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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-16 in the reply filed on 05/14/2026 is acknowledged. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/17/2023, 02/11/2025, 02/18/2026. 02/18/2026, and 02/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in FIG. 5A, reference character “302” has been used to designate both stock material and, the examiner assumes from the specification, arrow indicating longitudinal movement relative to the blade by stock material.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because FIG. 7D includes the following reference character not mentioned in the description: 603.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a marker band as described in the specification and claims 13 and 14, as well as the marker band channel being grooved as described in the specification and claim 14. It is unclear to the examiner how a marker band is to attach to the marker band channel, and in what way the marker band channel is meant to be grooved. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). For the purpose of examination, the examiner will interpret a marker band to fit around the outer surface of the marker band channel, in which the marker band channel is partially attached to the elongated member in order that the marker band be aligned with the outer diameter of the elongated member.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims objected to because of the following informalities:
Claim 8 states “an interior arc length to exterior arc length ratio for each beam of the one-cut-per-beam two-beam section is less than 1.2”. However, when discussing the ratio in claims 1, 6, and 11, as well as in the specification, the ratio is presented as “interior arc length:exterior arc length”. The examiner suggest presenting the ratio here in the same manner for cohesiveness. Appropriate correction is required. For the purposes of examination, the examiner will interpret the claim to mean “less than 1.2:1”.
Claim 12 states “at least some of the beams”. The use of “at least some” is broad in the sense that “some” is interpreted as an unspecified sum. The examiner suggest adding specificity to the claim language to avoid such a broad interpretation of the claim. Appropriate correction is required. For the purposes of examination, the examiner will interpret “at least some of the beams” to mean two or more beams.
Claim 15 states “multiple different polymers, each having a different modulus and/or different hardness”. The use of “and/or” is broad in the sense that the language includes multiple possible groups. The examiner suggest selecting either “and” or “or” to avoid such a broad interpretation of the claim. Appropriate correction is required. For the purposes of examination, the examiner will interpret the claim to allow for either groups including both a different modulus and a different hardness, or only allowing a different modulus or a different hardness.
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 14 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.
The term “substantially” in claim 14 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The use of the term "substantially" makes it unclear to the examiner the distal relationship between an outer surface of the marker band and an outer diameter of the elongated member. The examiner suggest clarifying in the specification what is considered “substantially flush” or modifying the claim to add specificity to the relationship between the marker band and elongated member. For the purposes of examination, the examiner will interpret the claim to mean an outer surface of the marker band is in line with an outer diameter of the elongated member.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Northrop et al. (United States Patent No. US 10,252,024 B2; herein, Northrop).
Regarding claim 1, Northrop discloses an intravascular device for an aspiration procedure (guidewire 10), the device comprising: an elongated member (tubular member 14) including a proximal end (Annotated on FIG. 1 below), a distal end (Annotated on FIG. 1 below), and a lumen extending therebetween (col. 4 lines 63-67 “’tubular member’ is any elongate device having a lumen”, FIG. 6B shows a lumen within tubular member 14), the elongated member including a plurality of fenestrations (openings 20) forming a plurality of axially extending beams (beams 24) and a plurality of circumferentially extending rings (annular rings 22), each beam including an interior surface (Annotated on FIG. 6C below), an exterior surface (Annotated on FIG. 6C below), and two lateral surfaces (Annotated on FIG. 6C below).
Northrop discloses in FIG. 6C an axial cross-sectional view along the line labeled A-A in FIG. 6A. Within the cross-sectional view, it is shown beams separate by openings, which have been formed by cutting and/or removing portions of the tube. The beams of FIG. 6C show an interior arc length (Annotated on FIG. 6C below) and an exterior arc length (Annotated on FIG. 6C below), with the interior arc length visually greater than the exterior arc length. However, Northrop does not explicitly disclose wherein at least one beam has an interior arc length to exterior arc length ratio ranging from about 1.2:1 to about 6:1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the beams of Northrop to specify an interior arc length to exterior arc length ratio ranging from about 1.2:1 to about 6:1 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the beams of Northrop would not operate differently with the claimed ratio and since the interior arc length is intended to be larger than the exterior arc length the beams would function appropriately having the specified claimed ratio. Northrop also discloses how openings enhance the flexibility of the tubular member and arranged to achieve desired properties (col. 8 lines 34-67). Further it appears that the applicant places no criticality on the range claimed, indicating simply that the lengths may be within the claimed ranges (specification [0021], [0100]), in which “the ratio and lengths of the [interior] and [exterior] arc lengths may be controlled and/or influenced by the method of manufacturing” (specification [0021], [0041]).
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Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Northrop as applied to claim 1 above, and further in view of Chou et al. (United States Patent Application Publication No. US 2021/0212707 A1; herein, Chou).
Regarding claim 2, Northrop does not disclose the intravascular device is an aspiration catheter. However, Chou teaches the intravascular device is an aspiration catheter ([0079], catheter 200 is typically a large-bore aspiration catheter). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular device disclosed by Northrop to be an aspiration catheter as taught by Chou in order for continuous aspiration to occur from distal tip of the device to an aspiration source ([0098]).
Regarding claim 15, Northrop does not disclose a set of polymer coatings disposed on an inner surface of the elongated member, an outer surface of the elongated member, or both, wherein the set of polymer coatings comprises multiple different polymers, each having a different modulus and/or different hardness, and wherein the multiple different polymers are arranged along the elongated member to contribute to a gradient flexibility profile. However, Chou teaches a set of polymer coatings ([0137], “Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, HYDAK coatings (e.g. B-23K, HydroSleek), and the like”) disposed on an inner surface of the elongated member, an outer surface of the elongated member, or both ([0137], “At least a portion of the outer surface of the catheter 200 can be coated with a lubricious coating”), wherein the set of polymer coatings comprises multiple different polymers, each having a different modulus and/or different hardness ([0137], “Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, HYDAK coatings (e.g. B-23K, HydroSleek), and the like, and mixtures and combinations thereof”; the example options here contain polymers with various modulus and hardnesses), and wherein the multiple different polymers are arranged along the elongated member to contribute to a gradient flexibility profile ([0137], lubricious polymers are known in the art to reduce friction and allow for more natural flection of the device). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular device disclosed by Northrop to include polymer coatings that contribute to the device’s flexibility profile as taught by Chou in order to reduce friction during tracking ([0137]).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Northrop as applied to claim 1 above, and further in view of Lippert et al. (United States Patent Application Publication No. US 2021/0228845 A1; herein, Lippert).
Regarding claim 3, Northrop does not disclose the elongated member includes a one-beam section in which a single beam extends between each pair of adjacent rings. However, Lippert teaches the elongated member includes a one-beam section ([0044], one-beam section 234) in which a single beam extends between each pair of adjacent rings (FIG. 4, one-beam section 234 shows a single beam between each rings 228). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular device disclosed by Northrop to include a one-beam section as taught by Lippert in order to gain greater flexibility, which comes from removing more stock material ([0043]).
Regarding claim 4, in the modified device of Northrop, Northrop does not disclose the one-beam section is distal of a two-beam section in which two beams extend between each pair of adjacent rings. However, Lippert teaches the one-beam section is distal of a two-beam section (FIG. 4, one-beam section 234 is distal of two-beam section 232) in which two beams extend between each pair of adjacent rings ([0044], two-beam section 232). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intravascular device disclosed by Northrop to include a two-beam section proximal of the one-beam section as taught by Lippert in order to provide a flexibility gradient across the tube where more flexibility increases closer to the distal end ([0043]).
Claims 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Northrop in view of Lippert as applied to claims 3 and 4 above, and further in view of Snyder (United States Patent Application Publication No. US 2020/0345975 A1).
Regarding claim 5, in the modified device of Northrop, Lippert teaches the two-beam section (two-beam section 232). Northrop does not disclose the two-beam section comprises a two-cut-per-beam two-beam section. However, Snyder teaches a process for cutting an elongated member ([0030]-[0031], [0037]-[0039]; Through this process of cutting stock material, cuts came be made on the same plane as previous cuts by rotating the stock material relative to the blade. The process can be repeated to form the desired number of cuts.). One having ordinary skill in the art can understand by using the process outlined by Snyder, multiple cuts can be made on the same plane of the elongated member until the desired design of the beam is created. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the two-beam section taught by Lippert of the modified intravascular device disclosed by Northrop to be cut in a two-cut-per-beam pattern by the process taught by Snyder in order to enhanced flexibility while maintaining sufficient outer circumferential structure for effectively transmitting torque ([0018]).
Regarding claim 6, in the modified device of Northrop, Lippert in view of Snyder teaches the two-cut-per-beam two-beam section (see claim 5 rejection above). Northrop discloses in FIG. 6C an axial cross-sectional view along the line labeled A-A in FIG. 6A. Within the cross-sectional view, it is shown beams separate by openings, which have been formed by cutting and/or removing portions of the tube. The beams of FIG. 6C show an interior arc length (Annotated on FIG. 6C below) and an exterior arc length (Annotated on FIG. 6C below), with the interior arc length visually greater than the exterior arc length. However, Northrop does not explicitly disclose wherein an interior arc length to exterior arc length ratio for each beam of the two-cut-per-beam two-beam section is within a range of about 1.2:1 to about 6:1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the two-beam section of the modified Northrop to specify an interior arc length to exterior arc length ratio ranging from about 1.2:1 to about 6:1 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the two-beam section of the modified Northrop would not operate differently with the claimed ratio and since the interior arc length is intended to be larger than the exterior arc length the beams would function appropriately having the specified claimed ratio. Northrop also discloses how openings enhance the flexibility of the tubular member and arranged to achieve desired properties (col. 8 lines 34-67). Further it appears that the applicant places no criticality on the range claimed, indicating simply that the lengths may be within the claimed ranges (specification [0021], [0100]), in which “the ratio and lengths of the [interior] and [exterior] arc lengths may be controlled and/or influenced by the method of manufacturing” (specification [0021], [0041]).
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Regarding claim 7, in the modified device of Northrop, Lippert teaches the two-beam section (two-beam section 232). Northrop does not disclose the two-beam section comprises a one-cut-per-beam two-beam section. However, Snyder teaches a process for cutting an elongated member ([0030]-[0031], [0037]-[0039]; Through this process of cutting stock material, cuts came be made on the same plane as previous cuts by rotating the stock material relative to the blade. The process can be repeated to form the desired number of cuts.). One having ordinary skill in the art can understand by using the process outlined by Snyder, multiple cuts can be made on the same plane of the elongated member until the desired design of the beam is created. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the two-beam section taught by Lippert of the modified intravascular device disclosed by Northrop to be cut in a one-cut-per-beam pattern by the process taught by Snyder in order to enhanced flexibility while maintaining sufficient outer circumferential structure for effectively transmitting torque ([0018]).
Regarding claim 8, in the modified device of Northrop, Lippert in view of Snyder teaches the one-cut-per-beam two-beam section (see claim 7 rejection above). The primary embodiment used in this office action of Northrop (FIG. 6A-6C) does not disclose an interior arc length to exterior arc length ratio for each beam of the one-cut-per-beam two-beam section is less than 1.2. However, an alternative embodiment of Northrop teaches an interior arc length to exterior arc length ratio for each beam of the one-cut-per-beam two-beam section is less than 1.2 (FIG. 5C annotated below, FIG. 5C visually shows two beams having equal or noticeably similar interior and exterior arc lengths. One having ordinary skill in the art would know an interior arc length being the same length as an exterior arc length would cause the ratio to be 0, or if the lengths are noticeably similar, the ratio would be less than 1.2.). In the instant case, the two-beam section of the modified Northrop would not operate differently with the claimed ratio and since the interior arc length is intended to be either slightly larger, of equal size, or smaller than the exterior arc length the beams would function appropriately having the specified claimed ratio. Northrop also discloses how openings enhance the flexibility of the tubular member and arranged to achieve desired properties (col. 8 lines 34-67). Further it appears that the applicant places no criticality on the range claimed, indicating simply that the lengths may be within the claimed ranges (specification [0021], [0100]), in which “the ratio and lengths of the [interior] and [exterior] arc lengths may be controlled and/or influenced by the method of manufacturing” (specification [0021], [0041]).
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Regarding claim 9, in the modified device of Northrop, Lippert teaches the two-beam section (two-beam section 232). Northrop does not disclose the one-cut-per-beam two-beam section is proximal of the two-cut-per-beam two-beam section. However, Snyder teaches a process for cutting an elongated member ([0030]-[0031], [0037]-[0039]; Through this process of cutting stock material, cuts came be made on the same plane as previous cuts by rotating the stock material relative to the blade. The process can be repeated to form the desired number of cuts.). One having ordinary skill in the art can understand by using the process outlined by Snyder, multiple cuts can be made on the same plane of the elongated member until the desired design of the beam is created. This would also include modifying the cut design within the same section of an elongated member. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the two-beam section taught by Lippert of the modified intravascular device disclosed by Northrop to include a two-beam section with a one-cut-per-beam pattern proximal of the two-cut-per-beam pattern cut by the process taught by Snyder in order to enhanced flexibility while maintaining sufficient outer circumferential structure for effectively transmitting torque ([0018]).
Regarding claim 10, in the modified device of Northrop, Lippert teaches the one-beam section (one-beam section 234). Northrop does not disclose the one-beam section comprises a three-cut-per-beam one-beam section. However, Snyder teaches a process for cutting an elongated member ([0030]-[0031], [0037]-[0039]; Through this process of cutting stock material, cuts came be made on the same plane as previous cuts by rotating the stock material relative to the blade. The process can be repeated to form the desired number of cuts.). One having ordinary skill in the art can understand by using the process outlined by Snyder, multiple cuts can be made on the same plane of the elongated member until the desired design of the beam is created. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one-beam section taught by Lippert of the modified intravascular device disclosed by Northrop to be cut in a three-cut-per-beam pattern by the process taught by Snyder in order to enhanced flexibility while maintaining sufficient outer circumferential structure for effectively transmitting torque ([0018]).
Regarding claim 11, in the modified device of Northrop, Lippert in view of Snyder teaches the three-cut-per-beam one-beam section (see claim 10 rejection above). Northrop discloses in FIG. 6C an axial cross-sectional view along the line labeled A-A in FIG. 6A. Within the cross-sectional view, it is shown beams separate by openings, which have been formed by cutting and/or removing portions of the tube. The beams of FIG. 6C show an interior arc length (Annotated on FIG. 6C below) and an exterior arc length (Annotated on FIG. 6C below), with the interior arc length visually greater than the exterior arc length. However, Northrop does not explicitly disclose wherein an interior arc length to exterior arc length ratio for each beam of the three-cut-per-beam one-beam section is within a range of about 1.2:1 to about 6:1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the one-beam section of the modified Northrop to specify an interior arc length to exterior arc length ratio ranging from about 1.2:1 to about 6:1 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the one-beam section of the modified Northrop would not operate differently with the claimed ratio and since the interior arc length is intended to be larger than the exterior arc length the beams would function appropriately having the specified claimed ratio. Northrop also discloses how openings enhance the flexibility of the tubular member and arranged to achieve desired properties (col. 8 lines 34-67). Further it appears that the applicant places no criticality on the range claimed, indicating simply that the lengths may be within the claimed ranges (specification [0021], [0100]), in which “the ratio and lengths of the [interior] and [exterior] arc lengths may be controlled and/or influenced by the method of manufacturing” (specification [0021], [0041]).
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Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Northrop in view of Lippert as applied to claim 3 above, and further in view of Lippert et al. (United States Patent Application Publication No. US 2018/0193607 A1; herein, Lippert (2)).
Regarding claim 12, in the modified device of Northrop, Northrop does not disclose at least some of the beams of the one-beam section are rotated relative to adjacent beams by about 100 degrees to about 150 degrees. However, Lippert teaches at least some of the beams of the one-beam section are rotated relative to adjacent beams (FIG. 4, [0048], individual beams of one-beam section 234 may be offset from the previous beam). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intravascular device disclosed by Northrop to include a one-beam section with offset beams as taught by Lippert in order to gain greater flexibility, which comes from removing more stock material ([0043]), and to avoid the formation of any preferred bending planes ([0047]).
Northrop in view of Lippert still does not disclose the rotation of beams being about 100 degrees to about 150 degrees. Lippert (2) teaches regarding rotational offsets of one-beam sections “rotational offsets can also be made at angles that are different than 180 degrees to 0 degrees” ([0045]) as well as “each successive cut…along the length of a given section is rotationally offset by about 1, 2, 3, 5, or 10 degrees off from 180 degrees in a one-beam configuration” ([0057]). However, Lippert (2) does not explicitly teach the rotation of beams being about 100 degrees to about 150 degrees. Lippert (2) teaches ([0056]) that the angular position of successive beams needs to be optimized to “minimize preferred bending directions of the guidewire over a length of several sets of cuts”. One having ordinary skill in the art would have had a reasonable expectation of success in modifying the Lippert (2) rotation angles to have an offset within the claimed range, as it involves only adjusting the dimension of the component disclosed to require the adjustment, in other words, adjusting the location of the successive cuts. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rotation angle of Lippert (2) by making the rotation angle of the adjacent beams to be between about 100 degrees to about 150 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 13-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Northrop as applied to claim 1 above, and further in view of Magnuson et al. (United States Patent Application Publication No. US 2007/0287957 A1; herein, Magnuson).
Regarding claim 13, Northrop does not disclose a marker band disposed within a marker band channel, the marker band channel being disposed at a distal tip at or near the distal end of the elongated member. However, Magnuson teaches a marker band (marker 32) disposed within a marker band channel (counterbore 26), the marker band channel being disposed at a distal tip at or near the distal end of the elongated member (Fig. 3, [0031]-[0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular device disclosed by Northrop to include a marker band and channel at the distal end of the elongate member as taught by Magnuson in order to accurately mark the position of the distal end of the catheter when exposed to x-rays ([0036]).
Regarding claim 14, in the modified device of Northrop, Northrop does not disclose the marker band channel is grooved and has a depth such that an outer surface of the marker band is substantially flush with an outer diameter of the elongated member. However, Magnuson teaches the marker band channel is grooved (Fig. 3) and has a depth such that an outer surface of the marker band is substantially flush with an outer diameter of the elongated member (Fig. 4, [0036], marker 32 fits within annular side wall 20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intravascular device disclosed by Northrop to position the marker band flush with the elongate member as taught by Magnuson in order accurately mark the position of the distal end of the catheter when exposed to x-rays ([0036]). Further, the device may also maintain a smooth outer surface for the medical instrument to more easily be pushed through a patient's skin or other openings with small clearances while minimizing harm to the patient ([0038]).
Regarding claim 16, Northrop does not disclose the intravascular device omitting coils attached to a distal section of the elongated member and extending distally therefrom past the distal end of the elongated member. However, Magnuson teaches the intravascular device omits coils attached to a distal section of the elongated member and extending distally therefrom past the distal end of the elongated member (Fig. 4 is an untapered distal end including a marker 32 formed of an x-ray reflective, or radiopaque, material to be viewed by the physician via radiography, fluoroscopy, or other usual visualization techniques [0034]. One having ordinary skill in the art would understand having a coil in the distal end would interfere with visualization techniques.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular device disclosed by Northrop to not include coils in the distal section of the elongated member as taught my Magnuson in order to not impose on the visualization of the distal tip by the physician ([0036]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jacobson et al. (United States Patent Application Publication No. US 2008/0021403 A1) is considered relevant prior art in regards to an intravascular device including a slotted tubular member, slots having both equal and unequal depths.
Nakade et al. (United States Patent Application Publication No. US 2018/0042623 A1) is considered relevant prior art in regards to an endoscope bending tube with a plurality of bending slits increasingly spread apart.
Batiste (United States Patent Application Publication No. US 2018/0042623 A1) is considered relevant prior art in regards to an aspiration catheter with slits.
Davis et al. (United States Patent Application Publication No. US 2020/0121308 A1) is considered relevant prior art in regards to an interventional device with micro-fabricated features for supporting flexibility.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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, Michael Tsai can be reached at 571-270-5246. 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.
/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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