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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 07/10/2026.
Status of the claims:
Claims 1 and 4 – 20 are pending in the application.
The affidavit under 37 CFR 1.132 filed 07/10/2026 is insufficient to overcome the rejection of claim 1 under Schwab and Arana as set forth in the last Office action because: the arguments fails to set forth any evidence based facts. More specifically:
With respect to paragraphs [0010 – 0017], while the Examiner acknowledges that Schwab states that ‘one’ use of the catheter is in PTCA procedures, Schwab does not limit the use of the catheter to only being used in PTCA; therefore, Applicant’s arguments directed to the catheter of Schwab, when used in PTCA, having the claimed length would be in operable as the branches of the coronary arteries routinely only extend 2 to 4 cm, is not persuasive as the catheter can be used in other procedures wherein the length of the tip would not affect the operability of the device. Alternatively, if the balloon catheter were to be used in a PTCA procedure, the Examiner notes that Schwab does not limit the use of the catheter to any one species of animals, which have varying sizes of branches in the coronary arteries, and the Examiner contemplates it is well within purview of one of ordinary skill in the art for the catheter of Schwab to be used on an animal with longer side branches in the coronary arteries wherein the claimed range would not cause the catheter of Schwab to be inoperable such that the balloon would be capable of reaching the target lesion.
With respect to paragraph [0006], [0014 – 0017], and [0020] the Examiner does not agree with Applicant’s statements directed to the length of normal PTCA catheters being between 2 to 5 mm, wherein it has been generally accepted that lengthy tips will adversely affect the performance and that the PTCA catheter of Schwab would be unable to function as needed with a tip length within the claimed range. Based on the newly cited reference Wijay, cited below, one of ordinary skill in the art would be motivated to have a PTCA catheter have a length tip with length within the claimed range; Wijay discloses a PTCA catheter with a lengthy tip, and wherein the length of the tip is a result effective variable, and it is known in the art to adjust the length of tip in order to obtain the desired bendability as well has having a tip length of 30mm, which is in the claimed range of 25mm to 35mm. Furthermore, Applicant states that the “modification to the tip length would result in the balloon catheter [of Schwab] unable to function as needed for “most” use in PTCA procedures”, which implies that there would be some instances wherein the modification would not render the balloon catheter of Schwab in operable. Further still, Applicant states that the increased length would need an increased diameter, would increase the amount of friction, and would result in less precise balloon positioning; the Examiner notes that “[t]the fact that a benefit comes at the expense of another benefit, however, should not nullify its combination. Instead, benefits, both lost and gained, should be weighed against one another (Winner Int 'l Royalty Corp. V. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000); see also Medichem, S. A. V. Rolabo, S. L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("[A] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine" (citation omitted). In this case, the benefits gained from increasing the length of the tip, such as the ability to reach through longer passages of a body and obtain the desired bendability (as taught by Wijay), may come at the expense of the precision and added frictional resistance (which can be further mitigated) should not nullify its use as the basis to modify Schwab to have the claimed length. It would have been obvious to a person of ordinary sill in the art to choose which advantages to pursue given the known tradeoffs stemming from these choices. Lastly, Wijay discloses a PTCA balloon catheter having a tip with a length of 30mm, the Examiner asserts that tip enhanced navigability provided by the tip with a length within the claimed range is not “unexpected” in view of the conventional wisdom regarding lengths for balloon catheters “(i.e., under 5mm)” since Wijay discloses conventional wisdom regarding lengths of tips includes tips with a length of 30mm; additionally, there is no evidence to suggest that the device of Schwab with the claimed tip length would not achieve the same “train car phenomena” when navigating through the vasculature.
With respect to paragraph [0019] Applicant has not provided any disclosure from any of the cited references that would suggest that the disclosures of said references teach away from the modification. The failure of the references to contemplate the claimed range does not teach away…if it merely expresses a general preference for an alternative invention by does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed” (DePuy Spine, Inc. V. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)).
Therefore, the statements within the affidavit are found to be not persuasive.
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.
Claims 1, 7 – 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schwab et al (US 5,769,819) (previously cited) in view of Arana et al (US 2009/0156998 A1) (previously cited) and Wijay et al (US 4,921,483).
Regarding claims 1, Schwab discloses a balloon catheter (balloon catheter / balloon catheter tip) (abstract, col. 3 lines 20 – 45, and Figs. 1 – 3) comprising:
a balloon inflation lumen (inflation lumen 25) and a guidewire lumen (guidewire lumen 65; designated in annotated Fig. 1) (col. 4 lines 43 – 55 and Fig. 1);
a balloon (balloon 35) having a balloon proximal end and a balloon distal end (distal tail 50) (col. 3 lines 35 – 45, col. 4 lines 56 – 63, Figs. 1 and 2) wherein a second portion of the guidewire lumen (portion within the balloon but outside of the distal tip extension 30; see annotated Fig. 1) extends at least partially through the balloon; and
a tip (distal tip extension 30) having a tip proximal end and a tip distal end (col. 3 lines 46 – 56, col. 4 line 56 – col. 5 line 5, Figs. 1, 3, and annotated Fig. 1), the tip comprising a medical- grade polymer (col. 4 lines 8 – 15), wherein:
a third portion of the guidewire lumen extends through the tip from the tip proximal end to the tip distal end (see annotated Fig. 1),
the balloon distal end is bonded to the tip at a balloon-tip junction towards the tip proximal end (col. 5 lines 13 – 39, Fig. 1, and annotated Fig. 1), and
a tip length from the tip distal end to the balloon distal end (see annotated Fig. 1).
However, Schwab is silent regarding (i) a hub, (ii) a shaft comprising the balloon inflation lumen, a first portion of the guidewire lumen, and with a distal end coupled to the proximal end of the balloon, and (iii) wherein the tip length is between 25 – 35 mm.
As to (i) and (ii), Arana teaches, in the same field of endeavor, a balloon catheter (balloon catheter 10) comprising a hub (adapter 41), a shaft (elongated shaft 11) attached to the distal end of the hub and attached to the proximal end of a balloon (balloon 14) and comprising a first portion of a guidewire lumen (guidewire lumen 13) and an inflation lumen (inflation lumen 12; which connects to the inner space of the balloon, which equates to the inflation lumen of Schwab) (abstract, paragraphs [0022], [0023], and Fig.1); wherein the hub and shaft are used for the purpose of connecting the balloon with an inflation source in order to inflate the balloon as intended (paragraph [0022]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Schwab with a hub and shaft that houses a first part of the inflation lumen and is connected to the proximal end of the balloon, as taught by Arana, for the purpose of being able to connect a fluid source to the balloon, in order to inflate the balloon as intended (paragraph [0022] – Arana).
As to (iii), Wijay teaches, in the same field of endeavor, a balloon catheter (catheter ‘C’) comprising a hub (‘F’ – Fig. 11), a shaft (catheter ‘C’ body – Fig. 11), a balloon (balloon ‘D’) attached to the shaft and a tip (tip ‘T’) extending from the balloon (col. 5 line 51 – col. 6 line 13 and Figs. 1 – 11) with a tip length (distance from the balloon to the distal end of the tip ‘T’) is 25mm to 35mm (Examiner’s note: as stated in col. 7 lines 64 – 66 the tip length can be 1mm to 30mm). It is further noted that Wijay teaches wherein the balloon catheter can be used in transluminal coronary angioplasty procedures.
Additionally, Wijay discloses in col. 7 lines 49 – 65 that the length of the tip is can be adjusted to affect the bendability of the catheter. Therefore, Wijay teaches wherein the tip length is a result effective variable wherein the bendability of the catheter is a result of the tip length. Moreover, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the length of the tip of Schwab to have a length within the claimed range, as it only involves adjusting the dimension of a component disclosed as being variable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Schwab to have a tip length be between 25mm and 35mm 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). Furthermore, Applicant has not provided evidence, such as how the claimed range has unexpected results. It is the Examiner’s position that one of ordinary skill in the art at the time of the invention was made would have known the approximate dimensions and locations of the organism’s body region (i.e., any animal) to be treated and the approximate length the tip required to effectively perform the procedure. Therefore, the claimed range is merely a number discoverable by routine skill in the art and fails to patentably distinct the claimed invention from the prior art.
Annotated Figure 1 of Schwab
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Regarding claim 7, as discussed above the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 11. Additionally, Schwab discloses wherein the medical-grade polymer comprises: low-density polyethylene (LDPE) (claim 6).
Regarding claim 8, as discussed above the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 11. Additionally, Schwab discloses wherein: the tip (distal tip extension 30) comprises:
a first outer diameter at the tip distal end (see annotated Fig. 1), and
a second outer diameter at the balloon-tip junction (see annotated Fig. 1), and the first outer diameter is smaller than the second outer diameter (see annotated Fig. 1).
Annotated Figure 1 of Schwab
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Regarding claim 9, as discussed above the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 11. Additionally, Schwab discloses wherein an outer diameter of the tip transitions from a first outer diameter at the tip distal end to a second outer diameter, greater than the first outer diameter, at the balloon-tip junction (see annotated Fig. 1).
Regarding claim 10, as discussed above the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 11. Additionally, Schwab discloses wherein the tip (distal tip extension 30) comprises a truncated conical shape with a smallest outer diameter at the tip distal end (Figs. 1, 3, and annotated Fig. 1).
Regarding claim 11, as discussed above the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 11. Additionally, Schwab discloses wherein:
the tip (distal tip extension 30) comprises a plurality of segments each having an outer diameter (see annotated Fig. 1), the plurality of segments comprising:
a first segment at the tip distal end with a first outer diameter (see annotated Fig. 1),
a second segment at the balloon-tip junction with a second outer diameter (see annotated Fig. 1),
a third segment between the first segment and the second segment with a third outer diameter (see annotated Fig. 1),
the second outer diameter is greater than the third outer diameter, and the third outer diameter is greater than the first outer diameter (see annotated Fig. 1).
Annotated Figure 1 of Schwab
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Regarding claim 12, as discussed above the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 11.
However, the combination of Schwab, Arana, and Wijay is silent regarding (i) wherein each of the plurality of segments is at least two (2) millimeters long.
As to the above, Schwab discloses in col. 3 lines 5 – 7 that the length of the tip component 10 can be optimized, which includes the length of each of the segments. There is no evidence of record that establishes that changing the length of each segment would result in a difference in function of the Schwab device. Further, a person having ordinary skill in the art, being faced with modifying length of each segment of the tip of Schwab, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths.
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 each segment of the tip extension of Schwab to have a length of at least 2 millimeters as an obvious matter of design choice within the skill of the art.
Additionally, 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 device of Schwab to have each segment be at least 2mm long 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.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the segments of the tip of Schwab would not operate differently with the claimed relative lengths and since overall length would remain the same the tip would function appropriately.
Regarding claim 19, as discussed above, the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 1.
However, the current combination of Schwab, Arana, and Wijay is silent regarding (i) wherein at least part of the third portion of the guidewire lumen comprises a polyimide thin-walled tube.
As to the above, Arana further teaches wherein the guidewire lumen (guidewire lumen 13) of the balloon catheter (balloon catheter 10) comprises a thin walled tube (inner tubular member 118; which equate to the guidewire shaft 70 of Schwab), which couples to the tip (tip member 119), and wherein the guidewire lumen / thin wall tube is made up of a polyimide (paragraph [0044]).
Arana states, in paragraph [0044], it is known to make catheter tubing out of polyimides. Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify at least a portion of the third portion of the guidewire lumen shaft 70 of Schwab to be made from polyimide, as taught by Arana, as polyimide is a known material known to be used make up known devices known to be used in the same manner, and one of ordinary skill in the art would have a reasonable expectation of success in modifying Schwab to incorporate polyimide into the guidewire shaft 70, and the results of the modification would have been predictable such that the device would be able to function as intended.
Claims 4 – 6 and 13 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Schwab et al (US 5,769,819) (previously cited) in view of Arana et al (US 2009/0156998 A1) (previously cited) and Wijay et al (US 4,921,483) , as applied to claim 1 above, and further in view of Halstead et al (US 2020/0030577 A1) (previously cited).
Regarding claims 4 and 5, as discussed above, the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 1.
However, the combination of Schwab, Arana, and Wijay is silent regarding (i) wherein the tip comprises a curvature, between 90 – 180 degrees, in a relaxed state.
As to the above, Halstead teaches, in the same field of endeavor, a balloon catheter (catheter system 100) comprising a hub (y-hub 110), a shaft (outer catheter 116 and 118), a balloon (balloon 120), and a tip (distal tip segment 124), wherein the tip comprises a curvature, between 90 – 180 degrees, in a relaxed state for the purpose of allowing the catheter system to track along a guidewire into branched / tortuous vasculature to the target tissue (abstract, paragraphs [0010 – 0011], [0028], [0033], and Figs. 1, 3A/B) (Examiner’s note: as stated in paragraph [0011] the distal tip segment has a curvature in the relaxed state).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the distal tip of Schwab in view of Arana to incorporate a curvature, as taught by Halstead, for the purpose of allowing the catheter system to track along a guidewire into branched / tortuous vasculature to the target tissue (paragraph [0033] – Halstead).
Regarding claims 6 and 13, as discussed above, the combination of Schwab, Arana, and Wijay teaches the balloon catheter of claim 1. Additionally, Wijay teaches in col. 7 lines 50 – 67 wherein the hardness of the tip is a known material property known to be adjusted in order to achieve the desired functionality of the catheter tip.
However, the combination of Schwab, Arana, and Wijay is silent regarding (i) [claim 6] the tip comprises a first durometer at the tip distal end and a second durometer at the tip proximal end, and the first durometer is less than the second durometer and/or (ii) [claim 13] wherein: the tip comprises a plurality of segments each having a durometer, the plurality of segments comprises a first segment at the tip distal end with a first durometer, a second segment at the balloon-tip junction with a second durometer, a third segment between the first segment and the second segment with a third durometer, the second durometer is greater than the third durometer, and the third durometer is greater than the first durometer.
As to the above, Halstead teaches, in the same field of endeavor, a balloon catheter (catheter system 100) comprising a hub (y-hub 110), a shaft (outer catheter 116 and 118), a balloon (balloon 120), and a tip (distal tip segment 124) (abstract, paragraphs [0028], [0035 – 0041], and Figs. 1, 4E); Halstead teaches (i) wherein the tip a first durometer at the tip distal end (durometer of material F – Fig. 4E) and a second durometer at the tip proximal end (durometer of material A – Fig. 4E) (Examiner’s note: as stated in paragraph [0035] Fig. 4E is the distal tip wherein the portion ‘A’ attaches to the inner catheter, which means that the portion ‘F’ is the distal end; furthermore, as stated in paragraph [0041] the durometer of each material gets lower / softer from moving distally, such that F is the softest material / material with the lowest durometer). Separately, Halstead teaches (ii) the tip (tip 124) comprises a plurality of segments (segments A – F) each having a durometer (paragraphs [0035] and [0041] and Fig. 4E), a first segment (segment F; which equates to the first segment of Schwab designated by the Examiner in annotated Fig. 1) at the tip distal end has a first durometer (durometer of material F), a second segment (segment D; which equates to the second segment of Schwab designated by the Examiner in annotated Fig. 1) at the ballon-tip junction has a second durometer (durometer of material D), a third segment (segment E; which equates to the third segment of Schwab designated by the Examiner in annotated Fig. 1) between the first segment and the second segment has a third durometer (durometer of material E) (paragraphs [0035] and [0041] and Fig. 4E), the second durometer is greater than the third durometer, and the third durometer is greater than the first durometer (Examiner’s note: as stated in paragraph [0035] Fig. 4E is the distal tip wherein the portion ‘A’ attaches to the inner catheter, which means that the portion ‘F’ is the distal end; furthermore, as stated in paragraph [0041] the durometer of each material gets lower / softer from moving distally, such that F is the softest material / material with the lowest durometer, the durometer of E is in between that of D and F, and the durometer of D is greater than that of E and F).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter tip of Schwab in view of Arana and Wijay to incorporate the claimed durometers, based on the teachings of Halstead, for the purpose of aiding in the tracking of the catheter and making it more easily to navigate through the tortuous vasculature (paragraphs [0027] and [0075] – Halstead).
Regarding claim 14, as discussed above, the combination of Schwab, Arana, Wijay, and Halstead teaches the balloon catheter of claim 13.
However, the combination of Schwab, Arana, Wijay, and Halstead is silent regarding (i) wherein each of the plurality of segments is at least two (2) millimeters long.
As to the above, Schwab discloses in col. 3 lines 5 – 7 that the length of the tip component 10 can be optimized, which includes the length of each of the segments. There is no evidence of record that establishes that changing the length of each segment would result in a difference in function of the Schwab device. Further, a person having ordinary skill in the art, being faced with modifying length of each segment of the tip of Schwab, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths.
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 each segment of the tip extension of Schwab to have a length of at least 2 millimeters as an obvious matter of design choice within the skill of the art.
Additionally, 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 device of Schwab to have each segment be at least 2mm long 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.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the segments of the tip of Schwab would not operate differently with the claimed relative lengths and since overall length would remain the same the tip would function appropriately.
Regarding claim 15, as discussed above, it would have been obvious to modify the tip of Schwab in view of Arana and Wijay to comprise a different durometer in each segment. Additionally, Halstead teaches, in paragraph [0041], that the first durometer of the first segment (durometer of material F) is less than the durometer of second and third segments, and the durometer of the third segment (durometer of material E) is less than the durometer of the second segment, which is the order in which Applicant’s segments vary on the durometer scale.
However, the current combination of Schwab, Arana, Wijay, and Halstead is silent regarding (i) the specific durometer values of each segment such that the first durometer is between 70A and 40D, the second durometer is between 45D and 55D, and the third durometer is between 40D and 45D.
As to the above, there is no evidence of record that establishes that changing the durometer of each segment to be within the claimed durometer range of each segment would result in a difference in function of the Schwab device. Further, a person having ordinary skill in the art, being faced with modifying the tip / tip extension of Schwab, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed durometer. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, indicating that the durometer “may” be within the claimed range, and offering alternate ranges (e.g., 80A to 45D, see Specification at para. [0037]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
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 each segment of the tip extension of Schwab in view of Halstead to have a durometer within the claimed range for each segment as an obvious matter of design choice within the skill of the art.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Schwab et al (US 5,769,819) (previously cited) in view of Arana et al (US 2009/0156998 A1) (previously cited) and Wijay et al (US 4,921,483), as applied to claim 1 above, and further in view of Tal (US 2007/0060882 A1) (previously cited).
Regarding claims 16 and 17, as discussed above, the combination of Schwab, Arana, and Wijay teach the balloon catheter of claim 1.
However, the combination is silent regarding (i) wherein at least a portion of the outer surface of the tip is coated with a slip agent comprising a hydrophilic coating.
As to the above, Tal teaches, in the same field of endeavor, a balloon catheter (balloon catheter 10) comprising a distal tip (catheter tip 78) comprising a slip agent comprising a hydrophilic coating (abstract, paragraphs [0053], [0081], and Fig. 1) for the purpose of allowing safer advancement of the catheter through the vasculature (paragraph [0081]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the distal tip of Schwab in view of Arana and Wijay to incorporate a hydrophilic coating / slip agent, based on the teachings of Tal, for the purpose of allowing safer advancement of the catheter through the vasculature (paragraph [0081] – Tal).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schwab et al (US 5,769,819) (previously cited) in view of Arana et al (US 2009/0156998 A1) (previously cited) and Wijay et al (US 4,921,483), as applied to claim 1 above, and further in view of Shuffler et al (US 2014/0005647 A1) (previously cited).
Regarding claim 18, as discussed above, the combination of Schwab, Arana, and Wijay teach the balloon catheter of claim 1.
However, the combination is silent regarding (i) wherein at least part of the third portion of the guidewire lumen comprises a polytetrafluoroethylene (PTFE) liner.
As to the above, Shuffler teaches a catheter device (catheter assembly 210) comprising a guidewire lumen (main lumen 216) comprising a PTFE liner for the purpose of facilitating the insertion of the guidewire therethrough (paragraphs [0090] and [0097]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the guidewire lumen of Schwab to incorporate a PTFE liner, based on the teachings of Shuffler, for the purpose of facilitating the insertion of the guidewire therethrough (paragraphs [0097] – Shuffler).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Schwab et al (US 5,769,819) (previously cited) in view of Arana et al (US 2009/0156998 A1) (previously cited) and Wijay et al (US 4,921,483), as applied to claim 1 above, and further in view of Hebert et al (US 2002/0165571 A1) (previously cited).
Regarding claim 20, as discussed above, the combination of Schwab, Arana, and Wijay teach the balloon catheter of claim 1.
However, the combination is silent regarding (i) wherein the tip comprises a plurality of radiopaque markers.
As to the above, Hebert teaches, in the same field of endeavor, a ballon catheter (catheter assembly 23) comprising a balloon (inflatable member 30) and a tip (lengthened distal section 200) comprising a plurality of radiopaque markers (markers 190 – 193) for the purpose of indicating the location of the distal end of the catheter within the body (abstract, paragraphs [0040], [0043], [0059], and Figs. 1, 5).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tip of Schwab to incorporate the multiple radiopaque markers, based on the teachings of Hebert, for the purpose of indicating the location of the distal end of the catheter within the body.
Response to Arguments
Applicant's arguments filed 07/10/2026 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument on point (1) and (2) see the Examiner’s response to the similar argument within the affidavit in the Response to Amendments section. Additionally, the Examiner further notes, that the newly recited reference, Wijay, teaches a PTCA catheter with a tip within the claimed range is known, and therefore, the PTCA catheter of Schwab would operate as intended given the claimed tip length. Furthermore, with respect to argument that with the given length, the PTCA catheter of Schwab would be inoperable because the length of most of the coronary side branches are within 2 to 4 cm in length, the Examiner notes that the use of a PTCA catheter is not limited to a single sized human, a PTCA catheter can be used on animals of varying sizes, which includes animals with larger than the most common coronary branch size; thus, the PTCA catheter of Schwab with the tip having a length within the claimed range would not inherently make the catheter inoperable for its intended use.
With respect to Applicant’s argument on point (3) similarly to what has been stated immediately above and within the response to the affidavit, the Examiner notes that the based on the newly recited reference, Wijay, the catheter of Schwab, when used as a PTCA catheter, would have a reasonable expectation of success with a tip length within the claimed range, as it is known within the art to have a PTCA catheter with a tip length within the claimed range, as well as it is known to adjust the length of the tip in order to arrive at the desired bendability of the catheter. Therefore, the Examiner asserts that the balloon catheter of Schwab would perform as expected and would not be in operable for its intended use with the claimed tip length; and that, based on the disclosure of Wijay, a tip length of 30mm (i.e., a length within the claimed range) is not ‘unexpected’ in view of the conventional wisdom regarding tip lengths.
With respect to Applicant’s argument on point (4) with respect to the “Design Choice” rational, the Examiner notes that based on the addition of the newly added reference, Wijay, the Examiner is no longer relying on the “Design Choice” rational. Therefore, the arguments directed to the use of the “Design Choice” rational are not persuasive, as they are not pertinent to the current rejection. Regarding Applicant’s other arguments on point (4) the Examiner has provided a response to similar arguments that are within the affidavit within the “Response to Amendments” section.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Brisken et al (US 2001/0051784 A1) teaches a balloon catheter with a tip length within the claimed range (i.e., 30mm).
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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