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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/04/2026 has been entered.
Response to Arguments
The previous rejection of claim(s) 6 and 8 over 35 U.S.C. 112(d) for failing to further limit the subject matter of claim 1 has been overcome in light of the amendments made to claim(s) 6 and 8 on 7/13/2026.
Applicant's arguments filed 7/13/2026 have been fully considered but they are not persuasive. With respect to Sardesai et al. (US 2021/0046291 A1), applicant argues that a balloon that merely can be partially inflated such that it does not fully occlude a vessel is not the same as a balloon that is structurally configured to permit blood perfusion during inflation.
However, applicant provides no evidence as to why a partially inflated balloon is structurally different than the claimed perfusion balloon. Because the lumen 104 that inflates the orienting balloon 107 is attached to a Luer connector 111 which is then connected to a syringe, valve etc. to provide for the introduction of balloon inflation media ([0055]), the user manually controls inflation of the balloon 107. Therefore, the user may partially inflate the balloon 107 such that its diameter does not occlude a vessel and in this scenario the balloon is configured to allow perfusion of blood flow. Further, as clearly shown in Figure 1, the balloon 107 is tapered toward the distal end of the catheter shaft. This tapering would also allow for perfusion of blood flow within a vessel at least when the balloon is only partially inflated by a user. It is noted that the claims do not require the balloon to be fully inflated to provide perfusion.
Applicant further argues the “wavy contour” surface of the balloon that serves to “provide channels for perfusion of blood across the orienting balloon when the orienting balloon is inflated” ([0062]) is fundamentally different from the claimed perfusion ballon, which itself is configured to allow perfusion of blood flow when inflated because a perfusion balloon inherently allows for blood perfusion during inflation.
However, the wavy contour surface of the balloon of Sardesai inherently allows blood perfusion during inflation and when the balloon is fully inflated. It appears applicant is arguing that because the wavy contour surface is optional, the orienting balloon is not a perfusion balloon when the option to not have the wavy contour surface is chosen. However, the rejection clearly modifies the orienting balloon 107 of Sardesai with the embodiment of Sardesai that teaches a perfusion orienting balloon 407 with a wavy contour or other three-dimensional contour when inflated to provide channels for perfusion of blood across the orienting balloon when the orienting balloon is inflated ([0062]). Thus, the modified orienting balloon of Sardesai always has channels to allow for blood perfusion and is therefore, a perfusion balloon.
Applicant argues the claim limitation “post-dilatory noncompliant balloon” is not merely a statement of intended use, it defines the structural configuration of the balloon. First, the examiner acknowledges the structure of a “noncompliant balloon” which is taught by Sardesai, as balloon 109 is noncompliant ([0065]). Instead, it is the “post-dilatory” limitation that is functional i.e., the way the noncompliant balloon is used. Applicant argues a post-dilatory balloon is designed and sized for post-dilation of a valve or anatomical structure, which requires specific structural characteristics including balloon diameter, compliance properties, and pressure ratings suitable for valve dilation.
However, as previously discussed, the anchoring balloon 109 is sized to inflate to the diameter of the transport catheter (see for example, Fig. 2), which is about the same size as the orienting balloon ([0065]) and the orienting balloon is 12-18 mm upon inflation ([0013]). Thus, the balloon 109 is about 12-18 mm upon inflation which is within applicant’s range of the “post-dilatory noncompliant balloon” as “the proximal balloon may have an inflated diameter of approximately 15-20 mm” ([0015]), therefore, has an appropriate diameter. The balloon 109 is noncompliant ([0065]), therefore, has appropriate compliance properties. Applicant does not provide any pressure ratings and the specification instead recites “the proximal balloon is inflated via standard practice to optimize valve performance” ([0072]). Thus, applicant admits that inflating a balloon to optimize valve performance is standard practice. Therefore, the standard, noncompliant, similar sized diameter balloon 109 of Sardesai is found structurally equivalent to the claimed “post-dilatory noncompliant balloon.” The fact that Sardesai discloses the anchoring balloon 109 may be used to anchor the transporter catheter to the inner surface of an introducer catheter, does not dispute the fact that Sardesai discloses a noncompliant balloon that could be used post-dilatory.
Applicant argues there is no evidence that Sardesai’s anchoring balloon 109 possess the structural characteristic necessary to perform post-dilation of a prosthetic heart valve. The examiner disagrees, and the structural equivalence of the balloon 109 of Sardesai and that claimed is discussed above.
In response to Applicant's argument that Sardesai discloses a transporter catheter that operates inside an introducer catheter or other outer catheter i.e., includes additional structure not required by Applicant's invention, it must be noted that Sardesai modified discloses the invention as claimed. The fact that Sardesai discloses additional structure not claimed is irrelevant.
With respect to amended claims 1 and 13, applicant argues Sardesai’s orienting balloon is designed for navigation through vasculature inside an introducer catheter, not for engaging prosthetic heart valves. However, Sardesai teaches in another embodiment “the transporter catheter is configured to perform a diagnostic, therapeutic, or interventional procedure where access to a target location inside a patient's body is desired. For example, the transporter catheter can be used to deliver and deploy a prosthetic device in the body” ([0091]). Sardesai teaches a first balloon 127, similar to orienting balloon 107, of the transporter catheter is configured “to deliver a prosthetic valve 121 to a native valve site” ([0092]; Fig. 28). Thus, Sardesai teaches a distal balloon 127 positioned to facilitate engagement with a prosthetic heart valve as claimed.
With respect to claims 10 and 19, applicant argues the claimed 8-10 mm distance is critical because it is a functional design parameter that enables the catheter to engage the top of a stent frame while maintaining sufficient catheter length distal to the balloon for crossing the valve. However, to demonstrate criticality of a claimed range, there must be a showing of unexpected results commensurate in scope with the claimed invention. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). No such showing was provided; therefore, the argument is not found persuasive.
Applicant argues the perfusion dilation catheter with the claimed 8-10 mm positioning would perform differently because this specific positioning enables the perfusion balloon to engage the top of a bioprosthetic valve stent frame during structural heart procedures. However, the applicant has not argued or provided evidence as to how or why the transporter catheter of Sardesai would perform differently by modifying the orienting balloon 107 to be positioned at 3 mm from the distal end of the catheter to be posited between 8-10 mm from the distal end of the catheter. In the instant case, it is the examiners position that Sardesai’s catheter would work equally well when the balloon 107 is 3 mm from the distal end of the catheter as it would when the balloon 107 is 8-10 mm from the distal end of the catheter.
With respect to claims 12 and 20, applicant argues Perkins’ wire lumens (158, 160) are configured to receive light fibers for activating drugs in vessel walls ([0047]), which is structurally and functionally distinct from wire lumens configured to receive wires through the elongated catheter shaft to the distal end of the elongated catheter shaft. The examiner respectfully disagrees. Applicant has not provided any evidence as to why Perkins’ wire lumens (158, 160) are structurally distinct from wire lumens configured to receive wires as claimed. It is the examiner’s position that the wire lumens (158, 160) of Perkins’ are capable of receiving wires therein as the lumens receive light fibers i.e., wires.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to modify Sardesai’s transporter catheter can be found in the teachings of Perkins’ as the light fibers allow for light transmission ([0042]). Further, one of knowledge generally available to one of ordinary skill in the art would know and understand the benefits of having light in a treatment site to better illuminate the site for more clear and accurate manipulation of the device. Additionally, all of applicants invention, that of Sardesai and that of Perkins are directed to the same, analogous art of balloon catheters. Therefore, one of ordinary skill in the art would have looked to Perkins when modifying Sardesai.
For at least the reasons stated above, applicant’s arguments are not found persuasive.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Similarly, should claim 2 be found allowable, claim 14 will be objected to, should claim 3 be found allowable, claim 15 will be objected to, should claim 4 be found allowable, claim 16 will be objected to, should claim 10 be found allowable, claim 19 will be objected to, and should claim 12 be found allowable, claim 20 will be objected to. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 1-4, 6-11, 13-16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardesai et al. (US 2021/0046291 A1).
Regarding claim 1, Sardesai discloses a perfusion dilatation catheter (catheter 100; Fig. 1) capable of use in a structural heart intervention procedure (the transporter catheter may be used to deliver a prosthetic valve; [0088]), comprising: an elongated catheter shaft (shaft 101), comprising a proximal end and a distal end (Fig. 1), configured to: enclose a plurality of lumens (including at least first lumen 104, second lumen 105, and third lumen 106; Fig. 1; [0053]), comprising: a proximal balloon inflation lumen (third lumen 106); and a distal balloon inflation lumen (first lumen 104); and house at least one inflation port (ports through connectors 111) configured to supply at least one inflation medium through the proximal balloon inflation lumen and the distal balloon inflation lumen ([0055]); a proximal balloon system, comprising: a proximal balloon (anchoring balloon 109) positioned along the elongated catheter shaft (Fig. 1); wherein the proximal balloon comprises a post-dilatory noncompliant balloon (balloon 109 is noncompliant and capable of being used “post-dilatory”; [0065]); and the proximal balloon inflation lumen (106; as 106 communicates with anchoring balloon 109; [0053]); and a distal balloon system, comprising: a distal balloon (orienting balloon 107) positioned along the elongated catheter shaft (Fig. 1), distal to the proximal balloon (Fig. 1), wherein the distal balloon (107) is tapered toward the distal end of the elongated catheter shaft (Fig. 1); and the distal balloon inflation lumen (104; as 104 communicates with orienting balloon 107; [0053]).
Sardesai fails to explicitly disclose wherein the distal balloon comprises a perfusion balloon configured to allow perfusion of blood flow when inflated.
However, Sardesai teaches an embodiment (Fig. 4a-4c) in which the distal balloon (orienting balloon 407) has a wavy contour or other three-dimensional contour when inflated to provide channels for perfusion of blood across the orienting balloon when the orienting balloon is inflated ([0062]).
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 distal balloon of Sardesai to be a perfusion balloon configured to allow perfusion of blood flow when inflated as taught by the additional embodiment of Sardesai in order to maintain blood flowing through a vessel wall during inflation, reducing the risk of myocardial injury.
While Sardesai discloses the perfusion balloon is sized appropriately to facilitate engagement with a prosthetic heart valve as the distal balloon (107) has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]), Sardesai fails to explicitly disclose the balloon 107 is positioned to facilitate engagement with a prosthetic heart valve.
However, Sardesai teaches an embodiment in which the transporter catheter is configured to perform a diagnostic, therapeutic, or interventional procedure where access to a target location inside a patient's body is desired. For example, the transporter catheter can be used to deliver and deploy a prosthetic device in the body ([0094]). In this embodiment, Sardesai teaches a first balloon 127, similar to orienting balloon 107, of the transporter catheter is configured “to deliver a prosthetic valve 121 to a native valve site” ([0092]; Fig. 28). Thus, Sardesai teaches a distal balloon 127 positioned to facilitate engagement with a prosthetic heart valve as claimed.
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 perfusion balloon of modified Sardesai to be positioned to facilitate engagement with a prosthetic heart valve in order to deliver and deploy a prosthetic device in the body.
Regarding claim 2, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein the proximal balloon (109) and the distal balloon (107): are affixed to an outer surface of the elongated catheter shaft (Fig. 1); and are separated by a set distance (Fig. 1).
Regarding claim 3, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein the set distance is approximately 10- 15 mm (as the gap between the distal end of the anchoring balloon and the proximal end of the orienting balloon may be in the range of about 10 mm; [0065]).
Regarding claim 4, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein: the at least one inflation port (111) comprises a first inflation port (111 at the proximal end of 106; Fig. 1) and a second inflation port (111 at the proximal end of 104; Fig. 1), the first inflation port (111 at end of 106) is configured to supply the at least one inflation medium through the proximal balloon inflation lumen (106) to the proximal balloon (109; as 106 communicates with anchoring balloon 109; [0053]), and the second inflation port (111 at end of 104) is configured to supply the at least one inflation medium through the distal balloon lumen to the distal balloon (107; as 104 communicates with orienting balloon 107; [0053]).
Regarding claim 6, Sardesai modified discloses wherein the perfusion balloon (modified 107) is configured to allow perfusion of blood flow when inflated by providing an inflated outer surface having a geometry (wavy contour or other three-dimensional contours) that permits blood to pass alongside the balloon ([0062]).
Regarding claim 7, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein the distal balloon (107) has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]).
Regarding claims 8-9, Sardesai modified fails to explicitly disclose wherein the post-dilatory noncompliant balloon (109) is configured to expand a previously deployed prosthetic heart valve, wherein the proximal balloon has an inflated diameter of approximately 15-20 mm.
However, Sardesai teaches that the distal balloon has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]) and both the distal (107) and proximal (109) balloons appear to have the same outer inflated diameter in Fig. 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify proximal balloon of modified Sardesai to have an inflated diameter of approximately 15-20 mm in light of the teachings of Sardesai in order to effectively anchor the proximal balloon within vasculature. A noncompliant balloon expanded to an inflated diameter of approximately 15-20 mm would be capable of expanding a previously deployed prosthetic heart valve as recited in claim 8.
Regarding claim 10, Sardesai modified discloses the invention as claimed above, and Sardesai discloses wherein: the distal balloon (107) comprises a proximal end and a distal end (Fig. 1), and the distal end of the distal balloon is approximately 3 mm from the distal end of the elongated catheter shaft ([0074]) but fails to explicitly disclose the distal end of the distal balloon is approximately 8-10 mm from the distal end of the elongated catheter shaft.
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 distal balloon of modified Sardesai to be approximately 8-10 mm from the distal end of the elongated catheter shaft 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 perfusion dilation catheter of Sardesai would not operate differently with the claimed distance of the distal balloon from the distal end of the elongated catheter shaft and since the distal balloon would still inflate at the modified distance, the catheter would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance “may” be within the claimed ranges (specification pp. [0016]).
Regarding claim 11, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein the plurality of lumens comprises a lumen (second lumen 105) configured to receive a curved-tipped guidewire (as the transporter catheter is configured to track over a guidewire that may have a variety of shapes in lumen 105; [0053]; [0066]).
Regarding claim 13, Sardesai discloses a perfusion dilatation catheter (catheter 100) capable of use in a structural heart intervention procedure (the transporter catheter may be used to deliver a prosthetic valve; [0088]), comprising: an elongated catheter shaft (shaft 101), comprising a proximal end and a distal end (Fig. 1), configured to: enclose a plurality of lumens (first lumen 104, second lumen 105, and third lumen 106), comprising: a proximal balloon inflation lumen (106); and a distal balloon inflation lumen (104); and house at least one inflation port (ports through connectors 111) configured to supply at least one inflation medium through the proximal balloon inflation lumen and the distal balloon inflation lumen ([0053]; [0055]); a distal balloon system, comprising: a balloon (compliant orienting balloon 107; [0066]) positioned along the elongated catheter shaft (Fig. 1) and tapered toward the distal end of the elongated catheter shaft (Fig. 1); and the distal balloon inflation lumen (104); and a proximal balloon system, comprising: a post-dilatory noncompliant balloon (noncompliant anchoring balloon 109; [0066]) positioned along the elongated catheter shaft (Fig. 1), proximal to the balloon (Fig. 1); and the proximal balloon inflation lumen (106).
Sardesai fails to explicitly disclose wherein the distal balloon comprises a perfusion balloon configured to allow perfusion of blood flow when inflated.
However, Sardesai teaches an embodiment (Fig. 4a-4c) in which the distal balloon (orienting balloon 407) has a wavy contour or other three-dimensional contour when inflated to provide channels for perfusion of blood across the orienting balloon when the orienting balloon is inflated ([0062]).
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 distal balloon of Sardesai to be a perfusion balloon configured to allow perfusion of blood flow when inflated as taught by the additional embodiment of Sardesai in order to maintain blood flowing through a vessel wall during inflation, reducing the risk of myocardial injury.
While Sardesai discloses the perfusion balloon is sized appropriately to facilitate engagement with a prosthetic heart valve as the distal balloon (107) has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]), Sardesai fails to explicitly disclose the balloon 107 is positioned to facilitate engagement with a prosthetic heart valve.
However, Sardesai teaches an embodiment in which the transporter catheter is configured to perform a diagnostic, therapeutic, or interventional procedure where access to a target location inside a patient's body is desired. For example, the transporter catheter can be used to deliver and deploy a prosthetic device in the body ([0094]). In this embodiment, Sardesai teaches a first balloon 127, similar to orienting balloon 107, of the transporter catheter is configured “to deliver a prosthetic valve 121 to a native valve site” ([0092]; Fig. 28). Thus, Sardesai teaches a distal balloon 127 positioned to facilitate engagement with a prosthetic heart valve as claimed.
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 perfusion balloon of modified Sardesai to be positioned to facilitate engagement with a prosthetic heart valve in order to deliver and deploy a prosthetic device in the body.
Regarding claim 14, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein the perfusion balloon (modified 107) and the post-dilatory noncompliant balloon (109): are affixed to an outer surface of the elongated catheter shaft (Fig. 1); and are separated by a set distance (Fig. 1).
Regarding claim 15, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein the set distance is approximately 10- 15 mm (as the gap between the distal end of the anchoring balloon and the proximal end of the orienting balloon may be in the range of about 10 mm; [0065]).
Regarding claim 16, Sardesai modified discloses the invention as claimed above, and Sardesai further discloses wherein: the at least one inflation port (111) comprises a first inflation port (111 at the proximal end of 106; Fig. 1) and a second inflation port (111 at the proximal end of 104; Fig. 1), the first inflation port (111 at end of 106) is configured to supply the at least one inflation medium through the proximal balloon inflation lumen (106) to the post-dilatory noncompliant balloon (109; as 106 communicates with anchoring balloon 109; [0053]), and the second inflation port (111 at end of 104) is configured to supply the at least one inflation medium through the distal balloon lumen to the perfusion balloon (modified 107; as 104 communicates with orienting balloon 107; [0053]).
Regarding claim 18, Sardesai modified discloses the invention as claimed above, and Sardesai discloses the perfusion balloon has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]), but fails to explicitly disclose wherein the post-dilatory noncompliant balloon has an inflated diameter of approximately 15-20 mm.
However, Sardesai teaches that the perfusion-style balloon has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]) and both the perfusion (modified 107) and post-dilatory noncompliant (109) balloons appear to have the same outer inflated diameter in Fig. 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify post-dilatory noncompliant balloon to have an inflated diameter of approximately 15-20 mm in light of the teachings of modified Sardesai in order to effectively anchor the post-dilatory noncompliant balloon within vasculature.
Regarding claim 19, Sardesai modified discloses the invention as claimed above, and Sardesai discloses wherein: the perfusion balloon (modified 107) comprises a proximal end and a distal end (Fig. 1), and the distal end of the perfusion balloon is approximately 3 mm from the distal end of the elongated catheter shaft ([0074]) but fails to explicitly disclose the distal end of the perfusion-style balloon is approximately 8-10 mm from the distal end of the elongated catheter shaft.
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 perfusion balloon of modified Sardesai to be approximately 8-10 mm from the distal end of the elongated catheter shaft 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 perfusion dilation catheter of Sardesai would not operate differently with the claimed distance of the perfusion-style balloon from the distal end of the elongated catheter shaft and since the perfusion-style balloon would still inflate at the modified distance, the catheter would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance “may” be within the claimed ranges (specification pp. [0016]).
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardesai et al. (US 2021/0046291 A1) in view of Perkins (US 2020/0276038 A1).
Regarding claims 12 and 20, Sardesai modified discloses the invention as claimed above, and Sardesai discloses wherein the plurality of lumens comprises a wire lumen (guidewire lumen 105) configured to receive a wire (guidewire) through the elongated catheter shaft to the distal end of the elongated catheter shaft ([0053]), but fails to disclose a plurality of wire lumens.
However, Perkins teaches a balloon catheter (100; Fig. 1) with a plurality of lumens (154, 150, 158, 160, 164; Fig. 4A) having a plurality of ports (115; Fig. 1), with first (150) and second (154) lumens inflating first and second distal balloons ([0046]), a guidewire lumen (164; [0037]) and additional wire lumens (158, 160) configured to receive wires (light fibers; [0047]).
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 plurality of lumens of modified Sardesai to comprise a plurality of wire lumens as taught by Perkins in order to allow for light fibers to be extended through the elongated catheter shaft to better illuminate the treatment site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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