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 .
Election/Restrictions
Claims 7-9, 13-14, and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of tunneling into tissue, and nonelected species of the inflatable element, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 17th 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2024 and 11/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-6, and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brannan et al (US20170056049A1) herein referred to as “Brannan”.
Regarding claim 1, Brannan teaches: A tissue tunneling system ([Abstract] the entire tissue dissector is seen as the tissue tunneling system) having a proximal end and a distal end, ([0023] there is a proximal and distal end) said tissue tunneling system comprising: a control handle at the proximal end of the tissue tunneling system; ([0023] there is a control handle which is seen as 16, at the proximal end) an elongate delivery member extending distally from said control handle; (See FIG 3 where there is an elongate delivery member which is seen as 17, extending distally from the control handle) a cutting device operatively associated with said elongate delivery member for delivery at the distal end of said tissue tunneling system; ([0032] the sharpened distal tip 15 is seen as the cutting device; See FIG 3 where it is associated with the elongated member which is seen as 17, at the distal end) and an inflatable device operatively associated with the distal end of said tissue tunneling system ([0026] the inflatable device is at the distal end and operatively connected to the entire system).
Regarding claim 2, Brannan teaches: The tissue tunneling system of claim 1, wherein said inflatable device is operatively associated with the distal end of said tissue tunneling system to be delivered to a target site proximal to said cutting device (See FIG 3 where the Tissue is proximal to the cutting device)
Regarding claim 3, Brannan teaches: The tissue tunneling system of claim 2, wherein said inflatable device is axially movable with respect to said cutting device (See FIG 2 and 3 where the inflatable device is deployed axially with respect to the cutting device).
Regarding claim 4, Brannan teaches: The tissue tunneling system of claim 3, wherein said inflatable device is operatively associated with a tubular elongate member axially shiftable with respect to said elongate delivery member ([0035] the inflatable device is operably coupled to the outer member 17 which is seen as the elongate delivery member).
Regarding claim 5, Brannan teaches: The tissue tunneling system of claim 4, wherein said tubular elongate member defines a lumen therethrough in fluid communication with said inflatable device ([0030] the lumen is in fluid communication with the inflatable device) to deliver an inflation medium to said inflatable device to selectively expand said inflatable device ([0039] the fluid from the lumen delivers fluid to make the inflatable device expand).
Regarding claim 6, Brannan teaches: The tissue tunneling system of claim 4, wherein said tubular elongate member defines a lumen therethrough (See FIG 3 where the elongate member 17 defines a lumen) and said elongate delivery member is insertable and axially translatable through the lumen of said tubular elongate member to move said cutting device and said inflatable device with respect to each other ([See FIG 2 and 3 where the elongate member moved axially to deploy the cutting device and the inflatable device with respect to each other]).
Regarding claim 10, Brannan teaches: The tissue tunneling system of claim 1, wherein said control handle comprises a first lumen for injection of fluid through a lumen defined through said cutting device, and a second lumen for injection of inflation fluid into said inflatable device ([See FIG 3] where the channel is seen as the first lumen and the annular lumen is seen as the second lumen which introduces fluid for the inflation of the inflatable device)
Regarding claim 11, Brannan teaches: A tissue tunneling assembly comprising: a cutting device at a distal end of said tissue tunneling assembly; ([0032] the sharpened distal tip 15 is seen as the cutting device) and an inflatable device positioned proximal to said cutting device (See FIG 4 where the inflatable device 22, is proximal to the cutting device 15).
Regarding claim 12, Brannan teaches: The tissue tunneling assembly of claim 11, wherein said inflatable device is axially movable with respect to said cutting device (See FIG 2 and 3 where the inflatable device is deployed in an axial direction with respect to the cutting device).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan in view of Skerven et al (US20130197554A1) herein referred to as “Skerven”.
Regarding claim 15, Brannan discloses: The tissue tunneling assembly of claim 11, however, Brannan does not explicitly disclose: wherein said cutting device is an electrosurgical knife.
Skerven discloses: wherein said cutting device is an electrosurgical knife ([0046] the knife is seen as an electrosurgical knife since electrical current is applied).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutting device as disclosed in Brannan to include an electrosurgical knife as disclosed in Skerven. The motivation being that using an electrosurgical knife can sufficiently incuse the tissue (Skerven [0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure CN110037767A.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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, Joanne M Rodden can be reached at 3032974276. 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.
/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights