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
A preliminary amendment was filed on 10/02/2023. Claims 1, 7-11, 13, and 19-21, and claims 12 and 22-26 have been canceled. Currently, claims 1-11 and 13-21 are pending and are being examined on the merits.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a guidance device configured to transcutaneously detect an indwelling catheter implanted in a patient.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In this instance, the guidance device is interpreted to be MRI, fluoroscopy, near-infrared spectroscopy, or equivalent structures in the art (see instant specification, paragraph 0031)
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites a reservoir at a distal end of the indwelling catheter. However, claim 1 recites that the reservoir is at a proximal end of the indwelling catheter. While either location of the reservoir reads upon the instant invention, as “proximal” and “distal” are relative to a reference point, examiner recommends keeping the language of the location of the reservoir consistent.
Moreover, claim 13 recites the limitation “trancutaneously” in line 2, which should read -transcutaneously-
Appropriate correction is required.
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.
Claims 1-2, 7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Osborn (US 20060235349) in view of Tosaya (US 8083707), and further in view of Brister (WO 2015085011) and Bonutti (US 20130253387).
Regarding claim 1, Osborn discloses a device comprising:
a transducer configured to transmit an ultrasonic pulse to a reservoir at a proximal end of an indwelling catheter (fig. 2, reservoir at proximal end of tubing 100 defined by the elastic membrane 118, where ultrasonic energy from transducer 107 acts upon it, paragraph 0037)
a controller communicatively coupled to the transducer (107) and configured to adjust one or more settings of the transducer (paragraph 0015, “a control unit connected to the signal generator for controlling the electrical signal”).
Osborn does not teach a guidance device configured to transcutaneously detect the indwelling catheter implanted in a patient, wherein the transducer transmit an ultrasonic pulse transcutaneously
However, Tosaya teaches a means for ultrasonic cleaning where acoustic treatment can be given outside the skin to apply acoustic treatment from inside (col. 8, lines 56-60, “Outside the skin surface 14, there is the possibility of applying a noninvasive acoustic treatment and/or an invasive treatment can be applied from inside the body.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the transducer transmits an ultrasonic pulse transcutaneously, as taught by Tosaya, for the purpose of providing a suitable means that applies the cleaning noninvasively (see Tosaya, abstract).
Osborn does not teach a guidance device configured to transcutaneously detect the indwelling catheter implanted in a patient.
However, Brister teaches wherein ultrasound, with the use of a guidance device configured to transcutaneously detect implants, is utilized to detect the position of an implanted device as a well-known practice in the art (paragraph 0761)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn in view of Jaggi such that the guidance device comprises MRI, as taught by Brister, for the purpose of providing a suitable structure that allows for tracking and monitoring of an implanted device (see Brister, abstract).
Osborn is silent to wherein the controller is configured to adjust one or more settings of the transducer.
However, Bonutti teaches wherein vibration adjustment is well known in the art for clearing occlusions in body cavities (paragraph 0170).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the controller is configured to adjust one or more settings of the transducer, as taught by Bonutti, for the purpose of providing a suitable structure that allows the device to be adjusted depending on the material characteristics of pathologic material or body tissue (see Bonutti, paragraph 0170)
Regarding claim 2, Osborn discloses wherein the ultrasonic pulse is part of an ultrasonic protocol comprising a series of ultrasonic pulses (paragraph 0040 describes a duty cycle of a pulse).
Regarding claim 7, Osborn does not teach wherein the guidance device comprises at least one of MRI, diagnostic ultrasound, fluoroscopy, or near-infrared spectroscopy
However, Brister teaches wherein ultrasound is utilized to detect the position of an implanted device as a well-known practice in the art (paragraph 0761)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn in view of Jaggi such that the guidance device comprises MRI, as taught by Brister, for the purpose of providing a suitable means to better track and monitor an implanted device (see Brister, abstract).
Regarding claim 9, Osborn discloses wherein the device further comprises a mechanical coupling compatible with a cap (117) of the reservoir (paragraph 0034, “Elastic membrane 118… is tightly coupled to the advice surface of the transducer 107)
Regarding claim 10, Osborn is silent to wherein the one or more settings of the transducer comprises at least one of a frequency, a power, or a focal distance (paragraph 0040).
However, Bonutti teaches wherein the one or more settings comprises the frequency and power (paragraph 0170)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the one or more settings of the transducer comprises at least one of a frequency, power, or focal distance, as taught by Bonutti, for the purpose of providing a suitable structure that allows the device to be adjusted depending on the material characteristics of pathologic material or body tissue (see Bonutti, paragraph 0170).
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Osborn in view of Tosaya, Brister, and Bonutti, and further in view of Jarvik (WO 2010033875).
Regarding claim 3, Osborn is silent to wherein the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.05-1.00 seconds in duration.
However, Jarvik teaches wherein ultrasound pulses last from 0.1-0.5 seconds (pg. 29, lines 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.05-1.00 seconds in duration, as taught by Jarvik, for the purpose of providing a suitable means that prevents heat accumulation in the targeted area (pg. 18, lines 20-21).
Regarding claim 4, wherein each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.05-1.00 seconds.
However, Tosaya teaches wherein frequencies can be in the range of 1 Hz-100 MHz (col. 10, lines 53-55), wherein a frequency of 1 Hz has pulses spaced at 1 second.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.05-1.00 seconds, as taught by Tosaya, for the purpose of providing the cleaning noninvasively (see Tosaya, abstract). Moreover, as applicant appears to have placed no criticality on the claimed range (paragraphs 0066-0067 give multiple acceptable ranges) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 5, Osborn is silent to wherein the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.0001-0.1 seconds in duration.
However, Jarvik teaches wherein ultrasound pulses last from 0.1-0.5 seconds (pg. 29, lines 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.001-0.1 seconds in duration, as taught by Jarvik, for the purpose of providing a suitable means that prevents heat accumulation in the targeted area (see Jarvik, pg. 18, lines 20-21). Moreover, applicant appears to have placed no criticality on the claimed range (paragraphs 0091 and 0092 recites multiple acceptable ranges for the duration) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 6, Osborn is silent to wherein each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.001-0.1 seconds in duration.
However, Tosaya teaches wherein pulses are in the range of 1 KHz to 10 MHz (col. 10, lines 53-55), wherein a frequency of 1 KHz spaces pulses by 0.001 seconds.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.001-0.1 seconds in duration, as taught by Tosaya, for the purpose of providing the cleaning noninvasively (see Tosaya, abstract). Moreover, as applicant appears to have placed no criticality on the claimed range (paragraphs 0066-0067 give multiple acceptable ranges) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Osborn in view of Tosaya, Brister and Bonutti, and further in view of Jaggi (US 8197494).
Regarding claim 8, Osborn does not teach the device further comprising a magnet at a distal end of the device
However, Jaggi teaches the use of a magnet (558) at a distal end of a device to detect a catheter (fig. 3, electromagnetic output coils 558 for producing a magnetic field)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that it further comprises a magnet at a distal end of the device, as taught by Jaggi, for the purpose of providing a suitable structure that allows a user to detect a specific area of an implanted device (see Jaggi, col. 5, lines 32-48)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Osborn in view of Tosaya, Brister, Bonutti, and Jarvik, and further in view of Tyler (US 20060111659).
Regarding claim 11, Osborn discloses wherein the controller comprises:
at least one processor (fig. 3, microprocessor-based signal generator 109)
data storage including program instructions stored thereon (fig. 3, a microprocessor would necessarily have some form of data storage in order for the device to perform its specific function, since a processor operates on an external data source)
Osborn is silent to wherein there is data storage including program instructions stored thereon that when executed by the at least one processor, cause the device to transmit a series of ultrasonic pulses measuring 0.05-1.00 seconds in duration, each of the ultrasonic pulses of the series of ultrasonic pulses spaced apart in time by 0.05-1.00 seconds.
However, Tosaya teaches wherein frequencies can be in the range of 1 Hz-100 MHz (col. 10, lines 53-55), wherein a frequency of 1 Hz has pulses spaced at 1 second.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.05-1.00 seconds, as taught by Tosaya, for the purpose of providing the cleaning noninvasively (see Tosaya, abstract). Moreover, as applicant appears to have placed no criticality on the claimed range (paragraphs 0066-0067 give multiple acceptable ranges) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Moreover, Jarvik teaches wherein ultrasound pulses last from 0.1-0.5 seconds (pg. 29, lines 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.001-0.1 seconds in duration, as taught by Jarvik, for the purpose of providing a suitable means that prevents heat accumulation in the targeted area (pg. 18, lines 20-21). Moreover, applicant appears to have placed no criticality on the claimed range (paragraphs 0091 and 0092 recites multiple acceptable ranges for the duration) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Osborn is silent to wherein there is data storage including program instructions stored thereon that when executed by the at least one processor, cause the device to transmit the pulses.
However, Tyler teaches wherein oscillatory pulses for clearing debris being programmed (and therefore likely requiring data storage of program instructions) is well known in the art (paragraph 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that there is data storage including program instructions stored thereon that when executed by the at least one processor, cause the device to transmit the pulses, as taught by Tyler, for the purpose of providing a suitable known structure that can keep programmed series of pulses for the processor to reference (see Tyler, paragraph 0032).
Claims 13-14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborn in view of Tosaya, and further in view of Jaggi and Bonutti.
Regarding claim 13, Osborn discloses a device comprising:
a transducer configured to transmit an ultrasonic pulse to a reservoir at a distal end of an indwelling catheter (fig. 2, reservoir at a proximal end of tubing 100 defined by the elastic membrane 118, where ultrasonic energy from transducer 107 acts upon it, paragraph 0037), and a controller communicatively coupled to the transducer (fig. 3, control unit 108 connected to transducer 107).
Osborn does not teach wherein the transducer transmits the pulse transcutaneously, wherein the device comprises a magnet, adjacent to the transducer, configured to transcutaneously detect the indwelling catheter, and a controller communicatively coupled to the transducer and configured to adjust one or more settings of the transducer.
However, Tosaya teaches a means for ultrasonic cleaning where acoustic treatment can be given outside the skin to apply acoustic treatment from inside (col. 8, lines 56-60, “Outside the skin surface 14, there is the possibility of applying a noninvasive acoustic treatment and/or an invasive treatment can be applied from inside the body.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the transducer transmits an ultrasonic pulse transcutaneously, as taught by Tosaya, for the purpose of providing a suitable means that applies the cleaning noninvasively (see Tosaya, abstract).
Osborn, as modified by Tosaya, does not teach a magnet, adjacent to the transducer, configured to transcutaneously detect the indwelling catheter, and wherein the controller is configured to adjust one or more settings of the transducer.
However, Jaggi teaches the use of a magnet (558) at a distal end of a device to detect a catheter (fig. 3, electromagnetic output coils 558 for producing a magnetic field)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that it further comprises a magnet at a distal end of the device, as taught by Jaggi, for the purpose of providing a suitable structure that allows a user to detect a specific area of an implanted device (see Jaggi, col. 5, lines 32-48)
Osborn does not teach wherein the controller is configured to adjust one or more settings of the transducer.
However, Bonutti teaches wherein vibration adjustment is well known in the art for clearing occlusions in body cavities (paragraph 0170).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the controller is configured to adjust one or more settings of the transducer, as taught by Bonutti, for the purpose of providing a suitable structure that allows the device to be adjusted depending on the material characteristics of pathologic material or body tissue (see Bonutti, paragraph 0170)
Regarding claim 14, Osborn discloses wherein the ultrasonic pulse is part of an ultrasonic protocol comprising a series of ultrasonic pulses (paragraph 0040 describes a duty cycle of a pulse).
Regarding claim 19, Osborn discloses wherein the device further comprises a mechanical coupling compatible with a cap (117) of the reservoir (paragraph 0034, “Elastic membrane 118… is tightly coupled to the advice surface of the transducer 107)
Regarding claim 20, Osborn is silent to wherein the one or more settings of the transducer comprises at least one of a frequency, a power, or a focal distance
However, Bonutti teaches wherein the one or more settings comprises the frequency and power (paragraph 0170)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the one or more settings of the transducer comprises at least one of a frequency, power, or focal distance, as taught by Bonutti, for the purpose of providing a suitable structure that allows the device to be adjusted depending on the material characteristics of pathologic material or body tissue (see Bonutti, paragraph 0170).
Claim 15-18 is rejected under 35 U.S.C. 103 as being unpatentable over Osborn in view of Tosaya, Jaggi, and Bonutti, and further in view of Jarvik.
Regarding claim 15, Osborn is silent to wherein the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.05-1.00 seconds in duration.
However, Jarvik teaches wherein ultrasound pulses last from 0.1-0.5 seconds (pg. 29, lines 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.05-1.00 seconds in duration, as taught by Jarvik, for the purpose of providing a suitable means that prevents heat accumulation in the targeted area (pg. 18, lines 20-21).
Regarding claim 16, Osborn does not teach wherein each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.05-1.00 seconds.
However, Tosaya teaches wherein frequencies can be in the range of 1 Hz-100 MHz (col. 10, lines 53-55), wherein a frequency of 1 Hz has pulses spaced at 1 second.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.05-1.00 seconds, as taught by Tosaya, for the purpose of providing the cleaning noninvasively (see Tosaya, abstract). Moreover, as applicant appears to have placed no criticality on the claimed range (paragraphs 0066-0067 give multiple acceptable ranges) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 17, Osborn does not teach wherein the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.0001-0.1 seconds in duration.
However, Jarvik teaches wherein ultrasound pulses last from 0.1-0.5 seconds (pg. 29, lines 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that the ultrasonic protocol comprises a series of ultrasonic pulses measuring 0.001-0.1 seconds in duration, as taught by Jarvik, for the purpose of providing a suitable means that prevents heat accumulation in the targeted area (see Jarvik pg. 18, lines 20-21). Moreover, applicant appears to have placed no criticality on the claimed range (paragraphs 0091 and 0092 recites multiple acceptable ranges for the duration) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 18, Osborn is silent to wherein each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.001-0.1 seconds in duration.
However, Tosaya teaches wherein pulses are in the range of 1 KHz to 10 MHz (col. 10, lines 53-55), wherein a frequency of 1 KHz spaces pulses by 0.001 seconds.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Osborn such that each ultrasonic pulse in the series of ultrasonic pulses are spaced apart in time by 0.001-0.1 seconds in duration, as taught by Tosaya, for the purpose of providing the cleaning noninvasively (see Tosaya, abstract). Moreover, as applicant appears to have placed no criticality on the claimed range (paragraphs 0066-0067 give multiple acceptable ranges) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Osborn in view of Browd (US 20120302938), and further in view of Tosaya and Brister.
Regarding claim 21, Osborn discloses a method comprising:
transmitting, via a transducer, an ultrasonic pulse into a reservoir on a proximal end of an indwelling catheter (fig. 2, reservoir at proximal end of tubing 100 defined by the elastic membrane 118, where ultrasonic energy from transducer 107 acts upon it, paragraph 0037), wherein the ultrasonic pulse is transmitted into the reservoir an imparts momentum into a fluid within the indwelling catheter such that a resulting fluid flow propels the fluid (abstract describes fluid waveform exerting shearing forces on the catheter, thus is considered propelling the fluid.)
Osborn is silent to wherein the fluid is propelled out of the pores at a distal end of the indwelling catheter, and does not teach the method comprising detecting, via a guidance device, an indwelling catheter implanted in a patient, wherein the indwelling catheter is detected transcutaneously, aligning the transducer with a reservoir on a proximal end of the indwelling catheter.
However, Browd teaches wherein obstructions are flushed out with body fluid (paragraph 0043), wherein debris is flushed out through the pores of the catheter (fig. 6B, plurality of openings 676 to flush out fluid).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Osborn such that fluid is propelled out of the pores at a distal end of the indwelling catheter, as taught by Browd, for the purpose of providing additional means of clearing and preventing and clearing obstructions by taking them out of the lumen (see Browd, paragraph 0043)
Osborn does not teach the method comprising detecting, via a guidance device, an indwelling catheter implanted in a patient, wherein the indwelling catheter is detected transcutaneously, aligning the transducer with a reservoir on a proximal end of the indwelling catheter.
However, Tosaya teaches a means for ultrasonic cleaning where acoustic treatment can be given outside the skin to apply acoustic treatment from inside (col. 8, lines 56-60, “Outside the skin surface 14, there is the possibility of applying a noninvasive acoustic treatment and/or an invasive treatment can be applied from inside the body.”). Moreover, if the reservoir of Osborn is being targeted with ultrasonic waves to propel the fluid, one of ordinary skill in the art would align the transducer of Tosaya with the reservoir on the proximal end of the catheter to achieve the effect.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method such that the ultrasonic pulse is transmitted transcutaneously into the reservoir, as taught by Tosaya, for the purpose of providing a suitable means that applies the cleaning noninvasively (see Tosaya, abstract).
Osborn does not teach the method comprising the method comprising detecting, via a guidance device, an indwelling catheter implanted in a patient, wherein the indwelling catheter is detected transcutaneously.
However, Brister teaches wherein ultrasound, with the use of a guidance device configured to transcutaneously detect implants, is utilized to detect the position of an implanted device as a well-known practice in the art (paragraph 0761)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Osborn such that it comprises detecting, via a guidance device, an indwelling catheter implanted in a patient, wherein the indwelling catheter is detected transcutaneously, as taught by Brister, for the purpose of providing a suitable structure that allows for tracking and monitoring of an implanted device (see Brister, abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781