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 Amendment
The amendment filed January 23rd 2026 has been entered. Claims 1-2, 4-5, 7-11, 13-17, and 19-24 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed September 5th 2025.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
Regarding claim 1, “proximal end of catheter” should be corrected to “proximal end of the catheter” for claim language consistency
Regarding claim 8, “an axial” should be corrected to “the axial” for claim language consistency.
Appropriate correction is required.
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.
Claims 15-17 and 19-20 are 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.
Claims 15 and 17 recites the limitation "the catheter main body" in the last paragraph of claim 15 and second to last paragraph of claim 17. There is insufficient antecedent basis for this limitation in the claim. The Examiner believes this may be a typographical error and that the limitation was intended to recite “the tubular sheath”. For purposes of examination, the limitation will be interpreted as reciting “the tubular sheath”.
Claim 20 is dependent on cancelled claim 18. For purposes of examination, claim 20 will be interpreted as dependent on claim 17.
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.
Claim(s) 1-2, 4-5, 7-11, 13-17, 19, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wada (WO 2018043427 A1), (US 20190192826 A1) used for reference citations, in view of Kennedy (US 20060211952 A1), and further in view of in view of Wada (US 20160375222 A1), hereinafter Wada ‘222.
Regarding claims 1 and 7, Wada discloses a medical elongated body (sheath 300, [0110] & Fig. 8) comprising: a catheter main body configured to be percutaneously inserted into a living body lumen (catheter body 310, [011] & Fig. 8); a hub connected to a proximal portion of the catheter main body (hub 120, [0111] & Fig. 8); the catheter main body including a first region and a second region, the second region being located on a proximal side of the first region (first region B1 and second region B2, [0111] & Fig, 8); the first region having a first hydrophilic coating having lubricity (region B1 including hydrophilic lubricating layer 170, [0042] & Fig. 8); the second region including a first groove portion extending from a distal side of the catheter main body toward a proximal end of catheter main body (groove portion Sg provided in region B2 is being interpreted as a first groove portion, which is seen extending longitudinally – from a distal side of body 310 toward a proximal end of body 310, [0116] & Fig. 8-9); and the first groove portion containing a drug (groove portion Sg including a drug part 360, which includes a hemostatic agent, [0111] & Fig. 8-9).
However, Wada fails to explicitly disclose the first groove portion extending spirally and a second groove portion extending spirally from the proximal end of the catheter main body toward the distal side of the catheter main body, and wherein the first groove portion and the second groove portion in the second region are not continuous in an axial direction of the catheter main body; and the first groove portion having a second hydrophilic coating containing a drug.
However, embodiment 100 of Wada teaches the first groove portion having a second hydrophilic coating containing a drug (drug part 160 having a drug carrier carrying the hemostatic agent, the carrier being gelatin which is hydrophilic, [0086]-[0087]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment 300 of Wada with embodiment 100 of Wada to include the first groove portion having a second hydrophilic coating containing a drug since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Further, Kennedy teaches a medical elongated body (elongated shaft 110, abstract and [0051] & Fig. 3A-4B) wherein the groove portion extends spirally from the distal side of the catheter main body toward the proximal side of the catheter main body (valleys 161 extending inwardly from the outer circumference 122 from first end portion 114 to second end portion 116 may be spirally or helically wound, [0054] and [0057] & Fig. 3A-4B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first groove portion of Wada with Kennedy to include the first groove portion extending spirally from the distal side of the catheter main body toward the proximal side of the catheter main body since such a modification would increase the surface area of the groove portion to enhance hydrophilic properties and therapeutic agent delivery and yield predictable results pertaining to enhanced drug delivery (see abstract, [0037], [0051], and [0057] of Kennedy).
Further, Wada ‘222 teaches a second groove portion (flexible portion 30 including at least one groove 32, [0032] and [0036] & Fig. 2; L1 may be 5-50 mm and L2 may be 5-50 mm) extending spirally from the proximal end of the catheter main body toward the distal side of the catheter main body (groove 32 being a helical groove 33 extending from a proximal end of main catheter body 12 (right of portion 17) toward a distal side of body 12 (left of portion 17), [0034] and [0036] & Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the medical elongated body of Wada with Wada ‘222 to include a second groove extending spirally from the proximal end of the catheter main body toward the distal side of the catheter main body, since such a modification would increase kink resistance in sections of the medical tube prone to kinking and yield predictable results pertaining to increased tube flexibility (see [0005], [0007], and [0044]-[0045] of Wada ‘222).
As modified, both sections of flexible portion 30 of Wada ’222 could be included proximally and distally of distal portion 332 of strain relief 330 of Wada, like sections defined by L1 and L2 of portion 30 of Wada ‘222. Distance L32 of Wada is disclosed as being 0-10 mm (see [0118] & Fig. 9). Section L1 of portion 30 of Wada ‘222, as included in the modification, could extend 5-9 mm and distance L32 of Wada could extend 10 mm. In this possible combination, which would have been obvious to one of ordinary skill in the art, the first groove portion (portion Sg of Wada) and the second groove portion (flexible portion 30 of Wada ‘222) would not be continuous in an axial direction of the catheter body 310.
Regarding claims 2 and 21-22, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body wherein the catheter main body includes a marker portion indicating a boundary portion between the first region and the second region (marker 318 indicating a portion between region B1 and B2, [0122] & Fig. 9; marker 318 visually indicating the distal portion 360a of drug part 360), wherein
the marker portion is provided on an outer surface on the distal side relative to a distal end of the second hydrophilic coating (marker 318 is provided on an outer surface of catheter body 310 distally relative to distal portion 360a of drug part 360, [0122] & Fig. 9), and
wherein the marker portion is covered with the first hydrophilic coating (marker 318 seen covered with hydrophilic lubricating layer 170, see Fig. 9).
Regarding claim 4, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body further comprising: a strain relief portion covering a distal end of the hub (strain relief 330 covering distal portion 121 of hub 120, [0111] & Fig. 8); and wherein the first groove portion is located on a distal side relative to a distal end of the strain relief portion (groove portion Sg located on a distal side relative to distal portion 332 of strain relief 330, [0111] & Fig. 9), the first groove portion provided with the second hydrophilic coating (groove portion Sg provided with drug part 160/360, [0111] & Fig. 9), and wherein the second groove portion is not provided with the second hydrophilic coating (flexible portion 30 of Wada ‘222, as modified onto catheter body 310, is not provided with a hydrophilic coating – intended to aid in flexibility, [0032] of Wada ‘222).
Regarding claim 5, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body further comprising: a strain relief portion covering a distal end of the hub (strain relief 330 covering distal portion 121 of hub 120, [0111] & Fig. 8); and wherein the first groove portion is formed from a distal side relative to a distal end of the strain relief portion toward a proximal side relative to the distal end of the strain relief portion (groove portion Sg is formed from a distal side relative to the distal end of strain relief 330, distal portion 360a, toward a proximal side relative to the distal end of strain relief 330, the proximal end of width L1, [0118] and [0122] & Fig. 8-9).
Regarding claim 8, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body wherein a length of the second region in an axial direction is shorter than a length of the first region in the axial direction (second region B2 is shorter than first region B1, see [0111] & Fig. 8).
Regarding claim 9, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body wherein the length of the second region is at least 20 mm (L1 can be 5mm to 30mm, [0083] & Fig. 4 and 8; the distance of L1 explained with regard to embodiment 100; however, Wada discloses that like components are denoted by the same numeral, [0112]).
Regarding claim 10, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body wherein the first and second groove portions are recessed from an outer surface of the catheter main body toward a central axis of a lumen of the catheter main body (groove portion Sg has a recessed depth H from an outer surface of body 310 toward a central axis of 116, [0116]-[0117] & Fig. 8-9; helical groove 33 of Wada ‘222, as modified onto catheter body 310, is recessed from an outer surface of body 12 of Wada ‘222, [0032]-[0033] & Fig. 2 of Wada ‘222, and would remain recessed as combined).
Regarding claim 11, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body wherein the first and second groove portions have a cross-sectional U-shape (as modified by Kennedy, groove portion Sg has a cross-sectional U-shape, see Fig. 4A-4B of Kennedy; helical groove 33 of Wada ‘222, as modified onto catheter body 310, has a cross-sectional U-shape, see Fig. 2 of Wada ‘222).
Regarding claim 13, Wada, as modified, discloses all the limitations of claim 1. Wada, as modified, further discloses the medical elongated body wherein the second hydrophilic coating is a layer (groove portion Sg including a drug part 360, which includes a hemostatic agent, [0111] & Fig. 8-9; as modified, the drug part has a drug carrier carrying the hemostatic agent, the carrier being gelatin, see [0086]-[0087]), and wherein the layer is configured to retain the drug (the drug carrier is disclosed as a biodegradable material that softens at a body temperature, which allows for the drug to be placed more reliably, [0086]; the drug carrier is being interpreted as configured to retain the drug).
However, Wada fails to explicitly disclose the medical elongated body wherein second hydrophilic coating is a hydrogel layer having a water swelling property, and wherein the hydrogel layer is configured to immobilize or retain the at least one of metal ions and the drug.
However, Kennedy teaches a medical elongated body (elongated shaft 110, abstract and [0051] & Fig. 3A and 3B) wherein second hydrophilic coating is a hydrogel layer having a water swelling property (coating 54 including a hydrophilic material that includes a hydrogel; [0050] & Fig. 2B; upon the application of water, the polymer swells), and wherein the hydrogel layer is configured to retain the drug (coating 54 comprises a therapeutic agent, [0046]; coating 54 is being interpreted as retaining and/or immobilizing the therapeutic agent, [0046] and [0048]-[0050]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the second hydrophilic coating of Wada with Kennedy to include a hydrogel layer having a water swelling property, wherein the hydrogel layer is configured to immobilize or retain the drug, since such a modification would provide structure capable of supporting a tensile stress of between 40,000-60,000 dynes/cm^2 and capable of maintaining stability in vivo and yield predictable results pertaining to drug delivery ([0048] and [0050] of Kennedy).
Regarding claim 14, Wada, as modified, discloses all the limitations of claim 1. Wada further discloses the medical elongated body wherein a proximal end of the first hydrophilic coating of the first region and a distal end of the second hydrophilic coating in the first groove portion of the second region overlap each other in an axial direction of the catheter main body (a part of layer 170 covers the distal portion of drug part 160/360 in an axial direction of body 310, as seen in Figs. 8-9 and explained with regard to embodiment 100 – which illustrates a synonymous relationship, see [0084] & Fig. 4; Wada discloses that like components are denoted by the same numeral, [0112]).
Regarding claim 15, Wada discloses an introducer sheath (sheath 300, [0110] & Fig. 8) comprising: a tubular sheath (catheter body 310, [011] & Fig. 8), the tubular sheath including a first region and a second region, the second region being located on a proximal side of the first region (first region B1 and second region B2, [0111] & Fig. 8); a hub connected to a proximal portion of the tubular sheath (hub 120, [0111] & Fig. 8); the first region including a first hydrophilic coating (region B1 including hydrophilic lubricating layer 170, [0042] & Fig. 8), and the second region including a groove portion extending from a distal side of the tubular sheath toward a proximal side of the tubular sheath (groove portion Sg provided in region B2, [0116] & Fig. 8-9), the groove portion containing a drug (groove portion Sg including a drug part 360, which includes a hemostatic agent, [0111] & Fig. 8-9);
a marker portion indicating a boundary portion between the first region and the second region on the tubular sheath (marker 318 indicating a portion between region B1 and B2, [0122] & Fig. 9; marker 318 visually indicating the distal portion 360a of drug part 360); a strain relief portion covering a distal end of the hub (strain relief 330 covering distal portion 121 of hub 120, [0111] & Fig. 8); and wherein the groove portion includes a first groove portion located on a distal side relative to a distal end of the strain relief portion (groove portion Sg, which is being interpreted as a first groove portion, located on a distal side relative to distal portion 332 of strain relief 330, [0111] & Fig. 9), the first groove portion provided with the second hydrophilic coating (groove portion Sg provided with drug part 360, [0111] & Fig. 9).
However, Wada fails to explicitly disclose the groove portion including a second hydrophilic coating containing at least one of metal ions and a drug, wherein the first groove portion extends spirally, and a second groove portion extending spirally from a proximal portion of the catheter main body and located on a proximal side of the distal end of the strain relief portion.
However, embodiment 100 of Wada teaches the groove portion including a second hydrophilic coating containing a drug (drug part 160 having a drug carrier carrying the hemostatic agent, the carrier being gelatin which is hydrophilic, [0086]-[0087]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment 300 of Wada with embodiment 100 of Wada to include the groove portion including a second hydrophilic coating containing a drug since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Further, Kennedy teaches a medical elongated body (elongated shaft 110, abstract and [0051] & Fig. 3A-4B) wherein the groove portion extends spirally (valleys 161 extending inwardly from the outer circumference 122 from first end portion 114 to second end portion 116 may be spirally or helically wound, [0054] and [0057] & Fig. 3A-4B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first groove portion of Wada with Kennedy to include the first groove portion extending spirally since such a modification would increase the surface area of the groove portion to enhance hydrophilic properties and therapeutic agent delivery and yield predictable results pertaining to enhanced drug delivery (see abstract, [0037], [0051], and [0057] of Kennedy).
Further, Wada ’222 teaches a second groove portion (flexible portion 30 including at least one groove 32, [0032] and [0036] & Fig. 2; L1 may be 5-50 mm and L2 may be 5-50 mm) extending spirally from a proximal portion of the catheter main body and located on a proximal side of the distal end of the strain relief portion (portion 30 at distance L2 located on a proximal side of the distal portion 17 of strain relief member 16, [0036] & Fig. 2; groove 32 being a helical groove 33 extending from a proximal end of main catheter body 12 (right of portion 17), [0034] and [0036] & Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the medical elongated body of Wada with Wada ‘222 to include a second groove portion extending spirally from a proximal portion of the catheter main body and located on a proximal side of the distal end of the strain relief portion since such a modification would increase kink resistance in sections of the medical tube prone to kinking and yield predictable results pertaining to increased tube flexibility (see [0005], [0007], and [0044]-[0045] of Wada ‘222).
As modified, both sections of flexible portion 30 of Wada ’222 could be included proximally and distally of distal portion 332 of strain relief 330 of Wada, like sections defined by L1 and L2 of portion 30 of Wada ‘222. Distance L32 of Wada is disclosed as being 0-10 mm (see [0118] & Fig. 9). Section L1 of portion 30 of Wada ‘222, as included in the modification, could extend 5-9 mm and distance L32 of Wada could extend 10 mm. In this possible combination, which would have been obvious to one of ordinary skill in the art, the first groove portion (portion Sg of Wada) and the second groove portion (flexible portion 30 of Wada ‘222) would not be continuous in an axial direction of the catheter body 310.
Regarding claim 16, Wada, as modified, discloses all the limitations of claim 15. Wada further discloses the introducer sheath wherein a proximal end of the first hydrophilic coating and a distal end of the second hydrophilic coating in the first groove portion overlap each other (a part of layer 170 covers the distal portion of drug part 160/360, as seen in Figs. 8-9 and explained with regard to embodiment 100 – which illustrates a synonymous relationship, see [0084] & Fig. 4; Wada discloses that like components are denoted by the same numeral, [0112]).
Regarding claim 17, Wada discloses a method of indwelling an introducer sheath into a body lumen (method of using assembly 20 includes placing sheath 300 into wound site P through lumen R, [0090] & [0126] & Figs. 5 and 6; the Examiner notes that the step of introducing drug part 360 into wound site P is the same as the step of introducing drug part 160 according to the first embodiment 100, except for the exposure of drug part 360, see [0127]), the method comprising: inserting the introducer sheath into the body lumen through a puncture site (placing sheath 100/300 into lumen R through site P, [0090] and [0126] & Figs. 5), the puncture site extending from a limb of a patient to a blood vessel wall (wound site P extending from tissue W to lumen R, see [0086], [0090], and [0126] & Figs. 5 and 6), the introducer sheath including a tubular sheath (catheter body 310, [011] & Fig. 8), a hub connected to a proximal portion of the tubular sheath (hub 120, [0111] & Fig. 8), and
a strain relief portion (strain relief 330 covering distal portion 121 of hub 120, [0111] & Fig. 8), the tubular sheath including a first region and a second region, the second region being located on a proximal side of the first region (first region B1 and second region B2, [0111] & Fig. 8), the first region having a first hydrophilic coating having lubricity (region B1 including hydrophilic lubricating layer 170, [0042] & Fig. 8), the second region including a groove portion extending from a distal side of the tubular sheath toward the proximal side of the tubular sheath (groove portion Sg provided in region B2, [0116] & Fig. 8-9), and
the groove portion containing a drug (groove portion Sg including a drug part 360, which includes a hemostatic agent, [0111] & Fig. 8-9), wherein the groove portion includes a first groove portion located on a distal side relative to a distal end of the strain relief portion (groove portion Sg, which is being interpreted as a first groove portion, is located on a distal side relative to distal portion 332 of strain relief 330, [0111] & Fig. 9), and wherein the drug is released from the first groove portion toward a periphery of the tubular sheath (hemostatic agent in drug apart 360 released from groove portion Sg toward the outer surface 117 of catheter body 310, [0111], [0115], [0117] & Fig. 6A and 9; portion Sg being recessed into outer surface 117 of body 310); and
positioning the second region over a length extending from the puncture site in the limb of the patient to the puncture site formed in the blood vessel wall (sheath 100/300 placed in lumen R with the drug part 160, synonymous to region B2 of sheath 300 with drug part 360, positioned over a length extending from wound site P to lumen R, [0091]-[0096] & Fig. 6A and 6B) to release the drug to the puncture site in the limb of patient and the blood vessel wall (cover 380 is removed exposing drug part 360, [0128]; the exposed drug part 360 being in contact with wound site P and lumen R, [0091]-[0096] & Fig. 6A and 6B).
However, Wada fails to explicitly disclose the groove portion having a second hydrophilic coating containing a drug, a first groove portion extending spirally,
the first groove portion provided with the second hydrophilic coating,
and a second groove portion extending spirally from a proximal portion of the catheter main body and located proximally of the distal end of the strain relief portion.
However, embodiment 100 of Wada teaches the groove portion having a second hydrophilic coating containing a drug (drug part 160 having a drug carrier carrying the hemostatic agent, the carrier being gelatin which is hydrophilic, [0086]-[0087]; the drug carrier is disclosed as a biodegradable material that softens at a body temperature, which allows for the drug to be placed more reliably, [0086]; the drug carrier is being interpreted as configured to retain the drug).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment 300 of Wada with embodiment 100 of Wada to include the groove portion having a second hydrophilic coating containing a drug since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. As modified, groove portion Sg, which is being interpreted as the first groove portion, containing drug part 360 would be provided with the second hydrophilic coating.
Further, Kennedy teaches a medical elongated body (elongated shaft 110, abstract and [0051] & Fig. 3A-4B) wherein the first groove portion extends spirally (valleys 161 extending inwardly from the outer circumference 122 from first end portion 114 to second end portion 116 may be spirally or helically wound, [0054] and [0057] & Fig. 3A-4B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first groove portion of Wada with Kennedy to include the first groove portion extending spirally since such a modification would increase the surface area of the groove portion to enhance hydrophilic properties and therapeutic agent delivery and yield predictable results pertaining to enhanced drug delivery (see abstract, [0037], [0051], and [0057] of Kennedy).
Further, Wada ‘222 teaches a second groove portion (flexible portion 30 including at least one groove 32, [0032] and [0036] & Fig. 2; L1 may be 5-50 mm and L2 may be 5-50 mm) extending spirally from a proximal portion of the catheter main body (groove 32 being a helical groove 33 extending from a proximal end of main catheter body 12 (right of portion 17), [0034] and [0036] & Fig. 2) and located proximally of the distal end of the strain relief portion (portion 30 at distance L2 located on a proximal side relative to the distal portion 17 of strain relief member 16, [0036] & Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the medical elongated body of Wada with Wada ‘222 to include a second groove portion extending spirally from a proximal portion of the catheter main body and located proximally of the distal end of the strain relief portion since such a modification would increase kink resistance in sections of the medical tube prone to kinking and yield predictable results pertaining to increased tube flexibility (see [0005], [0007], and [0044]-[0045] of Wada ‘222).
As modified, both sections of flexible portion 30 of Wada ’222 could be included proximally and distally of distal portion 332 of strain relief 330 of Wada, like sections defined by L1 and L2 of portion 30 of Wada ‘222. Distance L32 of Wada is disclosed as being 0-10 mm (see [0118] & Fig. 9). Section L1 of portion 30 of Wada ‘222, as included in the modification, could extend 5-9 mm and distance L32 of Wada could extend 10 mm. In this possible combination, which would have been obvious to one of ordinary skill in the art, the first groove portion (portion Sg of Wada) and the second groove portion (flexible portion 30 of Wada ‘222) would not be continuous in an axial direction of the catheter body 310.
Regarding claim 19, Wada, as modified, discloses all the limitations of claim 17. Wada, as modified, further discloses the method wherein the first groove portion and the second groove portion are not continuous in the axial direction of the tubular sheath (as modified in claim 17, the first groove portion (portion Sg of Wada) and the second groove portion (flexible portion 30 of Wada ‘222) would not be continuous in an axial direction of the catheter body 310) such that blood moving along the first groove portion does not reach the second groove portion (since the two groove portions are not continuous, blood, or any fluid, moving along portion Sg of Wada would not reach flexible portion 30 of Wada ‘222, see Figs. 5 and 6A-6B of Wada and Fig. 2 of Wada ‘222).
Regarding claims 23-24, Wada, as modified, discloses all the limitations of claim 15. Wada further discloses the introducer sheath wherein the marker portion is provided on an outer surface on the distal side relative to a distal end of the second hydrophilic coating (marker 318 is provided on an outer surface of catheter body 310 distally relative to distal portion 360a of drug part 360, [0122] & Fig. 9), and wherein the marker portion is covered with the first hydrophilic coating (marker 318 seen covered with hydrophilic lubricating layer 170, see Fig. 9).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wada (WO 2018043427 A1), (US 20190192826 A1) used for reference citations, in view of Kennedy (US 20060211952 A1), and further in view of in view of Wada (US 20160375222 A1), hereinafter Wada ‘222, and further in view of Sotak (US 20170042519 A1).
Regarding claim 20, Wada, as modified, discloses all the limitations of claim 17, as understood in light of the 112(b) rejection above. Wada, as modified, further discloses the method wherein the drug released from the first groove portion act on the puncture site in the limb of patient and the blood vessel wall to contribute to activation of blood coagulation factors (drug part 360 including a hemostatic agent released form groove portion Sg acts on wound site P and lumen R to promote hemostasis, [0016]-[0018] & Fig. 6A; hemostasis inherently contributing to the activation of blood coagulation factors).
However, Wada fails to explicitly disclose the method wherein the metal ions released from the first groove portion act on the puncture site in the limb of patient and the blood vessel wall to contribute to one or more of angiogenesis, collagen production, activation of blood coagulation factors, an antibacterial action, and prevention of infection diseases.
However, Sotak teaches a coating including a hemostatic composition. The composition containing metal ions, such as calcium and magnesium, which are suitable clotting agents present in effective amounts of hemostatic compositions (see [0211]). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the hemostatic agent of Wada, as modified, with Sotak to include metal ions in the drug part to be released from the first groove portion since such a modification would aid in stimulating or facilitating hemostasis and yield predictable results pertaining to imparting desired treatment effects, such as reducing the rate of blood flow loss (see [0211] of Sotak).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights