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 .
Response to Arguments
The amendments to claims 1, 6, 13-14, 22, and 24 are acknowledged and the previous claim objections are withdrawn.
Applicant’s arguments filed 06/18/2026 with respect to the amendment to claim(s) 1 and 14 further defining the conveying coil previously introduced in claim 23 have been considered but are moot because the new ground of rejection does not rely on the Bonnette reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Upon further consideration, a new ground(s) of rejection is made over Zeroni in view of Chatzizisis for the rejection of claim 1 and Zeroni in view of Chatzizisis and Kucklick for the rejection of claim 14.
Claim Objections
Claims 16 and 17 are objected to because of the following informalities:
Claim 16 (line 6) and claim 17 (line 12): “the inner layer” should recite “the tubular inner layer”.
Claim Rejections - 35 USC § 112
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.
Claim 24 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.
Claim 24 recites the limitation “the through-hole” in 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the through-hole” is interpreted as “the at least one through hole”.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 13, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis].
Regarding claim 1, Zeroni discloses a medical device 2 configured to remove an object in a body lumen (Fig. 1, para. 0030), the medical device comprising:
A rotatable drive shaft 6 (Figs. 2-3, para. 0030);
a cutting portion 7 fixed to a distal portion of the drive shaft 6 (Figs. 2-3, para. 0041) and configured to cut the object in the body lumen (para. 0030, 0041);
an outer tubular shaft 3 configured to rotatably accommodate the drive shaft 6 (Figs. 2-3, para. 0030, 0032);
the outer tubular shaft 3 including a tubular shapeable distal portion (see annotated Fig. 1 below, para. 0028, 0030: “the outer cutter drive shaft 3 may be comprised of a high modulus material or composite with flexibility and torquability e.g. a NiTi tube, stainless steel coil, or other composite layered polymer or metal material.”) and a tubular proximal portion (see annotated Fig. 1 below, para. 0030), the tubular proximal portion being proximal of the shapeable tubular distal portion (see annotated Fig. 1 below, para. 0030),
a handle (not shown but houses cutter drivers 10, 11; Fig. 1, para. 0034);
a second lumen 12 between the outer tubular shaft 3 and the drive shaft 6 extending to at least a distal end of the shapeable tubular distal portion of the outer tubular shaft 3 (Fig. 2, para. 0033), and the outer tubular shaft 3 is configured to be rotatable with respect to the handle (para. 0032, 0034),
wherein the drive shaft 6 includes a conveying coil 38 (Fig. 9, para. 0043: “Inner cutter drive shaft 6 has been formed with a left handed helical winding 38 that is continuous for at least a portion or all of the drive shaft as desired”), which comprises a winding with spacing between windings arranged on an outer peripheral surface of the drive shaft 6 (see Fig. 9), the conveying coil 38 configured to convey a liquid or object in a proximal direction or distal direction upon rotation of the drive shaft 6 (para. 0043: “As the inner cutter drive shaft 6 rotates in a counter-clockwise direction the helical winding 38 rotates, and cut material collected through bore flutes 31 and cutter element flutes 23 at the distal end of the catheter 2 is directed towards proximal opening 9”).
Zeroni further discloses in para. 0033 that “Catheter 2 may be provided with proximal opening 9 with tubing attached thereto to facilitate suction of cut debris or injection of fluid (including medications) through the annular space between the outer cutter drive shaft 3 and the inner cutter drive shaft 6”. Therefore, the catheter of Zeroni is provided with a single central lumen to either facilitate suction or irrigation.
However, Zeroni fails to disclose another lumen i.e. a first lumen such that the tubular proximal portion includes a tubular inner layer and a tubular outer layer, the tubular outer layer being fixed to the tubular inner layer and surrounding the tubular inner layer to define the first lumen between the tubular outer layer and the tubular inner layer extending to the shapeable tubular distal portion, wherein the tubular outer layer has at least one through-hole penetrating between an inner peripheral surface of the tubular outer layer.
Chatzizisis in the same field of endeavor of intravascular devices (para. 0002) teaches that it is known in the art for an intravascular catheter 102 to comprise comprises a tubular shaft 102 including a tubular distal portion 103 and a tubular proximal portion (interpreted as portion comprising lumen 106) (see annotated Fig. 2B below, para. 0030), the tubular proximal portion including a tubular inner layer 105 and a tubular outer layer (interpreted as outer wall of shaft 102), the tubular outer layer being fixed to the tubular inner layer and surrounding the tubular inner layer (Figs. 2A-B, para. 0025); and
a first lumen 106 between the tubular outer layer 102 and the tubular inner layer 105 extending to the tubular distal portion (Fig. 2B, para. 0027), wherein the tubular outer layer 102 has at least one through-hole 110 penetrating between an inner peripheral surface of the tubular outer layer 102 and an outer peripheral surface of the tubular outer layer 102 (Figs. 2A-B, para. 0028) for the purpose of providing the catheter with two separate lumens for two different utilities i.e. one for irrigation and the other for guidewire accommodation (see Fig. 2B, para. 0025, 0030).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular proximal portion of the outer tubular shaft in Zeroni to include the first lumen formed by the porous tubular outer layer and tubular inner layer as taught by Chatzizisis in order to increase the utility of the device by providing the device of Zeroni with one lumen for irrigation to deliver medications to a target site and another lumen for suctioning of debris, as desired by Zeroni (para. 0033 of Zeroni).
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Annotated Fig. 1 of Zeroni
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Annotated Fig. 2B of Chatzizsis
Regarding claim 13, modified Zeroni discloses wherein the shapeable tubular distal portion of the outer tubular shaft 3 includes at least one a bent portion, the at least one bent portion configured to shift an axial center of a proximal portion of the shapeable distal portion form an axial center of a distal portion of the shapeable tubular distal portion (see annotated Figs. 1 [A] and 1 [B] of Zeroni below).
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Annotated Fig. 1 [A] of Zeroni
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Annotated Fig. 1 [B] of Zeroni
Regarding claim 21, modified Zeroni discloses wherein the outer tubular shaft 3 further includes a distal bearing portion (interpreted as the cutting portion 4 of outer tubular shaft 3 comprising ledge 25 which functions as a bearing surface, Figs. 3-4, para. 0037) arranged distal of the shapeable tubular distal portion (see annotated Fig. 3 of Zeroni below) and configured to support the rotatable drive shaft 6 (Figs. 3-4, 8, para. 0037, 0041 of Zeroni)
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Annotated Fig. 3 of Zeroni
Regarding claim 22, modified Zeroni discloses wherein the at least one through-hole 110 in the tubular outer layer is located in a distal portion of the first lumen 106 (Fig. 2B, para. 0028 of Chatzizisis).
Regarding claim 23, modified Zeroni discloses wherein the conveying coil 38 is located in the same area as the distal portion of the first lumen (para. 0043 of Zeroni: “Inner cutter drive shaft 6 has been formed with a left handed helical winding 38 that is continuous for at least a portion or all of the drive shaft as desired”). Since the conveying coil may be located along the entire length of the drive shaft, at least a portion of the conveying coil would be located in the same area as the distal portion of the first lumen.
Regarding claim 24, modified Zeroni discloses wherein the drive shaft 6 includes a conveying portion (interpreted as a portion of the drive shaft comprising the conveying coil 38; Fig. 9, para. 0043 of Zeroni: “Inner cutter drive shaft 6 has been formed with a left handed helical winding 38 that is continuous for at least a portion or all of the drive shaft as desired”), and the through-hole (interpreted as the at least one through-hole 110 of Chatzizisis, see 112 (b) rejection above) in the tubular outer layer is located proximal to the conveying portion (The examiner notes that since the conveying coil 38 may be located along the entire length of the drive shaft, at least a portion of the conveying coil would be located in an area where the at least one through-hole provided in the tubular proximal portion of the outer tubular shaft would be proximal of the conveying portion of the drive shaft).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis] as applied to claim 1 above, and further in view of Nakano et al. (WO 2019188918; provided in IDS filed 08/23/2022, English Translation attached) [hereinafter Nakano].
Regarding claim 2, modified Zeroni discloses all of the limitations set forth above in claim 1. However, modified Zeroni fails to disclose wherein the handle includes a housing configured to rotatably accommodate the outer tubular shaft, the housing includes a first liquid delivering port configured to supply a delivered liquid, and a first liquid delivering lumen in communication with the first liquid delivering port and the first lumen; and at least one first seal portion is provided between an outer peripheral surface of the outer tubular shaft and an inner peripheral surface of the first liquid delivering lumen.
Nakano in the same field of endeavor teaches a medical device 10 used for cutting an object (Fig. 1, page 2, fourth paragraph) comprising an outer tubular shaft 30 comprising a first lumen 31 (Fig. 3, page 3, fourth paragraph), a handle 60 comprising a housing 61 (Fig. 2, page 4, seventh and eighth full paragraphs), wherein the housing includes a first liquid port 65 (interpreted as suction port 65 since the port delivers liquids proximally to a suction source) configured to supply a liquid (page 6, second to fourth full paragraphs) , and a first liquid lumen 94 in communication with the first liquid port 65 and the first lumen 31 (Figs. 2-3, page 6, second to fourth full paragraphs); and at least one first seal portion 92 is provided between an outer peripheral surface of the outer tubular shaft 30 and an inner peripheral surface of the first liquid lumen 94 (Fig. 2, page 6, fifth full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the first liquid delivering port, and the first liquid delivering lumen of Nakano since the combination would have yielded nothing more than predictable results, namely a way to deliver fluid to the first lumen (second to fourth full paragraphs of Nakano; see note below); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the at least one seal portion of Nakano in order to prevent external fluid form flowing into the housing during irrigation (page 6, fifth full paragraph of Nakano, see note below).
Note: The combination of modified Zeroni and Nakano would result in a product comprising “a first liquid delivering port configured to supply a delivered liquid, and a first liquid delivering lumen in communication with the first liquid delivering port and the first lumen; and at least one first seal portion is provided between an outer peripheral surface of the outer tubular shaft and an inner peripheral surface of the first liquid delivering lumen” since Chatzizisis is used to teach a first lumen for irrigation/delivering fluids to a target site (Fig. 2B, para. 0028 of Chatzizisis).
Therefore, the inclusion of the structure of Nakano would result in the first liquid delivering lumen 94 of Nakano in communication with the first liquid delivering port 65 of Nakano and the first lumen of Chatzizisis (Figs. 2-3, page 6, second to fourth full paragraphs of Nakano; Fig. 2B, para. 0028 of Chatzizisis); and the at least one first seal portion 92 of Nakano is provided between an outer peripheral surface of the outer tubular shaft of Chatzizisis and an inner peripheral surface of the first liquid delivering lumen 94 of Nakano (Fig. 2, page 6, fifth full paragraph of Nakano; Fig. 2B, para. 0028 of Chatzizisis).
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Annotated Fig. 2 of Nakano
Claim(s) 3, 5, 7-9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis], and Nakano et al. (WO 2019188918) [hereinafter Nakano] as applied to claim 2 above, and further in view of Shadeck (US 20090228030).
Regarding claim 5, modified Zeroni discloses all the limitations set forth above in claim 2.
Modified Zeroni further discloses wherein the housing 61 includes the first liquid delivering port 65 in communication with the first liquid delivering lumen 94 (Fig. 2, page 4, seventh and eighth full paragraphs, page 6, second to fourth full paragraphs), the first seal portion 92 is disposed on a distal side of the first liquid delivering port 65 (see annotated Fig. 2 of Nakano above).
However, modified Zeroni fails to disclose a discharge lumen in communication with the second lumen, and a discharge port in communication with the discharge lumen; the discharge lumen is disposed on a proximal side of the first liquid delivering lumen; and at least one second seal portion is provided on the proximal side of the first liquid delivering port and between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen.
Nakano further teaches a second liquid lumen 104 in communication with the second lumen 21 (Fig. 2, page 6, eighth full paragraph), and a second liquid port 64 (interpreted as liquid supply port 64 since the port discharges or releases liquid to the treatment site; Fig. 2, page 6, first full paragraph), in communication with the second liquid lumen 104 (Fig. 2, page 6, eighth full paragraph); the second liquid lumen 104 is disposed on a proximal side of the first liquid delivering lumen 94 (see Fig. 2); and at least one second seal portion 102 is provided on a proximal side of the first liquid delivering port 65 at a proximal portion of a drive shaft 20 (see Fig. 2, page 7, first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the second liquid port, and the second liquid lumen of Nakano since the combination would have yielded nothing more than predictable results, namely a way to discharge fluid from the second lumen (second to fourth full paragraphs of Nakano; see note below); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the at least one second seal portion of Nakano in order to prevent external fluid form flowing into the housing during suction (page 6, fifth full paragraph of Nakano; see note below).
Note: The combination of modified Zeroni and Nakano would result in a product comprising “a discharge lumen in communication with the second lumen, and a discharge port in communication with the discharge lumen; the discharge lumen is disposed on a proximal side of the first liquid delivering lumen; and at least one second seal portion is provided on a proximal side of the first liquid delivering port and between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen” since Zeroni discloses the second lumen 12 is for aspiration/suctioning of fluids from a target site (Figs. 2-3, para. 0033 of Zeroni). Therefore, the inclusion of the structure of Nakano would result in the discharge lumen 104 of Nakano in communication with the discharge port 64 of Nakano and the second lumen of Zeroni (Figs. 2-3, page 6, first and eighth full paragraphs of Nakano; Figs. 2-3, para. 0033 of Zeroni); and the at least one second seal portion 102 of Nakano is provided on a proximal side of the first liquid delivering port 65 and the proximal portion of the drive shaft 6 of Zeroni (Fig. 2, page 6, fifth full paragraph of Nakano; Figs. 2-3, para. 0030, 0032 of Zeroni).
However, modified Zeroni fails to disclose that the at least one second seal portion is provided
between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen.
Shadeck in the same field of endeavor teaches at least one first seal portion (interpreted as one of seals 130, see annotated Fig. 5 below) is provided between an outer peripheral surface of an outer tubular shaft 52 and an inner peripheral surface of a first liquid delivering lumen 110 (see annotated Fig. 5 below, para. 0051-0052), the first seal portion 130 is disposed on a distal side of the first liquid delivering port 134 (see annotated Fig. 5 below, para. 0051), and at least one second seal portion (interpreted as another one of seals 130, see annotated Fig. 5 below) is provided on a proximal side of the first liquid delivering port 134 and between the outer peripheral surface of the outer tubular shaft 52 and the inner peripheral surface of the first liquid delivering lumen 110 (see annotated Fig. 5 below, para. 0051-0052).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include an additional seal portion on the proximal side of the first liquid delivering port and between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen, as taught by Shadeck (Fig. 5, para. 0051-0052 of Shadeck), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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Annotated Fig. 5 of Shadeck
Regarding claims 3 and 7, modified Zeroni discloses all of the limitations set forth above in claims 2 and 5. However, modified Zeroni fails to disclose a first stopper protruding from the outer peripheral surface of the outer tubular shaft or the inner peripheral surface of the first liquid delivering lumen, and wherein the first stopper is contactable with the first seal portion and a second stopper protruding from the outer peripheral surface of the outer tubular shaft or an inner peripheral surface of the housing is formed, and wherein the second stopper is contactable with the second seal portion.
Shadeck further discloses a first stopper (see annotated Fig. 5 of Shaddock above) protruding from an outer peripheral surface of an outer tubular shaft 52, and wherein the first stopper is contactable with the first seal portion (see annotated Fig. 5 above, para. 0045, 0051-0052) and a second stopper (see annotated Fig. 5 of Shaddock above) protruding from an outer peripheral surface of an outer tubular shaft 52, and wherein the second stopper is contactable with the second seal portion (see annotated Fig. 5 above, para. 0045, 0051-0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the grooved structure comprising the first and second stoppers of Shadeck since the combination would have yielded nothing more than predictable results, namely a way to retain and space apart the first and second seal portions such as an o-ring within the housing (Fig. 5, para. 0044-0045 of Shadeck); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 8, modified Zeroni discloses all of the limitations set forth above in claim 5. Modified Zeroni further discloses an outer cutter driver 10 (Fig. 1, para. 0032) to power and rotate the outer tubular shaft (Fig. 1, para. 0032). However, modified Zeroni fails to disclose wherein the outer tubular shaft includes a restraining portion having a surface facing a distal side of the medical device; and the handle includes a restraining receiving portion having a surface facing a proximal side of the medical device, opposed to the restraining portion, and slidable with respect to the restraining portion.
Nakano further discloses wherein an outer tubular shaft 30 includes a restraining portion (interpreted as proximal end of operation unit 70) having a surface facing a distal side of a medical device 10 (see Figs. 1, 2 and annotated Fig. 2 [a] below, page 3, fourth paragraph); and a handle 60 (Fig. 2, page 4, seventh and eighth full paragraphs) includes a restraining receiving portion 67 having a surface facing a proximal side of the medical device (see annotated Fig. 2 [a] below), opposed to the restraining portion (see annotated Fig. 2 [a] below), and slidable with respect to the restraining portion (Fig. 2, page 4, eighth full paragraph) for the purpose of applying rotatable torque to the outer tubular shaft (page 3, fourth paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer tubular shaft and handle in modified Zeroni to include the operation unit having the restraining portion and the restraining receiving portion, respectively, of Nakano in order to allow a user manual control/rotation of the outer tubular shaft (page 3, fourth paragraph and page 5, second and third paragraphs of Nakano), thereby providing the device with an additional control means other than the automated control provided by the outer cutter driver.
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Annotated Fig. 2 [a] of Nakano
Regarding claim 9, modified Zeroni discloses all of the limitations set forth above in claim 5. Modified Zeroni further discloses an outer cutter driver 10 (Fig. 1, para. 0032) to power and rotate the outer tubular shaft (Fig. 1, para. 0032). However, modified Zeroni fails to disclose wherein the handle includes an operation rotating body fixed to an outer periphery of the outer tubular shaft.
Nakano further discloses wherein the handle 60 (Fig. 2, page 4, seventh and eighth full paragraphs) includes an operation rotating body 70 fixed to an outer periphery of an outer tubular shaft 30 (Fig. 2, page 5, second and third paragraphs) for the purpose of applying rotatable torque to the outer tubular shaft (page 3, fourth paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the handle in modified Zeroni to include the operation unit of Nakano in order to allow a user manual control/rotation of the outer tubular shaft (page 3, fourth paragraph and page 5, second and third paragraphs of Nakano), thereby providing the device with an additional control means other than the automated control provided by the outer cutter driver.
Regarding claim 11, modified Zeroni discloses wherein the first liquid delivering lumen 94 in communication with the discharge lumen 104 (Figs. 2-3, page 6, first, second to fourth, and eighth full paragraphs of Nakano; see note below).
Note: The first liquid delivering lumen 94 is in communication with the discharge lumen 104 by way of their common connection to the handle housing (see Fig. 2 of Nakano). The examiner notes that language such as “in communication with” does not mean “directly” in communication but indicates that two things can be “linked to” each other by way of their common connection to something else.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis], Nakano et al. (WO 2019188918) [hereinafter Nakano], and Shadeck (US 20090228030) as applied to claim 5 above, and further in view of Biel et al. (US 20130310734) [hereinafter Biel].
Regarding claim 6, modified Zeroni discloses all of the limitations set forth above in claim 5. However, modified Zeroni fails to disclose wherein the outer tubular shaft includes a second sealing portion configured to seal the first lumen at a proximal portion of the tubular inner layer.
Biel in the same field of endeavor of multi-functional catheter 100 (Fig. 1, para. 0024) teaches that it is known in the art to construct an outer tubular shaft 26 (Figs. 2, 6, para. 0027 of Biel) with a second sealing portion (interpreted as adhesive) configured to seal a first lumen 68 at a proximal portion of an inner layer 32, 36 (see Fig. 5 which illustrates the proximal portion of the outer tubular shaft (which includes the inner layer) secured to handle 55; para. 0032 and 0034 discloses that the adhesive seals or secures the first lumen 68 to the handle; The examiner notes that in the instant application, “a second sealing portion” is referred to as an adhesive, see para. 0048 of the instant application).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Biel to the outer tubular shaft of modified Zeroni would have yielded predicable results, namely, a way to sufficiently couple the outer tubular shaft to the handle (para. 0032, 0034 of Biel; para. 0032, 0034 of Zeroni); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis], Nakano et al. (WO 2019188918) [hereinafter Nakano], and Shadeck (US 20090228030)] as applied to claim 5 above, and further in view of Rigby et al. (US 5254117) [hereinafter Rigby].
Regarding claim 10, modified Zeroni discloses all of the limitations set forth above in claim 5. However, modified Zeroni fails to disclose wherein the housing includes a second liquid delivering port configured to supply the delivered liquid, and a second liquid delivering lumen communicating the second liquid delivering port with the discharge lumen.
Rigby teaches a multi-functional medical device 10 used for cutting an object in a body lumen (Figs. 1, 6, col. 5 lines 6-21) comprising a handle comprising housing 42 (Fig. 6, col. 5 lines 6-21), wherein the housing includes a second liquid delivering port 39 configured to supply a low velocity stream of delivered liquid (Fig. 6, col. 6 lines 17-28), and a second liquid delivering lumen 45 communicating the second liquid delivering port 39 with a discharge lumen (interpreted as lumen of suction hose 12) (Fig. 6, col. 9 lines 67-68 and col. 19 lines 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the housing in modified Zeroni to include the second liquid delivering port and second liquid delivering lumen communicating with the discharge lumen, as taught by Rigby, in order to allow the user to selectively control the second lumen to deliver low velocity liquid to a target site and to discharge liquid from the target site with aspiration during operation (col. 6 lines 22-28 of Rigbey).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis] and Kucklick et al. (US 20050043682) [hereinafter Kucklick].
Regarding claim 14, Zeroni a medical device 2 configured to remove an object in a body lumen (Fig. 1, para. 0030), the medical device comprising:
A rotatable drive shaft 6 (Figs. 2-3, para. 0030);
a cutting portion 7 fixed to a distal portion of the drive shaft 6 (Figs. 2-3, para. 0041) and configured to cut the object in the body lumen (para. 0030, 0041);
an outer tubular shaft 3 configured to rotatably accommodate the drive shaft 6 (Figs. 2-3, para. 0030, 0032);
the outer tubular shaft including a shapeable tubular distal portion (see annotated Fig. 1 above, para. 0028, 0030: “the outer cutter drive shaft 3 may be comprised of a high modulus material or composite with flexibility and torquability e.g. a NiTi tube, stainless steel coil, or other composite layered polymer or metal material.”) and a tubular proximal portion (see annotated Fig. 1 above para. 0030), the tubular proximal portion being proximal of the shapeable tubular distal portion (see annotated Fig. 1 above, para. 0030),
a handle (not shown but houses cutter drivers 10, 11; Fig. 1, para. 0034);
a second lumen 12 between the outer tubular shaft 3 and the drive shaft 6 extending to at least a distal end of the shapeable tubular distal portion of the outer tubular shaft 3 (Fig. 2, para. 0033), and the outer tubular shaft 3 is configured to be rotatable with respect to the handle (para. 0032, 0034); and
wherein the drive shaft 6 includes a conveying coil 38 (Fig. 9, para. 0043: “Inner cutter drive shaft 6 has been formed with a left handed helical winding 38 that is continuous for at least a portion or all of the drive shaft as desired”), which comprises a wire rod wound around the drive shaft 6 with spacing between windings on an outer peripheral surface of the drive shaft 6 (Fig. 9, para. 0042: “The inner cutter drive shaft may be made of helically wound stainless steel wires that may be left hand or right hand wound and that have welded proximal and distal ends that do not extend past the outside dimension of the wound wires”), the conveying coil 38 configured to convey a liquid or object in a proximal direction or a distal direction upon rotation of the drive shaft 6 (para. 0043: “As the inner cutter drive shaft 6 rotates in a counter-clockwise direction the helical winding 38 rotates, and cut material collected through bore flutes 31 and cutter element flutes 23 at the distal end of the catheter 2 is directed towards proximal opening 9 (from right to left in FIG. 9)”).
Zeroni further discloses that the conveying coil may be located along a portion of the drive shaft or along the entire drive shaft (para. 0043: “Inner cutter drive shaft 6 has been formed with a left handed helical winding 38 that is continuous for at least a portion or all of the drive shaft as desired”). However, Zeroni fails to explicitly disclose that a distal end of the conveying coil 38 is located on a proximal side of the shapable tubular distal portion of the outer tubular shaft.
Since Zeroni expressly states that the conveying coil may either be on a portion of the drive shaft or continuous along the entire of the drive shaft as discussed in para. 0043. There are only a finite number of ways to position the conveying coil on the drive shaft as described in Zeroni above such as positioning the conveying coil on the entire length of the drive shaft, a distal portion of the drive shaft or a proximal portion of the drive shaft such that the distal end of the conveying coil is located on the proximal side of the shapable tubular distal portion of the outer tubular shaft. Each possibility yields the predictable result of drawing clot material proximally within the outer tubular shaft and facilitating destruction of the clot material (para. 0043 of Zeroni: “As the inner cutter drive shaft 6 rotates in a counter-clockwise direction the helical winding 38 rotates, and cut material collected through bore flutes 31 and cutter element flutes 23 at the distal end of the catheter 2 is directed towards proximal opening 9 (from right to left in FIG. 9). Additionally, as both the inner and outer cutter drive shafts rotate in opposite directions, the physical and compressive forces created by the counter-rotation of the helical windings 38 of the inner drive shaft 6 and the shears 28 or helical ribs of the outer drive shaft, break down blood clots that may have formed and larger portions of tissue collected”).
Therefore, it would be obvious to one of ordinary skill to modify the conveying coil in Zeroni to be positioned on the proximal portion of the drive shaft, in order to achieve the predictable result of drawing the clot material proximally within the outer tubular shaft and facilitating destruction of the clot material as the clot material moves towards the proximal end of the device (para. 0043 of Zeroni); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Zeroni further discloses in para. 0033 that “Catheter 2 may be provided with proximal opening 9 with tubing attached thereto to facilitate suction of cut debris or injection of fluid (including medications) through the annular space between the outer cutter drive shaft 3 and the inner cutter drive shaft 6”. Therefore, the catheter of Zeroni is provided with a single central lumen to either facilitate suction or irrigation.
However, Zeroni fails to disclose another lumen i.e. a first lumen such that the tubular proximal portion includes a tubular inner layer and a tubular outer layer, the tubular outer layer being fixed to the tubular inner layer and surrounding the tubular inner layer to define the first lumen between the tubular outer layer and the tubular inner layer extending to the shapeable tubular distal portion, wherein the tubular outer layer has at least one through-hole penetrating between an inner peripheral surface of the tubular outer layer.
Chatzizisis in the same field of endeavor of intravascular devices (para. 0002) teaches that it is known in the art for an intravascular catheter 102 to comprise comprises a tubular shaft 102 including a tubular distal portion 103 and a tubular proximal portion (interpreted as portion comprising lumen 106) (see annotated Fig. 2B above, para. 0030), the tubular proximal portion including a tubular inner layer 105 and a tubular outer layer (interpreted as outer wall of shaft 102), the tubular outer layer being fixed to the tubular inner layer and surrounding the tubular inner layer (Figs. 2A-B, para. 0025); and
a first lumen 106 between the tubular outer layer 102 and the tubular inner layer 105 extending to the tubular distal portion (Fig. 2B, para. 0027), wherein the outer layer 102 has at least one through-hole 110 penetrating between an inner peripheral surface of the outer layer 102 and an outer peripheral surface of the outer layer 102 (Figs. 2A-B, para. 0028) for the purpose of providing the catheter with two separate lumens for two different utilities i.e. one for irrigation and the other for guidewire accommodation (see Fig. 2B, para. 0025, 0030).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular proximal portion of the outer tubular shaft in Zeroni to include the first lumen formed by the porous tubular outer layer and tubular inner layer as taught by Chatzizisis in order to increase the utility of the device by providing the device of Zeroni with one lumen for irrigation to deliver medications to a target site and another lumen for suctioning of debris, as desired by Zeroni (para. 0033 of Zeroni).
However, modified Zeroni fails to disclose wherein the tubular outer layer includes an outer sheath that is attached to the outer peripheral surface of the tubular outer layer, and the tubular outer layer has the at least one through-hole opening penetrating between an inner peripheral surface of the tubular outer layer and an outer peripheral surface of the outer sheath.
Kucklick in the same field of endeavor of fluid delivery devices teaches a shaft 14 comprising an outer layer (interpreted as the wall of the shaft 14) includes an outer sheath (interpreted as the low friction coating described in para. 0044) that is attached to an outer peripheral surface of the outer layer (Figs. 1-2, para. 0026, para. 0044 teaches that the low friction coating such as a Teflon coating may be provided or applied to the outer surface of the cannula), and the outer layer has a through-hole opening 34 penetrating between an inner peripheral surface of the outer layer and an outer peripheral surface of the outer sheath (Fig. 2, para. 0028, 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the outer layer in modified Zeroni to include the low friction coating of Kucklick in order to increase ease of insertion (para. 0044 of Kucklick) and thereby aid in reducing friction between the outer tubular shaft and the introduction sheath of modified Zeroni.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis] and Kucklick et al. (US 20050043682) as applied to claim 14 above, and further in view of Nakano et al. (WO 2019188918; provided in IDS filed 08/23/2022, English Translation attached) [hereinafter Nakano].
Regarding claim 15, modified Zeroni discloses all of the limitations set forth above in claim 14. However, modified Zeroni fails to disclose wherein the handle includes a housing configured to rotatably accommodate the outer tubular shaft, the housing includes a first liquid delivering port configured to supply a delivered liquid, and a first liquid delivering lumen in communication with the first liquid delivering port and the first lumen; and at least one first seal portion is provided between an outer peripheral surface of the outer tubular shaft and an inner peripheral surface of the first liquid delivering lumen.
Nakano in the same field of endeavor teaches a medical device 10 used for cutting an object (Fig. 1, page 2, fourth paragraph) comprising an outer tubular shaft 30 comprising a first lumen 31 (Fig. 3, page 3, fourth paragraph), a handle 60 comprising a housing 61 (Fig. 2, page 4, seventh and eighth full paragraphs), wherein the housing includes a first liquid port 65 (interpreted as suction port 65 since the port delivers liquids proximally to a suction source) configured to supply a liquid (page 6, second to fourth full paragraphs) , and a first liquid lumen 94 in communication with the first liquid port 65 and the first lumen 31 (Figs. 2-3, page 6, second to fourth full paragraphs); and at least one first seal portion 92 is provided between an outer peripheral surface of the outer tubular shaft 30 and an inner peripheral surface of the first liquid lumen 94 (Fig. 2, page 6, fifth full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the first liquid delivering port, and the first liquid delivering lumen of Nakano since the combination would have yielded nothing more than predictable results, namely a way to deliver fluid to the first lumen (second to fourth full paragraphs of Nakano; see note below); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the at least one seal portion of Nakano in order to prevent external fluid form flowing into the housing during irrigation (page 6, fifth full paragraph of Nakano, see note below).
Note: The combination of modified Zeroni and Nakano would result in a product comprising “a first liquid delivering port configured to supply a delivered liquid, and a first liquid delivering lumen in communication with the first liquid delivering port and the first lumen; and at least one first seal portion is provided between an outer peripheral surface of the outer tubular shaft and an inner peripheral surface of the first liquid delivering lumen” since Chatzizisis was used to teach a first lumen for irrigation/delivering fluids to a target site (Fig. 2B, para. 0028 of Chatzizisis). Therefore, the inclusion of the structure of Nakano would result in the first liquid delivering lumen 94 of Nakano in communication with the first liquid delivering port 65 of Nakano and the first lumen of Chatzizisis (Figs. 2-3, page 6, second to fourth full paragraphs of Nakano; Fig. 2B, para. 0028 of Chatzizisis); and the at least one first seal portion 92 of Nakano is provided between an outer peripheral surface of the outer tubular shaft of Chatzizisis and an inner peripheral surface of the first liquid delivering lumen 94 of Nakano (Fig. 2, page 6, fifth full paragraph of Nakano; Fig. 2B, para. 0028 of Chatzizisis).
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Annotated Fig. 2 of Nakano
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zeroni et al. (US 20120109171) [hereinafter Zeroni] in view of Chatzizisis et al. (US 20200179643) [hereinafter Chatzizisis], Kucklick et al. (US 20050043682), and Nakano et al. (WO 2019188918) [hereinafter Nakano] as applied to claim 15 above, and further in view of Shadeck (US 20090228030) and Biel et al. (US 20130310734) [hereinafter Biel].
Regarding claim 16, modified Zeroni discloses all of the limitations set forth above in claim 15. However, modified Zeroni fails to disclose a first seal portion.
Biel in the same field of endeavor of multi-functional catheter 100 (Fig. 1, para. 0024) teaches that it is known in the art to construct an outer tubular shaft 26 (Figs. 2, 6, para. 0027 of Biel) with a first sealing portion (interpreted as an adhesive) configured to seal a first lumen 68 at a distal portion of the inner layer 32,36 (Fig. 6, para. 0032 discloses that tubes 32 and 36 which form an inner layer are adhered together, wherein the adhesive is used to secure the two tubes together to thereby seal the first lumen at a distal portion of the inner layer; The examiner notes that in the instant application, “a first sealing portion” is referred to as an adhesive, see para. 0048 of the instant application) (as required by claim 16).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Biel to the outer tubular shaft of modified Zeroni would have yielded predicable results, namely, a way to sufficiently secure the inner layer to the outer tubular shaft to thereby seal the first lumen (para. 0032 of Biel); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
However, modified Zeroni fails to disclose a first stopper protruding from the outer peripheral surface of the outer tubular shaft or the inner peripheral surface of the first liquid delivering lumen, and wherein the first stopper is contactable with the first seal portion.
Shadeck further discloses a first stopper (see annotated Fig. 5 of Shaddock above) protruding from an outer peripheral surface of an outer tubular shaft 52, and wherein the first stopper is contactable with the first seal portion (see annotated Fig. 5 above, para. 0045, 0051-0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the grooved structure comprising the first and second stoppers of Shadeck since the combination would have yielded nothing more than predictable results, namely a way to retain and space apart the first and second seal portions such as an o-ring within the housing (Fig. 5, para. 0044-0045 of Shadeck); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 17, modified Zeroni discloses all the limitations set forth above in claim 16.
Modified Zeroni further discloses wherein the housing 61 includes the first liquid delivering port 65 in communication with the first liquid delivering lumen 94 (Fig. 2, page 4, seventh and eighth full paragraphs, page 6, second to fourth full paragraphs), the first seal portion 92 is disposed on a distal side of the first liquid delivering port 65 (see annotated Fig. 2 of Nakano above). Modified Zeroni further discloses wherein the outer tubular shaft 26 (Figs. 2, 6, para. 0027 of Biel) includes a second sealing portion (interpreted as adhesive) configured to seal the first lumen 68 at a proximal portion of the inner layer 32, 36 (see Fig. 5 which illustrates the proximal portion of the outer tubular shaft (which includes the inner layer) secured to handle 55; para. 0032 and 0034 discloses that the adhesive seals or secures the first lumen 68 to the handle; The examiner notes that in the instant application, “a second sealing portion” is referred to as an adhesive, see para. 0048 of the instant application).
However, modified Zeroni fails to disclose a discharge lumen in communication with the second lumen, and a discharge port in communication with the discharge lumen; the discharge lumen is disposed on a proximal side of the first liquid delivering lumen; and at least one second seal portion is provided on a proximal side of the first liquid delivering port and between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen.
Nakano further teaches a second liquid lumen 104 in communication with the second lumen 21 (Fig. 2, page 6, eighth full paragraph), and a second liquid port 64 (interpreted as liquid supply port 64 since the port discharges or releases liquid to the treatment site; Fig. 2, page 6, first full paragraph), in communication with the second liquid lumen 104 (Fig. 2, page 6, eighth full paragraph); the second liquid lumen 104 is disposed on a proximal side of the first liquid delivering lumen 94 (see Fig. 2); and at least one second seal portion 102 is provided on a proximal side of the first liquid delivering port 65 at a proximal portion of a drive shaft 20 (see Fig. 2, page 7, first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the second liquid port, and the second liquid lumen of Nakano since the combination would have yielded nothing more than predictable results, namely a way to discharge fluid from the second lumen (second to fourth full paragraphs of Nakano; see note below); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle in modified Zeroni to include the at least one second seal portion of Nakano in order to prevent external fluid form flowing into the housing during suction (page 6, fifth full paragraph of Nakano; see note below).
Note: The combination of modified Zeroni and Nakano would result in a product comprising “a discharge lumen in communication with the second lumen, and a discharge port in communication with the discharge lumen; the discharge lumen is disposed on a proximal side of the first liquid delivering lumen; and at least one second seal portion is provided on a proximal side of the first liquid delivering port and between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen” since Zeroni discloses the second lumen 12 is for aspiration/suctioning of fluids from a target site (Figs. 2-3, para. 0033 of Zeroni). Therefore, the inclusion of the structure of Nakano would result in the discharge lumen 104 of Nakano in communication with the discharge port 64 of Nakano and the second lumen of Zeroni (Figs. 2-3, page 6, first and eighth full paragraphs of Nakano; Figs. 2-3, para. 0033 of Zeroni); and the at least one second seal portion 102 of Nakano is provided on a proximal side of the first liquid delivering port 65 and the proximal portion of the drive shaft 6 of Zeroni (Fig. 2, page 6, fifth full paragraph of Nakano; Figs. 2-3, para. 0030, 0032 of Zeroni).
However, modified Zeroni fails to disclose that the at least one second seal portion is provided
between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen.
Shadeck in the same field of endeavor teaches at least one first seal portion (interpreted as one of seals 130, see annotated Fig. 5 above) is provided between an outer peripheral surface of an outer tubular shaft 52 and an inner peripheral surface of a first liquid delivering lumen 110 (see annotated Fig. 5 above, para. 0051-0052), the first seal portion 130 is disposed on a distal side of the first liquid delivering port 134 (see annotated Fig. 5 above, para. 0051), and at least one second seal portion (interpreted as another one of seals 130, see annotated Fig. 5 above) is provided on a proximal side of the first liquid delivering port 134 and between the outer peripheral surface of the outer tubular shaft 52 and the inner peripheral surface of the first liquid delivering lumen 110 (see annotated Fig. 5 above, para. 0051-0052).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include an additional seal portion on the proximal side of the first liquid delivering port and between the outer peripheral surface of the outer tubular shaft and the inner peripheral surface of the first liquid delivering lumen, as taught by Shadeck (Fig. 5, para. 0051-0052 of Shadeck), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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