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 .
Claim Objections
Claim(s) 3, 5, 6, 8, 14, 15 and 16 is/are objected to due to the following informalities:
In claim 3, line 1, “the braided layer” should be corrected to “the stainless-steel braided layer” for claim language consistency.
In claim 5, “the outer layer” in lines 2-3 and 5 should be corrected to “the polymeric blend outer layer” for claim language consistency.
In claim 6, line 2, “the outer layer” should be corrected to “the polymeric blend outer layer” for claim language consistency.
In claim 8, lines 3-4, “and a small support catheter” should be corrected to “or a small support catheter” in order to be grammatically correct.
In claim 8, line 5, “the medium support catheters” should be corrected to “the medium support catheter” in order to be grammatically correct.
In claim 14, lines 3-4, “and a small support catheter” should be corrected to “or a small support catheter” in order to be grammatically correct.
In claim 15, line 1, “the outer layer” should be corrected to “the polymeric outer layer” for claim language consistency.
In claim 16, line 2, “medium support catheter and the small support catheter” should be corrected to “medium support catheter or the small support catheter” in order to be grammatically correct.
Claim 18 recites the terms “distalmost” which should be corrected to “distal-most” in order to be grammatically correct.
Claim 19 recites the terms “distalmost” and “proximalmost” which should be corrected to “distal-most” and “proximal-most” in order to be grammatically correct.
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(s) 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 is/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.
Claim 7 contains the trademark/trade names VESTAMID® Care ME71 and VESTAMID® Care ML 18. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polyether block amide (PEBA) polymers and, accordingly, the identification/description is indefinite. Applicant is therefore suggested to amend claim 7 to overcome rejection.
Claim 8, lines 1-4 requires the support catheter to comprise one of a large, medium or small support catheter. However, lines 4-6 recites “the large support catheter is adapted to allow either one of the medium support catheters and the small support catheter to be advanced within the large support catheter”. It is unclear how the large support catheter is adapted to accommodate a medium or small support catheter since claim 8 also requires only one of the three catheters in its configuration. Applicant is therefore suggested to amend claim 8 to overcome rejection.
Claim 9, line 2 recites “a PEBA outer layer”. Claim 9 is dependent on claim 1, and claim 1 recites in lines 9-10 “the polymeric blend outer layer comprising a blend of polyether block amide (PEBA) polymers”. It is unclear if claim 9 is intended to introduce a new material or refer to the material in claim 1. For the sake of examination, “a PEBA outer layer” of claim 9 is being interpreted to refer to the material of claim 1. Applicant is therefore suggested to amend claim 9 to overcome rejection.
Claim 10 line 12 introduces a trademark “VESTAMID® Care” and therefore suffers the same issue as claim 7. Applicant is suggested to amend claim 10 to overcome rejection.
Claim 11-16 is rejected by virtue of their dependency on claim 10.
Claim 15 recites trademark “VESTAMID® Care ME71” and “VESTAMID® Care ML 18” in lines 2, 4, 6 and 8, and therefore suffers the same issue as claim 7. Applicant is suggested to amend claim 15 to overcome rejection.
Claim 16 requires “the large support catheter to be adapted to allow either one of the medium support catheter and the small support catheter” and due to its dependency on claim 14, suffers from the same issue as claim 8. Applicant is therefore suggested to amend claim 16 to overcome rejection.
Claim 17, line 14 recites the term “the distal region” but this term was not previously introduced in claim 17 and therefore there is a lack of antecedent basis for this claim. It is unclear if the Applicant intended for “the distal region” to refer to the “distal end” in line 2, or introduce a new term. If the Applicant intended to introduce a “distal region”, then it is unclear if this region belongs to the shaft or the whole device. Applicant is therefore suggested to amend claim 17 to overcome rejection.
Claim 18-20 is rejected by virtue of their dependency on claim 17.
Claim 20 recites trademark “VESTAMID® Care ME71” and “VESTAMID® Care ML 18” in line 2 and therefore suffers the same issue as claim 7. Applicant is suggested to amend claim 20 to overcome rejection.
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, 3, 4, 5, 6, 8, 17, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1, herein Brown) and further in view of Takeshita et al (EP 2213325 A1, herein Takeshita) and Chou et al. (US 20180207399 A1, herein Chou).
Regarding claim 1, Brown discloses a support catheter (catheter 100 in Fig. 8) comprising:
an elongate shaft (elongated catheter body 112 in Fig. 8) extending from a proximal region (proximal end region 114 in Fig. 8) to a distal region (distal end region 116 in Fig. 8), the elongate shaft comprising:
a polymeric inner layer (inner layer 20 in Fig. 2) extending from the proximal region to the distal region (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]);
a polymeric blend outer layer (outer layer 24 in Fig. 2) partially embedded within the stainless- steel braided layer (reinforcing layer 22 may become embedded and/or at least partially embedded within outer layer 24 [0067]), the polymeric blend outer layer comprising a blend of polyether block amide (PEBA) polymers (Outer layer 24 may include one or more polymers such as polyether block amide, polyurethane, combinations or blends thereof [0064]);
Brown further discloses a braided layer (reinforcing layer or metal braid 22 in Fig. 2) exterior to the polymeric inner layer (metal braid disposed between the outer layer and the inner layer [0006]) and extending from the proximal region to the distal region (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]); but fails to explicitly disclose stainless-steel braided layer; and
wherein the elongate shaft is adapted to provide a pushability value of at least 900 grams per centimeter and a torque response value of less than 300 degrees.
However, Takeshita teaches a reinforcing material layer 36 located between an inner layer 34 and outer layer 35 [0075] and the reinforcing material is composed of stainless steel wires [0092].
Takeshita further teaches the rigidity of the guiding catheter is needed also for enhancement of pushability and torque transmission performance in the distal direction [103]. Takeshita further teaches an angiography catheter having a distal portion had a crushing strength of 935 gf [0161].
Furthermore, Chou teaches the reinforcement structures 650, 652 of the microcatheter 600 can provide a tailored amount of flexibility and torquability to achieve a balance in deliverability and accessibility [0208]. Chou further teaches the distal luminal portion 222 can perform a 180 degree turn [0100].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown to include stainless-steel braided layer and wherein the elongate shaft is adapted to provide a pushability value of at least 900 grams per centimeter and a torque response value of less than 300 degrees as taught by Takeshita and Chou since such a modification may enable the catheter of Brown to have improved performance, flexibility and deliverability. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 2, Brown as modified by Takeshita and Chou disclosed all limitations of claim 1. Brown further discloses further comprising a distal tip (distal tip 134 in Fig. 9, which is a close-up schematic of Fig. 8) forming a butt joint with a distal end of the elongate shaft (the distal tip 134 is secured to the catheter body 112 such that that it abuts and is in contact with a second end 152 of the marker element 130 [0077]).
Regarding claim 3, Brown as modified by Takeshita and Chou disclosed all limitations of claim 2. Brown further discloses wherein the braided layer extends along an entire length of the elongate shaft to the butt joint (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]).
Regarding claim 4, Brown as modified by Takeshita and Chou disclosed all limitations of claim 2. Brown further discloses further comprising:
a first radiopaque marker band located proximal of the butt joint (see annotated Fig. 8 below); and
a polymeric sleeve spanning the butt joint (heat shrink tubing 166 in Fig. 11D);
wherein the polymeric sleeve extends over and surrounds the first radiopaque marker band and the distal tip (heat shrink tubing 166 is provided over the catheter body 112 including the marker element 130 and at least a proximal portion 154 of the distal tip 134 [0080; Fig 11D).
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Annotated Fig. 8 from Brown
Regarding claim 5, Brown as modified by Takeshita and Chou disclosed all limitations of claim 4. Brown further discloses further comprising a second radiopaque marker band proximal of and spaced apart from the first radiopaque marker band (see annotated Fig. 8 above), the outer layer reflowed around the second radiopaque marker band (fillet 40 and 48 in Fig. 4) such that the second radiopaque marker band is embedded into the outer layer (fillet 40 and 48 forms a recess in which marker 30 is located in Fig. 8) with the outer layer in contact with a proximal annular surface and a distal annular surface of the second radiopaque marker band (proximal and distal surfaces of the marker element 30 in contact with ends 42 and 44 [0071]).
Regarding claim 6, Brown as modified by Takeshita and Chou disclosed all limitations of claim 5, Brown further discloses wherein an outer diameter of the second radiopaque marker band is greater than an outer diameter of the outer layer just proximal and distal of the second radiopaque marker band (the outer diameter D1 (see FIG. 5) of the marker element 30 is substantially equal to or slightly greater than the outer diameter D2 of the thin strip of polymeric material 40 and/or 48 [0072]; see Fig. 5).
Regarding claim 8, Brown as modified by Takeshita and Chou disclosed all limitations of claim 1. Brown further discloses wherein the support catheter comprises one of a large support catheter adapted to accommodate a 0.035-inch guidewire, a medium support catheter adapted to accommodate a 0.018-inch guidewire, and a small support catheter adapted to accommodate a 0.014-inch guidewire (liner 20 may be disposed on a mandrel. The mandrel may be a silver coated copper core or other suitable mandrel with an outer diameter in the range of about 0.01 to 0.05 inches [0067]; it can be interpreted that a mandrel of outer diameter 0.05 inches requires the liner 20 to have an inner diameter of 0.05 inches, which can accommodate guidewires of any size up to 0.05 inches), wherein the large support catheter is adapted to allow either one of the medium support catheters and the small support catheter to be advanced within the large support catheter (it can be interpreted from the previous passage of the claim that the claim only requires one of the large, medium or small catheter).
Regarding claim 17, Brown discloses a support catheter (catheter 100 in Fig. 8), the support catheter comprising:
an elongate shaft (elongated catheter body 112 in Fig. 8) extending from a proximal end (proximal end region 114 in Fig. 8) to a distal end distal end region 116 in Fig. 8), the elongate shaft including:
a polymeric inner layer (inner layer 20 in Fig. 2) extending continuously from the proximal end to the distal end (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]);
a braided layer (reinforcing layer or metal braid 22 in Fig. 2) surrounding the polymeric inner layer (metal braid disposed between the outer layer and the inner layer [0006]) and extending continuously from the proximal end to the distal end (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]); and
a polymeric blend outer layer (outer layer 24 in Fig. 2) extending continuously from the proximal end to the distal end (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]), the polymeric blend outer layer surrounding and partially embedded within the braided layer(reinforcing layer 22 may become embedded and/or at least partially embedded within outer layer 24 [0067]), the polymeric blend outer layer comprising a blend of polyether block amide (PEBA) polymers(Outer layer 24 may include one or more polymers such as polyether block amide, polyurethane, combinations or blends thereof [0064]);
a distal tip (distal tip 134 in Fig. 9, which is a close-up schematic of Fig. 8) secured to the distal end of the elongate shaft via a butt joint (the distal tip 134 is secured to the catheter body 112 such that that it abuts and is in contact with a second end 152 of the marker element 130 [0077]); and
a plurality of radiopaque marker bands disposed within the distal region proximal of the butt joint (see annotated Fig. 8 above);
Brown however failed to explicitly disclosed wherein the elongate shaft is adapted to provide a pushability value of at least 900 grams per centimeter and a torque response value of less than 300 degrees.
However, Takeshita teaches the rigidity of the guiding catheter is needed also for enhancement of pushability and torque transmission performance in the distal direction [0103]. Takeshita further teaches an angiography catheter having a distal portion had a crushing strength of 935 gf [0161].
Furthermore, Chou teaches the reinforcement structures 650, 652 of the microcatheter 600 can provide a tailored amount of flexibility and torquability to achieve a balance in deliverability and accessibility [0208]. Chou further teaches the distal luminal portion 222 can perform a 180 degree turn [0100].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown to include wherein the elongate shaft is adapted to provide a pushability value of at least 900 grams per centimeter and a torque response value of less than 300 degrees as taught by Takeshita and Chou since such a modification may enable the catheter of Brown to have improved performance, flexibility and deliverability. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 18, Brown as modified by Takeshita and Chou disclosed all limitations of claim 17. Brown further discloses further comprising a polymeric sleeve spanning the butt joint (heat shrink tubing 166 in Fig. 11D); wherein the polymeric sleeve extends over and surrounds a distalmost one of the plurality of radiopaque marker bands and the distal tip (heat shrink tubing 166 is provided over the catheter body 112 including the marker element 130 and at least a proximal portion 154 of the distal tip 134 [0080; Fig 11D).
Regarding claim 19, Brown as modified by Takeshita and Chou disclosed all limitations of claim 18. Brown further discloses wherein the plurality of radiopaque marker bands includes a proximalmost one of the plurality of radiopaque marker bands located proximal of the distalmost one of the plurality of radiopaque marker bands (see annotated Fig. 8 above), wherein the polymeric blend outer layer is reflowed around the proximalmost one of the plurality of radiopaque marker bands (fillet 40 and 48 in Fig. 4) such that the proximalmost one of the plurality of radiopaque marker bands is embedded into the polymeric blend outer layer (fillet 40 and 48 forms a recess in which marker 30 is located in Fig. 8) with the polymeric blend outer layer in contact with a proximal annular surface and a distal annular surface of the proximal most one of the plurality of radiopaque marker bands (proximal and distal surfaces of the marker element 30 in contact with ends 42 and 44 [0071]).
Claim(s) 7, 10, 12, 14, 15, 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1, herein Brown) and further in view of Takeshita et al. (EP 2213325 A1, herein Takeshita), Chou et al. (US 20180207399 A1, herein Chou) and Vrba et al. (US 20020072705 A1, herein Vrba).
Regarding claim 7, Brown as modified by Takeshita and Chou disclosed all limitations of claim 1. However, Brown as modified by Takeshita and Chou failed to explicitly discloses wherein the polymeric blend outer layer comprises a blend of VESTAMID® Care ME71 and VESTAMID® Care ML 18.
However, Vrba teaches the proximal outer tube may be made of nylon, a polyamide, such as DURETHAN available from Bayer, GRILAMID available from EMS-American Grilon, Inc., a DURETHAN, GRILAMID, CRISTAMID or CRISTAMID/VESTAMID blend braid or polyetheretherketone (PEEK) braid [0037].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown as modified by Takeshita and Chou to include wherein the polymeric blend outer layer comprises a blend of VESTAMID® Care ME71 and VESTAMID® Care ML 18 as taught by Vrba since such a modification may enable the catheter of Brown to have a balance of stiffness and flexibility [0037]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 10, Brown discloses a support catheter (catheter 100 in Fig. 8) adapted for use with a guidewire in order to provide additional support to the guidewire (medical device 100 may comprise an endoscopic device, laproscopic device, embolic protection device, guidewire [0075]), the support catheter comprising:
an elongate shaft (elongated catheter body 112 in Fig. 8) having a proximal end (proximal end region 114 in Fig. 8) and a distal end (distal end region 116 in Fig. 8), the elongate shaft including:
a perfluoro inner layer (inner layer 20 in Fig. 2; Liner 20 may include lubricious material such as polytetrafluoroethylene (PTFE), etched PTFE, fluorinated ethylene propylene (FEP), or the like [0064]) extending continuously from the proximal end to the distal end (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]);
a distal tip (distal tip 134 in Fig. 9, which is a close-up schematic of Fig. 8) joined to the elongate shaft at a butt joint at the distal end of the elongate shaft (the distal tip 134 is secured to the catheter body 112 such that it abuts and is in contact with a second end 152 of the marker element 130 [0077]);
Brown further discloses a braided layer (reinforcing layer or metal braid 22 in Fig. 2) exterior to the perfluoro inner layer (metal braid disposed between the outer layer and the inner layer [0006]) and extending continuously from the proximal end to the distal end (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]);
a polymeric outer layer (outer layer 24 in Fig. 2) extending continuously from the proximal end to the distal end (all of the layers 20, 22, 24 may extend along the full length of elongated catheter body 12 [0064]), the polymeric outer layer surrounding and partially embedded within the braided layer (reinforcing layer 22 may become embedded and/or at least partially embedded within outer layer 24 [0067]), but fails to explicitly disclose stainless-steel braided layer;
the polymeric outer layer comprising a blend of VESTAMID® Care PEBA polymers;
wherein the elongate shaft is adapted to provide a pushability value of at least 900 grams per centimeter and a torque response value of less than 300 degrees.
However, Takeshita teaches a reinforcing material layer 36 located between an inner layer 34 and outer layer 35 [0075] and the reinforcing material is composed of stainless steel wires [0092]
Furthermore, Vrba teaches the proximal outer tube may be made of nylon, a polyamide, such as DURETHAN available from Bayer, GRILAMID available from EMS-American Grilon, Inc., a DURETHAN, GRILAMID, CRISTAMID or CRISTAMID/VESTAMID blend braid or polyetheretherketone (PEEK) braid [0037].
Furthermore, Takeshita teaches the rigidity of the guiding catheter is needed also for enhancement of pushability and torque transmission performance in the distal direction [103]. Takeshita further teaches an angiography catheter having a distal portion had a crushing strength of 935 gf [0161].
Furthermore, Chou teaches the reinforcement structures 650, 652 of the microcatheter 600 can provide a tailored amount of flexibility and torquability to achieve a balance in deliverability and accessibility [0208]. Chou further teaches the distal luminal portion 222 can perform a 180 degree turn [0100].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown to include stainless-steel braided layer; the polymeric outer layer comprising a blend of VESTAMID® Care PEBA polymers; wherein the elongate shaft is adapted to provide a pushability value of at least 900 grams per centimeter and a torque response value of less than 300 degrees as taught by Takeshita, Vrba and Chou since such a modification may enable the catheter of Brown to have improved performance, balance of stiffness and flexibility, and deliverability. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 12, Brown as modified by Takeshita, Vrba and Chou disclosed all limitations of claim 10. Brown further discloses further comprising: a first radiopaque marker band located proximal of the butt joint (see annotated Fig. 8 above); and a polymeric sleeve spanning the butt joint (heat shrink tubing 166 in Fig. 11D); wherein the polymeric sleeve extends over and surrounds the first radiopaque marker band and the distal tip (heat shrink tubing 166 is provided over the catheter body 112 including the marker element 130 and at least a proximal portion 154 of the distal tip 134 [0080; Fig 11D).
Regarding claim 14, Brown as modified by Takeshita, Vrba and Chou disclosed all limitations of claim 10. Brown further discloses wherein the support catheter comprises one of a large support catheter adapted to accommodate a 0.035-inch guidewire, a medium support catheter adapted to accommodate a 0.018-inch guidewire, and a small support catheter adapted to accommodate a 0.014-inch guidewire (liner 20 may be disposed on a mandrel. The mandrel may be a silver coated copper core or other suitable mandrel with an outer diameter in the range of about 0.01 to 0.05 inches [0067]; it can be interpreted that a mandrel of outer diameter 0.05 inches requires the liner 20 to have an inner diameter of 0.05 inches, which can accommodate guidewires of any size up to 0.05 inches).
Regarding claim 15, Brown as modified by Takeshita, Vrba and Chou disclosed all limitations of claim 14. However, Brown failed to explicitly disclose wherein the outer layer comprises a blend of VESTAMID® Care ME71 and VESTAMID® Care ML 18, and wherein: the large support catheter has a polymeric blend outer layer comprising VESTAMID® Care ME71 and VESTAMID® Care ML 18 blended in a first ratio; the medium support catheter has a polymeric blend outer layer comprising VESTAMID® Care ME71 and VESTAMID® Care ML 18 blended in a second ratio; and the small support catheter has a polymeric blend outer layer comprising VESTAMID® Care ME71 and VESTAMID® Care ML 18 blended in a third ratio.
However Vrba teaches the proximal outer tube may be made of nylon, a polyamide, such as DURETHAN available from Bayer, GRILAMID available from EMS-American Grilon, Inc., a DURETHAN, GRILAMID, CRISTAMID or CRISTAMID/VESTAMID blend braid or polyetheretherketone (PEEK) braid [0037]. It can be further interpreted from claim 14 that the support catheter of claim 15 only requires one of the large, medium or small catheter.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown as modified by Takeshita, Vrba and Chou to include wherein the outer layer comprises a blend of VESTAMID® Care ME71 and VESTAMID® Care ML 18, and wherein: the large support catheter has a polymeric blend outer layer comprising VESTAMID® Care ME71 and VESTAMID® Care ML 18 blended in a first ratio; the medium support catheter has a polymeric blend outer layer comprising VESTAMID® Care ME71 and VESTAMID® Care ML 18 blended in a second ratio; and the small support catheter has a polymeric blend outer layer comprising VESTAMID® Care ME71 and VESTAMID® Care ML 18 blended in a third ratio as taught by Vrba since such a modification may enable the need to use VESTAMID blend as required to make the catheter of Brown to achieve improved performance, balance of stiffness and flexibility, and deliverability. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Regarding claim 16, Brown as modified by Takeshita, Vrba and Chou disclosed all limitations of claim 14. It can be further interpreted from claim 14 that the support catheter of claim 16 only requires one of the large, medium or small catheter.
Regarding claim 20, Brown as modified by Takeshita and Chou disclosed all limitations of claim 17. However, Brown as modified by Takeshita and Chou fails to explicitly discloses wherein the polymeric blend outer layer comprises a blend of VESTAMID® Care ME71 and VESTAMID® Care ML 18.
However, Vrba teaches the proximal outer tube may be made of nylon, a polyamide, such as DURETHAN available from Bayer, GRILAMID available from EMS-American Grilon, Inc., a DURETHAN, GRILAMID, CRISTAMID or CRISTAMID/VESTAMID blend braid or polyetheretherketone (PEEK) braid [0037].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the support catheter of Brown as modified by Takeshita and Chou to include wherein the polymeric blend outer layer comprises a blend of VESTAMID® Care ME71 and VESTAMID® Care ML 18 as taught by Vrba since such a modification may enable the catheter of Brown to have improved performance, balance of stiffness and flexibility, and deliverability. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1, herein Brown) and further in view of Takeshita et al (EP 2213325 A1, herein Takeshita), Chou et al. (US 20180207399 A1, herein Chou) and Lim et al. (US 20170072163 A1, herein Lim).
Regarding claim 9, Brown as modified by Takeshita and Chou disclosed all limitations of claim 1. However, Brown as modified by Takeshita and Chou failed to explicitly disclose wherein the polymeric inner layer comprises a bi-layer structure with a perfluoro inner layer and a PEBA outer layer.
However, Lim teaches wherein the polymeric inner layer comprises a bi-layer structure (the inner polymer structure 114 includes a first layer 112 and a second layer 113 surrounding at least a portion of the first layer 112. [0022]) with a perfluoro inner layer and a PEBA outer layer (The first layer 112 can comprise a lubricious polymer such as HDPE or PTFE, for example, or platinum, PEEK, PE, PP, or a copolymer of tetrafluoroethylene, such as FEP, a copolymer of tetrafluoroethylene with perfluoroethers, such as perfluoroalkoxy alkanes (PFA) (more specifically, perfluoropropyl vinyl ether or perfluoromethyl vinyl ether), or the like. The second layer 113 can be made of any of the materials with respect to the inner polymer structure 114 such as, for example, PEBA, PVC, PE, etc. [0022]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Robert as modified by Takeshita and Chou to include wherein the polymeric inner layer comprises a bi-layer structure with a perfluoro inner layer and a PEBA outer layer as taught by Lim, since such a modification would reduce friction or abrasion that maybe caused during sliding of guidewire in the catheter. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1, herein Brown) and further in view of Takeshita et al (EP 2213325 A1, herein Takeshita), Chou et al. (US 20180207399 A1, herein Chou), Vrba et al. (US 20020072705 A1, herein Vrba) and Lim et al. (US 20170072163 A1, herein Lim).
Regarding claim 11, Brown as modified by Takeshita, Vrba and Chou disclosed all limitations of claim 10. However, Brown as modified by Takeshita, Vrba and Chou failed to explicitly disclose further comprising a polymeric tie layer disposed between the perfluoro inner layer and the stainless-steel braided layer.
However, Lim teaches second layer 113 (can be made of any of the materials described above with respect to the inner polymer structure 114 such as, for example, PEBA, PVC, PE, etc [0022]), located between lubricious first layer 112 and inner braid 160.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown as modified by Takeshita and Chou include further comprising a polymeric tie layer disposed between the perfluoro inner layer and the stainless-steel braided layer as taught by Lim, since such a modification may provide added friction between the perfluoro inner layer and braided layer via a second polymeric layer as it may be necessary due to perfluoro or lubricious polymers having low coefficient of friction [0021]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1, herein Brown) and further in view of Takeshita et al (EP 2213325 A1, herein Takeshita), Chou et al. (US 20180207399 A1, herein Chou), Vrba et al. (US 20020072705 A1, herein Vrba), and Tanghoej et al. (EP 2216064 B1, herein Tanghoej).
Regarding claim 13, Brown as modified by Takeshita, Vrba and Chou disclosed all limitations of claim 10. However, Brown as modified by Takeshita and Chou failed to explicitly disclose wherein the support catheter is packaged in a linear orientation in order to avoid providing a curved set to the support catheter.
However, Tanghoej teaches the catheter package 7 is of a general elongate shape with said joint 10 arranged to define said cavity 11 to accommodate the catheter 1 in a substantially linear orientation [claim 11; see also Fig. 1].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Brown as modified by Takeshita and Chou to include wherein the support catheter is packaged in a linear orientation in order to avoid providing a curved set to the support catheter as taught by Tanghoej since such a modification may enable the catheter to prevent deformation. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Conclusion
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783