DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 (i.e., changing from AIA to pre-AIA ) 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/2025 has been entered.
Response to Arguments
4. Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
5. Regarding amended Claim 1, the limitation “the non-blade member includes a groove configured to penetrate from an inside of the tube to an outside of the tube” was previously recited in Claim 9. This limitation was rejected under U.S.C. 103 as being unpatentable over the combination of Baerveldt, Shah, and Davies. The rejection relies upon Davies to teach “a groove configured to penetrate from an inside of the tube to an outside of the tube”.
6. The applicant argues that Davies fails to teach the above limitation, reasoning that the ‘insulating insert 144’, which the Examiner maps to the groove does not penetrate does not penetrate any structure of the electrosurgical device in Davies. However, the Examiner disagrees.
7. Penetrate is defined as “to pass into or through” by Merriam-Webster (see www.merriam-webster.com/dictionary/penetrate). When looking at Davies, ref num 144 passes through a tube, ref num 102 (when viewing Figs. 5a-5c, ref num 144 is shown to extend through ref num 105 which is part of the tube, ref num 102, as shown in Figs. 1 and 2a). Further, ref num 144 passes through the tube from an inside to a outside, since there is a distal face of ref num 144 that is exposed (see Fig. 5c). There is no language recited in the claim to indicate any axis in which the groove ‘penetrates’ the structures of the tool. Therefore, the rejection is proper and stands.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
10. Claim 22 recites the limitation "the tubular member" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, which Claim 22 depends from, does not recite any tubular member, only a tube (which is also recited later in Claim 22). Proper correction is required.
Claim Rejections - 35 USC § 103
11. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
12. Claims 1-5, 11-13, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt U.S. 2018/0289544 (herein referred to as “Baerveldt”) and in view of Shah U.S. 2016/0338734 (herein referred to as “Shah”), McNall U.S. 2012/0330311 (herein referred to as “McNall”), and Davies U.S. 2016/0374751 (herein referred to as “Davies”).
13. Regarding Claim 1, Baerveldt teaches a treatment tool (Fig. 1), comprising:
a. a tube (Fig. 2, ref num 14) including an opening (Fig. 2, ref num 18) and a tube main body that has a tubular shape (Fig. 2 and 3, ref num 26), the tube being configured to suction a tissue piece through the opening (para 0042); and
b. a scraping member provided on an opening edge of the opening (Fig. 3A, ref num 20; para 0046); and
c. a non-blade member disposed on a distal end of the tube (Fig. 3A, ref num 16).
Baerveldt fails to teach (b) the scraping member being a wire electrode, (c) the non-blade member including a sliding surface, (d) a part of the non-blade member comprises the opening, and (e) the non-blade member includes a groove configured to penetrate from an inside of the tube to an outside of the tube.
Shah teaches a treatment tool of analogous art (Figs. 1 and 7), comprising: a tube (Fig. 1, ref num 30) including an opening (Fig. 2, ref num 22), a blade member (Fig. 7, ref num 26), and a non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”). The non-blade member includes a sliding surface (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”) and a part of the non-blade member comprises the opening (Fig. 6, ref num 24 makes up part of the opening, ref num 22; para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them. Blasting the heel of the bevel (the proximal, inner edge defining the central opening 22) may smooth it”). By having the non-cutting member include a sliding surface and part of it comprising the opening, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
McNall teaches a tool of analogous art (Fig. 1A), wherein the tool comprises a member configured to cut/resect tissue (Fig. 1B, 1C, ref num 130). McNall also teaches that this member may include an electrode assembly, such as a wire electrode (para 0011). The wire electrode improves the cutting performance of the tool since it reduces the surface area where tissue build-up may occur (para 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the scraping member be a wire electrode in order to produce the same expected result of resecting tissue in order to be removed from the target site.
Davies teaches a treatment tool of analogous art (Fig. 1) comprising a tube (Fig. 2a, ref num 102), a blade member (Fig. 2a, ref num 103a), and a non-blade member (Fig. 2a, ref num 105a). The non-blade member includes a groove (Fig. 5b, ref num 144; para 0071, “insert 144 defining at least a portion of the at least one non-cutting portion 105a”) configured to penetrate from an inside of the tube main body to an outside of the tubular main body (Figs. 5a and 5b, ref num 144, in cut away you can see how ref num 144 extends from inside the main body to outside). The groove also extends linearly in a circumferential direction of the tubular main body (Fig. 5b, ref num 144). The groove also defines the fluid lumen (Fig. 5a, ref num 107; para 0074). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the non-blade member include a groove in order to define both the non-blade member and the fluid lumen, as this facilitates the proper flow within the device throughout treatment.
14. Regarding Claim 2, Baerveldt teaches the scraping member is provided on a first part of the opening edge (see Fig. 3A, ref num 20 is on a first part of ref num 18) and is configured to scrape the tissue piece (para 0046).
Baerveldt fails to teach the part of the non-blade member that comprises the opening is provided on at least a second part of the opening edge, the non-blade member configured to allow the tissue piece to slide on the non-blade member, and wherein the second part of the opening edge is outside the first part of the opening edge.
Shah teaches a treatment tool of analogous art (Figs. 1 and 7), comprising: the non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”) that includes a sliding surface (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”), as well as a part of the non-blade member comprises the opening (Fig. 6, ref num 24 makes up part of the opening, ref num 22; para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them. Blasting the heel of the bevel (the proximal, inner edge defining the central opening 22) may smooth it”). The part of the non-blade member that comprises the opening is provided on at least a second part of the opening edge (see Fig. 6, ref num 24 is on a different part of the opening compared to ref num 26), wherein the second part is outside the first part of the opening edge (see Fig. 6, ref num 24 is outside ref num 26). The sliding surface allows the tissue piece to slide (para 0093). By having the non-cutting member include a sliding surface and part of it comprising the opening separate from the part of the scraping member, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
15. Regarding Claim 3, Baerveldt teaches the scraping member has a u-shape that follows a shape of the opening (Fig. 4A and 6A-6D, ref nums 20).
16. Regarding Claim 4, Baerveldt teaches the opening is provided on a distal end of the tube (Fig. 2, ref num 18 is on the distal end of ref num 14), and wherein an imaginary plane containing the opening is inclined from a distal end side toward a proximal end side of the tube (Fig. 4B, reference character “BAX” refers to plane in which opening is inclined from a distal toward a proximal end of ref num 14).
17. Regarding Claim 5, Baerveldt teaches the opening is provided on a distal end of the tube (Fig. 2, ref num 18 is on the distal end of ref num 14), wherein an imaginary plane containing the opening is inclined from a distal end side toward a proximal end side of the tube (Fig. 4B, reference character “BAX” refers to plane in which opening is inclined from a distal toward a proximal end of ref num 14), and wherein the scraping member is provided on a proximal end side of the opening edge (Fig. 3A, ref num 20 is proximal end of ref num 18).
18. Regarding Claim 11, Baerveldt teaches a treatment system (Fig. 1) comprising:
a. a treatment tool configured to be inserted into a subject (Fig. 1, ref num 10, para 0045); and
b. a suction device configured to suction a tissue piece through the treatment tool (Fig. 1, ref nums 32 and 34; para 0042);
c. wherein the treatment tool includes:
c.1 a tube (Fig. 2, ref num 14) including an opening (Fig. 2, ref num 18) and a tube main body that has a tubular shape (Fig. 2 and 3, ref num 26), the tube being configured to suction a tissue piece through the opening (para 0042);
c.2 a scraping member provided on an opening edge of the opening (Fig. 3A, ref num 20; para 0046); and,
c.3 a non-blade member disposed on a distal end of the tube (Fig. 3A, ref num 16).
Baerveldt fails to teach (c.2) the scraping member is a wire electrode; (c.3) the non-blade member including a sliding surface, (d) a part of the non-blade member comprises the opening; and the non-blade member includes a groove configured to penetrate from an inside of the tube to an outside of the tube.
Shah teaches a treatment tool of analogous art (Figs. 1 and 7), comprising: a tube (Fig. 1, ref num 30) including an opening (Fig. 2, ref num 22), a blade member (Fig. 7, ref num 26), and a non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”). The non-blade member includes a sliding surface (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”) and a part of the non-blade member comprises the opening (Fig. 6, ref num 24 makes up part of the opening, ref num 22; para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them. Blasting the heel of the bevel (the proximal, inner edge defining the central opening 22) may smooth it”). By having the non-cutting member include a sliding surface and part of it comprising the opening, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
McNall teaches a tool of analogous art (Fig. 1A), wherein the tool comprises a member configured to cut/resect tissue (Fig. 1B, 1C, ref num 130). McNall also teaches that this member may include an electrode assembly, such as a wire electrode (para 0011). The wire electrode improves the cutting performance of the tool since it reduces the surface area where tissue build-up may occur (para 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the scraping member be a wire electrode in order to produce the same expected result of resecting tissue in order to be removed from the target site.
Davies teaches a treatment tool of analogous art (Fig. 1) comprising a tube (Fig. 2a, ref num 102), a blade member (Fig. 2a, ref num 103a), and a non-blade member (Fig. 2a, ref num 105a). The non-blade member includes a groove (Fig. 5b, ref num 144; para 0071, “insert 144 defining at least a portion of the at least one non-cutting portion 105a”) configured to penetrate from an inside of the tube main body to an outside of the tubular main body (Figs. 5a and 5b, ref num 144, in cut away you can see how ref num 144 extends from inside the main body to outside). The groove also extends linearly in a circumferential direction of the tubular main body (Fig. 5b, ref num 144). The groove also defines the fluid lumen (Fig. 5a, ref num 107; para 0074). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the non-blade member include a groove in order to define both the non-blade member and the fluid lumen, as this facilitates the proper flow within the device throughout treatment.
19. Regarding Claim 12, Baerveldt teaches the scraping member is the scraping member configured to scrape the tissue piece in response to a supplied high frequency power (para 0046).
20. Regarding Claim 13, Baerveldt teaches the scraping member is provided on a first part of the opening edge (see Fig. 3A, ref num 20 is on a first part of ref num 18) and is configured to scrape the tissue piece (para 0046).
Baerveldt fails to teach the part of the non-blade member that comprises the opening is provided on at least a second part of the opening edge, the non-blade member configured to allow the tissue piece to slide on the non-blade member, and wherein the second part of the opening edge is outside the first part of the opening edge.
Shah teaches a treatment tool of analogous art (Figs. 1 and 7), comprising: the non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”) that includes a sliding surface (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”), as well as a part of the non-blade member comprises the opening (Fig. 6, ref num 24 makes up part of the opening, ref num 22; para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them. Blasting the heel of the bevel (the proximal, inner edge defining the central opening 22) may smooth it”). The part of the non-blade member that comprises the opening is provided on at least a second part of the opening edge (see Fig. 6, ref num 24 is on a different part of the opening compared to ref num 26), wherein the second part is outside the first part of the opening edge (see Fig. 6, ref num 24 is outside ref num 26). The sliding surface allows the tissue piece to slide (para 0093). By having the non-cutting member include a sliding surface and part of it comprising the opening separate from the part of the blade member, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
21. Regarding Claim 20, Baerveldt teaches the opening is smaller than the non-blade member (para 0040; see Fig. 4A).
22. Regarding Claim 21, Baerveldt fails to teach the groove extends along a longitudinal axis of the tube.
Davies teaches a treatment tool of analogous art (Fig. 1) comprising a tube (Fig. 2a, ref num 102), a blade member (Fig. 2a, ref num 103a), and a non-blade member (Fig. 2a, ref num 105a). The non-blade member includes a groove (Fig. 5b, ref num 144; para 0071, “insert 144 defining at least a portion of the at least one non-cutting portion 105a”) configured to penetrate from an inside of the tube main body to an outside of the tubular main body (Figs. 5a and 5b, ref num 144, in cut away you can see how ref num 144 extends from inside the main body to outside). The groove also extends along a longitudinal axis of the tubular main body (Fig. 5b, ref num 144). The groove also defines the fluid lumen (Fig. 5a, ref num 107; para 0074). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the non-blade member include a groove in order to define both the non-blade member and the fluid lumen, as this facilitates the proper flow within the device throughout treatment.
23. Regarding Claim 22, Baerveldt teaches the opening is disposed offset to a center of the tube from an edge of a distal face of the tube (see Fig. 2, the opening is offset from a center of ref num 14 compared to an edge of ref num 14).
23. Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt, Shah, McNall, and Davies, and further in view Lee Shee U.S. 2012/0172907 (herein referred to as “Lee Shee”).
24. Regarding Claim 6, Baerveldt teaches wherein a second part of the opening edge forms at least a part of the scraping member (Figs. 2 and 3A, ref num 20 is on a second part of ref num 18).
Baerveldt fails to teach an imaginary plane containing the sliding surface is inclined downward from a distal end side toward a proximal side of the sliding surface; wherein the proximal end side of the sliding surface includes a ridge line that forms a first part of the opening edge.
Shah teaches a treatment tool of analogous art (Figs. 1 and 7), comprising: the non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”) that includes a sliding surface (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”). An imaginary plane contains the sliding surface and is inclined (see Fig. 6, ref num 24 has a plane and is inclined), such that an end side of the sliding surfaces includes a ridge line that forms a first part of the opening edge (see Fig. 6, ref num 24 has a ridge line that forms part of the opening, ref num 22). By having the non-cutting member include a sliding surface and part of it comprising the opening, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
However, Baerveldt modified by Shah fails to teach the imaginary plane is inclined downward from a distal end side toward a proximal end side of the sliding surface, as well as the proximal end side of the sliding surface including the ridge line.
Lee Shee teaches a treatment tool of analogous art (Fig. 1A, 2A, and 2B), wherein the treatment tool comprises a non-blade member with a sliding surface (Fig. 2A, ref num 114 with sliding surface, ref num 200). The sliding surface has an imaginary plane that is inclined downward from a distal end toward a proximal end of the sliding surface (See Fig. 2B, if rotated 180 degrees, the distal end of ref num 200 is inclined downward towards the proximal end). The proximal end of the sliding surface also includes a ridge line that forms a part of the opening edge (see Fig. 2A, ref num 200 ridge forms the opening, ref num 160). This configuration reduces damage to the tissue during advancement to the target site (para 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Baerveldt to have the incline of the sliding surface as well as the ridge line forming the opening, as this reduces damage to the tissue.
25. Regarding Claim 14, Baerveldt teaches wherein a second part of the opening edge forms at least a part of the scraping member (Figs. 2 and 3A, ref num 20 is on a second part of ref num 18).
Baerveldt fails to teach the sliding surface is configured to allow the tissue piece to slide on the sliding surface, an imaginary plane containing the sliding surface is inclined downward from a distal end side toward a proximal side of the sliding surface; wherein the proximal end side of the sliding surface includes a ridge line that forms a first part of the opening edge.
Shah teaches a treatment tool of analogous art (Figs. 1 and 7), comprising: the non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”) that includes a sliding surface configured for tissue to slide on it (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”). Shah also teaches an imaginary plane that contains the sliding surface and is inclined (see Fig. 6, ref num 24 has a plane and is inclined), such that an end side of the sliding surfaces includes a ridge line that forms a first part of the opening edge (see Fig. 6, ref num 24 has a ridge line that forms part of the opening, ref num 22). By having the non-cutting member include a sliding surface and part of it comprising the opening, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
However, Baerveldt modified by Shah fails to teach the imaginary plane is inclined downward from a distal end side toward a proximal end side of the sliding surface, as well as the proximal end side of the sliding surface including the ridge line.
Lee Shee teaches a treatment tool of analogous art (Fig. 1A, 2A, and 2B), wherein the treatment tool comprises a non-blade member with a sliding surface (Fig. 2A, ref num 114 with sliding surface, ref num 200). The sliding surface has an imaginary plane that is inclined downward from a distal end toward a proximal end of the sliding surface (See Fig. 2B, if rotated 180 degrees, the distal end of ref num 200 is inclined downward towards the proximal end). The proximal end of the sliding surface also includes a ridge line that forms a part of the opening edge (see Fig. 2A, ref num 200 ridge forms the opening, ref num 160). This configuration reduces damage to the tissue during advancement to the target site (para 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Baerveldt to have the incline of the sliding surface as well as the ridge line forming the opening, as this reduces damage to the tissue.
26. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt, Shah, McNall, and Davies, and further in view of Woloszko U.S. 11,116,569 (herein referred to as “Woloszko”).
27. Regarding Claim 7, Baerveldt fails to teach the scraping member is an electrode configured to scrape the tissue piece in response to a supplied high frequency power.
Woloszko teaches a treatment tool of analogous art (Figs. 1 and 2) comprising a tube configured to suction a tissue piece (Fig. 3A, ref num 312 with suction lumen, ref num 310; Col. 12, lines 55-56) and a blade member provided on an edge of the opening (Fig. 3A, ref num 300 having a blade portion, ref num 322; Col 12, lines 51-53). The blade member is an electrode configured to scrape the tissue piece in response to a supplied high frequency power (Col. 3, lines 43-46; Col. 4, lines 23-26; Col. 11, lines 8-54). The electrode allows the target tissue to be finely dissect via the energy, such as ablation energy, so that it may be removed from the target location via the suction lumen (col. 9, lines 44-47; Col. 11, lines 16-22). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blade member of Baerveldt to be an electrode supplied with high frequency power in order to finely dissect the tissue for removal.
28. Claims 15-18, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt, and in view of Shah, McNall, Davies, and Trosper U.S. 2019/0142452 (herein referred to as “Trosper”).
29. Regarding Claim 15, Baerveldt teaches a treatment method of collecting a tissue piece (para 0042), comprising:
b. suctioning the tissue piece through an opening included in a treatment tool (Fig. 1 and 2, ref num 18; para 0042);
b. while suctioning the tissue piece, scraping off a part of the tissue piece using a scraping member provided on the opening (Fig. 2, ref num 20; para 0042, 0046);
d. wherein the treatment tool comprises: a non-blade member disposed on a distal end of the tube (Fig. 3A, ref num 16).
Baerveldt discusses suctioning saline that was delivered to the target site (para 0007), but fails to teach.
Baerveldt fails to teach (a) filling a bladder with a physiological saline solution; (b) suctioning the physiological saline solution; (c) the scraping member is a wire electrode, (c) suctioning the part of the tissue piece that was scraped off, (d) the non-blade member including a sliding surface, and (e) a part of the non-blade member comprises the opening.
Trosper teaches a treatment method of analogous art (Fig. 1, para 0049), wherein the method comprises scraping off a part of a tissue piece using a blade member provided on an opening (Fig. 2, ref num 201 = tissue piece, ref num 204 = blade, ref num 203 = suction lumen; para 0051, “substance 201 will be broken apart or fragmented by shearing or other interactions between blade 204”), as well as suctioning the part of the tissue piece that was scraped off (para 0050, “fragments of the target substance 201 are drawn into and through lumen 203 to a proximal region of the catheter”). This process aids in the device ingesting large substances in order to promote the evacuation of such tissue (para 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Baerveldt to suction the part of the tissue that was scraped off in order to remove the tissue from the target spot.
Shah teaches a method of analogous art including a treatment tool (Figs. 1 and 7), comprising: a tube (Fig. 1, ref num 30) including an opening (Fig. 2, ref num 22), a blade member (Fig. 7, ref num 26), and a non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”). The non-blade member includes a sliding surface (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”) and a part of the non-blade member comprises the opening (Fig. 6, ref num 24 makes up part of the opening, ref num 22; para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them. Blasting the heel of the bevel (the proximal, inner edge defining the central opening 22) may smooth it”). By having the non-cutting member include a sliding surface and part of it comprising the opening, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
McNall teaches a tool of analogous art (Fig. 1A), wherein the tool comprises a member configured to cut/resect tissue (Fig. 1B, 1C, ref num 130). McNall also teaches that this member may include an electrode assembly, such as a wire electrode (para 0011). The wire electrode improves the cutting performance of the tool since it reduces the surface area where tissue build-up may occur (para 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the scraping member be a wire electrode in order to produce the same expected result of resecting tissue in order to be removed from the target site.
Davies also discusses suctioning saline that was delivered to the target site (para 0007), but fails to explicitly teach filling a bladder with a physiological saline solution. However, one of ordinary skill would know that collecting the physiological saline solution would require filling the bladder with the solution when it is suctioned from the site.
30. Regarding Claim 16, Baerveldt teaches the method of claim 15, but fails to teach: (a) after suctioning a part of the tissue piece that was scraped off, suctioning to turn the tissue piece; (b) scraping off a second part of the tissue piece using a scraping member; and, (c) suctioning the second part of the tissue piece that was scraped off.
Trosper teaches a treatment method of analogous art (Fig. 1, para 0049), wherein the method comprises scraping off a part of a tissue piece using a blade member provided on an opening (Fig. 2, ref num 201 = tissue piece, ref num 204 = blade, ref num 203 = suction lumen; para 0051, “substance 201 will be broken apart or fragmented by shearing or other interactions between blade 204”), as well as suctioning the part of the tissue piece that was scraped off (para 0050, “fragments of the target substance 201 are drawn into and through lumen 203 to a proximal region of the catheter”). This process includes rotating the tissue piece and repeating the steps of scraping and suctioning (para 0062, 0064). By continuing to breakdown the tissue piece, large tissue pieces are more easily removed from the target location, and the repeated process increases the effectiveness of the removal system (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to repeat the process of scraping and suction the tissue pieces until the fragment is removed from the target location, as this increases the effectiveness of the suctioning system and allows for larger tissue pieces to be removed.
31. Regarding Claim 17, Baerveldt as modified teaches the method of claim 15, as well as teaches the scraping member is configured to scrape the tissue piece in response to a supplied high frequency power (para 0046).
32. Regarding Claim 18, Baerveldt teaches the method of claim 15, as well as the scraping member is provided on a first part of the opening edge (see Fig. 3A, ref num 20 is on a first part of ref num 18) and is configured to scrape the tissue piece (para 0046), wherein the treatment tool further comprises a non-blade member that is provided on at least a second part of the opening edge (Fig. 3A, ref num 16), the non-blade member configured to allow the tissue piece to slide on the non-blade member (para 0045), and wherein the second part of the opening edge is outside the first part of the opening edge (Fig. 4B, ref num 16 is outside of ref num 20).
33. Regarding Claim 23, Baerveldt fails to teach the treatment tool further comprises a lead wire comprising the wire electrode at a distal end of the lead wire, and wherein the non-blade member includes a groove configured to penetrate from an inside of the tube main body to an outside of the tube main body.
McNall teaches a tool of analogous art (Fig. 1A), wherein the tool comprises a member configured to cut/resect tissue (Fig. 1B, 1C, ref num 130). McNall also teaches that this member may include an electrode assembly, such as a lead wire comprising the wire electrode at a distal end of the lead wire (para 0011; see Fig. 3, ref num 306). The wire electrode improves the cutting performance of the tool since it reduces the surface area where tissue build-up may occur (para 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the scraping member be a wire electrode in order to produce the same expected result of resecting tissue in order to be removed from the target site.
Davies teaches a treatment tool of analogous art (Fig. 1) comprising a tube (Fig. 2a, ref num 102), a blade member (Fig. 2a, ref num 103a), and a non-blade member (Fig. 2a, ref num 105a). The non-blade member includes a groove (Fig. 5b, ref num 144; para 0071, “insert 144 defining at least a portion of the at least one non-cutting portion 105a”) configured to penetrate from an inside of the tube main body to an outside of the tubular main body (Figs. 5a and 5b, ref num 144, in cut away you can see how ref num 144 extends from inside the main body to outside). The groove also extends linearly in a circumferential direction of the tubular main body (Fig. 5b, ref num 144). The groove also defines the fluid lumen (Fig. 5a, ref num 107; para 0074). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to have the non-blade member include a groove in order to define both the non-blade member and the fluid lumen, as this facilitates the proper flow within the device throughout treatment.
34. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt, Shah, Trosper, Davies, and McNall, and further in view of Lee Shee.
35. Regarding Claim 19, Baerveldt teaches the method of claim 15, as well as a second part of the opening edge forms at least a part of the scraping member (Figs. 2 and 3A, ref num 20 is on a second part of ref num 18).
Baerveldt fails to teach the sliding surface is configured to allow the tissue piece to slide on the sliding surface, an imaginary plane containing the sliding surface is inclined downward from a distal end side toward a proximal side of the sliding surface; wherein the proximal end side of the sliding surface includes a ridge line that forms a first part of the opening edge.
Shah teaches a method of analogous art comprising a treatment tool (Figs. 1 and 7), comprising: the non-blade member (Fig. 7, ref num 24; para 0091, “the cutting edge 14 is formed only on more distal portions of the secondary bevels 26”; para 0093, “the remainder of the edges of the bevels 24.. may be rounded into smoothed, non-cutting edges”) that includes a sliding surface configured for tissue to slide on it (para 0093, “the heel and other edges of the primary bevel 24 may be blasted with media to smooth them… may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 10 insertion”). An imaginary plane contains the sliding surface and is inclined (see Fig. 6, ref num 24 has a plane and is inclined), such that an end side of the sliding surfaces includes a ridge line that forms a first part of the opening edge (see Fig. 6, ref num 24 has a ridge line that forms part of the opening, ref num 22). By having the non-cutting member include a sliding surface and part of it comprising the opening, this minimizes trauma to the surrounding soft tissue not meant to be cut (para 0064). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baerveldt to include a sliding surface on the non-blade member around the opening, as this minimizes trauma to the non-target tissue.
However, Baerveldt modified by Shah fails to teach the imaginary plane is inclined downward from a distal end side toward a proximal end side of the sliding surface, as well as the proximal end side of the sliding surface including the ridge line.
Lee Shee teaches a treatment tool of analogous art (Fig. 1A, 2A, and 2B), wherein the treatment tool comprises a non-blade member with a sliding surface (Fig. 2A, ref num 114 with sliding surface, ref num 200). The sliding surface has an imaginary plane that is inclined downward from a distal end toward a proximal end of the sliding surface (See Fig. 2B, if rotated 180 degrees, the distal end of ref num 200 is inclined downward towards the proximal end). The proximal end of the sliding surface also includes a ridge line that forms a part of the opening edge (see Fig. 2A, ref num 200 ridge forms the opening, ref num 160). This configuration reduces damage to the tissue during advancement to the target site (para 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Baerveldt to have the incline of the sliding surface as well as the ridge line forming the opening, as this reduces damage to the tissue.
Conclusion
36. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM 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 at 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.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794