DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Restriction Election
Applicant has elected Group II, including claims 2-6, drawn to a fenestration system, without traverse. Therefore, claim 1 was canceled as being directed to non-elected group 1. Claims 7-10 have been withdrawn as being directed to non-elected group 3.
Status of Claims
The amendments and remarks filed on 10NOV2025 have been entered and considered.
Claims 2-21 are currently pending.
Claims 2-4, 6 have been amended.
Claims 11-21 has been added.
Claim 1 has been canceled.
Claims 7-10 have been withdrawn.
Claims 2-6 & 11-21are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14JUN2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because
Figure 4 parts 400/402 have lines that are pointing to the same component.
Figure 5 contains part 542 which is not labeled clearly as to what component is meant to be 542.
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.
Specification
The disclosure is objected to because of the following informalities:
¶0077:
¶0077 of Specification states prosthetics 500 describing Figure 5. This is not in Figure 5.
¶0078:
¶0078 states “coronary artery 612”. This should be coronary artery 544 to have consistent terminology.
¶0078 states “coronary ostia 610”. This should be coronary ostia 542 to have consistent terminology.
¶0079:
¶0079 states “coronary artery 612”. This should be coronary artery 544 to have consistent terminology.
¶0079 states “coronary ostia 610”. This should be coronary ostia 542 to have consistent terminology.
Regarding the term fenestration system 800
There are multiple disclosures of fenestration system 800 but in ¶85& ¶82 part 800 is labeled as “laser ablation system”. Part 800 should have consistent terminology throughout the Specification.
¶0089:
¶0089 in the specification say “FIG. 12 shows a simplified diagram of the SAPIEN 3ULTRA valve 1200, as a second example of a commercial transcatheter aortic valve. Similar to valve 1100 of FIG. 11, valve 1200 includes a stent frame 1210 and leaflets 1120 ". This isn’t in Figure 12. Leaflets appear to be labeled as 1220 not 1120.
¶0095:
"Method 1700 terminates in an end step 920. " , but Figure 17 says step end is 1720.
Regarding term “C”
Term “C” as seen in Figure 4 is not found in the specification.
Appropriate correction is required.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
Applicant claims benefit of provisional application 63/351,687 filed 13JUN2022. A review of the priority dates of each claim is detailed below.
Regarding Claim 2:
The following items are not mentioned in provisional application 63/351,687 filed 13JUN2022: “ A fenestration system for The present application 18/209,170 is a continuation of provisional application 63/351,687 and recites a fenestration system in claims 2 & 18, a controller in claim 2, laser source in claims 2, 15-17, & 19, optical fiber in claims 2 & 20-21, and user interface in claims 2 & 18. The earliest benefit the application can claim for the fenestration system, controller, and user interface is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claims 3 & 19:
Claims 3 & 19 recite substantially the same limitations. No limitations from claims 3 & 19 can be found mentioned in provisional application 63/351,687 filed 13JUN2022: The earliest benefit the application can claim for claims 3 & 19 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 4:
No limitations from claim 4 can be found mentioned in provisional application 63/351,687 filed 13JUN2022: The earliest benefit the application can claim for claim 4 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 5:
No limitations from claim 5 can be found mentioned in provisional application 63/351,687 filed 13JUN2022: The earliest benefit the application can claim for claim 5 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 6:
The following items are not mentioned in provisional application 63/351,687 filed 13JUN2022: “calcified tissue”, “fabric skirt”, “frame”. The present application is a continuation of provisional application 63/351,687 and recites a calcified tissue in claim 6, a frame in claim 6, and a fabric skirt in claim 6. The earliest benefit the application can claim for the “calcified tissue”, “fabric skirt”, “frame” is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 11:
The following items are not mentioned in provisional application 63/351,687 filed 13JUN2022: coronary access. The present application is a continuation of provisional application 63/351,687 and recites a coronary access in claim 11. The earliest benefit the application can claim for the coronary access is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 12:
Claim 12 recites limitations that are found in the provisional application 63/351,687 filed 13JUN2023. Therefore, the earliest benefit the application can claim for claim 12 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 13:
Claim 13 recites limitations that are found in the provisional application 63/351,687 filed 13JUN2023. Therefore, the earliest benefit the application can claim for claim 13 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 14:
The following items are not mentioned in provisional application 63/351,687 filed 13JUN2022: “pulmonic intervention.” present application is a continuation of provisional application 63/351,687 and recites a pulmonic intervention in claim 14. The earliest benefit the application can claim for a pulmonic intervention is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 15:
The following items are not mentioned in provisional application 63/351,687 filed 13JUN2022: “laser source” and “medical-grade laser”. The present application is a continuation of provisional application 63/351,687 and recites a medical grade laser in claim 15, and laser source in claims 2, 15-17, & 19. The earliest benefit the application can claim for a laser source & medical grade laser is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 16:
Claim 16 recites limitations that are found in the provisional application 63/351,687 filed 13JUN2023. Therefore, the earliest benefit the application can claim for claim 16 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 17:
Claim 17 recites limitations that are found in the provisional application 63/351,687 filed 13JUN2023. Therefore, the earliest benefit the application can claim for claim 12 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 18:
Claim 18 recites limitations that are found in the provisional application 63/351,687 filed 13JUN2023. Therefore, the earliest benefit the application can claim for claim 18 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 20:
Claim 20 recites limitations that are found in the provisional application 63/351,687 filed 13JUN2023. Therefore, the earliest benefit the application can claim for claim 20 is from the instant application 18209170 with a filing date of 6/13/23.
Regarding Claim 21:
The following items are not mentioned in provisional application 63/351,687 filed 13JUN2022: optical fiber. The present application is a continuation of these applications and recites an optical fiber in claims 2 & 20-21. The earliest benefit the application can claim for the optical fiber is from the instant application 18209170 with a filing date of 6/13/23.
Duplicate claim warning
Applicant is advised that should claim 3 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 & 15-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 11:
The claim recites “improving coronary access” in line 2. Paragraphs 49, 51, & 57 of the specification states maintaining coronary access, but there is no disclosure found for “improving coronary access”. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Regarding Claim 15:
The claim recites “medical-grade laser” in lines 1-2. The specification does not provide a disclosure of a medical grade laser as claimed in claim 15. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Regarding Claim 16:
The claim recites “wherein the laser source is an ultraviolet laser” in line 1. The specification does not provide a disclosure of a ultraviolet laser as claimed in claim 16. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Regarding Claim 17:
The claim recites “wherein the laser source is a thulium fiber laser” in line 1. The specification does not provide a disclosure of a thulium laser as claimed in claim 17. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
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 2-6 & 11-21 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.
Regarding Claim 2:
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “tissue” in line 6, and the claim also recites “a valve structure” in line 6, which is the narrower statement of the range/limitation. A valve structure relates to a type of tissue and represents a functional arrangement of tissues for its structure, where a tissue is not always a valve structure and can represent a plurality of various organic items such as skin, organs, cartilage, etc. The valve structure is therefore a narrower example of a tissue. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “for delivering the laser energy to at least one of a tissue” in line 6, and the claim also recites “for delivering the laser energy to at least one of a valve structure” in line 6 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 3-6 & 11-21 are further rejected for depending upon the rejected claim 2
Regarding Claim 11:
The claim recites “wherein results of the intervention procedure comprise at least one of improving blood flow, improving coronary access, reducing blood flow stasis, in the sinus or neo-sinus regions, or reducing coronary obstruction” in Lines 1-3. It is unclear from the claims how these intended results are achieved by the system. The claim limitations are directed towards systems claims but do not further limit the independent claim 2, and is therefore indefinite. Clarification is required.
Regarding Claim 12:
The claim recites “wherein the heart valve intervention procedure comprises a mitral valve intervention” in Lines 1-2. The claim limitations are directed towards systems claims but do not further limit the independent claim 2, and is therefore indefinite. Clarification is required.
Regarding Claim 13:
The claim recites wherein the heart valve intervention procedure comprises a tricuspid intervention” in Lines 1-2. The claim limitations are directed towards systems claims but do not further limit the independent claim 2, and is therefore indefinite.
Regarding Claim 14:
The claim recites “wherein the heart valve intervention procedure comprises a pulmonic intervention” in Lines 1-2. The claim limitations are directed towards systems claims but do not further limit the independent claim 2, and is therefore indefinite.
Regarding Claim 15:
The claim recites “wherein the laser source comprises a medical-grade laser suitable for tissue ablation” in Lines 1-2. It is unclear how the system would contain a different type of laser source that is not medical grade when the system is intended to be used within a body. For the purpose of examination, the examiner is interpreting this as any ablation laser source being a medical grade laser for the purpose of ablation. Clarification is required.
Regarding Claim 18:
The claim recites “a user interface” in Line 2. It is unclear if this user interface is the same user interface as recited in claim 2 with additional functions, or if this is intended to be a new user interface. For the purpose of examination, the examiner is interpreting this as the same user interface. Clarification is required.
Regarding Claim 20:
Claim 20 is directed to a system. The claims recite “wherein the valve structure is at least a portion of a previously implanted prosthetic valve” in lines 2-3 of claim 20. The remainder of the claim limitation recites limitations requires the method step of delivering. Claim 20 recites product and process limitations in the same claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See MPEP 2173.05(p). For purpose of examination, claim 20 is interpreted as being directed wherein the optical fiber is configured to deliver the laser energy to the valve structure.
The claim recites “wherein the optical fiber delivers the laser energy to the valve structure, and wherein the valve structure is at least a portion of a previously implanted prosthetic valve” in Lines 1-3. The claim limitations are directed towards systems claims but do not further limit the independent claim 2, and is therefore indefinite.
Regarding Claim 21:
Claim 21 is directed to a system. The claim recites “wherein the valve structure is a valve-in-valve structure.” in Lines 1-2 of claim 21. The remainder of the claim limitations recite requires the method step of delivering. Claim 21 recites product and process limitations in the same claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See MPEP 2173.05(p). For purpose of examination, claim 21 is interpreted as being directed to a fenestration system for treating a valve in valve structure configured to perform the recited method steps.
The claim recites “wherein the optical fiber delivers the laser energy to the valve structure, and wherein the valve structure is a valve-in-valve structure.” in Lines 1-2. The claim limitations are directed towards systems claims but do not further limit the independent claim 2, and is therefore indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2, 6, 11-15, 18, & 20-21 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Bataille (WO Publication No. 2021046643; Publication date 18MAR2021).
Regarding claim 2, Bataille discloses a fenestration system for performing a laser ablation process in association with an intervention procedure (Bataille Abstract; ¶0021 “In some embodiments, the deflectable sheath or dilator or catheter may include an additional optical fiber for use as part of an ultrafast laser for calcium removal on or in heart valve tissue or for performing surgical intervention of the heart, the additional optical fiber running along a length of another of the one or more lumens.”), the fenestration system comprising: a catheter (Bataille ¶0075 catheter 60 as seen in Lines 3-4 “The system may have a focal catheter that may be advanced near the heart valve to be treated (e.g. 2, 10, 11 ,12) and the focal catheter 60 can be guided to the heart valve leaflet with a deflection mechanism”); a laser source for producing laser energy (Bataille ¶0075 Line 8 referring to Figure 2A “an ultrafast laser with harmonic generator and its controls 50”); an optical fiber (Bataille ¶0075 Describing Figure 2A, Line 20 “Optical fiber outer Core 54.”) for delivering the laser energy to at least one of a tissue or a valve structure through the catheter during the intervention procedure (Bataille ¶0016 Lines 5-7 “catheter further comprises an additional optical fiber for use as part of an ultrafast laser for calcium removal on or in heart valve tissue or for performing surgical intervention of the heart,”); and a controller for controlling the laser source via a user interface (Bataille ¶0102 Lines 1-4 “The user input interface 109 receives input from a user to, e.g., turn on/off power source 105a, power source 106b, adjust the properties of the laser source 104b, control the steering mechanism 107 via the actuator 106, etc. The user input interface 109 may be, e.g., a touchscreen, a keyboard, a mouse, a microphone, a button, etc.”), the catheter being configured to guide the optical fiber through a circulatory system (Bataille ¶0075 Lines 4-6 “the focal catheter 60 can be guided to the heart valve leaflet with a deflection mechanism 58 in the catheter or sheath handle 43 where, by actuating the deflection mechanism, one or more pull wires are pulling on the pull wire ring assembly 40 to deflect the catheter tip 39 so it can reach the heart valve leaflet.”), wherein the intervention procedure is an aortic intervention procedure, a heart valve intervention procedure, or a combination of an aortic intervention procedure and a heart valve intervention procedure. (Bataille ¶0074 Lines 3-5 “Embodiments described herein may be specifically designed to treat any heart valve, such as the mitral valve 2, the tricuspid valve 10, the pulmonary valve 11 , and or the aortic valve 12.”).
Regarding claim 6, claim 2 is anticipated by Bataille. Bataille further discloses wherein the tissue comprises at least one of a calcified tissue (Bataille ¶0058 Line 1 “FIG. 2a is an illustration of an exemplary system for performing decalcification”), and wherein the valve structure comprises a leaflet of the valve structure (Bataille ¶0075 Lines 1-3 “illustrating an exemplary diagnostic and therapeutic system for the diagnosis, detection and treatment of calcium in the cardiovascular system and heart valve leaflet treatment.”).
Regarding claim 11, claim 2 is anticipated by Bataille. Bataille further discloses wherein results of the intervention procedure comprise at least one of improving blood flow, improving coronary access, or reducing coronary obstruction(Bataille ¶0016 Lines 8-9 “ultrafast laser for removing calcium on or in heart valve tissue or for performing surgical intervention of the heart.” Where the examiner maintains the removal of calcium will have these intended results).
Regarding claim 12, claim 2 is anticipated by Bataille. Bataille further discloses wherein the heart valve intervention procedure comprises a mitral valve intervention. (Bataille ¶0074 Lines 3-5 “Embodiments described herein may be specifically designed to treat any heart valve, such as the mitral valve 2, the tricuspid valve 10, the pulmonary valve 11, and or the aortic valve 12. “).
Regarding claim 13, claim 2 is anticipated by Bataille. Bataille further discloses wherein the heart valve intervention procedure comprises a tricuspid intervention. (Bataille ¶0074 Lines 3-5 “Embodiments described herein may be specifically designed to treat any heart valve, such as the mitral valve 2, the tricuspid valve 10, the pulmonary valve 11, and or the aortic valve 12. “).
Regarding claim 14, claim 2 is anticipated by Bataille. Bataille further discloses wherein the heart valve intervention procedure comprises a pulmonic intervention. (Bataille ¶0074 Lines 3-5 “Embodiments described herein may be specifically designed to treat any heart valve, such as the mitral valve 2, the tricuspid valve 10, the pulmonary valve 11, and or the aortic valve 12. “).
Regarding claim 15, claim 2 is anticipated by Bataille. Bataille further discloses wherein the laser source comprises a medical-grade laser suitable for tissue ablation. (Bataille ¶0074 Line 5 “The devices may be designed to be used in a minimally invasive surgery “ Showing the system is designed to be used during a medical procedure).
Regarding claim 18, claim 2 is anticipated by Bataille. Bataille further discloses a user interface for receiving input in operating the fenestration system and for controlling the laser energy (Bataille ¶0102 Lines 1-4 “The user input interface 109 receives input from a user to, e.g., turn on/off power source 105a, power source 106b, adjust the properties of the laser source 104b, control the steering mechanism 107 via the actuator 106, etc. The user input interface 109 may be, e.g., a touchscreen, a keyboard, a mouse, a microphone, a button, etc.”).
Regarding claim 20, claim 2 is anticipated by Bataille. Bataille further discloses wherein the optical fiber delivers the laser energy to the valve structure, and wherein the valve structure is at least a portion of a previously implanted prosthetic valve. (Bataille ¶0075 Lines 16-17 “The setting can also determine the proper wavelength to safely pulverize the calcium without affecting the native or prosthetic tissue “ showing that the invention is intended for both native or prosthetic tissue).
Regarding claim 21, claim 2 is anticipated by Bataille. Bataille further discloses wherein the optical fiber delivers the laser energy to the valve structure, and wherein the valve structure is a valve-in-valve structure (Bataille ¶0075 Lines 16-17 “The setting can also determine the proper wavelength to safely pulverize the calcium without affecting the native or prosthetic tissue “ showing that the invention is intended for both native or prosthetic tissue, where an example of prosthetic tissue is described in reference to valve over valve procedures in ¶0010 Line 4).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bataille (WO Publication No. 2021046643; Publication Date 18MAR2021; English translation of the Description) in view of Gelfand et al (DE Publication No. 112013002175; Publication Date 22JAN2015; English Translation of the Description).
Regarding claim 3, claim 2 is anticipated by Bataille. Bataille further discloses a monitoring system (Bataille [English Translation] ¶0075 Lines 14-16 “The operator can decide to set the system manually for calcification pulverization or use the integrated algorithm, based on the OCT, to set the ultrafast laser to the optimal setting of the precise and particular site of the pulverization.”)configured to monitor at least one of operating conditions of the laser source, a power output of the laser source (Bataille [English Translation] ¶0075 Lines 16-18 “The setting can also determine the proper wavelength to safely pulverize the calcium without affecting the native or prosthetic tissue or can be set to human biological tissue pulverization for anatomy sculpting.”). Bataille does not further disclose a temperature sensor used in monitoring the ablation system.
Gelfand in a similar field of laser ablation systems teaches a temperature sensor used in monitoring the ablation system(Gelfand [English Translation] ¶0227 Line 5-7 “precise control of a laser ablation process by having an optical temperature sensor within a laser source console that measures blackbody radiation from the ablation zone used to modulate laser energy for optimal ablation formation;”).
Before the effective filing date, one of ordinary skill in the art would think to combine the ablation system of Bataille with the temperature sensor used in monitoring the ablation system of Gelfand for the purpose of monitoring the state of the tissue during an ablation procedure to help reduce unwanted tissue damage.
Regarding claim 19, claim 2 is anticipated by Bataille. Bataille further discloses a monitoring system (Bataille [English Translation] ¶0075 Lines 14-16 “The operator can decide to set the system manually for calcification pulverization or use the integrated algorithm, based on the OCT, to set the ultrafast laser to the optimal setting of the precise and particular site of the pulverization.”) configured to monitor at least one of operating conditions of the laser source, or a power output of the laser source (Bataille[English Translation] ¶0075 Lines 16-18 “The setting can also determine the proper wavelength to safely pulverize the calcium without affecting the native or prosthetic tissue or can be set to human biological tissue pulverization for anatomy sculpting.”). Bataille does not further disclose a temperature sensor used in monitoring the ablation system.
Gelfand in a similar field of laser ablation systems teaches a temperature sensor used in monitoring the ablation system(Gelfand [English Translation] ¶0227 Lines 5-7 “precise control of a laser ablation process by having an optical temperature sensor within a laser source console that measures blackbody radiation from the ablation zone used to modulate laser energy for optimal ablation formation;”).
Before the effective filing date, one of ordinary skill in the art would think to combine the ablation system of Bataille with the temperature sensor used in monitoring the ablation system of Gelfand for the purpose of monitoring the state of the tissue during an ablation procedure to help reduce unwanted tissue damage.
Claims 4-5 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bataille (WO Publication No. 2021046643; Publication Date 18MAR2021; [English Translation of the Description]) in view of Ben-Oren et al (US Publication No. 2019321103; Publication Date 24OCT2019).
Regarding claim 4, claim 2 is anticipated by Bataille. Bataille does not further disclose a flush mechanism configured to flush
Ben Oren in a similar field of endeavor of hybrid catheters teaches a flush mechanism configured to flush (Ben-Oren ¶0141 Lines 2-3 “This can be at least partially resolved by minimizing ablation area (depth and width), use of short laser pulses and with saline flushing.”), wherein the flush mechanism comprises a liquid reservoir, a pump, and tubing (Ben-Oren ¶0157 Lines 1-3 “In accordance with some embodiments, the catheter is connected to a suction pump that generates low pressure to collect undesired material, saline and/or the like through the catheter. The pump may be a peristaltic pump,” where the peristaltic pumps are used in ablation flushing and inherently contain the pump, reservoir, and tubing necessary to deliver/remove fluids).
Before the effective filing date, one of ordinary skill in the art would think to have a flushing system in the ablation system of Bataille, such as taught in Ben-Oren for the purpose of removing debris caused by the ablation procedure to maintain a clean workspace.
Regarding claim 5, claims 2 & 4 are obvious over Bataille in view of Ben-Oren. Bataille does not further disclose wherein the flush mechanism is a saline flush mechanism. Ben-Oren further teaches wherein the flush mechanism is a saline flush mechanism (Ben-Oren ¶0144 Lines 6-9 “Optionally, the area of ablation may be flushed with a saline solution in order to reduce side effects (such as cavitation), clean the area of ablation and catheter and/or facilitate collection of debris.”). Before the effective filing date, one of ordinary skill in the art would think to have a flushing system in the ablation system of Bataille, such as taught in Ben-Oren for the purpose of removing debris caused by the ablation procedure to maintain a clean workspace, where saline is a neutral fluid not known to cause unwanted reactions in medical procedures.
Regarding claim 16, claim 2 is anticipated by Bataille. Bataille does not further disclose wherein the laser source is an ultraviolet laser. Ben Oren further teaches wherein the laser source is an ultraviolet laser. (Ben-Oren ¶0140 Line 1 “An example of an appropriate laser of some embodiments is a solid state ultraviolet (UV) laser”). Before the effective filing date, one of ordinary skill in the art would think to utilize ultraviolet lasers in the ablation system of Bataille, such as taught in Ben-Oren for the purpose of improving ablation results by providing increased precision which is provided by the ultraviolet laser.
Regarding claim 17, claim 2 is anticipated by Bataille. Bataille does not further disclose wherein the laser source is a thulium fiber laser. Ben Oren further teaches (Ben-Oren ¶0063 Line 1 “In some embodiments, said laser is a pulse Thulium fiber laser.”). Before the effective filing date, one of ordinary skill in the art would think to utilize thulium lasers in the ablation system of Bataille, such as taught in Ben-Oren for the purpose of improving ablation results by providing increased precision which is provided by the thulium laser.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on M-F 9:30-4:30. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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