DETAILED ACTION
This action is in response to preliminary amendments received on 3/21/2024. It is acknowledged that all of the originally filed claims 1-50 have been canceled and new claims 51-70 added. A complete action on the merits of claims 51-70 follows below.
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 .
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 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.
Claim Objections
Claims 52-63, 65-66 and 68-70 are objected to because of the following informalities:
“A cryocatheter” at the beginning of the preamble of dependent claims 52-63 should be amended to recite --The cryocatheter-- in order to imply it is the cryocatheter of independent claim 1 being further limited.
“A device” at the beginning of the preamble of dependent claims 55-56 should be amended to recite --The cryotherapy device-- in order to imply it is the cryotherapy device of independent claim 64 being further limited and to be consistent.
“A method” at the beginning of the preamble of dependent claims 68-70 should be amended to recite --The cryotherapy method-- in order to imply it is the cryotherapy method of independent claim 67 being further limited and to be consistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 67-68 and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kochavi (US Pub. No. 2020/0297403).
Regarding Claim 67, Kochavi teaches a cryotherapy method, comprising:
navigating a cryotherapy device comprising an endoscope 16 and a cryocatheter 1002 into a hollow organ, wherein said cryocatheter comprises at least one cryofluid channel 1006 and at least one washing fluid channel 1014 coupled to each other (Fig. 1A);
bending a bendable distal section of said endoscope positioned within said hollow organ in at least 45 degrees relative to a section of said endoscope located outside said hollow organ (Figs. 1F-3 and 5A-5D); releasing cryofluid from at least one distal opening of said at least one cryofluid channel located at said bendable distal section, when said bendable distal section is bent ([0298] and Figs. 1F-3 and 5A-5D).
Regarding Claim 68, Kochavi teaches comprising: releasing washing fluid from a least one washing fluid opening (“the washing channel 1014 comprises at least one forward-facing wash nozzle at the distal end of the cryotherapy device, facing the tissue” [0240]) of said at least one washing fluid channel 1014 located at said bendable distal section, when said bendable distal section is bent, wherein said washing fluid is released before, during and/or after the cryofluid release ([0239]-[0241], [0245] and [0268]).
Regarding Claim 70, Kochavi teaches wherein said navigating, said bending and said releasing is performed during a treatment for ablating tissue within said hollow organ ([0160]-[0162], [0181], [0259], [0308]-[0314] and Figs. 8A-8G).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 51, 53-54, 56, 58-66 and 69 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kochavi as applied above in view of Suwito (US Pub. No. 2009/0192496).
Regarding Claim 51, Kochavi teaches a cryocatheter 10/1002 (Figs. 1A-1F and [0238] and [0276]), comprising:
an elongated body terminating with a bendable distal section, which is shaped and sized to penetrate into a hollow organ (various embodiments shown in Figs. 1A-5D, 8A-D and 10A-D), wherein said bendable distal section comprises a distal tip 24 ([0287]);
at least one cryofluid channel 133/1006 located within said bendable distal section (Figs. 4A-D-7B), comprises at least one distal opening (49/69 and “the inflow channel 1006 comprises at least one forward facing cryo-nozzle configured to spray cryogenic fluid” [0236]) at said distal tip 24 configured to release cryofluid from said at least one cryofluid channel ([0234]-[0236], [0288]-[0291]);
at least one washing fluid channel 1014 ([0239]-[0242] and Fig. 1A) located within said bendable distal section and coupled to said at least one cryofluid channel 1006, wherein said at least one washing fluid channel comprises at least one distal opening at said distal tip configured to release washing fluid from said at least one washing channel (“the washing channel 1014 comprises at least one forward-facing wash nozzle at the distal end of the cryotherapy device” [0240]);
wherein bending of said bendable distal section in an angle of at least 45 degrees relative to a section of the elongated body proximal to said bendable distal section ([0266], [0298] and Figs. 1F-3 and 5A-5D show the bendable distal section in an angle of at least 45 degrees relative to a section of the elongated body proximal to said bendable distal section),
Kochavi teaches actively controlling the flow of cryofluid “the control circuitry 1026 is electrically connected to at least one cryo flow regulator on the cryo inflow path, for example a valve. In some embodiments, the control circuitry regulates the flow through the cryo inflow path, for example reducing flow within the inflow path, for example stopping flow within the inflow path and/or increasing flow within the inflow path for example by delivering a signal to the cryo flow regulator. In some embodiments, the control circuitry regulates the cryogenic fluid flow within the cryo inflow path, for example when the pressure within the body lumen is higher than a pre-determined pressure value. Alternatively, the control circuitry regulates the cryogenic fluid flow within the cryo inflow path, for example when the temperature inside the body lumen is below a pre-determined temperature value” [0251],; thereby examiner takes the position that either by bending the bendable section as seen in Figs. 1A-5D, 8A-D and 10A-D the flow of cryofluid is not reduced and thus interpreted as being reduced by less than 10 percent relative to cryofluid flow through said distal opening when said bendable distal section is unbent or alternatively in view of teachings of Suwito in the same field of invention “an angle of insertion .theta. may be selected within the range of 1.degree. to 90.degree” [0043] and “bending surface is provided over which a flexured portion of the catheter may gently bend to accommodate the transition of the catheter from the catheter adapter to the insertion site without occluding the catheter” abstract and [0024]; therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the catheter of Kochavi bend to an angle of at least 45 degrees without reducing the flow of cryofluid to maximize treatment without unexpected reduction of fluid flow.
Regarding Claim 53, Kochavi in view of Suwito teaches wherein said at least one cryofluid channel in said elongated body is formed from an elongated cryofluid tube comprising a distal flexible section at said bendable distal section, and a proximal section, wherein an outer diameter of said distal flexible section is smaller than an outer diameter of said proximal section to allow bending of said distal flexible section in an angle of at least 45 degrees relative to said proximal section (section 14 vs. section 18 of Suwito in Fig. 2).
Regarding Claim 54, Kochavi teaches wherein said flexible distal section of said at least one cryofluid channel is configured to bend in a radius of curvature which is smaller than a radius of curvature of said proximal section (Figs. 1F-3 and 5A-D).
Regarding Claim 56, Kochavi teaches wherein an outer diameter of said distal flexible section of said at least one cryofluid channel is in a range of 0.1- 2 mm ([0213]).
Regarding Claim 58, Kochavi in view of Suwito teaches wherein said distal flexible section of said at least one cryofluid channel is formed from Nitinol, Titanium, or Stainless-Steel ([0023] of Suwito).
Regarding Claim 59, Kochavi teaches wherein said bendable distal section of said elongated body is configured to bend in at least 45 degrees without crimping or kinking ([0096], [0121] and [0222]).
Regarding Claim 60, Kochavi teaches wherein said at least one cryofluid channel 1006 is coaxially positioned within said at least one washing fluid channel 1014 (Fig. 1A also see Fig. 20B).
Regarding Claim 61, Kochavi teaches wherein said cryocatheter is shaped and sized to be positioned within a working channel of a flexible endoscope 16 and to extend out from a distal opening of the working channel (Figs. 1C-3).
Regarding Claim 62, Kochavi teaches wherein said elongated body has an outer diameter in a range of 1 mm to 3 mm ([0213] and [0233]).
Regarding Claim 63, Kochavi teaches wherein said at least one washing fluid channel comprises a plurality of openings 1117 in the wall of the at least one washing fluid channel distributed on a circumference of the washing fluid channel (Fig. 20B and [0357]).
Regarding Claim 64, Kochavi teaches a cryotherapy device (Fig. 1A), comprising:
an endoscope 16 comprising: an elongated insertion tube having a distal tip shaped and sized to penetrate into a hollow organ (Figs. 1C-3); a working channel within said elongated insertion tube comprising a proximal opening and a distal opening at said distal tip (Figs. 1A-3); a cryocatheter according to claim 51 (see the rejection of claim 51 above), wherein said cryocatheter is shaped and sized to move within the working channel and to extend at least partly from said working channel distal opening, to position said at least one washing fluid distal opening in a selected distance and/or orientation relative to said elongated insertion tube distal tip ([0240]-[0241], [0282] and Figs. 2A-3).
Regarding Claim 65, Kochavi teaches wherein said endoscope 16 comprises at least one optical element 1022 at said distal tip, and wherein said cryocatheter 1002 controllably moves within said working channel to position said at least one washing fluid distal opening in a selected distance and/or orientation relative to said optical element ([0240]-[0241], [0282] and Figs. 2A-3).
Regarding Claim 66, Kochavi teaches wherein said endoscope 16 comprises at least one optical element 1022 at said distal tip defining a field of view (FOV) distal to said at least one optical element and wherein said cryocatheter 1002 controllably moves within said working channel to position said at least one washing fluid distal opening in a selected distance and/or orientation relative to said FOV ([0240]-[0241] and [0282] and Figs. 2A-3).
Regarding Claim 69, Kochavi teaches actively controlling the flow of cryofluid “the control circuitry 1026 is electrically connected to at least one cryo flow regulator on the cryo inflow path, for example a valve. In some embodiments, the control circuitry regulates the flow through the cryo inflow path, for example reducing flow within the inflow path, for example stopping flow within the inflow path and/or increasing flow within the inflow path for example by delivering a signal to the cryo flow regulator. In some embodiments, the control circuitry regulates the cryogenic fluid flow within the cryo inflow path, for example when the pressure within the body lumen is higher than a pre-determined pressure value. Alternatively, the control circuitry regulates the cryogenic fluid flow within the cryo inflow path, for example when the temperature inside the body lumen is below a pre-determined temperature value” [0251]; thereby examiner takes the position that either by bending the bendable section of the endoscope bendable distal section as seen in Figs. 1A-5D, 8A-D and 10A-D the flow of said cryofluid from said distal opening during said cryofluid is not reduced and thus interpreted as being releasing by less than 10 percent relative to cryofluid flow through said distal opening when said endoscope bendable distal section is unbent or alternatively in view of teachings of Suwito in the same field of invention “an angle of insertion .theta. may be selected within the range of 1.degree. to 90.degree” [0043] and “bending surface is provided over which a flexured portion of the catheter may gently bend to accommodate the transition of the catheter from the catheter adapter to the insertion site without occluding the catheter” abstract and [0024]; therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the catheter of Kochavi bend to an angle of at least 45 degrees without reducing the flow of cryofluid to maximize treatment without unexpected reduction of fluid flow.
Claims 52, 55 are rejected under 35 U.S.C. 103 as being unpatentable over Kochavi in view of Suwito as applied above and further in view of Engelman (US Pub. No. 2014/0018788).
Regarding Claims 52 and 55, Kochavi teaches wherein a bending radius of said bendable distal section as shown in Figs. 1F-3 and Figs. 5A-D, but does not specifically teach the radius is in a range of 5-20 mm and wherein a length of said distal flexible section of said at least one cryofluid channel is in a range of 20-150 mm.
In the same field of flexible/bendable catheters, Engelman teaches a catheter can include different flexibilities and radius of curvature along its length for a specific treatment procedure and thus gives examples of “the radius of curvature 18 and length 19 of the deflectable segment are configured for use in the vicinity of the carotid bifurcation with the radius of curvature 18 being between 5 mm and 20 mm, and the length of the deflectable segment 19 being between 10 mm and 25 mm” in [0132] as shown in Fig. 4B.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to flex/bend the distal bendable section of the catheter of Kochavi to have a radius of curvature in a range of 5-20 mm as Engelman teaches since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Kochavi in view of Suwito as applied above and further in view of Dobak (US Patent No. 6,254,626).
Regarding Claim 57, Kochavi in view of Suwito teaches the invention as applied above, but does not specify wherein a wall of said distal flexible section has a width in a range of 0.02 mm to 0.2 mm.
In the same field of invention, Dobak teaches “structure of the tube sections 25, 27 allows them to bend, extend and compress, which increases the flexibility of the heat transfer element 14 so that it is more readily able to navigate through blood vessels. The tube sections 25, 27 are also able to tolerate cryogenic temperatures without a loss of performance. The tube sections 25, 27 may have a predetermined thickness of their walls, such as between about 0.5 and 0.8 mils. The predetermined thickness is to a certain extent dependent on the diameter of the overall tube” in Col. 9, ll. 15-24.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to structure the distal bendable section of the catheter of Kochavi to have a predetermined thickness of the wall such as in the range of 0.5-0.8 mil (0.0127 mm-0.2mm) as Dobak teaches in order to allow it to have the sufficient flexibility required while tolerating cryogenic temperatures without a loss of performance since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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, Linda Dvorak can be reached on (571) 272-4764. 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.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
Prosecution Insights