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 amendment received 06/23/2026.
Acknowledgement is made to the amendment of claims 1, 4, 9, 11, 13-14, and 18.
Acknowledgement is made to the cancellation of claim 8.
Acknowledgement is made to the withdrawal of claims 6-7, 9-13, and 16.
Acknowledgement is made to the newly added claims 19-21.
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Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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 1-5, 14-15, and 17-21 are pending as rejected below. A complete action on the merits appears below.
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.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clement (US 5797907 A).
Regarding claim 19, Clement teaches a medical device (Fig. 17-18; lavage assembly 810) comprising:
an elongate member (Fig. 17-18; outer cannula 816) defining a lumen, the elongate member including:
a side window (Fig. 17-18; notch 870) at a distal portion of the elongate member; and
a front window at a distal end of the elongate member (Fig. 17; inner cannula 814 is shown as extending distal to outer cannula 816), wherein the front window:
defines an opening at the elongate member distal end (Fig. 17; inner cannula 814 is shown as extending distal to outer cannula 816);
faces forward and away from a proximal end of the elongate member (Fig. 17; inner cannula 814 is shown as extending distal to outer cannula 816); and
is perpendicular to a central axis of the elongate member (Fig. 17; inner cannula 814 is shown as extending distal to outer cannula 816); and
a resection element (Fig. 17-18; inner cannula 814) extending through the elongate member lumen to the elongate member distal end (Col. 14, Lines 57-64), the resection element is being movable within the elongate member lumen (Col. 15, Lines 14-16), the resection element having a side window (Fig. 17-18; notch 868) that is alignable with the elongate member side window (Col. 14, Lines 46-47), the resection element includes a cutting element at the resection element distal end (Col. 15, Lines 43-55).
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 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (US 5797907 A) in view of Magno (US 20190021765 A1).
Regarding claim 1, Clement teaches a medical device (Fig. 17-18; lavage assembly 810) comprising:
an elongate member (Fig. 17-18; outer cannula 816) defining a lumen, the elongate member including:
a side window (Fig. 17-18; notch 870) at a distal portion of the elongate member; and
a front window at a distal end of the elongate member (Fig. 17; inner cannula 814 is shown as extending distal to outer cannula 816), the front window defining an opening at the elongate member distal end (Fig. 17; inner cannula 814 is shown as extending distal to outer cannula 816, providing an opening so as to allow the inner cannula to extend past this point); and
a resection element (Fig. 17-18; inner cannula 814) extending through the elongate member lumen to the elongate member distal end, wherein:
the resection element is movable within the elongate member lumen between a first position in which a surface at a distal end of the resection element is flush within the elongate member distal end and a second position in which the resection element surface is axially movable to protrude from the elongate member front window (Col. 15, Lines 43-55);
the resection element has a side window (Fig. 17-18; notch 868) that at least partially aligns with the elongate member side window when the resection element is in the first position; and
the resection element includes a cutting element at the resection element distal end (Col. 15, Lines 55-65).
However, Clement fails to teach the side window of the resection element as at least partially aligning with the elongate member side window when the resection element is in the position in which the surface of the distal end of the resection element is flush with the elongate member distal end.
Clement does however teach the notches of the inner and outer cannulas as being alignable at a variety of positions, such as a position where the inner cannula distal end is proximal to the outer cannula distal end (Fig. 18) and where the inner cannula distal end is distal to the outer cannula distal end (Fig. 15).
Magno teaches a tissue resection device having reciprocating tubular members having openings which may be aligned (Abstract, [0031]).
Magno further teaches these openings as being aligned when the distal portion of the tubular member which is positioned within the outer tubular member is at an extended position which is aligned with the distal portion of the outer tubular member ([0031], [0034]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position of the concentric tubular members which have openings which are aligned, as is taught by Magno, into the inner and outer cannulas having notches which are able to be aligned at a variety of distal and proximal relative positions as is taught by Clement, to produce the predictable result of providing two openings which may be aligned when the tubular member positioned within the outer tubular member is positioned flush with the outer tubular member, as is taught by Magno, 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 18, the method steps provided are the same as described as the steps the system is configured to perform or within the ordinary use of the device and therefore taught by in the same way as seen in claim 1.
Claims 2-5 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (US 5797907 A) in view of Orczy-Timko (US 20160346036 A1).
Regarding claim 2, Clement teaches the medical device of claim 1.
However, Clement fails to teach the medical device wherein the cutting element is an electrically active electrode and the elongate member defines a return electrode.
Orczy-Timko teaches an elongated shaft assembly including a rotatable inner cutting sleeve and a non-rotating outer sleeve (Abstract). The inner cutting sleeve having an electrode to cut tissue when rotated (Abstract). The electrode being provided to cut certain types of tissue, as an energized electrode is discussed as working better than arthroscopic cutting members when cutting, for example, soft tissue ([0007], [0012]).
Orczy-Timko further teaches the device as having the active electrode for use in an arthroscopic procedure (Fig. 4A; shaft portion 182 of electrode 150) and a metal sleeve portion of the outer sleeve as providing a return electrode for connection to the RF source ([0065]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the distal end of the inner sleeve which cuts tissue as containing an active electrode and the outer sleeve as providing a return electrode for connecting to the RF source, as is taught by Orczy-Timko, into the rotatable tubular members for cutting patient tissue, as is taught by Clement, to produce the predictable result of cutting specific types of tissue, such as soft tissue, as is taught by Orczy-Timko, 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 3, Clement teaches the medical device of claim 2, wherein the resection element defines an opening at the elongate member front window (Col. 15, Line 61- Col. 16, Line 5).
In accordance with the above rejection of claim 2, Orczy-Timko teaches the resection element includes a cross-member that extends across the resection element opening (Fig. 4A; shaft portion 182 of electrode 150).
Regarding claim 4, In accordance with the above rejection of claim 2, Orczy-Timko teaches he medical device of claim 3, wherein a portion of the cross- member forms a portion of the active element ([0063]).
Regarding claim 5, Clement teaches the medical device of claim 2, wherein the resection element is rotatable and slidable within the elongate member lumen (Col. 15, Line 40- Col. 16, Line 5).
Regarding claim 20, Clement teaches the medical device of claim 19.
However, Clement fails to teach the medical device, wherein:
the cutting element is an electrically active electrode and the elongate member defines a return electrode;
the resection element defines an opening at the elongate member front window and the resection element includes a cross-member that extends across the resection element opening; and
a portion of the cross-member forms a portion of the active element.
Orczy-Timko teaches an elongated shaft assembly including a rotatable inner cutting sleeve and a non-rotating outer sleeve (Abstract). The inner cutting sleeve having an electrode to cut tissue when rotated (Abstract). The electrode being provided to cut certain types of tissue, as an energized electrode is discussed as working better than arthroscopic cutting members when cutting, for example, soft tissue ([0007], [0012]).
Orczy-Timko further teaches the device as having the active electrode for use in an arthroscopic procedure (Fig. 4A; shaft portion 182 of electrode 150) and a metal sleeve portion of the outer sleeve as providing a return electrode for connection to the RF source ([0065]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the distal end of the inner sleeve which cuts tissue as containing an active electrode and the outer sleeve as providing a return electrode for connecting to the RF source, as is taught by Orczy-Timko, into the rotatable tubular members for cutting patient tissue, as is taught by Clement, to produce the predictable result of cutting specific types of tissue, such as soft tissue, as is taught by Orczy-Timko, 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 21, Clement teaches the medical device of claim 19, wherein:
the resection element is rotatable and slidable within the elongate member lumen (Col. 15, Line 65- Col. 16, Line 5).
In accordance with the above rejection of claim 20, Orczy-Timko teaches the cutting element being an electrically active electrode and the elongate member defines a return electrode ([0007], [0012], [0065]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Clement (US 5797907 A) in view of Ryan (US 7674263 B2).
Regarding claim 14, Clement teaches the medical device of claim 1.
However, Clement fails to teach the medical device wherein the resection element side window defines an active electrode.
Ryan teaches a surgical instrument comprising a hollow tube, an outer tube and an inner tube is provided, wherein the hollow tube and the inner tube contain cutting windows at a distal end and the hollow tube and the outer tube contain apertures at their distal-most ends (Abstract).
Ryan further teaches the apertures as being provided so as to expose an area so as to treat tissue in an area which is remote from the cutting windows (Col. 5, Line 57- Col. 6, Line 5).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the side window of the inner element as defining an active electrode, as is taught by Ryan, into the device having inner and outer element for cutting tissue as is taught by Clement, to produce the predictable result of having a distal-most portion of the device and a side portion of the device which are separate from one another and both treat tissue, as is taught by Ryan, 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).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Clement (US 5797907 A) in view of Bloom (US 20150173827 A1).
Regarding claim 15, Clement teaches the medical device of claim 1.
However, Clement fails to teach the medical device further comprising an insulator disposed between the elongate member and the resection element, the insulator defining an opening at the front window and a side window that is alignable with the elongate member side window and the resection element side window.
Bloom teaches an electrosurgical device having a tubular outer shaft and a tubular inner shaft (Abstract).
Bloom further teaches the inner and outer shafts as being selectively covered or coated with an insulator, so as to isolate the outer shaft from the inner shaft ([0035]), specifically, the areas surrounding windows of the tubular shafts which function as cutting elements, such as electrodes, are taught as not being covered ([0035], [0042]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the inner and outer shafts having an insulator therebetween and defining an opening at the windows of the shafts, as is taught by Bloom, into the rotating shafts as is taught by Clement, to produce the predictable result of isolating the shafts which rotate and cut tissue as is taught by Bloom, 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).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Clement (US 5797907 A) in view of Truckai (US 20160346037 A1).
Regarding claim 17, Clement teaches the medical device of claim 1.
However, Clement fails to teach the medical device wherein the resection element is extendible distally outward from the front window.
Truckai teaches a tissue resection device having an element for cutting tissue, such as an electrode (Abstract).
Truckai further teaches this electrode as being moveable from a first position in which a distal tip is disposed at a periphery of the opening and a second position in which the distal tip extends distally beyond the opening, as these positions allow the device to be used in separate manners, such as for use in separate types of tissue ([0008]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the element for cutting tissue as being extendable distally, as is taught by Truckai, into the device having a distal element for cutting tissue as is taught by Clement, to produce the predictable result of allowing the device to be used in separate manners, as is taught by Truckai, 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 Magno reference are moot in view of the new rejections under Clement.
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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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
