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 .
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.
Status of the Claims
The current office action is made responsive to claims filed 06/26/2026.
Acknowledgement is made to the amendment of claim 18.
Acknowledgement is made to the withdrawal of claims 1-17.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 18-20 are pending. A complete action on the merits appears below.
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 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 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 20190090727 A1) in view of Widenhouse (US 20100081880 A1).
Regarding claim 18, Shelton teaches a delivery device (Fig. 1; medical device 10) for delivering an ablation assembly into an airway of a patient, the delivery device comprising:
a rigid body (Fig. 1; handpiece 14);
a flexible working shaft (Fig. 1; insertion tube 12) coupled to the body at a first end of the shaft, the shaft being configured to be partially or entirely positioned within the airway ([0015]), the second end of the shaft comprising a working end (Fig. 1; distal end 18);
an insertion port (Fig. 1; working channel port 24) formed on the rigid body, the port including structure defining a port channel ([0036]); and
structure defining a working channel (Fig. 1; working channel 16) extending through the rigid body and the flexible working shaft ([0036]- [0037]), the working channel including a linear portion ([0036] discusses the working channel port as providing the medical instrument to the working channel of the insertion tube wherein this working channel port provides said instrument to the handpiece portion of the working channel) and a non-linear portion ([0037] discusses the working channel portion which is located within the insertion tube, wherein the insertion tube is taught in [0018] as being substantially flexible, and therefore non-linear as broadly as is currently claimed), wherein a first end of the linear portion is coupled to the port channel and a second end of the linear portion is coupled to the non-linear portion ([0036]- [0037]),
wherein a first end of the working channel is coupled to the port channel, and a second end of the working channel is coupled to the working end of the flexible shaft ([0036]- [0037], [0039], [0042] teaches the working channel as being the channel in which the medical instrument can be inserted and the medical instrument is taught as being inserted at the working channel port, which is the proximal point of the working channel, and moves towards the distal end of the insertion tube), and
wherein the insertion port is coupled to the rigid body ([0036]), the insertion port being positioned at a first insertion position in which the first end of the working channel is collinear with the port channel ([0036]- [0037], and
wherein the insertion port is configured to receive the ablation assembly through the port channel while the insertion port is in the first insertion position ([0002], [0036]- [0037]).
However, Shelton fails to teach the insertion port which is coupled to the rigid body as being pivotably coupled to the rigid body and being pivotable from the first insertion position to a second insertion position in which the first end of the working channel is not colinear with the port channel, and
wherein the insertion port is configured to be pivoted from the first insertion position to the second position after the ablation assembly is inserted through the working channel.
Widenhouse teaches a surgical access device which allows a surgical instrument to be inserted through a proximal portion to provide surgical access into a body cavity (Abstract- [0001], [0007], [0116]). This surgical access device is taught as allowing the surgical instrument to be inserted at variable angles of insertion to allow for ease of manipulation of the surgical instrument during a medical procedure ([0105]).
Widenhouse further teaches the surgical instrument as being able to be inserted at variable angles of insertion as the proximal portion of the surgical access device is configured for pivotal movement and is freely movable relative to the housing such that the angular orientation of the central axis is adjustable ([0008]). This proximal portion for insertion of the surgical instrument is taught as being moveable between a configuration which is shown as being colinear with a distal channel, also referred to as the inner elongate portion, which the surgical instrument is positioned within (Fig. 3A) and a configuration in which the proximal portion is shown as not being colinear with said distal channel (Fig. 3B).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ability of the proximal portion of a device, which has a port for inserting a surgical instrument, as being pivotable between a position which is colinear with a distal channel and a position which is not colinear with a distal channel, as is taught by Widenhouse, into the medical device having a working channel port in which a medical instrument can be inserted, as is taught by Shelton, to produce the predictable result of providing an ease of manipulation of a surgical instrument within a device for inserting a surgical instrument within a body of a patient during a surgical procedure, as is taught by Widenhouse, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 19, Shelton teaches the delivery device of claim 18, wherein the delivery device comprises a flexible bronchoscope or flexible endoscope ([0015] teaches the medical device as being any type of endoscope, such as a bronchoscope).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 20190090727 A1) in view of Widenhouse (US 20100081880 A1) and Dimmer (US 20120310233 A1).
Regarding claim 20, Shelton as modified teaches the delivery device of claim 18.
Shelton further teaches the insertion port being configured to be coupled to a catheter assembly ([0036] teaches a medical instrument being inserted into the working channel by the working channel port and [0021] teaches the medical instrument as including a catheter).
However, Shelton is silent on the catheter assembly comprising:
an elongate shaft having a proximal end and a distal end; and
an ablation assembly coupled to the distal end of the elongate shaft, the ablation assembly being configured to be positioned through the working channel and within the airway to deliver energy to the target tissue, the ablation assembly including –
an expandable member movable between a retracted configuration and an expanded configuration, and
an energy emitter coupled to the expandable member, wherein energy emitter is configured to be positioned proximate the target tissue when the expandable member is in the expanded position.
Dimmer teaches a system and method for treating tissue, such as the tissue of a patient’s airway, using a treatment system which is inserted by an access apparatus, such as an endoscope or bronchoscope (Abstract, [0089], [0124]).
Dimmer further teaches the treatment system as including a catheter system having a catheter and an ablation assembly, the ablation assembly is taught as being located at the distal end of said catheter ([0089], [0112]), as being configured to be positioned through the access apparatus to be positioned at the tissue to be treated ([0089]), as being configured to be expandable between an expanded state and a collapsed state ([0112]) and being configured to hold an electrode assembly proximate the tissue through which energy is delivered ([0112]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of a catheter assembly which is delivered to patient tissue by an endoscope, such as a bronchoscope, for treating patient tissue, such as the tissue within an airway, as having an expandable balloon and electrodes, as is taught by Dimmer, into the catheter which is delivered by a bronchoscope for treating patient tissue, as is taught by Shelton, to produce the predictable result of treating patient tissue using a known catheter which is configured to be delivered by a bronchoscope, as is taught by Dimmer, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Drontle in view of Patel and Piskun reference are moot in view of the new rejections under Shelton and Widenhouse.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY REGAN LANCASTER whose telephone number is (571)272-7259. The examiner can normally be reached Monday-Thursday 8-4 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, Joseph Stoklosa can be reached on 571-272-1213. 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.
/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights