arranged proximally in relation to the first closure element (10).
Regarding claim 11, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses (Fig. 4b) wherein a chamber (2) for conveying pressure medium to and/or from the at least one proximal opening or the proximal openings and/or the at least one distal opening or the distal openings is/are arranged between an outer surface of the guide tube and an inner surface of the carrier unit (Col. 3, lines 63-67 & Col. 4, lines 1-10).
Regarding claim 12, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses (Fig. 4b) wherein the lithotripsy device has a connection port (4) for connecting to the drive device and for continuously supplying or discharging the pressure medium (Col. 4, lines 1-10).
Regarding claim 13, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses wherein, by means of the drive device, a negative pressure and/or an overpressure can be applied to the cavity or a part of the cavity of the acceleration tube (Col. 4, lines 1-10).
Regarding claim 14, an invention relating to lithotripsy, Leibersperger discloses a method for accelerating a projectile of a lithotripsy device (Abstract), wherein the lithotripsy device comprises a guide tube (1) and an acceleration tube [i.e. portion of element 8 inside element 1] with a cavity [i.e. hollow in element 8] (Col. 4, lines 61-63), and the acceleration tube is at least partially surrounded by the guide tube (Fig. 4b), wherein a projectile (3) movable between a resilient proximal stop element and a resilient distal stop element is arranged in the cavity of the acceleration tube (see annotated figure below), and the acceleration tube has at least one proximal opening (4) and at least one distal opening (5) for the inflow and/or outflow of a pressure medium into and/or out of its cavity for the back and forth movement of the projectile between the resilient proximal stop element and the resilient distal stop element, and the lithotripsy device is configured to be assigned a drive device [i.e. compressed air source] for supplying and/or discharging the pressure medium and a probe [i.e. portion of element 8 outside element 1], and the acceleration tube is arranged to be movable in the axial direction on the inside at an acceleration tube proximal end portion by means of the resilient proximal stop element and at an acceleration tube distal end portion by means of the resilient distal stop element (Col. 3, lines 10-14; Col 4, lines 1-22, 61-67; Col. 5, lines 1-10), having the following steps: supplying and/or discharging the pressure medium by means of the drive device and flowing the pressure medium through the at least one proximal opening into the cavity of the acceleration tube, and moving the projectile by means of the pressure medium to the resilient distal stop element, accelerating the projectile by means of the pressure medium, impacting the projectile on the resilient distal stop element and moving the acceleration tube by means of the resilient distal stop element in a distal direction to switch the flow of the pressure medium, transmitting an impact pulse of the projectile upon impact by means of the resilient distal stop element to a probe, and/or supplying and/or discharging the pressure medium by means of the drive device and flowing the pressure medium through the at least one distal opening into the cavity of the acceleration tube, and moving the projectile back by means of the pressure medium to the resilient proximal stop element, accelerating the projectile by means of the pressure medium, impacting the projectile on the resilient proximal stop element and displacing the acceleration tube by means of the resilient proximal stop element in a proximal direction to switch the flow of the pressure medium, and repulsing the projectile on the resilient proximal stop element (Col. 3, lines 10-14; Col 4, lines 1-22, 61-67; Col. 5, lines 1-10).
Regarding claim 15, Leibersperger discloses a method according to claim 14. Leibersperger further discloses wherein the supply and/or discharge of the pressure medium is carried out continuously (Col. 4, lines 1-22).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Leibersperger et al. (US 5,951,570) as applied to claim 1 above, and further in view of Novak et al. (US 2020/0113777).
Regarding claim 2, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger fails to further disclose wherein for a proximal stop of the axially movable acceleration tube, a first valve opening position is created for the pressure medium to flow through the at least one proximal opening into and/or out of the cavity of the acceleration tube, for moving the projectile towards the distal stop element, or for moving the projectile back towards the proximal stop element, and for a distal stop of the axially movable acceleration tube, a second valve opening position is created for the pressure medium to flow through the at least one distal opening into and/or out of the cavity of the acceleration tube, for moving the projectile back towards the proximal stop element or for moving the projectile to the distal stop element.
In the analogous art of lithotripsy, Novak teaches wherein for a proximal stop of the axially movable acceleration tube, a first valve opening position is created for the pressure medium to flow through the at least one proximal opening into and/or out of the cavity of the acceleration tube, for moving the projectile towards the distal stop element, or for moving the projectile back towards the proximal stop element, and for a distal stop of the axially movable acceleration tube, a second valve opening position is created for the pressure medium to flow through the at least one distal opening into and/or out of the cavity of the acceleration tube, for moving the projectile back towards the proximal stop element or for moving the projectile to the distal stop element (Par. 0037 & 0043-0044).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Leibersperger to have wherein for a proximal stop of the axially movable acceleration tube, a first valve opening position is created for the pressure medium to flow through the at least one proximal opening into and/or out of the cavity of the acceleration tube, for moving the projectile towards the distal stop element, or for moving the projectile back towards the proximal stop element, and for a distal stop of the axially movable acceleration tube, a second valve opening position is created for the pressure medium to flow through the at least one distal opening into and/or out of the cavity of the acceleration tube, for moving the projectile back towards the proximal stop element or for moving the projectile to the distal stop element. Doing so would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (Par. 0037), as taught by Novak.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Leibersperger et al. (US 5,951,570) as applied to claim 1 above, and further in view of Leibersperger et al. (US 5,951,570).
Regarding claim 3, Leibersperger discloses a lithotripsy device according to claim 1. Leibersperger further discloses wherein the acceleration tube has a second distal opening and/or further distal through-openings (see annotated figure below). However, Leibersperger fails to disclose wherein the acceleration tube has a second proximal opening and/or further proximal openings. However, the choice of designing the acceleration tube to have a second proximal opening and/or further proximal openings has no patentable significance. This instant application does not recite any criticality or advantage to having a second proximal opening and/or further proximal openings over one proximal opening. As such, the forming a second proximal opening and/or further proximal openings is considered a mere design choice and it appears the proximal opening of Leibersperger would work equally well regardless of there being a second proximal opening and/or further proximal openings. Through experimentation, one of ordinary skill can determine what configuration is most effective based on the intended use of the device. Under KSR reasoning, it would have been obvious for one having ordinary skill in the art before the effective filing date to try different a number of proximal openings to find the most effective number of openings and show a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
PNG
media_image3.png
254
714
media_image3.png
Greyscale
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Leibersperger et al. (US 5,951,570) as applied to claim 7 above, and further in view of St. George et al. (US 2014/0336666).
Regarding claim 9, Leibersperger discloses a lithotripsy device according to claim 7. Leibersperger further disclosure wherein the distal stop element has an impact pin distally in relation to the second cylindrical portion and/or to the second end portion for transmitting an impact of the projectile (see annotated figure below). However, Leibersperger fails to disclose wherein a second spring element is arranged distally in relation to the second end portion and/or around the impact pin of the distal stop element.
PNG
media_image4.png
254
714
media_image4.png
Greyscale
In the analogous art of lithotripsy, St. George teaches wherein a second spring element (140, 142) is arranged distally in relation to the second end portion (Par. 0083).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Leibersperger to have wherein a second spring element is arranged distally in relation to the second end portion and/or around the impact pin of the distal stop element. Doing so would providing a linear bearing element function while also providing a necessary mechanical spring element function (Par. 0083), as taught by St. George.
Allowable Subject Matter
Claims 5, 8, and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Concerning claim 5, cited prior art reference Leibersperger discloses wherein the proximal stop element has a first cylindrical portion and the distal stop element has a second cylindrical portion (Fig. 4b). However, Leibersperger fails to disclose wherein the proximal end portion of the acceleration tube is arranged to be movable in the axial direction around the first cylindrical portion and the distal end portion of the acceleration tube is arranged to be movable around the second cylindrical portion. All the other cited prior art references fail to read on this limitation as well. Modifying the prior art to include the missing limitations wouldn’t have been obvious because modification would only be motivated by hindsight and would possibly render the device inoperable. Furthermore, a teaching reference with this missing structure could not be found.
Concerning claim 8, cited prior art reference Leibersperger fails to disclose wherein the distal stop element has an impact pin distally in relation to the second cylindrical portion and/or to the second end portion for transmitting an impact of the projectile to the probe. All the other cited prior art references fail to read on this limitation as well. Modifying the prior art to include the missing limitations wouldn’t have been obvious because modification would only be motivated by hindsight and would possibly render the device inoperable. Furthermore, a teaching reference with this missing structure could not be found.
Concerning claim 10, cited prior art reference Leibersperger fails to disclose wherein the first spring element and at least partially the proximal stop element are accommodated in a proximal holding unit and the second spring element and at least partially the distal stop element are accommodated in a distal holding unit, wherein the proximal holding unit and the distal holding unit are each directly or indirectly connected to an outer side of the acceleration tube and are movable in the axial direction. All the other cited prior art references fail to read on this limitation as well. Modifying the prior art to include the missing limitations wouldn’t have been obvious because modification would only be motivated by hindsight and would possibly render the device inoperable. Furthermore, a teaching reference with this missing structure could not be found. Note, claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 January 29, 2026