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.
Response to Amendment
Acknowledgement is made to the claims received 09/11/2025.
Acknowledgement is made to the withdrawal of claims 1-17.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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 as rejected below. 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.
Claim 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US 20110071349 A1), in view of Patel (US 20070288001 A1), and Piskun (US 20100113886 A1).
Regarding claim 18, Drontle teaches a delivery device (Fig. 1-3; endoscope 2) for delivering a tissue treatment assembly into an airway of a patient ([0004], [0007]), the delivery device comprising:
a rigid body (Fig. 1-3; housing 6);
a flexible working shaft (Fig. 1-3; shaft 4) coupled to the body at a first end of the shaft, the shaft being configured to be partially or entirely positioned within the airway ([0007]), the second end of the shaft comprising a working end;
an insertion port (Fig. 1-3; proximal port 14) formed on the rigid body, the port including structure defining a port channel ([0029]- [0030]); and
structure defining a working channel ([0029]- [0030] discusses the shaft 4 as having an interior working lumen 38) extending through the rigid body and the flexible working shaft,
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 ([0029]- [0031]), and
wherein the insertion port is coupled to the rigid body in a position in which the first end of the working channel is colinear with the port channel ([0029]- [0031]).
Drontle further teaches the assembly for treating patient tissue as occurring by expanding the distal portion of the treatment assembly into the patient airway.
However, Drontle fails to teach the assembly for treating patient tissue as being an ablation assembly.
Patel teaches an assembly which is inserted through an endoscope having a distal expandable element for providing treatment to the patient tissue, such as within the airways of a patient ([0024]).
Patel further teaches the distal expandable element as treating tissue by both expanding tissue and providing ablation energy ([0024]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the treatment assembly having an expandable element which is capable of being inserted into the airway of patient tissue as is taught by Drontle, with the ablation assembly having an expandable element capable of providing ablation to patient tissue which is capable of being inserted into the airway of patient tissue, as is taught by Patel, as a simple substitution of one known expandable endoscopic treatment assembly for another to produce the predictable result of treating patient tissue, such as that of the airway.
Drontle further fails to teach the insertion port being coupled as being pivotably coupled so that the insertion port is pivotable between a first insertion position in which the first end of the working channel is collinear with the port channel, and a second position in which the first end of the working channel is not collinear with the port channel.
Piskun teaches a surgical device for inserting instruments into the body of a patient via a cannula (Abstract, [0011]- [0012]).
Piskun further teaches the cannula for inserting instruments as being pivotable so as to alter the position of instruments inserted therethrough ([0040], [0205], [0224]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the port for inserting a catheter into an endoscope for treating patient tissue of Drontle with the pivotable cannula for inserting instruments into a patient during a surgical procedure as is taught by Piskun to produce the predictable result of enabling the movement of the position of instruments inserted therethrough, as is taught by Piskun.
Regarding claim 19, Drontle teaches the delivery device of claim 18, wherein the delivery device comprises a flexible bronchoscope or flexible endoscope (Fig. 1-3; endoscope 2).
Regarding claim 20, Drontle teaches the delivery device of claim 18, wherein the insertion port is configured to be coupled to a catheter assembly ([0029]- [0031]) comprising:
an elongate shaft (Fig. 1-3; elongate member 22) having a proximal end and a distal end; and
a treatment assembly (Fig. 1-3; expandable balloon 24) coupled to the distal end of the elongate shaft, the treatment assembly being configured to be positioned through the working channel and within the airway to deliver treatment to the target tissue, the treatment assembly including –
an expandable member movable between a retracted configuration and an expanded configuration ([0035]).
In accordance with the above rejection of claim 18, Patel teaches the treatment assembly which delivers treatment as being an ablation assembly which delivers energy 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 ([0024]).
Response to Arguments
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive. Applicant’s arguments that incorporating Piskun into the reference of Drontle would not have taught the claim limitation of the insertion port being pivotable is currently unpersuasive as broadly as is currently claimed. Specifically, as Applicant argues that the light input port being adjacent to the proximal port would cause the proximal port to be incapable of being pivotable or movable is currently unpersuasive. First, it is unclear how a first port being positioned adjacent to a second port would make the second port entirely incapable of being pivotable so as to have a proximal end which moves from being colinear with a working channel to not being colinear with a working channel, specifically, as even if that first port were to make the second port incapable of being pivotable to the exact position of the first port, the second port could be pivotable in any other direction in which its position is not being impacted by the first port. Additionally, it should be understood that as there are no limitations to the direction of the pivoting, the degree to which the pivoting occurs, or the manner in which it the port is being pivoted, any amount of pivoting which would occur would teach this claim language as broadly as is currently claimed. Additionally, it should be noted that Piskun teaches there being a plurality of insertion ports which may be pivoted about a traverse axis and/or swiveled about a longitudinal axis of surgical instruments, teaching that multiple ports being positioned adjacent to one another do not necessarily cause the ports to be incapable of pivoting as broadly as is currently claimed ([0144]- [0146]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794