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 1 is objected to because of the following informalities: lines 5, and 8-9 are repetitive. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 as amended introduces new matter and contains subject matter “wherein the outer layer is at least partially bonded on and/or into the braided skeleton.”. The original disclosure does not have support for this “bonded” limitation. The examiner recommends to use the original term “intercalated”.
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 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.
Claims 1, 6-11, 14, and 16-17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al (US 2002/0156459), in view of Nita et al (US 5951539 A), and further view of Miller et al (U.S. 2002/0198492).
Regarding claims 1 and 14, Ye discloses a microcatheter 10 with a hub 18 (figs 1, 2) comprising
an inner layer 24,
a strike layer (2nd layer 26) and
an outer layer (4th layer 44) and
a skeleton (3rd layer coil 30) located between the inner layer 24 and the outer layer (44),
wherein the inner layer (24) is made of Polytetrafluoroethylene (PTFE) [0020] and has a thickness of 0.0015 inch or less [0021],
wherein the strike layer (26) comprises a polyether block amide [0022], and
wherein a distal portion (49,50,48) of said outer layer (44) is made of a polymer ([0029,0030] with decreasing/differing durometer) having a length,
wherein the distal portion comprises a first distal section 48 and a second distal section 50 having, wherein the first distal section 48 is distal to the second distal section 50, and
wherein the outer layer (44) is at least partially bonded (by heat fusion) on and/or into the braided skeleton [0032]. It is noted that "bonded" is part of a process of making not disclosed in the specification. However, the claim will be considered a product- by-process claim despite so not being disclosed. Only the end product will be given patentable weight. See MPEP 2113.
Ye does not expressly state that hub is a luer lock hub, the strike layer has a thickness of 0.001 inch or less, that the skeleton is a braided skeleton, a distal portion of said outer layer has a length of 175-200 mm, that the distal portion of said outer layer is made of polycarbonate-based thermoplastic polyurethane having a shore of about 80A-90A, and the first distal section having a length of 100-200 mm and the second distal section having a length of 40-80 mm.
Regarding the thickness of the strike layer, the Examiner’s position is that it would have been obvious to one of ordinary skill in the art before the effective fling date of the present invention to have modified the thickness of the strike layer/2nd layer of the device of Ye to have a thickness of 0.001 inch or less since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
The modified device of Ye et al. will hereinafter be referred to as the modified device of Ye et al. The modified device of Ye does not expressly teach that hub is a luer lock hub, the skeleton is a braided skeleton,
a distal portion of said outer layer is made of polycarbonate-based thermoplastic polyurethane having a shore of about 80A-90A and
the distal portion of said outer layer has a length of 175-200 mm were
a first distal section having a length of 100-200 mm and
a second distal section having a length of 40-80 mm.
Nita teaches a catheter (micro-catheters in col 17 lines 9-16) including a luer lock hub (col. 13 lines 54-57),
the catheter having a coiled or braided skeleton 543 or 574 (figs 11-12, 14a; col. 16 lines 30-45, and col. 17 lines 37-41) that can be merely substituted or selected,
the distal portion of said outer layer is made of polycarbonate-based thermoplastic polyurethane (CARBOTHANE; col. 12 line 63 - col 13 line 4);
a distal portion (distal section 102) of said outer layer has a length of 2-30cm (equals to 20-300mm which covers applicants’ range of 100-200mm; col. 10, line 6).
In figure 3D, Nita further discloses a first distal section 246 having a length of 2-20cm (equals 20-200mm) and a second distal section 244 having a length of 5-20cm (equals to 50-200 mm) (see col. 14, lines 37-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified Ye’s hub with the luer lock of Nita since such modification is old and well known in the catheter’s art. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified Ye’s catheter with the Nita’s teachings set forth above since such modifications would have enhanced the catheter characteristics of reinforcement and maneuverability for the intended purpose or procedure as taught old and well known in the catheter’s art.
The modified device of Ye et al in view of Nita et al. will hereinafter be referred to as the modified device of Ye et al. and Nita et al. The modified device of Ye et al. and Nita et al. does not expressly state that the distal portion of said outer layer made of polycarbonate-based thermoplastic polyurethane has a shore about 80A-90A.
Miller et al. teaches a multilayer catheter construction has variable stiffness throughout the catheter, where the distal portion has a low durometer. The catheter can have a distal portion (most distal section 192) of an outer layer (outer covering 184) is made of polycarbonate-based thermoplastic polyurethane (carbothane, [0077]) having a low durometer shore of 30-40A, but not specifically a shore of about 80A-90A). Miller further states in [0078] that other catheter uses will allow other stiffnesses.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the modified device of Ye et al. and Nita et al., so that the distal portion of the outer layer made of polycarbonate-based thermoplastic polyurethane has a shore of less than 90A, since Ye et al. teaches that the outer layer can be made of suitable polymers ([0029] of Ye et al.), and since Miller et al. expressly states that a polycarbonate-based thermoplastic polyurethane has a low durometer shore for outer coverings of catheters [0078] of Miller et al.) to avoid kinking and flexibility. Furthermore, this parameter of catheter stiffness/durometer (shore) is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results, in this particular case to select a shore about 80A-90A since Miller established it can have other stiffness depending on the intended use.
The modified device of Ye et al., Nita et al. and Miller et al. will hereinafter be referred to as Ye/Nita/Miller.
Regarding claim 6, Ye/Nita/Miller teaches the claimed invention as discussed above. Ye et al. further teaches that the durometer of the sections of the outer layer decrease from the proximal end to the distal end of the microcatheter (paragraph 30), but Ye et al. does not expressly state that the first distal section has a shore of 80A or below and the second distal section has a shore of 90A.
However, Miller et al. teaches that the outer layer is formed a number of segments, each having a different shore durometer, wherein a first distal section (most distal section 192) has a shore of 80A or below (most distal section 192 has a shore durometer of between 30-40D (paragraph 78) and 30D is approximately the same as 80A) and the second distal section (next most distal section 190) has a shore of 90A or below (next most distal section 190 has a shore durometer of between 35-45D (paragraph 78) which is less than 90A). Miller further states in [0078] that other catheter uses will allow other stiffnesses.
Therefore, this parameter (shore durometer) is deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Ye et al. expressly teaches that the durometer of the sections of the outer layer decrease from the proximal end to the distal end of the microcatheter ([0030] of Ye et al.) and since Miller et al. teaches that the claimed durometer values are useful in neurovascular microcatheter applications ([0078] of Miller et al.).
Regarding claim 7, Ye/Nita/Miller teaches the claimed invention as discussed above concerning claim 1. Ye further teaches that an intermediary portion (defined by middle section 49 and middles section 50) of said outer layer (4th layer 44) comprises at least a first (middle section 50) and a second (middle section 49) intermediary section, wherein the first intermediary section (middle section 50) is distal to the second intermediary section (middle section 49) (see Fig. 2) and wherein said first intermediary section (middle section 50) has a lower shore than that of the second intermediary section (middle section 49) (Ye further discloses that the durometer of the sections of the outer layer decrease from the proximal end to the distal end of the microcatheter; [0030]).
Regarding claim 8, Ye/Nita/Miller teaches the claimed invention as discussed above concerning claim 7. Ye further discloses that the intermediary portion further comprises a third intermediary section (a distal portion of proximal portion 46), wherein the third intermediary section (a distal portion of proximal portion 46) is proximal to the second intermediary section (middle section 49) and wherein the third intermediary section (a distal portion of proximal portion 46) has a higher shore than the second (middle section 49) and first intermediary (middle section 50) sections (Ye further teaches that the durometer of the sections of the outer layer decrease from the proximal end to the distal end of the microcatheter; [0030]).
Regarding claim 9, Ye/Nita/Miller teaches the claimed invention as discussed above concerning claim 8. Ye further discloses that the first intermediary section (middle section 50) is made of a polyether block amide ([0030]), and Miller et al. further teaches that the that the first intermediary section (next more distal portion 190) has a shore of about 40D [0078].
Ye further discloses that the second intermediary section (middle section 49) is made of a polyether block amide [0030] and Miller et al. further teaches that the second intermediary section (the next more distal portion 188) has a shore of about 55D [0078].
Ye further discloses that the third intermediary section (a distal portion of proximal portion 46) is made of polyether block amide [0030], but Ye does not expressly state that the third intermediary section has a shore of about 60 D). Miller et al. teaches that the third intermediary section (most proximal portion 186) has a shore of about 65D to 78D [0078].
However, none of Ye et al., Nita et al., or Miller et al. expressly state that the shore of the third intermediary section is 60D.
The Examiner is of the position that it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to modify the third intermediary section of the modified device of Ye/Nita/Miller so that the third intermediary section has a shore of about 60D since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (the range being the values that correspond to the claimed “about 60D”) involves only routine skill in the art. MPEP 2144.05(I). Similarly, it would have been an obvious matter of design choice to modify the third intermediary section of Ye/Nita/Miller so that the third intermediary section has a shore of about 60D, since applicant has not disclosed that having the third intermediary section with a shore of about 60D solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the third intermediary section having a shore of about 60D, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 10, Ye/Nita/Miller discloses the claimed invention as discussed above concerning claim 7. But none of Ye et al., Nita et al., or Miller et al. expressly states that the intermediary portion has a length of 400 mm or below. Ye further teaches that the microcatheter has a length (various components of Ye are disclosed as having specific length ranges; paragraph 21-23 and 29 and in order for the device of Ye to be practically useful, it must have an overall useful length).
The Examiner is of the position that it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to modify the length of the intermediary portion of the Ye/Nita/Miller so that the intermediary portion has a length of 400 mm or below since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I). Similarly, it would have been an obvious matter of design choice to modify the length of the intermediary section of the modified device of Ye et al., Nita et al., and Miller et al. so that the intermediary portion has a length of 400 mm or below, since applicant has not disclosed that having the intermediary portion have a length of 400 mm or below solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the intermediary portion having a length of 400 mm or below, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 11, Ye/Nita/Miller discloses the claimed invention as discussed above concerning claim 1. Ye further discloses that a proximal portion (proximal end 46) of the outer layer (4th layer 44) is made of a polyether block amide [0030] and Miller et al. further teaches that the proximal portion (most proximal portion 186) having a shore of above 65D [0078].
Regarding claims 16 and 17, Ye/Nita/Miller discloses the claimed invention as discussed above concerning claim 1, respectively, and Ye further teaches that a distal end of the microcatheter is generally more flexible at the distal end [0023].
But none of Ye et al., Nita et al., or Miller et al. expressly states that the flexural rigidity ranges of a proximal portion (as recited in claim 16) and the distal portion (as recited in claim 17).
The Examiner is of the position that it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to modify the flexural rigidity of the proximal and distal portions of Ye/Nita/Miller so that to have the recited flexural rigidities since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I). Similarly, it would have been an obvious matter of design choice to modify the flexural rigidities of the proximal and distal portions of Ye/Nita/Miller so that the proximal portion has a flexural rigidity of about 0.003 to 0.01 lbs-in^2 and the distal portion has a flexural rigidity of about 0.0001 to about 0.002 lbs-in^2, since applicant has not disclosed that having the proximal portion has a flexural rigidity of about 0.003 to 0.01 lbs-in^2 and the distal portion has a flexural rigidity of about 0.0001 to about 0.002 lbs-in^2 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the proximal portion has a flexural rigidity of about 0.003 to 0.01 lbs-in^2 and the distal portion has a flexural rigidity of about 0.0001 to about 0.002 lbs-in^2, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 19, Ye/Nita/Miller discloses the claimed invention as discussed above concerning claim 1. Ye further discloses that the microcatheter has an inner diameter (see Fig. 2) and that the microcatheter has a smaller outer diameter at its distal end and a larger outer diameter at its proximal end (See Fig. 2), and an active length (various components of Ye are disclosed as having specific length ranges; paragraph 21-23 and 29 and in order for the device of Ye to be practically useful, it must have an overall useful/active length).
But none of Ye et al., Nita et al., or Miller et al. expressly states that the microcatheter has an inner diameter of 0.50-0.7 mm and outer diameter of 0.8-0.9 mm at its distal end and 0.8-1.0 mm at its proximal end.
However, the Examiner is of the position that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Ye/Nita/Miller to include an inner diameter of 0.50-0.7 mm and outer diameter of 0.8-0.9 mm at its distal end and 0.8-1.0 mm at its proximal end, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Additionally, the Examiner is of the position that it would have been an obvious matter of design choice to adjust the size of various components of Ye/Nita/Miller to include an inner diameter of 0.50-0.7 mm and outer diameter of 0.8-0.9 mm at its distal end and 0.8-1.0 mm at its proximal end since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(A). Similarly, it would have been an obvious matter of design choice to modify size of Ye/Nita/Miller to include an inner diameter of 0.50-0.7 mm and outer diameter of 0.8-0.9 mm at its distal end and 0.8-1.0 mm at its proximal end, since applicant has not disclosed that having to include an inner diameter of 0.50-0.7 mm and outer diameter of 0.8-0.9 mm at its distal end and 0.8-1.0 mm at its proximal end, solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of an inner diameter of 0.50-0.7 mm and outer diameter of 0.8-0.9 mm at its distal end and 0.8-1.0 mm at its proximal end, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 20, Ye/Nita/Miller teaches the claimed invention as discussed above concerning claim 1, but none of Ye et al., Nita et al., or Miller et al. expressly states that the distal potion's outer layer has an ultimate tensile strength of 9000-10000 psi and an ultimate elongation of 350-450%.
However, the Examiner is of the position that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Ye/Nita/Miller so that the distal section's outer layer has an ultimate tensile strength of 9000-10000 psi and an ultimate elongation of 350-450%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I). Similarly, it would have been an obvious matter of design choice to modify Ye/Nita/Miller so that the distal section's outer layer has an ultimate tensile strength of 9000-10000 psi and an ultimate elongation of 350-450%, since applicant has not disclosed that having the distal section's outer layer has an ultimate tensile strength of 9000-10000 psi and an ultimate elongation of 350-450% solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of a distal section's outer layer has an ultimate tensile strength of 9000-10000 psi and an ultimate elongation of 350-450%, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ye et al., in view of Nita et al., further in view of Miller et al., and further in further view of Watanabe et al (U.S. 2010/0036363).
Regarding claim 2, Ye/Nita/Miller disclose the claimed invention as discussed above concerning claim 1, but none of Ye et al., Nita et al., and Miller et al. expressly state that the polyether block amide of the strike layer has a shore of about 55D.
Watanabe et al. teaches a microcatheter 1 comprising an inner layer 8, a strike layer (first outer layer 11) and an outer layer (layer(s) 12/13) and a braided skeleton (reinforcing layer 7 is a braid [0053]) located between the inner layer 8 and the outer layer (layer(s) 12/13) (see Fig. 3), wherein the inner layer is made of Polytetrafluoroethylene (PTFE) and has a thickness of 0.0015 inch or less, wherein the strike layer (first outer layer 11) comprises a polyether block amide (paragraph 63). Watanabe et al. further expressly states that the polyether block amide of the strike layer has a shore of about 55D [0063].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified Ye/Nita/Miller such that the strike layer has a shore of about 55D, as taught by Watanabe et al., since Watanabe et al. teaches that this is a known and useful property (55D shore hardness) for a strike layer of a microcatheter to have ([0063] of Watanabe et al.).
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. in view of Nita et al., further in view of Miller et al., and further in further view of Mortier et al (U.S. 5,730,733).
Regarding claim 3, Ye/Nita/Miller disclose the claimed invention as discussed above concerning claim 1, but none of Ye et al., Nita et al., and Miller et al. expressly state that the braided skeleton has a wire arrangement of 130 Picks Per Inch (PPI), and the distal portion has a tapered inner surface.
Mortier et al. teaches that it is known to adjust the picks per inch of a reinforcing braid skeleton structure of a catheter structure in order to affect both flexibility and strength (col. 9, lines 28-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the picks per inch of the braid skeleton of Ye/Nita/Miller as taught by Mortier et al. in order to affect both flexibility and strength (col. 9, lines 28-33 of Mortier et al.). It further would have been obvious to one of ordinary skill in the art to adjust the picks per inch value of the braid skeleton of Ye/Nita/Miller, in view of the teachings of Mortier et al., to be 130 picks per inch since discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al., in view of Nita et al., further view of Miller et al, and further in view of Stern (US 20170182290 A1).
Regarding claims 15 and 18, Ye/Nita/Miller disclose the invention substantially as claimed. However, they fail to disclose a hydrophilic coating covering the outer layer, and the distal portion having a tapered inner surface.
Stern teaches a catheter 10 with the diameter tapering toward the distal end 12b [0148], and has a hydrophilic coating covering the outer layer [0194]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ye/Nita/Miller with the teachings of Stern’s outer layer coating, and the tapered inner diameter surface (as taught old and well known) since such modification would have enhanced the catheter performance within the blood vessel.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. in view of Nita et al., further in view of Miller et al., and further view of Carlson et al (U.S. 2007/0162108).
Regarding claim 12, Ye/Nita/Miller disclose the claimed invention. Ye further discloses a first radiopaque marker band (distal most radiopaque marker 40) positioned at a first distal section (distal end 48) of the outer layer (4th layer 44), wherein the first radiopaque marker band is made of a radiopaque material (paragraph 28) submerged (embedded) in the first distal section's outer layer (shown in Fig. 2).
Ye does not expressly state that the first radiopaque marker is made of a radiopaque alloy, or that the first radiopaque marker band is positioned at the first distal section of the outer layer approximately 1 mm from a distal end opening of the microcatheter. However, Ye does disclose that the first radiopaque marker can be formed from a number of radiopaque materials including, but not limited to, gold, platinum, and plastic material loaded with a radiopaque filler [0028].
Carlson teaches using radiopaque markers in catheters, wherein the radiopaque marker is made of a radiopaque alloy (palladium-based alloys, for example; ([0045] and table 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the radiopaque material of the first radiopaque marker of Ye/Nita/Miller to be a radiopaque alloy, as taught by Carlson since Ye teaches that the radiopaque material is not particularly limited ([0028] of Ye) and since Carlson et al. expressly teaches that radiopaque alloys, such as palladium based alloys, are useful and effective radiopaque alloys for used in catheters ([0045] of Carlson et al.).
The modified device of Ye et al., Nita et al., and Miller et al., in further view of Carlson et al. will hereinafter be referred to as Ye/Nita/Miller/Carlson.
Ye/Nita/Miller/Carlson does not expressly state that the first radiopaque marker band is positioned at the first distal section of the outer layer approximately 1 mm from a distal end opening of the microcatheter. However, Ye does show that the first radiopaque marker band (distal most radiopaque marker 40) is positioned some distance away from the distal end opening of the microcatheter (see Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to modify the position of the first radiopaque marker of Ye/Nita/Miller/Carlson so that the position of the first radiopaque marker band is positioned at the first distal section of the outer layer approximately 1 mm from a distal end opening of the microcatheter since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (the range encompassed by “approximately 1 mm”) involves only routine skill in the art. MPEP 2144.05(I).
Similarly, it would have been an obvious matter of design choice to modify the position of the first radiopaque marker of the modified device of Ye/Nita/Miller/Carlson so that the position of the first radiopaque marker band is positioned at the first distal section of the outer layer approximately 1 mm from a distal end opening of the microcatheter since applicant has not disclosed that having the first radiopaque marker band is positioned at the first distal section of the outer layer approximately 1 mm from a distal end opening of the microcatheter solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the first radiopaque marker band being positioned at the first distal section of the outer layer approximately 1 mm from a distal end opening of the microcatheter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 13, Ye/Nita/Miller/Carlson discloses the claimed invention as discussed above concerning claim 12, and Ye further teaches a second radiopaque marker band (proximal most radiopaque marker 40) positioned at the first distal section (distal end 48) of the outer layer (4th layer 44) proximally to the first radiopaque maker band (distal most radiopaque marker 40), wherein the second radiopaque marker band is made of a radiopaque material (paragraph 28) embedded d in the first distal section's outer layer (shown in Fig. 2).
Ye does not expressly state that the second marker band comprises a radiopaque powder embedded in the outer layer of the first distal section, or that the second marker band is located positioned approximately 5-15 mm proximal to the first marker band.
However, Carlson et al. teaches using radiopaque markers in catheters, wherein the radiopaque marker is made of a radiopaque powder embedded in a plastic/polymer [0045]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified second radiopaque marker of the modified device of Ye/Nita/Miller to be a radiopaque powder, as taught by Carlson since Carlson teaches that this is a known construction for radiopaque markers in catheters ([0045] of Carlson) and since it would help in differentiating the first and second radiopaque markers during fluoroscopy (i.e., the first and second radiopaque markers would give off different visualizations during fluoroscopy, thereby allowing a user to better determine the orientation of the catheter in the body).
Ye/Nita/Miller/Carlson does not expressly state that the second marker band is located positioned approximately 5-15 mm proximal to the first marker band. However, Ye does show that the first radiopaque marker band (distal most radiopaque marker 40) and the second radiopaque marker (proximal most radiopaque marker 40) are positioned apart from one another (see Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to modify the position of the first and/or second radiopaque marker(s) of Ye/Nita/Miller/Carlson so that the second marker band is located positioned approximately 5-15 mm proximal to the first marker band, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Similarly, it would have been an obvious matter of design choice to modify the position of the first and/or second radiopaque marker(s) of the modified device of Ye/Nita/Miller/Carlson so that the second marker band is located positioned approximately 5-15 mm proximal to the first marker band since applicant has not disclosed that that the second marker band is located positioned approximately 5-15 mm proximal to the first marker band solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the second marker band is located positioned approximately 5-15 mm proximal to the first marker band, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783