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 .
Benefit
The application, filed 3 February 2025, claims benefit of US Provisional 63/551,634 (9 February 2024).
Formal Matters
Claims 1-20 are pending and under examination.
Drawings - Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Flow regulators are claimed at the distal end of the delivery tube (claim 14), at the distal end of the evacuation tube (claim 15) and wherein the flow regulator comprises a check-valve (claim 16). However, none of the drawings show these features. Therefore, the flow regulators and check-valve must be shown in the drawings or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
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.
Claim Rejections - 35 USC § 112(b)
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 3-7 and 9-20 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 3 recites the limitation "wherein a first catheter includes the delivery tube and a second catheter include the evacuation tube" in lines 1 and 2. There is insufficient antecedent basis for the multiple catheter limitations in the claims. Claim 3 is dependent on claim 1, which does not recite a catheter or otherwise provide for a transition for the method to encompass a first or a second catheter. Claims 4-7 are rejected as depending from claim 3.
Claim 9 recites the limitation "the catheter" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 10-20 are rejected as being directly or indirectly dependent on claim 9.
Claim 11 recites the limitation "wherein a first catheter includes the delivery tube and a second catheter include the evacuation tube" in lines 1 and 2. Claim 11 is dependent on claim 9, which recites a single “the catheter”, but which also lacks antecedent basis (as set forth above) and does not otherwise provide antecedent basis support for multiple catheters. Claim 12 is rejected as depending from claim 11.
Claim 13 recites the limitation "the catheter" twice in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 13 is dependent on claim 9, which recites “the catheter” and lacks antecedent basis (as set forth above).
Claim 17 recites the limitation "the catheter" in lines 1, 2, and 3. There is insufficient antecedent basis for this limitation in the claim. Claim 17 is dependent on claim 9, which recites “the catheter” and lacks antecedent basis (as set forth above).
Claim 18 recites the limitation "the catheter" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. Claim 18 is dependent on claim 17, which is dependent on claim 9, which recites “the catheter” and lacks antecedent basis (as set forth above).
Claim 19 recites the limitation "the catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 is dependent on claim 9, which recites “the catheter” and lacks antecedent basis (as set forth above).
Claim 20 recites the limitation "the catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20 is dependent on claim 9, , which recites “the catheter” and lacks antecedent basis (as set forth above).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Brar, US 10,300,182 (28 May 2019).
Regarding claim 1, Babaev ‘694 teaches a method (claims 1-15) of using a debridement system (FIG 1, ¶11), comprising:
introducing at least a delivery tube (supply tube 60; ¶38) and at least an evacuation tube (return tube 70; ¶39) into an site (claim 8, incision; ¶39);
administering fluid (liquid 50; ¶38) to the site (claim 8, incision; ¶39) via the delivery tube (60; ¶38);
applying ultrasonic waves (claim 16, continuous waves or pulsed frequency; ¶35) to the infection site using an ultrasonic generator (ultrasonic generator 15; ¶31); and
clearing debris (claim 15) from the site (claim 8, incision; ¶39) via the evacuation tube (return tube 70; ¶39).
Babaev ‘694 does not expressly teach that the site is an infection site.
However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51).
Brar teaches systems, devices, and methods of treatment comprising using antimicrobial devices for infections (claim 1; col 1, lines 34-45) and wound care (claims 1 and 6; col 1, lines 49-50) including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694 and Brar given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694 and Brar teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Brar, US 10,300,182 (28 May 2019) and further in view of Passafaro, US 5,324,255 (28 June 1994).
Regarding claim 2, Babaev ‘694 modified by Brar teaches the method of claim 1, as set forth above, for the reasons set forth above.
Babaev ‘694 teaches wherein the delivery tube and the evacuation tube are comprised in a tube (FIG 2) and are applied to a site (claim 8, incision; ¶39).
Babaev ‘694 does not expressly teach that the tube is a catheter, that the catheter is introduced, or that the site is an infection site.
Brar teaches systems, devices, and methods of treatment comprising using antimicrobial devices for infections (claim 1; col 1, lines 34-45) and wound care (claims 1 and 6; col 1, lines 49-50) including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6).
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Brar, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Brar, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 3, Babaev ’694 modified by Brar teaches the method of claim 1, as set forth above, for the reasons set forth above.
Babaev ‘694 does not expressly teach that the tubes are comprised in a first or second catheter or the catheter is introduced.
Brar teaches wherein a first catheter includes the delivery tube (FIG 1.0, tube 518; col 5, lines 19-25) and a second catheter includes the evacuation tube (FIG 1.0, tube 517; col 5, lines 30-31), wherein the first catheter and the second catheter are each introduced into the infection site (FIG 1.0 wound care device 200; col 5, lines 20-21 and 30-31).
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Brar, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Brar, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. The catheters taught by Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Regarding claim 4, Babaev ’694 modified by Brar and Passafaro teaches the method of claim 3, as set forth above, for the reasons set forth above.
Brar teaches wherein applying ultrasonic waves (FIG 2.1, via ultrasonic transducer 210) to the infection site (FIG 1; col 9, lines 25-27) comprises propagating ultrasonic waves via the first catheter (“saline water is delivered to the wound care device 200 using the tube 518”; col 6, lines 11-12), the second catheter or both the first catheter and the second catheter (col 9, lines 25-27).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Brar, US 10,300,182 (28 May 2019), and further in view of Cheng, US 20220211401 (7 July 2022).
Regarding claim 5, Babaev ‘694 modified by Brar teaches the method of claim 4, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Brar does not teach wherein applying ultrasonic waves to the infection site comprises propagating ultrasonic waves along one or more wires disposed within the first catheter, the second catheter or both the first catheter and the second catheter.
Cheng teaches wherein applying ultrasonic waves to the infection site (biofilm, ¶59) comprises propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Brar, and Cheng given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Brar, and Cheng teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for deep in vivo applications (to reach infection sites deep within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Brar, US 10,300,182 (28 May 2019), and further in view of Cheng, US 20220211401 (7 July 2022) and Passafaro, US 5,324,255 (28 June 1994).
Regarding claim 6, Babaev ‘694 modified by Brar teaches the method of claim 3, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Brar do not teach the method further comprising a third catheter for applying ultrasonic waves to the infection site.
Cheng teaches wherein applying ultrasonic waves to the infection site (biofilm, ¶59) comprises propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12).
Cheng does not teach teaches the method further comprising a third catheter.
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Brar, Cheng, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Brar, Cheng, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver wire-based ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface. Passafaro’s teachings make it obvious to use ultrasonic transmission wires fitted within a standard catheters as a modular system that can be adapted to any use-case basis depending on individual need, anatomy, or surgical circumstance.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. Catheters such as the ones taught by Cheng and Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Regarding claim 7, Babaev ‘694 modified by Brar and Passafaro teaches the method of claim 6, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Brar do not teach wherein applying ultrasonic waves to the infection site comprises propagating ultrasonic waves along a wire disposed within the third catheter.
Cheng teaches wherein applying ultrasonic waves to the infection site (biofilm, ¶59) comprises propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59).
Cheng does not teach wherein the wires are disposed within the third catheter.
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Brar, Cheng, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Brar, Cheng, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). A person of ordinary skill in the art attempting to render Babaev 694’s ‘694 system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver wire-based ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface. Passafaro’s teachings make it obvious to use ultrasonic transmission wires fitted within a standard catheters as a modular system that can be adapted to any use-case basis depending on individual need, anatomy, or surgical circumstance.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. Catheters such as the ones taught by Cheng and Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Regarding claim 8, Babaev ‘694 modified by Brar teaches the method of claim 2, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Brar do not teach wherein applying ultrasonic waves to the infection site comprises propagating ultrasonic waves along a wire disposed in the catheter.
Cheng teaches wherein applying ultrasonic waves to the infection site (biofilm, ¶59) comprises propagating ultrasonic waves (¶59) along a wire (FIG 19, ultrasonic transmission wire 90, ¶59) disposed in the catheter (FIG 19, angioplasty catheter; ¶38; claim 12).
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Brar, Cheng, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Brar, Cheng, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Brar specifically addresses systems, devices, and methods of treatment comprising using antimicrobial devices for wound care including using a device against microbial infections (claim 1) comprising an inlet tube configured to deliver a fluid (claim 1) and an ultrasonic transducer (claim 4) in a system for treating a wound (claim 6) also comprising an outlet/aspiration tube (claim 6). Because Brar includes system comprising an ultrasound transducer on infection site, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system specifically in infection sites would reasonably consult Brar’s infection site solution. Brar’s infection site solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component to treat infection sites) using known methods, such as the ones taught by Brar (claims 1 and 6; col 1, lines 29-30), without redesigning Babaev ‘694’s method.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver wire-based ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface. Passafaro’s teachings make it obvious to use ultrasonic transmission wires fitted within a standard catheters as a modular system that can be adapted to any use-case basis depending on individual need, anatomy, or surgical circumstance.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. Catheters such as the ones taught by Cheng and Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Babaev US 2020138036 (26 September 2002) (hereinafter Babaev ‘036).
Regarding independent claim 9, Babaev ‘694 teaches a system (FIG 1), comprising: at least a delivery tube (supply tube 60; ¶38) and at least an evacuation tube (return tube 70; ¶39); and an ultrasonic generator (ultrasonic generator 15; ¶31) configured to cause ultrasonic waves (continuous waves or pulsed frequency; ¶35) to be emitted from a distal end.
Babaev ‘694 does not expressly teach that the distal end comprises a catheter using that term.
Babaev ‘036 teaches ultrasound catheter system 2 comprising ultrasound generator 4, and catheter 12 (FIG 1).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694 modified by Babaev ‘036, given that the prior art included each element claimed, although not necessarily in a single reference.
Babaev ‘694 modified by Babaev ‘036 teach in the same field of endeavor, ultrasound systems for treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the distal end comprises a catheter. Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Because the references address the same engineering problem (ultrasound systems useful for treatment of the human body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a catheter to permit the ultrasound transducer to reach into lumens of the human body), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 10, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Babaev US 2020138036 (26 September 2002) (hereinafter Babaev ‘036) and further in view of Passafaro, US 5,324,255 (28 June 1994).
Regarding claim 10, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 teaches wherein the delivery tube (supply tube 60; ¶38) and the evacuation tube (return tube 70; ¶39) are comprises in a tube (FIG 2).
Babaev ‘694 do not expressly teach that the delivery tube and the evacuation tube are comprised in a catheter, using that term.
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. Catheters such as the ones taught by Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Regarding claim 11, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 teaches a system (FIG 1), comprising: at least a delivery tube (supply tube 60; ¶38) and at least an evacuation tube (return tube 70).
Babaev ‘036 teaches ultrasound catheter system 2 comprising ultrasound generator 4, and catheter 12 (FIG 1).
Babaev ‘694 and Babaev’ 036 do not teach wherein a first catheter includes the delivery tube and a second catheter includes the evacuation tube.
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end. Babaev ‘694 teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. Catheters such as the ones taught by Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Regarding claim 13, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 teaches wherein the ultrasonic generator (ultrasonic generator 15; ¶31) is disposed at the distal end of a tube (FIG 1).
Passafaro teaches an ultrasonic generator (FIG 1, ultrasonic generator 24; col 4, line 42) is connected ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter to deliver ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Babaev US 2020138036 (26 September 2002) (hereinafter Babaev ‘036) and further in view of Cheng, US 20220211401 (7 July 2022) and Passafaro, US 5,324,255 (28 June 1994).
Regarding claim 12, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 11, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach wherein a wire is disposed within the first catheter, the second catheter or both the first catheter and the second catheter.
Cheng teaches wherein applying ultrasonic waves to the infection site (biofilm, ¶59) comprises propagating ultrasonic waves (¶59) along a wire (FIG 19, ultrasonic transmission wire 90, ¶59) disposed in the catheter (FIG 19, angioplasty catheter; ¶38; claim 12). Cheng teaches wherein a wire (90) is disposed within the first catheter (claim 12; ¶38) the second catheter or both the first catheter and the second catheter.
Passafaro teaches ultrasonic catheter device 10 (FIG 1; col 4, lines 31-32) comprising ultrasound transmission member 28 (FIG 2) and ultrasound transducer 22 (FIG 1). Passafaro teaches “the delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22). Passafaro also teaches that “the delivery of ultrasound may be accomplished by passing an independent or separate ultrasound transmission wire through any working lumen of an existing catheter, balloon dilation catheter, laser ablation catheter, atherectomy catheter, device or other intravascular catheter or surgical member” (col 12, lines 49-55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, Cheng, and Passafaro given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, Cheng, and Passafaro teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for deep in vivo applications (to reach infection sites deep within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng.
Passafaro discloses delivery of ultrasound transmitting components, separate ultrasound transmission wires may be done through any working lumen of a standard catheter or other intravascular device for the delivery of ultrasonic energy at or near the distal end of the catheter or device” (col 3, lines 14-22; col 12, lines 49-55). Passafaro makes it obvious to use any catheter or any number of catheters to deliver wire-based ultrasound/ultrasonic energy to a treat infections. A person of ordinary skill in the art attempting to utilize one or more than one catheter in a system for in vivo applications to treat infection sites within the human body would look for established designs to avoid creating a novel interface. Passafaro’s teachings make it obvious to use ultrasonic transmission wires fitted within a standard catheters as a modular system that can be adapted to any use-case basis depending on individual need, anatomy, or surgical circumstance.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, Applicant’s attention is drawn to MPEP 2144.04. In In, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The specification does not recite any criticality of utilizing more than one catheter. Catheters such as the ones taught by Cheng and Passafaro are old and well-known to have multiple channels that can carry irrigation tubes and fluids, aspiration tubes that provide vacuum/suction, active working components such as end effectors and ultrasound transmission means, as well as visualization/imaging modalities. Accordingly, the selection of one or more catheters is broadly considered a mere duplication of parts where there is otherwise no evidence that any new or unexpected result would be produce from there being more than one catheter.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Babaev US 2020138036 (26 September 2002) (hereinafter Babaev ‘036) and further in view of Pacetti US 6,419,657 (16 July 2002).
Regarding claim 14, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach the system further comprising a flow regulator at a distal end of the delivery tube.
Pacetti teaches a catheter system (col 4, lines 25-28) comprising a flow regulator (FIG 1, valve regulator valve 10, col 2, lines 53-55) at a distal end of the delivery tube (FIGs 1, “situated in the flow path of the inflation lumen” col 4, line 31).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Pacetti given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Pacetti teach in the same field of endeavor comprising treatment systems for the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Pacetti discloses a catheter system (col 4, lines 25-28) comprising a flow regulator (FIG 1, valve regulator valve 10, col 2, lines 53-55) at a distal end of the delivery tube (FIGs 1, “situated in the flow path of the inflation lumen” col 4, line 31). Pacetti’s ball poppet valve works bidirectionally in distal end fluidics tubes and regulates flow at a defined rate that is also adjustable (col 7, lines 16-18). Pacetti also teaches modifications to incorporate a check-valve (col 7, lines 37-40). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Pacetti’s tube internal flow regulator system can be adapted to be fitted within a standard catheter tubing (col 8, lines 18-29).
Because the references address the same engineering problem (methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing flow regulation in fluidic in vivo systems), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 15, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach the system further comprising a flow regulator at a distal end of the evacuation tube.
Pacetti teaches a catheter system (col 4, lines 25-28) comprising a flow regulator (FIG 1, valve regulator valve 10, col 2, lines 53-55) at a distal end of the evacuator tube (FIGs 1, “purge inflation fluid” col 5, lines 35, 67-60).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Pacetti given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Pacetti teach in the same field of endeavor comprising treatment systems for the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Pacetti discloses a catheter system (col 4, lines 25-28) comprising a flow regulator (FIG 1, valve regulator valve 10, col 2, lines 53-55) at a distal end of the evacuator tube (FIGs 1, “purge inflation fluid” col 5, lines 35, 67-60). Pacetti’s ball poppet valve works bidirectionally in distal end fluidics tubes and regulates flow at a defined rate that is also adjustable (col 7, lines 16-18).Pacetti also teaches modifications to incorporate a check-valve (col 7, lines 37-40). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Pacetti’s tube internal flow regulator system can be adapted to be fitted within a standard catheter tubing (col 8, lines 18-29).
Because the references address the same engineering problem (methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing flow regulation in fluidic in vivo systems), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 16, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 15, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach wherein the flow regulator comprises a check valve.
Pacetti discloses a catheter system (col 4, lines 25-28) comprising a flow regulator (FIG 1, valve regulator valve 10, col 2, lines 53-55) where the flow regulator comprises a check-valve (col 7, lines 37-40).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Pacetti given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Pacetti teach in the same field of endeavor comprising treatment systems for the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Pacetti discloses a catheter system (col 4, lines 25-28) comprising a flow regulator (FIG 1, valve regulator valve 10, col 2, lines 53-55) where the flow regulator comprises a check-valve (col 7, lines 37-40). Pacetti’s ball poppet valve works bidirectionally in distal end fluidics tubes and regulates flow at a defined rate that is also adjustable (col 7, lines 16-18).Pacetti also teaches modifications to incorporate a check-valve (col 7, lines 37-40). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Pacetti’s tube internal flow regulator system can be adapted to be fitted within a standard catheter tubing (col 8, lines 18-29).
Because the references address the same engineering problem (methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing flow regulation in fluidic in vivo systems), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Babaev US 2020138036 (26 September 2002) (hereinafter Babaev ‘036) and further in view of Cheng, US 20220211401 (7 July 2022).
Regarding claim 17, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach further comprising a wire disposed within the catheter, the wire configured to transmit the ultrasonic waves from the ultrasonic generator to the distal end of the catheter.
Cheng teaches the system further comprising a wire (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the catheter (FIG 19, angioplasty catheter; ¶38; claim 12), the wire configured to transmit the ultrasonic waves from the ultrasonic generator to the distal end of the catheter (¶59).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Cheng, given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Cheng teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites deep within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 18, Babaev ‘694 modified by Babaev ‘036 and Cheng teaches the system of claim 17, as set forth above, for the reasons set forth above.
Babaev ‘694 teaches wherein the evacuation tube (FIG 2, return tube 70; ¶39) is connected to a vacuum at a proximal end of the catheter, such that the evacuation tube provides suction at the distal end of the catheter (¶39).
Regarding claim 19, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach the system further comprising a radiopaque marker disposed at the distal end of the catheter.
Cheng teaches wherein applying ultrasonic waves to the infection site (biofilm, ¶59) comprises propagating ultrasonic waves (¶59) along a wire (FIG 19, ultrasonic transmission wire 90, ¶59) disposed in the catheter (FIG 19, angioplasty catheter; ¶38; claim 12). Cheng also teaches a radiopaque marker disposed at the distal end of the catheter (¶60).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Cheng, given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Cheng teach in the same field of endeavor, ultrasound systems for wound care and treating the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Cheng discloses applying ultrasonic waves to infection site (biofilm, ¶59) comprising propagating ultrasonic waves (¶59) along one or more wires (FIG 19, ultrasonic transmission wire 90, ¶59) disposed within the first catheter, the second catheter or both the first catheter and the second catheter (FIG 19, angioplasty catheter; ¶38; claim 12). Cheng also teaches a radiopaque marker disposed at the distal end of the catheter (¶60). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for deep in vivo applications (to reach infection sites deep within the human body) would look for established designs to avoid creating a novel interface. Cheng’s ultrasonic transmission wire fitted within a standard angioplasty catheter is modular and can be adapted to any catheter device to enable wire-based ultrasonic/ultrasound activation for treatment of infections, such as the indwelling biofilms exemplified by Cheng. Additionally, a person of ordinary skill in the art seeking to visualize the distal end of the catheter would look to Cheng’s radiopaque marker.
Because the references address the same engineering problem (ultrasound systems and methods useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (directing ultrasound treatment to wound and infection sites), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Babaev US 20090306694 (10 December 2009) (hereinafter Babaev ‘694) in view of Babaev US 2020138036 (26 September 2002) (hereinafter Babaev ‘036) and further in view of Dalton, US 5498251 (12 March 1996).
Regarding claim 20, Babaev ‘694 modified by Babaev ‘036 teaches the system of claim 9, as set forth above, for the reasons set forth above.
Babaev ‘694 modified by Babaev ‘036 do not teach wherein the catheter further comprises a hoop on an exterior side of the catheter, the hoop configured to receive a stitch to hold the catheter in place during a procedure.
Dalton teaches catheters (col 1, lines 5-6) wherein the catheter further comprises a hoop (FIG 1, suture ring or flange, 21) on an exterior side of the catheter, the hoop configured to receive a stitch to hold the catheter in place during a procedure (col 6, line 64 to col 7, line 1).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Babaev ‘694, Babaev ‘036, and Dalton given that the prior art included each element claimed, although not necessarily in a single reference. Babaev ‘694, Babaev ‘036, and Dalton teach in the same field of endeavor comprising treatment systems for the human body.
Although, Babaev ‘694 discloses the claimed system comprising a delivery tube, an evacuation tube, and an ultrasonic generator configured to cause ultrasonic waves emitted from a distal end, Babaev ‘694 does not expressly teach that the site is an infection site. However, Babaev teaches pathogen deactivation through the use of ultrasound energy (¶51). Babaev ‘036 specifically addresses an ultrasound catheter system 2 comprising ultrasound generator 4, and a catheter 12 (FIG 1). Because Babaev ‘036 includes system comprising an ultrasound generator and a catheter, a person of ordinary skill in the art, seeking to utilize Babaev 694’s system in different areas inside the body would reasonably consult Babaev ‘036’s catheter solution. Babaev ‘036’s catheter solution can be incorporated alongside Babaev ‘694’s system (same general location and providing the ultrasound transducer component at the distal end of the catheter) using known assembly methods, including the ones expressly taught in Babaev 036’s system without redesigning Babaev ‘694’s core device.
Dalton teaches catheters (col 1, lines 5-6) wherein the catheter further comprises a hoop (FIG 1, suture ring or flange, 21) on an exterior side of the catheter, the hoop configured to receive a stitch to hold the catheter in place during a procedure (col 6, line 64 to col 7, line 1). A person of ordinary skill in the art attempting to render Babaev 694’s system effective for in vivo applications (to reach infection sites within the human body) would look for established designs to avoid creating a novel interface. Dalton’s suture ring or flange solution would provide a known catheter retention solution for a fluidics catheter to remain in place during a procedure.
Because the references address the same engineering problem (devices and components useful for treatment of infection sites and wounds) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing a way to secure a catheter in place during a procedure), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Parham et al., US 20130331872 (12/12/2013) teaches systems and methods for tissue treatment.
Babaev, US 2008183109 (7/31/2008) teaches method for debriding wounds.
Gill US 9962181 (5/8/2018) teaches subcutaneous wound debridement.
Gill US 10709461 (7/14/2020) teaches subcutaneous wound debridement
Gill US 20230181202 (6/15/2023) teaches subcutaneous wound debridement
Gill US 20160059043 (3/3/2016) teaches subcutaneous wound debridement.
Silberg US 20150297879 (10/22/2015) teaches ultrasonic dispersion of compositions in tissue.
Galvalda US 20190054172 (2/21/2019) teaches system for thermotherapy treatment and prevention of antimicrobial resistant or biofilm infections.
Brar, US 10300182 (5/28/2019) teaches antimicrobial device for wound care.
Babaev US 20020138036 (9/26/2002) teaches ultrasonic catheter drug delivery method and device.
Babaev US 20080183200 (7/31/2008) teaches method of selective and contained ultrasound debridement.
Nash et al., US 20080097499 (4/24/2008) teaches thrombectomy and soft debris removal device.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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