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 .
Response to Amendment
The following is in response to the amendment received on 5/5/26. Claims 1 and 10 have been amended. Claim 2 has been cancelled. Claims 3-9 and 11-13 are unamended. Claims 14-19 are withdrawn.
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 of this title, 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.
Claim(s) 1 and 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honig (US 2014/0142552 A1, cited previously and hereafter "Honig") Lee et al. (US 2018/0249973 A1, hereafter “Lee”), and further in view of Besz et al. (US 11,253,166 B2, cited previously and hereafter “Besz”).
As to claim 1, Honig discloses a method of exchanging a catheter comprising:
establishing positioning of a first catheter (10; see Figs. 1-4) at a treatment location within a patient (para 0022);
advancing an exchange wire (40) through the first catheter to a predefined target insertion depth (para 0026, 0027);
removing the first catheter from the patient (para 0027);
advancing a replacement catheter over the exchange wire (para 0027; a new/replacement tube is placed over the wire).
While Honig discloses using real time x-ray or fluoroscopy during a replacement procedure (see para 0027, 0028), Honig does not expressly recite producing a first fixed radiographic image of a patient on an electronic display establishing positioning of a first catheter at a treatment location within a patient. Lee discloses an apparatus and method for tracking a location of a surgical tool which includes producing a first fixed radiographic image of a patient on an electronic display establishing positioning of the tool at a treatment location within a patient (see para 0002, 0013, 0014, 0021, 0027, 0032, 0063). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Honig to include producing a first fixed radiographic image of a patient on an electronic display establishing positioning of a first catheter at a treatment location within a patient. One would have been motivated to do so as an alternative/safer way of establishing the location of the first catheter (see para 0002, 0006, 0013, 0014, 0021, 0027, 0032, 0063 of Lee).
Honig and Lee are silent to producing a second fixed radiographic image of the patient on an electronic display confirming placement of the second catheter at the treatment location within the patient. Besz teaches a catheter locating, imaging, and display apparatus and method (Col 5 In 21-60) comprising producing a first image on an electronic display (Fig. 6: electronic display, Col 9 In 30-62) an explicitly teaches “the procedure of re-checking the position of the caudal/distal end of the catheter and retracing the route of the catheter at future times can be easily conducted and the results compared with earlier records of the catheter tip position” (Col 9 ln 43-47). It therefore would have been obvious to one having ordinary skill in the art, well aware of the imaging techniques described above in Lee, to have further modified the method of Honig to include producing a second fixed radiographic image of the patient on an electronic display confirming placement of the second catheter at the treatment location within the patient. One would have been motivated to do so as a way to confirm a proper positioning of the second catheter.
As to claim 3, Honig in view of Lee and Besz teaches the method of claim 1 as described above. Honig further discloses confirming advancement of the exchange wire to the predefined target insertion depth via an indelible indicator (46) upon at least one of the exchange wire or the first catheter (para 0027).
As to claim 4, Honig in view of Lee and Besz teaches the method of claim 3 as described above. Honig further discloses wherein the indelible indicator includes a marking upon the exchange wire (para 0027).
As to claim 5, Honig in view of Lee and Besz teaches the method of claim 3 as described above. Honig further discloses wherein the first catheter and the second catheter are interchangeable for service at the treatment location within the patient (para 0013, 0023, 0027).
As to claim 6, Honig in view of Lee and Besz teaches the method of claim 5 as described above. Honig further discloses wherein the treatment location is in the patient's gastro-intestinal (GI) tract (para 0022).
As to claim 7, Honig in view of Lee and Besz teaches the method of claim 6 as described above. Honig further discloses wherein each of the first catheter and the second catheter includes a gastro-jejunal (GJ) feeding tube (para 0022).
As to claim 8, Honig in view of Lee and Besz teaches the method of claim 7 as described above. While Honig does not expressly recite wherein the producing the first image includes producing the first image establishing a jejunal feeding tip of the first catheter has not slipped back above the pylorus in the patient's GI tract, Honig does teach that imaging is performed for initial placement of its guide wire in an already-placed feeding tube (see para 0027, 0028), and Lee teaches producing a first image indicating proper positioning of a tool at a treatment location (see para 0002, 0013, 0014, 0021, 0027, 0032, 0063). It therefore follows that one having ordinary skill in the art, when performing the modified method of Honig, would have sought to ensure proper positioning of the first catheter, which would include establishing a jejunal feeding tip of the first catheter has not slipped back above the pylorus in the patient's GI tract (i.e. verifying the location of an already placed feeding tube and/or placement of a guidewire therein would confirm that the first catheter has not slipped back above the pylorus in the patient's GI tract).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honig in view of Lee and Besz as applied to claim 1 above, and further in view of Singh (US 2018/0055740 A1, cited previously).
As to claims 9-11, Honig in view of Lee and Besz teaches the method of claim 1 as described above, but are silent to establishing access for the exchange wire through the first catheter at a location between a proximal end and a distal end of the first catheter, wherein the establishing access includes forming an opening to a normally closed retrieval lumen of the first catheter, and wherein the forming an opening to the normally closed retrieval lumen includes cutting at least partially through the first catheter.
Singh discloses establishing access for an exchange wire through a first catheter at a location between a proximal end and a distal end of the first catheter, wherein the establishing access includes forming an opening to a normally closed retrieval lumen of the catheter, and wherein the forming an opening to the normally closed retrieval lumen includes cutting at least partially through the first catheter (see para 0100, 0165, claim 34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Honig (as already modified above), and to modify the method by including a step of cutting the first catheter such that establishing access for the exchange wire through the first catheter at a location between a proximal end and a distal end of the first catheter, wherein the establishing access includes forming an opening to a normally closed retrieval lumen of the catheter, and wherein the forming an opening to the normally closed retrieval lumen includes cutting at least partially through the first catheter. One would have been motivated to do so to suit the physical dimensions as required for the patient/procedure (see para 0100, 0165, claim 34 of Singh).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honig in view of Lee and Besz as applied to claim 1 above, and further in view of Govari et al. (US 2011/0040150 A1, cited previously and hereafter “Govari”).
As to claim 13, Honig in view of Besz teaches the method of claim 1 as described above, but is silent to activating a transducer embedded in a tip of the first catheter to produce a signal, and the producing a first image includes producing the first image based on the signal.
Govari however discloses “catheter 22 also comprises a position transducer 30 within its distal tip, for use in determining position coordinates of the tip. For example, transducer 30 may comprise a magnetic field sensor, which detects magnetic fields generated by field transducers 32 at known locations outside the body” (para 0029).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Honig (as already modified above) to include activating a transducer embedded in a tip of the first catheter to produce a signal, and the producing a first image includes producing the first image based on the signal. One would have been motivated to do so as Govari teaches that transducers positioned within the distal tip of a catheter can be used to determine position coordinates of the tip (see para 0029 of Govari).
Allowable Subject Matter
Claim 12 is 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:
As to claim 12, while Honig in view of Lee, Besz and Singh teaches the method of claim 11 as described above, each are silent to limiting a cut depth radially through the first catheter via an embedded anti-cut structure of the first catheter in combination with all the limitation of the claims from which claim 12 depends (i.e. in combination with claim 1 and all intervening claims).
Response to Arguments
Applicant’s Remarks submitted 5/5/26 have been considered.
With regard to the previous claim objections and rejections under 35 U.S.C. 112(b), the Remarks are persuasive/moot as the amendments have obviated the previous issues.
With regard to the previous rejection under 35 U.S.C. § 103, the examiner was under the impression that a “fixed” radiographic image was an image from a fixed radiographic device, rather than a portable one, hence the previous Benseghir (US 2023/0045275 A1) reference. Based on the applicant’s Remarks, a “fixed” radiographic image appears to refer to a non-real time image/singular frame. This has resulted in usage of the Lee reference above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 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, Chelsea Stinson can be reached at 571-270-1744. 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.
/James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights