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 .
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 tongue projection that is naturally spring biased (claim 14) must be shown or the feature(s) canceled from the claim(s). 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 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no clear discussion (and no depiction in the Figures) of a tongue projection that is naturally spring biased as required by this claim. The language exists in the specification, but there is no specific description of how the tongue projection may be positioned in the catheter or the means by which the tongue projection is extended from the catheter. Nor is there any figure which clearly shows the structure.
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 16 and 19 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.
These claims are unclear with the scope of the claim, particularly in that they both recite positive recitations with respect to the second catheter, but the second catheter is never positively recited as an element in the claims. It is noted that claim 1 is directed to “A catheter comprising”, and all other recitations of the second catheter are done inferentially without positive recitation of the second catheter.
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.
Claims 1-8, 10, 12, 13 and 15-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pate et al (2019/0133678).
Regarding claim 1, Pate et al disclose a catheter comprising a catheter body (Figure 2, for example), a modification device (i.e. electrode) and a nesting region (i.e. magnetic attraction region). The modification device is configured to project from a working site of the catheter (Figure 1, for example) and the nesting region is configured to geometrically engage a nesting region of a second catheter (104 – Figure 1, for example).
Regarding claim 2, the modification device is an electrode (para. [0041], for example) and there is inherently a wire connecting the electrode to the energy source and controller. Regarding claim 3, the nesting region may be proximal to the working site (Figures 11A and 11B with a nesting region (1104) both proximal and distal to the working site (i.e. electrode 1102/1110). Regarding claim 4, the nesting regions is a channel (1100 – i.e. catheter lumen) with the electrode wire (1116) extending through the channel. Regarding claim 5, see again Figures 11A and 11B which shows nesting regions (i.e. magnets) proximal and distal of the electrode. Regarding claim 6, the nesting region is comprised of magnets (Figures 11A and 11B and associated discussion). Regarding claim 7, see again Figures 11A and 11B which show two catheters nesting at their respective nesting regions. Regarding claim 8, see again Figures 11A and 11B. Regarding claim 10, the catheter body comprises a fist portion having a first height (902 – Figure 9D, for example), a transition region (904) having a second height less than the first height and the transition region is positioned between the first portion (902) and the nesting region (908). Regarding claim 12, the catheter body (902 – Figure 9D) has a first height (i.e. diameter) and the maximum height of the nesting region (908) is greater than the first height. Regarding claim 13, the nesting region may comprise a tongue body (610) and a tongue projection (610) extending from the tongue body (Figure 6B, for example). Regarding claim 15, the modification device defines an active side of the catheter and the tongue projection extends from the tongue body from the active side of the catheter (Figure 6B, for example). Regarding claim 16, the nesting region (614) of the second catheter comprises a recess configured to receive the tongue of the first catheter (Figure 6B). Regarding claim 17, the nesting region comprises a groove body and a (606) and a groove recess (614) in the groove body (Figure 6B). Regarding claim 18, the modification device defines and active side of the catheter and the groove recess (614) is positioned on the active side of the catheter (Figure 6B). Regarding claim 19, the nesting region of the second catheter comprises a tongue projection (610 – Figure 6B) configured to be received in the groove recess.
Regarding claim 20, Pate et al provide a system for forming a fistula between two blood vessels (Abstract and para. [0003]) comprising a first catheter (600) comprising a first catheter body and a tongue, wherein the tongue comprises a tongue body and a tongue projection (610) that extends from the tongue body and the second catheter (606) comprises a second catheter body and a groove, the groove comprises a groove body and a groove recess (614) in the groove body and the groove recess is configured to receive the tongue projection (Figure 6B). The device includes a modification device (i.e. energy delivery means) to treat tissue as described throughout the specification. See, also, paragraph [0036]. Also note figures 7 and 8 which show one catheter (700) with a tongue (706) and a second catheter (800) with a groove having a recess (806) for receiving the tongue.
Regarding claim 21, the two catheters of Figure 6B and the two catheters of Figures 7 and 8 are designed to interlock to treat tissue as disclosed. Regarding claim 22, the first and second catheters are configured to be placed in first and second blood vessels (Abstract, for example). Regarding claim 23, the walls of the blood vessels are positioned within the groove and recess of the two catheters to capture tissue as claimed. Regarding claims 24 and 25, the Pate et al disclosure discusses the use of magnetic materials to attract the two catheters throughout the disclosure. Regarding claim 26, each catheter has a working site at the location of the nesting location (i.e. tongue and groove) as disclosed by Pate et al.
Claims 1-8, 10, 11, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohn et al (5,830,224).
Regarding claim 1, Cohn et al disclose a catheter comprising a catheter body (20), a modification device (i.e. electrode 114) and a nesting region (100A and 100B) wherein the modification device is configured to project from a working site of the catheter (Figures 9A-9D, for example) and the nesting region is configured to geometrically engage a nesting region of a second catheter (see Figure 12, for example, which shows both catheters engaged at their nesting regions).
Regarding claim 2, the modification device is an electrode (114) and an electrode wire (not shown in Figure 9, but inherently necessary and shown in Figure 14, for example). Regarding claim 3, the nesting region (100A) is proximal the working site (Figure 9). Regarding claim 4, the nesting region comprises a channel (112) and the electrode wire would have to extend through the channel to reach the electrode (114). Regarding claim 5, the nesting region (100B) is distal the working site. Regarding claims 6 and 7, the nesting region is made up of magnets that mate with the nesting region of a second catheter (Figure 12, for example). Regarding claim 8, the nesting region is made up of an array of magnets (100A and 100B) longitudinally positioned along the catheter body. Regarding claim 10, the catheter body comprises a first portion (proximal to 112 in Figure 9A) having a first height and a transition region (112) having a second height less that the first height, and the transition region is positioned between the first portion and the nesting region (100B). Regarding claim 11, the maximum height of the nesting region (100B) is equal to the first height of the catheter body. Regarding claims 17 and 18, the nesting region (i.e. distal end of the catheter) comprises a groove body (112) and a groove recess (110) positioned along an active side of the catheter.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pate et al (2019/0133678) in view of the teaching of Verin et al (8,048,072).
Pate et al fail to disclose a ball bearing associated with either of the catheters. Verin et al disclose another device that includes two catheters disposed on opposing sides of tissue, with each catheter having a magnetic nesting region for attracting the other catheter. See Figure 9, for example. In particular, Verin et al teach that it is known to provide a ball bearing (25 – Figure 12) positioned adjacent the nesting region to allow for motion of the second catheter along tissue and to determine a distance traveled by the catheter. See also column 7, lines 13-20.
To have provided the Pate et al device with a ball bearing positioned adjacent the nesting region to allow the catheter to move along tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Verin et al fairly teach it is known to use such a ball bearing in a similar catheter system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pate et al (10,695,534 and 2017/0202616), Miller et al (9,017,323), Rios et al (9,486,276) and Berman et al (10,603,040) disclose various other devices that utilize two catheters and magnetic attraction for creating fistulas in tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL PEFFLEY/
Primary Examiner
Art Unit 3794
/M.F.P/ June 8, 2026
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