DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1-15 are pending in the application. Claims 1-15 have been amended.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/23 and 7/31/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: line 2 recites “its longitudinal direction and/or its proximal end.” The Examiner suggests amending the claims to avoid use of the term “its.” Appropriate correction is required.
Claim 14 is objected to because of the following informalities: line 2 recites “its outer surface” and line 3 recites “its longitudinal direction.” The Examiner suggests amending the claims to avoid use of the term “its.” 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 1-15 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 1 recites the holding device being “assignable a force generation apparatus...” This limitation has rendered the claim indefinite because it lacks clarity as to the structural relationship between the holding device and the force generation apparatus. It is unclear what “assignable” refers to, i.e., as written one of ordinary skill in the art would not reasonably understand the scope of the claimed invention because the limitation fails to provide structural boundaries and creates ambiguity as to what the limitation is referring to. Appropriate correction is required.
Claim 1 also recites “a force generation apparatus configured to generate a force to move the projectile back and/or forth between the proximal-side abutment element and the distal-side abutment element…” The use "and/or" has rendered the claims indefinite because it creates an ambiguous scope, and based on the broadest reasonable interpretation, prevents from determining the metes and bounds of the claim.
Claim 1 further recites “the vibration compensation apparatus allows decoupling of the acceleration tube from the excitation of vibrations by the vibration excitation apparatus.” This limitation is also unclear and has rendered the claim indefinite. It is unclear what “allows decoupling” refers to, i.e., as written one of ordinary skill in the art would not reasonably understand the scope of the claimed invention because the limitation fails to provide structural boundaries and creates ambiguity as to what the limitation is referring to. Appropriate correction is required.
Claims 2-15 are dependent on rejected claim 1, thus are also rendered indefinite.
Claim 3 also recites the limitation "the mass" in line 2 and “said mass” in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 3 also recites the limitation "the longitudinal direction" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 4 also recites the limitation "the mass" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 also recites the limitation "the connection elements" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 7 also recites the limitation "the mass" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 11 also recites the limitation "the mass” in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 11 also recites the limitation "the at least one connection element" in line 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 also recites “at least one piezo element as a vibration exciter…” It is unclear if this is the same structure as the “vibration excitation apparatus” recited in claim 1, or a different structure. Appropriate correction is required.
The use of “and/or” limitations in claim 12 has also rendered the claim indefinite because it creates an ambiguous scope, and based on the broadest reasonable interpretation, prevents from determining the metes and bounds of the claim. Appropriate correction is required.
Claim 14 also recites the limitation "the mass" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 15 also recites the lithotripsy device comprising a sonotrode and a holding device as claimed in claim 1. Claim 1 recites that the holding device comprises a sonotrode being connectable to the distal end of the housing. It is unclear if the lithotripsy device in claim 15 has a single sonotrode (the sonotrode recited in claim 15 is the same sonotrode as recited in claim 1) or two sonotrodes (the sonotrode recited in claim 15 is a different sonotrode). Appropriate correction is required.
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.
Claims 1-3, 6-10, 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hirt (US 2002/0010486 A1) in view of Kühne (US 5,741,272).
Regarding claim 1, Hirt discloses (Figures 1 and 2) a holding device configured for a lithotripsy device configured to fragment calculi, the holding device comprising: a housing (15) with a distal end and a proximal end and a sonotrode (8) being connectable to the distal end, arranged within the housing there being an acceleration tube (25) with a longitudinal center axis, a cavity (27), a proximal end, and a distal end, and with a moveable projectile (22) within the cavity for shock excitation of the sonotrode, a proximal-side abutment element arranged at the proximal end and a distal-side abutment element (21) arranged at the distal end of the acceleration tube, and the holding device being assignable a force generation apparatus configured to generate a force to move the projectile back and/or forth between the proximal-side abutment element and the distal-side abutment element (paragraph 0015), and a vibration excitation apparatus (1, 2,) configured to excite vibrations of the sonotrode being arranged in the housing, wherein the holding device comprises a vibration compensation apparatus with at least one mass (29) and at least one damping element (31) such that the vibration compensation apparatus allows decoupling of the acceleration tube from the excitation of vibrations by the vibration excitation apparatus (paragraph 0017).
Hirt discloses (Figure 2) that the damping element is tubular. However, Hirt fails to explicitly disclose that the damping element is at least one spring element.
In the same field of endeavor, Kühne teaches a lithotripter with a damping element. Kühne teaches that it is known in the art that a damping element can comprise at least one spring element (Column 8, lines 13-17).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the damping element disclosed by Hirt to be at least one spring element, as taught by Kühne. Kühne teaches that it is well known in the art for a spring, laminated springs, a rubber-elastic tubular piece, or otherwise elastic material to serve as a damping element (Kühne, Column 8, lines 13-17). Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 2, Hirt as modified by Kühne teaches (Hirt, Figures 1 and 2) that at its proximal end, the mass (29) is arranged without a connection to the housing (15). The mass (29) is disposed within the housing, but there is not a direct connection between the structures.
Regarding claim 3, Hirt as modified by Kühne teaches (Hirt, Figures 1 and 2) that the mass (29) is indirectly connected to the housing substantially transversely to the longitudinal direction of said mass by at least one connection element (32; paragraph 0018).
Regarding claim 6, Hirt as modified by Kühne teaches the invention substantially as claimed. However, the combined teaching fails to teach that the at least one connection element or the connection elements comprises or comprise plastic.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one connection element taught by Hirt in view of Kühne to be made of plastic, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 7, Hirt as modified by Kühne teaches (Hirt, Figure 2) that the at least one spring element (31) is a tube portion with a wall thickness of the tube portion being smaller than a material thickness of the mass (29).
Regarding claim 8, Hirt as modified by Kühne teaches (Hirt, Figure 2) that the vibration compensation apparatus comprises a cavity and/or cutout to accommodate at least one sealing element (30; paragraph 0017).
Regarding claim 9, Hirt as modified by Kühne teaches (Hirt, Figure 2) that the vibration compensation apparatus is at least partially arranged around the acceleration tube (25).
Regarding claim 10, Hirt as modified by Kühne teaches (Hirt, Figure 2) that the vibration compensation apparatus is arranged concentrically around the acceleration tube (25).
Regarding claim 14, Hirt as modified by Kühne teaches (Hirt, Figure 2) that the mass (29) comprises at least one cutout in its longitudinal direction configured for guiding a tube (30; paragraph 0017).
Regarding claim 15, Hirt as modified by Kühne teaches (Hirt, Figures 1 and 2) a lithotripsy device configured to fragment calculi, the lithotripsy device comprising a sonotrode (8) and the holding device as claimed in claim 1 (see rejection of claim 1 above).
Allowable Subject Matter
Claims 4, 5, and 11-13 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.
The following is a statement of reasons for the indication of allowable subject matter: Claim 4 recites that the mass is directly or indirectly connected to the housing by at least three radially uniformly spaced apart connection elements. This limitation, in combination with the limitations of claim 1 and intervening claim 3, is not disclosed or suggested in the prior art of record. The Hirt and Kühne references, individually or in combination, fail to disclose or suggest this means of connection.
Claim 5 recites that a respective punctiform direct or indirect connection to the housing is formed by the at least one connection element or the connection element. This limitation, in combination with the limitations of claim 1 and intervening claim 3, is not disclosed or suggested in the prior art of record. The Hirt and Kühne references, individually or in combination, fail to disclose or suggest this means of connection.
Claim 11 recites that the holding device comprises a circuit board holder, the circuit board holder being at least partially arranged around the vibration compensation apparatus and the mass of the vibration compensation apparatus being connected to the circuit board holder by the at least one connection element. These limitations, in combination with the limitations of claim 1, are not disclosed or suggested in the prior art of record. The Hirt and Kühne references, individually or in combination, fail to disclose or suggest the holding device comprising a circuit board holder as claimed.
Claim 12 recites that the holding device comprises a horn distally and a bolt proximally of the horn, the horn and the bolt surrounding a distal portion of the acceleration tube, a counter bearing is arranged on the bolt proximally of the horn and at least one piezo element as a vibration exciter is arranged and mechanically coupled beween the counter bearing and the horn, the horn comprising the distal-side abutment element and/or the horn being connectable to the distal-side abutment element and/or the sonotrode and the at least one piezo element being electrically connectable to an assignable ultrasonic generator, the vibration compensation apparatus being arranged proximally on and/or of the horn, the bolt, and/or the counter bearing. These limitations, in combination with the limitations of claim 1, are not disclosed or suggested in the prior art of record. The Hirt reference discloses a horn (4) and a piezo element (paragraphs 0012-0014). However, the Hirt reference fails to disclose or suggest a bolt and a counter bearing as claimed. Further, the combined teaching fails to teach the arrangement of the components as recited in claim 12
Claim 13 is dependent on claim 12, thus would also 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 claim 1 and claim 12.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771