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 03/09/2026.
Acknowledgement is made to the withdrawal of claims 6-7, 9-13, and 16.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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, 8, 14-15 and 17-18 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.
Claims 1 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Magno (US 20190021765 A1).
Regarding claim 1, Magno teaches a medical device (Fig. 1; medical device 10) comprising:
an elongate member (Fig. 5; outer blade 16) defining a lumen, the elongate member including:
a side window (Fig. 5; first window 32) at a distal portion of the elongate member; and
a front window (Fig. 5; second window 34) at a distal end of the elongate member, the front window defining an opening at the elongate member distal end; and
a resection element (Fig. 6; middle blade 16) extending through the elongate member lumen to the elongate member distal end, the resection element being movable within the elongate member lumen ([0033]), the resection element having a side window (Fig. 6; first window 40) that is alignable with the elongate member side window, the resection element includes a cutting element (Fig. 6; second window 42, [0030]- [0031] teach that the edges of the windows may be serrated or contain knife edges suitable for cutting) at the resection element distal end.
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.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Magno (US 20190021765 A1) in view of Orczy-Timko (US 20160346036 A1).
Regarding claim 2, Magno teaches the medical device of claim 1.
However, Magno 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 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 Magno, 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, Magno as modified teaches the medical device of claim 2, wherein the resection element defines an opening at the elongate member front window (Fig. 6; second window 42).
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, Orczy-Timko teaches the medical device of claim 2, wherein a portion of the cross-member forms a portion of the active element ([0063]).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Magno (US 20190021765 A1) in view of Schmitz (US 20080103504 A1).
Regarding claim 5, Magno teaches the medical device of claim 2, wherein the resection element is rotatable within the elongate member lumen ([0029]).
However, Magno as currently modified fails to teach the resection element as being slidable within the elongate member lumen.
Schmitz teaches a tissue removal cannula having a side-opening aperture and a tissue cutter located within the cannula (Abstract).
Schmitz further teaches the cutting member as being moveable in any number of ways which are suitable to cut tissue, such as by sliding, rotating, retracting, advancing, or reciprocated ([0069]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have combined the inner cutting element as being rotatable as is taught by Magno with the tissue cutter which is located within the cannula as being slidable and rotatable as is taught by Schmitz as both being slidable and being rotatable are ways of being moveable and perform the same function of being suitable ways of movement for cutting tissue, as is taught by Schmitz, and it has been held that combining parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 8, in accordance with the above rejection of claim 5, Schmitz further teaches the medical device of claim 1, wherein the resection element is slidable within the elongate member lumen between a first position relative to the elongate member lumen and a second position relative to the elongate member lumen ([0069] discusses the cutting member as being moved along the shaft, therefore teaching the claim limitation as broadly as is currently claimed).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Magno (US 20190021765 A1) in view of Ryan (US 7674263 B2).
Regarding claim 14, Magno teaches the medical device of claim 1.
However, Magno fails to teach the medical device wherein the resection element side window defines the 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 Magno, 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 Magno (US 20190021765 A1) in view of Bloom (US 20150173827 A1).
Regarding claim 15, Magno teaches the medical device of claim 1.
However, Magno 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 Magno, 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 Magno (US 20190021765 A1) in view of Truckai (US 20160346037 A1).
Regarding claim 17, Magno teaches the medical device of claim 1.
However, Magno 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 Magno, 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).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794