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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-12 in the reply filed on 03/16/2026 is acknowledged.
Claims 13-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2026.
Information Disclosure Statement
Due to a long list of IDS submitted, examiner refers Applicant to MPEP 2004 and in particular to point 13 which states: It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant's attention and/or are known to be of most significance. See Penn Yan Boats, Inc. V. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff'd, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC V. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
In the instant case, it appears that many of the cited references are either irrelevant or marginally pertinent. Note that consideration by the examiner of the information submitted in an IDS means nothing more than considering the documents in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the coated portion extending along an entire length of the stylet as recited in claim 10 must be shown or the feature canceled from the claim. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 11 is objected to because of the following informalities:
Line 2, “lumina” should be changed to “luminal”.
Appropriate correction is required.
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.
Claim 10 is 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 10 recites the coated portion extending along “an entire length of the stylet…” However, since the coating is electrically insulative as required in claim 7 upon which claim 10 eventually depends, the coating would then cover the sensor and then the sensor would no longer be allowed to function. Claim 1 specifies that the sensor detects electrical signals, which would not be able to be detected if the sensor is covered by an insulator. For the purpose of examination, it will be assumed that the coated portion extends along at least a majority of the stylet, which does not include the distal end where the actual sensor is positioned.
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 1-3 and 7-11 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]), wherein the sensor is located at the distal end of the stylet (Fig. 6E), 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 7, Fields and Salamini teach the assembly according to claim 1 as shown above, the stylet (2202, Figs. 23A & 23B) of Salamini further including a coating ([0201], insulation layers of the leads) extending along a coated portion of the stylet, and the coating is electrically insulative ([0201]).
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 an entire length of the stylet disposed within the second lumen, since the coating cover the majority of the stylet (see 112 rejection above for interpretation).
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 lumina 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]).
Conclusion
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.
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/B.K./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783