8DETAILED 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 .
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.
Claims 1-6 and 8-12 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.
Claim 1 recites “the coating extending along a coated portion of the stylet within the second lumen.” First, it is unclear if the “coating” is the same coating used in the “coated portion” or if it a different coating meaning there are two coatings being claimed. Second, it is unclear if the “coated portion” is on the stylet or if it is part of the second lumen. For examination purposes, a single coating will be assumed that is only on the stylet.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,066,489 to Fields et al. (“Fields”) in view of U.S. Patent Publication 2023/0285719 to SALAMINI et al. (“Salamini”).
Regarding claim 1, Fields teaches a catheter assembly (Fig. 1 & 7) comprising a catheter including a catheter tube (15) configured for placement within a vasculature of a patient, the catheter tube defining a distal end (right end of 15, Fig. 7), a first lumen (20) extending along the catheter tube, the first lumen in fluid communication with a first extension leg (27) and a second lumen (22) extending along the catheter tube, the second lumen in fluid communication with a second extension leg (29), a stylet (48) disposed within the second lumen, and a sensor pocket of the second lumen, the sensor pocket positioned at a closed distal end of the second lumen (right closed-end of lumen 22, Fig. 7), but does not teach the sensor and the aperture.
Salamini teaches a stylet ([0131]-[0132], Fig. 6E, dotted line or also labeled 502 in other figures) including a sensor (Fig. 6E, clear circle, also labeled 302 in other figures) configured to detect an electrical signal emanating from the patient ([0126]), a coating ([0201]) disposed on an outer surface of the stylet (Fig. 23B, the enclosure 2206 is co-extruded with the insulation layer forming a coating) extending along a coated portion of the stylet (Fig. 23B), wherein the coating is electrically insulative ([0201]), the sensor is located at the distal end of the stylet (Fig. 6E, the sensor/white dot is at the distal end of the stylet/dotted line), and an aperture (602) extending through a luminal wall of the lumen defines a fluid pathway between a sensor pocket and the vasculature ([0132]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor-type stylet of Salamini for the stylet of Fields in order to identify a location of the catheter to determine whether the catheter is in the correct position ([0126]). Once combined, the sensor would be disposed within the sensor pocket of the second lumen of Fields.
Regarding claim 2, Fields and Salamini teach the assembly according to claim 1 as shown above, Salamini further teaching the aperture defines an electrical pathway between the sensor and the vasculature (601 forms an electrical pathway for the sensor to operate).
Regarding claim 3, Fields and Salamini teach the assembly according to claim 1 as shown above, once the pocket of Fields is modified with the aperture of Salamini, the aperture would be positioned adjacent the pocket.
Regarding claim 8, Fields and Salamini teach the assembly according to claim 1 as shown above, Fields further teaching the second lumen includes a fluid opening (45) extending through the luminal wall, and fluid opening is disposed proximal the aperture (Fig. 7).
Regarding claim 9, Fields and Salamini teach the assembly according to claim 8 as shown above, once combined the coated portion would be disposed adjacent the fluid opening, since the coating covers the majority of the stylet.
Regarding claim 10, Fields and Salamini teach the assembly according to claim 8 as shown above, once combined the coated portion would extend along at least a majority of the stylet disposed within the second lumen.
Regarding claim 11, Fields and Salamini teach the assembly according to claim 8 as shown above, once combined the coating substantially occupies an annular space between the stylet and the luminal wall, since the majority of the stylet is covered by the coating and the stylet is inserted into the catheter adjacent the lumina wall.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fields in view of Salamini as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2010/0256487 to Hawkins et al. (“Hawkins”).
Regarding claim 4, Fields and Salamini teach the assembly according to claim 1, Fields further teaching the catheter tube includes a tapered distal portion defining a first diameter at the distal end and a second diameter at a proximal end of the tapered distal portion, the second diameter is greater than the first diameter, and the pocket is disposed along the tapered distal portion (the distal tip of 15 is tapered as shown in Fig 7 and therefore shows the relative diameters), but do not explicitly show the tapered distal portion extending proximally away from the distal end of the catheter tube.
Hawkins teaches a tapered distal portion (9, Fig. 2) extending proximally away from the distal end (8) of a catheter tube (5) in a similar device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tapered distal end of Fields with the tapered distal end of Hawkins to yield the predictable result of providing a tapered distal end of a dual lumen catheter for navigating a vasculature of a patient, the two tapered distal end types being art-recognized alternative variants to suit particular needs or applications as would be understood by a skilled artisan.
Regarding claim 5, Fields, Salamini, and Hawkins teach the assembly according to claim 4 as shown above, once combined with the tip of Hawkins, the distance between the distal end of the catheter tube and the pocket would be less than one half of a length of the tapered distal portion (Hawkins, Fig. 2).
Regarding claim 6, Fields, Salamini, and Hawkins teach the assembly according to claim 4 as shown above, but do not explicitly mention the claimed distance.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the distance between the distal end of the catheter tube and the pocket taught by Fields, Salamini, and Hawkins have a range of less than 2 cm, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Fields, Salamini, and Hawkins would not operate differently with the claimed distance between the pocket and the distal end of the catheter tube, as this distance would be suitable for allowing the tip of the catheter tube to navigate the vasculature of a patient for particular applications as would be understood by a skilled artisan.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fields in view of Salamini as applied to claim 8 above, and further in view of U.S. Patent Publication No. 2009/0062772 to Wakeford et al. (“Wakeford”).
Regarding claim 12, Fields and Salamini teach the assembly according to claim 8 as shown above, but do not explicitly mention a lubricant.
Wakeford teaches a coating includes a lubricant on a stylet ([0073]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a lubricant on the stylet of Fields and Salamini as taught by Wakeford in order to facilitate easy sliding of the stylet ([0073]).
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant's arguments with respect to art rejections have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues that channel 602 of Salamini is not an aperture that extends through a luminal wall to the vasculature. Examiner respectfully disagrees. As can be seen in Fig. 6E, the bottom portion of 602 extends through the luminal wall of the stylet into the vasculature (right end of 602 opening into the vasculature), this provides a connection between the sensor positioned therein to the vasculature at the opening at the right end. Applicant also argues that the combination would not teach the sensor being disposed within the sensor pocket of the second lumen of fields and that Salamini does not show a sensor disposed on a stylet. Examiner respectfully disagrees. As shown in Fig. 6E, the sensor (white circle) is disposed on the stylet (dotted line). Examiner is not relying on Salamini for aspects of the stylet, merely a sensor that is disposed thereon. Once modified, the stylet of Fields & Salamini would be disposed in the sensor pocket or end of the lumen of fields. Applicant also argues that the power supplied to the electrode 35 of Fields would interfere with the sensor of the modified Fields reference. Examiner respectfully disagrees. Examiner submits the potential existence of interference is merely conjecture. As stated by Applicant, Fields supplies low intensity current and without specifics as to the exact type of sensor and the fact that the sensor and electrode would be physically isolated, there is no specific evidence that such interference would absolutely exist. Lastly, Applicant argues that Salamini does not disclose the new limitation of a coating disposed on an outer surface of the stylet. As shown above, paragraph [0201] of Salamini discloses the use of insulating materials including an embodiment where the enclosure 2206 can be coextruded with in the insulating layers of the leads as shown in Fig. 23B, which shows the same insulating material surrounding both the lead (left 2202) and the stylet forming a “coating” as best demonstrated by reference numeral 2206 surrounding the stylet.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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.
/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights