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) 15 and 19 is/are objected to due to the following informalities:
In claim 15, line 1, “the outer layer” should be corrected to “the polymeric outer layer” for claim language consistency.
In claim 19, line 3, “distalmost” should be corrected to “distal-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) 8, 16, 17, 18 and 19 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 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 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 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, 10, 12, 14, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1) and further in view of Takeshita et al (EP 2213325 A1), Boston Scientific (“Mustang Balloon Dilation Catheter”) and Brayton et al. (US 4777955 A).
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 that the braided layer is a stainless-steel braided layer and that 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].
Further, Boston Scientific teaches in annotated figure below (push response versus trackability graph from page 2), wherein the push response has a range of 750 to 1050 g/cm.
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Annotated figure of Boston Scientific
Furthermore, Brayton teaches the mapping lead 10 in Fig. 1 is stiff with respect to the placement of a torque on the proximal end 26 of the lead 10. This is important since, by providing a torque transmitting main body portion 12, a physician can rotate the proximal end 26 of the lead 10 to obtain the same amount of rotation of a distal end 42 of the main body portion 12 to which the tip portion 14 is connected [Col. 3, lines 31-38] which is a torque response value of 0 degrees.
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, Boston Scientific and Brayton since such a modification enables the catheter of Brown to negotiate around curves in vessels within which it is received [Brayton, col. 3, lines 29-31].
Regarding claim 2, Brown as modified by Takeshita, Boston Scientific and Brayton 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, Boston Scientific and Brayton disclosed all limitations of claim 2. Brown further discloses wherein the stainless-steel 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, Boston Scientific and Brayton 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, Boston Scientific and Brayton 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 polymeric blend 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 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 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, Boston Scientific and Brayton 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 polymeric blend 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, Boston Scientific and Brayton 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, or 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 catheter 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 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]), the polymeric 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]) but fails to explicitly disclose that the braided layer is a stainless-steel braided layer and that 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].
Further, Boston Scientific teaches in annotated figure above (push response versus trackability graph from page 2), wherein the push response has a range of 750 to 1050 g/cm.
Furthermore, Brayton teaches the mapping lead 10 in Fig. 1 is stiff with respect to the placement of a torque on the proximal end 26 of the lead 10. This is important since, by providing a torque transmitting main body portion 12, a physician can rotate the proximal end 26 of the lead 10 to obtain the same amount of rotation of a distal end 42 of the main body portion 12 to which the tip portion 14 is connected [Col. 3, lines 31-38] which is a torque response value of 0 degrees.
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, Boston Scientific and Brayton since such a modification enables the catheter of Brown to negotiate around curves in vessels within which it is received [Brayton, col. 3, lines 29-31].
Regarding claim 12, Brown as modified by Takeshita, Boston Scientific and Brayton 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, Boston Scientific and Brayton 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, Boston Scientific and Brayton disclosed all limitations of claim 14. However, Brown discloses wherein the outer layer comprises 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), but fails to disclose and wherein: the large support catheter has a polymeric blend outer layer comprising polyether block amide (PEBA) polymers blended in a first ratio; the medium support catheter has a polymeric blend outer layer comprising block amide (PEBA) polymers blended in a second ratio; and the small support catheter has a polymeric blend outer layer comprising block amide (PEBA) polymers blended in a third ratio.
However, it is interpreted from claim 14 that the support catheter of claim 15 only requires one of the large, medium or small catheter.
Regarding claim 16, Brown as modified by Takeshita, Boston Scientific and Brayton 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.
Claim(s) 9 and 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), Boston Scientific (“Mustang Balloon Dilation Catheter”), Brayton et al. (US 4777955 A) and Lim et al. (US 20170072163 A1, herein Lim).
Regarding claim 9, Brown as modified by Takeshita, Boston Scientific and Brayton disclosed all limitations of claim 1. However, Brown as modified by Takeshita, Boston Scientific and Brayton 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 Brown as modified by Takeshita, Boston Scientific and Brayton 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).
Regarding claim 11, Brown as modified by Takeshita, Boston Scientific and Brayton disclosed all limitations of claim 10. However, Brown as modified by Takeshita, Boston Scientific and Brayton 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 Boston Scientific and Brayton 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 [Lim, 0021].
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), Boston Scientific (“Mustang Balloon Dilation Catheter”), Brayton et al. (US 4777955 A), and Tanghoej et al. (EP 2216064 B1, herein Tanghoej).
Regarding claim 13, Brown as modified by Takeshita, Boston Scientific and Brayton disclosed all limitations of claim 10. However, Brown as modified by Takeshita, Boston Scientific and Brayton 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, Boston Scientific and Brayton 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).
Claim(s) 17, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20160114130 A1) and further in view of Boston Scientific (“Mustang Balloon Dilation Catheter”) and Brayton et al. (US 4777955 A).
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 disclose 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.
Further, Boston Scientific teaches in annotated figure below (push response versus trackability graph from page 2), wherein the push response has a range of 750 to 1050 g/cm.
Furthermore, Brayton teaches the mapping lead 10 in Fig. 1 is stiff with respect to the placement of a torque on the proximal end 26 of the lead 10. This is important since, by providing a torque transmitting main body portion 12, a physician can rotate the proximal end 26 of the lead 10 to obtain the same amount of rotation of a distal end 42 of the main body portion 12 to which the tip portion 14 is connected [Col. 3, lines 31-38] which is a torque response value of 0 degrees.
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, Boston Scientific and Brayton since such a modification enables the catheter of Brown to negotiate around curves in vessels within which it is received [Brayton, col. 3, lines 29-31].
Regarding claim 18, Brown as modified by Boston Scientific and Brayton 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 Boston Scientific and Brayton 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]).
Response to Amendment
Applicant has amended claims 3, 5, 6, 8, 14, 16 and 18 which were previously objected to. Examiner accordingly withdraws the objections of claims 3, 5, 6, 8, 14, 16 and 18. Applicant has failed to address the objections of claims 15 and 19 and therefore the objections of claims 15 and 19 are maintained.
Applicant has canceled claims 7 and 20; Examiner accordingly withdraws the 112(b) rejections of claims 7 and 20 which were previously set forth in the previous Non-Final Office Action. Applicant has amended claims 9 and 10 which were previously rejected under 35 U.S.C § 112(b) rejection; Examiner accordingly withdraws the 112(b) rejections of claims 9 and 10 and rejections of claims 11-16 which were dependent on claim 10. Applicant failed to address the U.S.C § 112(b) rejections of claims 8, 16 and 17 and, therefore, the 112(b) rejections of claims 8 and 16-19 are maintained.
Response to Arguments
Applicant’s argument filed on 06/05/2026 have been fully considered but they are not found persuasive.
Applicant has argued in page 8 of the argument that Brown, Takeshita and Chou either separately or in combination fail to disclose the limitation of claim 1 reciting “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, Brown in combination with Takeshita, Boston Scientific and Brayton fully reads on the limitations of claim 1 as per the 103 rejection of claim 1 as set forth above. Furthermore, Applicant argued that claims 2-6 and 8 are patentable however the 103 rejections of claims 2-6 and 8 is maintained by Examiner due to the above reasons.
Applicant has argued in page 10 of the argument that Brown, Takeshita and Chou either separately or in combination fail to disclose the limitation of amended claim 10 reciting “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, Brown in combination with Takeshita, Boston Scientific and Brayton fully reads on the limitations of amended claim 10 as per the 103 rejection of claim 10 as set forth above. Furthermore, Applicant argued that the claims 12-16 is patentable however 103 rejections of claims 12-16 is maintained by Examiner due to the above reasons.
Applicant has argued in page 9 of the argument that Brown, Takeshita and Chou either separately or in combination fail to disclose the limitation of amended claim 17 reciting “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, Brown in combination with Boston Scientific and Brayton fully reads on the limitations of amended claim 17 as per the 103 rejection of claim 17 as set forth above. Furthermore, Applicant argued that the claims 18-19 is patentable however 103 rejections of claims 18 and 19 is maintained by Examiner.
Applicant has argued in pages 10-11 that claim 9 which depend from claim 1 is patentable. However, since 103 rejection of claim 1 is maintained for reasons set forth above, the 103 rejection of claim 9 is also maintained.
Applicant has argued in page 11 that claim 11 which depend from claim 10 is patentable. However, since 103 rejection of claim 10 is maintained for reasons set forth above, the 103 rejection of claim 11 is also maintained.
Applicant has argued in page 11 that claim 13 which depend from claim 10 is patentable. However, since 103 rejection of claim 10 is maintained for reasons set forth above, the 103 rejection of claim 13 is also maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday to Friday 8am - 5pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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