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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a method of exchanging a catheter, classified in A61M25/0169.
II. Claims 14-16, drawn to a method of swapping out a gastro-jejunal (GJ) feeding tube, classified in A61J15/0015.
III. Claims 17-19, drawn to a catheter and catheter assembly, classified in A61M25/0026.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have materially different functions and/or effects. For example, the method of Invention I does not necessarily need to be performed in the gastro-jejunal tract, and could be performed in veins/arteries for treating conditions such as plaque removal. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product (invention III) does not necessarily need to be used with a replacement catheter or be used with steps of producing a second image on an electronic display and therefore could be used in a materially different process.
Inventions II and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product (invention III) does not necessarily need to be used in the GI tract, and could be used in methods that involve treating other parts of a patient such as veins/arteries.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The different invention would require a different search, including different classes/subclasses and/or search strings. For example, the search for invention II would require searching for a step of swapping a first GJ tube for a replacement GJ tube over a common exchange wire without radiography that would not necessarily be required in a search for invention I or III.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Johnathan Yates on 12/15/25 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 1-14 are objected to because of the following informalities:
As to claim 1, the examiner recommends amending the preamble to recite “A method of exchanging a catheter, the method comprising:” in order to make it more apparent that the word “comprising” applies to the method and not to the catheter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 10-12 are 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 catheter” in lines 2-3 which is unclear as there is more than one catheter mentioned previously.
Claims 11-12 are rejected as they depend from rejected claim 10.
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, hereafter "Honig") in view of Besz et al. (US 11,253,166 B2, 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 image on an electronic display establishing positioning of a first catheter at a treatment location within a patient, and producing a second image 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) and producing a second image on an electronic display (Col 9 in 43-47). It would have been obvious to one of ordinary skill in the art at before the effective filing date of the claimed invention to modify Honig with the teaching of Besz for the purpose of conveniently displaying the route of the catheter/feeding tube in a manner which directly relates it to the anatomy of a patient, enabling appropriate positioning of the detection apparatus on the patient, and providing the ability to reference position on a display monitor with position of internal parts of a patient. Consequently, 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. Furthermore, the route displayed will have characteristics that are likely to reassure a clinician that a desired route of the catheter has in fact been taken (Besz Col 9 In 36-47).
As to claim 3, Honig in view of 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 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 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 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 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 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 Besz teaches real-time imaging of location of a tip of a catheter (Col 9 ln 12-62). Thus, when producing the first image as noted in the rejection of claim 1, it follows that establishing the positioning of the first catheter would thus 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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honig in view of Besz as applied to claim 1 above, and further in view of Benseghir et al. (US 2023/0045275 A1, hereafter “Benseghir”)
As to claim 2, Honig in view of Besz teaches the method of claim 1 as described above, but does not expressly recite wherein the producing a first image includes producing a first fixed radiographic image, and the producing a second image includes producing a second fixed radiographic image.
Benseghir discloses methods and a system for guided device insertion and teaches the “imaging system 10 may be a table and/or wall stand system in a fixed x-ray room where the x-ray detector 34 is either permanently mounted together with the system or portable” (para 0031).
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) such that the producing a first image includes producing a first fixed radiographic image, and the producing a second image includes producing a second fixed radiographic image. One would have been motivated to do so as choosing between fixed versus portable types of imaging devices would have involved only a routine selection of known alternatives (see para 0031 of Benseghir).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honig in view of Besz as applied to claim 1 above, and further in view of Singh (US 2018/0055740 A1).
As to claims 9-11, Honig in view of 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 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 Besz as applied to claim 1 above, and further in view of Govari et al. (US 2011/0040150 A1, 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 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to claim 12, while Honig in view of 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).
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.
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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.
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/James D Ponton/Primary Examiner, Art Unit 3783