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 .
Detailed Action
This is in response to the preliminary amendment filed 05/14/2025.
Allowable Subject Matter
Claim 20, 35-37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 20 recites, wherein the dilator and the guidewire are integrally formed. Claim 35 recites wherein the dilator is integral to the conduit. Claim 36 recites wherein the dilator is integral to the guidewire. Claim 37 recures wherein the dilator is integral to the conduit and the guidewire.
The Office agrees the art of record fail to teach or suggest these features.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 19, 26, 27, 29, 31, 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2011/0218520 (Andrich)
Regarding claims 1-3, 19, 26, 33 Andrich discloses as shown in Figure 1a, a catheter comprising: a conduit assembly having: a conduit (elongate shaft 12, see paragraph [0068]) having a proximal end portion, a distal end portion, and a lumen that extends through the conduit from the proximal end portion to the distal end portion; and a balloon (balloon 24, see paragraph [0070]) coupled to and configured to extend radially outwardly of the conduit, wherein the distal end portion of the conduit has: a distal tip of the conduit; and at least one inlet to the lumen that is positioned between the balloon and the distal tip of the conduit; see paragraph [0070]; and a guidewire (guidewire 38, see paragraph [0071]) is coupled to the conduit, wherein the guidewire extends distally of the distal end portion of the conduit, wherein the guidewire is removable from the lumen of the conduit, wherein the guidewire is non-removably coupled to the conduit, wherein the least one inlet to the lumen comprises two elongate inlets (holes 22, see paragraph [0069]) on opposed sides of the conduit, the catheter further comprising a fluid inlet in fluid communication with the balloon, wherein the fluid inlet is configured to receive a fluid to inflate the balloon; and a fluid source in communication with the fluid inlet, A method comprising: inserting the distal end portion of the conduit of a catheter into an interior passage of a patient; and inflating the balloon to secure the conduit within the interior passage, wherein the interior passage is a blood vessel, a biliary tract, a gastrointestinal tract, an oral passage, a pharyngeal passage, a laryngeal passage, or a pulmonary tract. See figures 1A, 1B.
Regarding claim 31, Andrich discloses further comprising: inverting the distal end portion of the conduit; and after inverting the distal end portion of the conduit, removing the distal end portion of the conduit of the catheter from the interior passage. See paragraph [0086].
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.
Claim(s) 4-7, 21, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218520 (Andrich) in view of U.S. Patent Publication Number 2015/0306361 (Feig et al.)
Regarding claims 4-7, 21, 34 Andrich fails to disclose a dilator that extends distally from the distal end portion of the conduit, wherein at least a portion of the dilator has a taper in a distal direction, wherein the dilator surrounds and receives a portion of the guidewire, wherein the guidewire extends beyond the distal end portion of the conduit by a first length, and wherein the dilator extends beyond the distal end portion of the conduit by a second length that is less than the first length, wherein the dilator has a length, wherein the dilator comprises: a distal end portion having consistent cross sections in planes perpendicular to the length of the dilator; and a proximal end portion that defines the taper, further comprising: a dilator that extends distally from the distal end portion of the conduit; and a flow channel in communication with the dilator, wherein the dilator is configured to inflate upon receipt of fluid from the flow channel, wherein the distal end portion of the conduit comprises a taper or a helical shape that defines a dilator
Feig et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, where the catheter includes a dilator (soft tip 22, see paragraph [0137]) that extends distally from the distal end portion of the conduit, wherein at least a portion of the dilator has a taper in a distal direction, wherein the dilator surrounds and receives a portion of the guidewire, wherein the guidewire extends beyond the distal end portion of the conduit by a first length, and wherein the dilator extends beyond the distal end portion of the conduit by a second length that is less than the first length, wherein the dilator has a length, wherein the dilator comprises: a distal end portion having consistent cross sections in planes perpendicular to the length of the dilator; and a proximal end portion that defines the taper, further comprising: a dilator that extends distally from the distal end portion of the conduit; and a flow channel in communication with the dilator, wherein the dilator is configured to inflate upon receipt of fluid from the flow channel, wherein the distal end portion of the conduit comprises a taper or a helical shape that defines a dilator for the purpose of facilitating passage of the catheter through bending or tortuous passages in the body. See paragraph [0137].
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 disclosed by Andrich to include the dilator disclosed by Feig et al. such that a catheter includes a dilator that extends distally from the distal end portion of the conduit, wherein at least a portion of the dilator has a taper in a distal direction, wherein the dilator surrounds and receives a portion of the guidewire, wherein the guidewire extends beyond the distal end portion of the conduit by a first length, and wherein the dilator extends beyond the distal end portion of the conduit by a second length that is less than the first length, wherein the dilator has a length, wherein the dilator comprises: a distal end portion having consistent cross sections in planes perpendicular to the length of the dilator; and a proximal end portion that defines the taper in order to facilitate passage of the catheter through bending or tortuous passages in the body, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 22, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218520 (Andrich) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.)
Regarding claim 22, 23 Andrich fails to disclose wherein the guidewire has a length, wherein the guidewire defines a major cross sectional dimensions in cross section in respective planes perpendicular to the length, wherein the major cross sectional dimensions of the guidewire vary along the length of the guidewire, wherein the guidewire has a length, wherein the guidewire has a variable stiffness along the length of the guidewire.
Schock et al. from the same field of endeavor teaches a similar catheter as shown in Figures 4A-4E where the guidewire has a length, wherein the guidewire defines a major cross sectional dimensions in cross section in respective planes perpendicular to the length, wherein the major cross sectional dimensions of the guidewire vary along the length of the guidewire, wherein the guidewire has a length, wherein the guidewire has a variable stiffness along the length of the guidewire. See paragraphs [0045]-[0049].
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 disclosed by Andrich by substituting the guidewire disclosed by Schock for the one taught by Feig et al. such that wherein the guidewire has a length, wherein the guidewire defines a major cross sectional dimensions in cross section in respective planes perpendicular to the length, wherein the major cross sectional dimensions of the guidewire vary along the length of the guidewire, wherein the guidewire has a length, wherein the guidewire has a variable stiffness along the length of the guidewire because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218520 (Andrich) in view of U.S. Patent Number 5,772,609 (Nguyen et al.)
Regarding claim 24, Andrich fails to disclose wherein the guidewire has a length and a coating, wherein the coating varies along the length of the guidewire.
Nguyen et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, where the guidewire includes a coating, wherein the coating varies along the length of the guidewire, for the purpose of a lubricating parts of the guide wire. See abstract.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the coating taught by Nguyen et al. on the guidewire disclosed by Andrich in order to lubricate parts of the guide wire, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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