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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/25/2025 has been entered.
Response to Arguments
The amendment filed 09/25/2025 has been entered. Claims 1-4, 6-10, 12-19, 21-23 are pending in the application, claims 1-4, 6-10, 12-13 are withdrawn. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Final Office Action mailed 04/28/2025.
Claim Rejections - 35 USC § 103
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 14, 16, 18-19, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US 2010/0256487) in view of Rogers (US 2018/0256037).
Regarding Claim 14, Hawkins discloses a pediatric catheter (1, Fig 1) comprising: a shaft (7, Fig 1) including a distal end (8, Fig 1) and a proximal end (end of shaft 7 near hub 49, Fig 1), a length of the shaft defined between the distal end and the proximal end, the shaft further including: a first section (section of shaft from the distal tip to line 2A-A, Fig 2) positioned near the distal end, the first section being defined by an outer wall (21, Fig 2) and including a first aperture (57, Fig 2) extending therethrough and a second aperture (13, Fig 2)extending therethrough, at least a portion of the outer wall having a tapered surface (9, Fig 2); and a second section (section of shaft from line 2A-A to the hub, Figs 1-2) extending from the first section to the proximal end, the second section being defined by an outer wall that is coextensive with a portion of the outer wall of the first section (See Fig 2), the second section having a third aperture (part of the lumen 13 that is within the second section, Fig 2) that is coextensive with the second aperture of the first section; a plurality of holes (10, Fig 2) extending through the outer wall of the first section and configured to allow fluid to flow from the second aperture (Para 0043), the holes being positioned circumferentially about the outer wall of the first section (the holes are positioned along a circumference of the first section), each of the holes being positioned at different distances from the distal end (See Fig 2); a hub (49, Fig 1) coupled to the proximal end and configured to receive a guidewire therethrough (Para 0070, See Fig 9A).
Hawkins is silent regarding a plurality of reinforcement elements coupled to the second section, an opening being defined between the outer wall and a surface of each of the reinforcement elements, wherein the reinforcement elements are each configured to support the guidewire as it moves through the corresponding opening.
Rogers teaches an analogous catheter (100, Fig 1) comprising: a shaft including a distal end and a proximal end, a length of the shaft defined between the distal end and the proximal end, the shaft further including: a first section (104, Fig 1) positioned near the distal end, the first section being defined by an outer wall and including a first aperture (112, Fig 1) extending therethrough and a second aperture (108, Fig 1) extending therethrough, at least a portion of the outer wall having a tapered surface (See Fig 1); and a second section (102, Fig 1) extending from the first section to the proximal end, the second section having a third aperture (132, Fig 1); and a plurality of reinforcement elements (309, Fig 8) coupled to the second section, an opening (opening that receives guidewire 800, Fig 8) being defined between the outer wall and a surface of each of the reinforcement elements, wherein the reinforcement elements are each configured to support the guidewire as it moves through the corresponding opening (Para 0055).
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 second section to have a c-shaped cross-section and further comprise reinforcement elements as taught by Rogers in order to have a catheter with a reduced proximal cross-sectional profile to better track through guide catheters and blood vessels (Para 0005-0006).
Regarding Claim 16, the modified invention of Hawkins and Rogers discloses the second aperture (13, Fig 2A -Hawkins) and the third aperture (132, Fig 4A -Rogers) define a crescent-shaped lumen (Fig 4A, Para 0040 -Rogers).
Regarding Claim 18, the modified invention of Hawkins and Rogers discloses a length of the tapered surface ranges from 10 mm to 22 mm (Para 0042 -Hawkins; the tapered surface is defined as 1cm which is equivalent to 10mm).
Regarding Claim 19, the modified invention of Hawkins and Rogers discloses the first section extends along about 5% to 22% of the length of the shaft (the tapered portion 9 has a length of 1 cm as detailed in Para 0042 of Hawkins and the entire length of the shaft can be 10cm-15cm as detailed in Para 0055 of Hawkins. Thus, the at least a portion of the first section extends along 6.67% to 10% of the length of the shaft).
Regarding Claim 22, the modified invention of Hawkins and Rogers discloses the outer wall of the second section creates a recess (130, Fig 4A -Roger) that is aligned with the first aperture (112, Fig 5) such that the first aperture and the recess are configured to receive the guidewire (Para 0040; See Fig 5 -Roger), and wherein each of the openings is defined by the recess and one of the plurality of reinforcement elements (See Fig 8 -Rogers).
Regarding Claim 23, the modified invention of Hawkins and Rogers discloses the second section makes up about 25% to 66% of the length of the shaft (As detailed in the rejection of claim 19, the first section extends along at least 6.67% to 10%, thus the second section would make up at least 25%-66%), however, is silent regarding the reinforcement elements are spaced apart by distances of about 2 mm to 8 mm.
Rogers teaches that the number of reinforcement members and ultimately the spacing of the reinforcement members can be adjusted in order to retain the guidewire in the groove 332 (Para 0055).
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 reinforcement elements to be spaced apart by distances of about 2 mm to 8 mm since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US 2010/0256487) in view of Rogers (US 2018/0256037) and further in view of Galgon (US 2015/0165136).
Regarding Claim 15, the modified invention of Hawkins and Rogers discloses the plurality of holes (10, Fig 2 0Hawkins), however, is silent regarding the holes are offset from one another in a clockwise direction and in a horizontal direction.
Galgon teaches an analogous catheter (20, Fig 1A) comprising a plurality of holes (21, Fig 1A) extending through the outer wall of the first section and configured to allow fluid to flow from the second aperture (Para 0045), the holes being positioned circumferentially about the outer wall, wherein the holes are offset from one another in a clockwise direction and in a horizontal direction (Para 0049-0050; the holes can be arranged in a helical arrangement which would have them offset from one another in a clockwise direction and in a horizontal direction).
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 holes to be arranged in a helical arrangement as taught by Galgon in order to have desired characteristics of the delivery spray pattern (Para 0050).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US 2010/0256487) in view of Rogers (US 2018/0256037) and further in view of Eskridge (US 2006/0264905).
Regarding Claim 17, the modified invention of Hawkins and Rogers discloses the tapered surface (9, Fig 2 -Hawkins), however is silent regarding the tapered surface defines an angle ranging from 15 degrees to 30 degrees relative to an axis that is defined through the first aperture.
Eskridge teaches an analogous catheter (20, Fig 2) comprising a tapered distal surface (24, Fig 2) wherein the tapered surface defines an angle ranging from 15 degrees to 30 degrees relative to an axis that is defined through the first aperture (Para 0030).
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 tapered surface to have an angle ranging from 15 degrees to 30 degrees as taught by Eskridge in order to have a substantially atraumatic distal tip (Para 0008).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US 2010/0256487) in view of Rogers (US 2018/0256037) and further in view of Bornhoft (US 2019/0054270).
Regarding Claim 21, the modified invention of Hawkins and Rogers discloses all of the elements of the invention as discussed above, however, is silent regarding a plurality of radiopaque markers that are spaced along the length of the shaft.
Bornhoft discloses a catheter having a plurality of radiopaque markers (37, Fig 3) that are spaced along the length of the shaft (Para 0032).
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 catheter to include radiopaque markers as taught by Bornhoft in order to enhance visibility of the catheter in an x-ray (Para 0032).
Response to Arguments
Applicant’s arguments filed 09/25/2025, on pages 6-8, regarding Hawkin and Twardowski failing to teach the reinforcement elements as claimed in amended claim 14 have been fully considered but are moot in view of the current rejection that relies on Rogers to now teach the reinforcement element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner,
Art Unit 3783
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