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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/21/2023, 8/4/2023, 8/8/2025 and 1/22/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claim(s) 1-11, 14, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bond et al. (US 2014/0371636).
Bond discloses (see Figs. 2 and 13-16G) an ultrasonic transducer and method with shock pulsing masses comprising the following claim limitations:
(claim 1) A lithotripsy device, comprising: an elongate probe (32f) which is insertable into the interior of a human or animal body (see [0001]; [0070]; [0098]); and a drive arrangement arranged on a proximal portion of the probe (32f) and serving to deflect the probe (32f) (as shown in exemplary Fig. 2); wherein the drive arrangement comprises an ultrasonic converter unit (14, Fig. 2) for exciting ultrasonic vibrations in the direction of a longitudinal extent of the probe (32f) ([0068]); and the drive arrangement comprises a deflection device (28f/42f/48f, Figs.13-16G) for exerting a time-variable force on the probe (32f) in a direction transverse to the longitudinal extent of the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f to create wagging of the distal end of the probe); and characterized in that wherein the deflection device is designed to exert the time-variable force by an impact exerted on a lateral surface of the probe (32f) by means of at least one impact element (48f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f thereby providing an impact force to the lateral surface of the probe to create wagging motion of the distal end);
(claim 2) wherein a frequency and/or an intensity of the time-variable force is adjustable ([0103]; adjustment expressly disclosed via the use of different materials and/or changing characteristics of the spring 46f);
(claim 3) wherein the at least one impact element (48f) is designed as a ram or hammer which is movable by means of a drive device (14/20, exemplary Fig. 2) in order to exert the impact on the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f thereby providing an impact force to the lateral surface of the probe to create wagging motion of the distal end);
(claim 4) wherein the at least one impact element (48f) is designed as a frame (i.e., a circular frame as depicted) which is movable by means of a drive device (14) (as shown in Figs. 13-16G), or as a slotted disk (i.e., circular disk 48f comprises a divot/slot 67f therein) which is movable by means of a drive device (14), in order to exert the impact on the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f thereby providing an impact force to the lateral surface of the probe to create wagging motion of the distal end);
(claim 5) wherein the drive device (14) is designed as a linear drive ([0068]; piezoelectric crystals expressly provide a linear/longitudinal vibration drive) or in the manner of a hammer interrupter;
(claim 6) wherein the drive device (14/20) comprises includes a cam disk acting against a spring force, or a slider crank (20) which can be driven by an electric motor, a piezo motor (14), a pneumatic motor or a turbine, or comprises an electric motor which can be controlled to perform a reciprocating movement ([0068]; reciprocating piezoelectric motion is linearly transferred along the horn 20 to the probe);
(claim 7) wherein the at least one impact element (48f) is designed as a mass body which is movable by means of a drive device (14/20) on a circular path in order to exert the impact on the probe (32f) (as shown in Figs. 16A-61G; [0099]-[0103]; mass bodies 48f expressly moved along a wagging circular path, as shown by the circular motion arrows in Figs. 16A-16G);
(claim 8) wherein the deflection device for exerting the time-variable force on the probe (32f) is designed in the form of an unbalance which can be driven by means of a drive device (14/20) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are freely movable and unbalanced thereby providing a random wobble that transversely hammers onto fitting 28f and stop 42f to create wagging of the distal end of the probe) or in the form of an eccentric which can be driven by means of a drive device;
(claim 9) wherein the drive device (14/20) includes an electric motor, a piezo motor (as shown in Figs. 13-16G; [0068]; piezoelectric motor expressly disclosed), a pneumatic motor, a turbine, or an electric motor which can be controlled to perform a reciprocating movement;
(claim 10) wherein a motor (14) of the drive device is connected to the deflection device (28f/42f/48f) via a flexible shaft (20) (as shown in Figs. 2 and 13-16G; flexible tubular horn 20 flexes and transmits longitudinal and transverse vibrations);
(claim 11) wherein the deflection device (28f/42f/48f) is arranged in such a way that the time-variable force acts on the probe (32f), in the direction transverse to the longitudinal extent of the probe (32f), distally with respect to the ultrasonic converter unit (14) (as expressly shown in Figs. 2 and 13-16G; deflection device expressly disposed distal to the piezoelectric ultrasonic unit 14);
(claim 14) wherein the ultrasonic converter unit (14) is mounted movably in a surrounding housing (18) (as expressly shown in exemplary Fig. 2; [0068]; piezoelectric crystals 14 expressly move vibrationally move within device housing 18);
(claim 16) wherein the drive arrangement is designed to exert a further time-variable force on the probe in a further direction transverse to the longitudinal extent of the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; at least two shock-pulsing masses 48f expressly disclosed and are free to randomly wobble and free to move in transverse directions wherein each of the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f, respectively, to create wagging of the distal end of the probe); and
(claim 18) A method for operating a lithotripsy device comprising an elongate probe (32f), wherein the probe (32f), in a proximal portion, is excited to perform ultrasonic vibrations in the direction of a longitudinal extent of the probe (32f), which ultrasonic vibrations are transmitted through the probe (32f) to a distal end of the probe (as shown in Figs. 2 and 13-16G; [0068]; ultrasonic vibrations of piezoelectric crystals 14 expressly produces ultrasonic longitudinal vibrations that are transferred to and through the probe 32f to its distal end), and, in the proximal portion, a time-variable force is exerted on the probe (32f) in a direction transverse to the longitudinal extent of the probe (32f), and a lateral deflection of the probe (32f) brought about thereby is transmitted through the probe (32f) to the distal end of the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f to create wagging of the distal end of the probe); and wherein the time-variable force is exerted by an impact exerted on a lateral surface of the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f thereby providing an impact force to the lateral surface of the probe to create wagging motion of the distal end).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bond as applied to claim 1 above, and further in view of Yamada et al. (US 2005/0021065).
Bond, as applied above, discloses an ultrasonic transducer and method with shock pulsing masses comprising the following claim limitations:
(claim 17) A lithotripsy system comprising: a lithotripsy device according to claim 1 (see claim 1 rejection above in view of Bond); and, effected by the time-variable force in the direction transverse to the longitudinal extent of the probe (32f), to be transmitted to a distal end of the probe (32f) (as shown in Figs. 16A-16G; [0099]-[0103]; shock-pulsing masses 48f are free to randomly wobble and free to move in transverse directions wherein the masses 48f wobble and transversely hammer onto fitting 28f and stop 42f thereby providing an impact force to the lateral surface of the probe to create wagging motion of the distal end).
Bond, as applied above, discloses an ultrasonic transducer and method with shock pulsing masses comprising all the limitations of the claim except for an endoscope having a channel for inserting the probe into the interior of the human or animal body, wherein the channel is dimensioned so as to allow a lateral deflection of the probe.
However, Yamada teaches a similar ultrasonic treatment apparatus comprising an endoscope having a channel for inserting the probe into the interior of the human or animal body, wherein the channel is dimensioned so as to allow a lateral deflection of the probe in order to beneficially incorporate an endoscope to both guide the lithotripsy device through the body to a calculus treatment site and further allowing the endoscope to be used to visualize and confirm the treatment target tissue ([0005]-[0006]; [0067]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Bond to have an endoscope having a channel for inserting the probe into the interior of the human or animal body, wherein the channel is dimensioned so as to allow a lateral deflection of the probe in order to beneficially incorporate an endoscope to both guide the lithotripsy device through the body to a calculus treatment site and further allowing the endoscope to be used to visualize and confirm the treatment target tissue, as taught by Yamada.
Allowable Subject Matter
Claims 12-13 and 15 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771