DETAILED ACTION
Applicant’s amendments and remarks, filed February 20, 2026, are fully acknowledged by the Examiner. Currently, claims 43-52 are pending with claims 1-42 cancelled, and claims 43, 44, 47 and 48 amended. Applicant’s amendments to the claims have obviated the previously-filed Drawing objections as well as the rejection of claim 44 under 35 U.S.C. 112(b). The following is a complete response to the February 20, 2026 communication.
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 requirement in claim 43 of “an insulated spiral coil wire or braided wire configured to improve pushability and prevent kinking during penetration” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The Examiner notes that page 22 of the filed Specification sets forth that the insulated coil wire or braided wire is not shown.
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.
Claims 43-52 are 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.
Regarding claim 43, the claim has been amended to recite, amongst other limitations, the following limitations:
a guidewire lumen extending through the tapered tip and configured to receive a guidewire;
the intraseptal insertion part is configured to be advance along the guidewire through the septal vein … interventricular septum; and
wherein the guidewire lumen is dimensioned to closely receive the guidewire such that the intraseptal insertion part advances in axial alignment with the guidewire while lateral deflection of the tapered tip relative to the guidewire is substantially prevented during penetration of the interventricular septum.
The Examiner is of the position that requirements of each of 1) the advancing of the insertion part to be in axial alignment with the guidewire and 2) that lateral deflection of the tapered tip relative to the guidewire is substantially prevented are 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
The Examiner notes that the filed Specification sets forth a number of instances where a “close” contact is provided between the tip lumen and the guidewire. For example, lines 4-6 on page 5 set forth that “a tip lumen provided in the tapered tip may be in close contact with the guidewire and thus there may be no space therebetween”. Similar page 18 sets forth that “[t]he tip lumen 112 and the guidewire 10 are required to be in close contact with each other to have no space therebetween “ in lines 10-12. Page 18, line 18 – page 19, line 2 discuss that “there should be no space between the tip lumen and the guidewire” and that “[w]hen a space is defined between the tip lumen and the guidewire, the tapered tip is resisted by the interventricular septum”. Lastly, lines 4-7 of page 19 discuss that “although the tip lumen is in close contact with the guidewire, the close contact is required to be made to the degree that the RF ablation catheter moves along the guidewire.”
The Examiner, however, has failed to find any description that this close relationship disclosed in pages 5, 18 and 19 that the specific manner of advancement results in the insertion part to specifically be “in axial alignment with the guidewire”. The instant disclosure fails to define any manner of axis of the guidewire and, fails to define any manner of axis of the guidewire lumen and, as a result, fails to define any manner of relationship between such axes that would result in the claimed “axial alignment”. The Examiner notes that while various figures (see figures 6, 7 and 11) appear to show a limited section of the insertion portion including the guidewire lumen to have the guidewire located therein, the illustrated guidewire 10 includes multiple bends both internal and external to the insertion portion. Thus, the Examiner cannot effectively determine an axis of the guidewire and whether or not the insertion portion remains in axial alignment with the guidewire. The Examiner further notes that the most relevant depiction in figure 4 that shows the guidewire lumen at 112 along the tapered part of the insertion portion appears to define an opening that tapers from a larger size to a smaller size. Thus, the Examiner cannot find that the disclosure and illustrations readily support that “in axial alignment with the guidewire” as presently required in claim 43.
Continuing along these lines, the Examiner fails to find that this disclosed “close” or any other relationship ensures that lateral deflection of the tapered tip relative to the guidewire is substantially prevented. Again, the Examiner finds that the illustrated guidewire 10 includes multiple bends both internal and external to the insertion portion where the tapered tip will laterally deflect relative to the guidewire. Further, various embodiments of the depicted guidewire 10 and lumen through the catheter include off-axis bends (figures 4 and 7 with the off-axis opening at 118) and a tapered sizing of the lumen within the tapered tip (inset illustrations in figures 4 and 6). Thus, the Examiner cannot find that the disclosure and illustrations readily support that “lateral deflection of the tapered tip relative to the guidewire is substantially prevented” as presently required in claim 43.
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 43-52 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.
Regarding claim 43, the claim presently sets forth that lateral deflection is “substantially prevented” therein. The term “”substantially prevented” is being interpreted as a relative term which renders the claim indefinite. The term “substantially prevented” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant case, the Examiner is of the position that one of ordinary skill would not be reasonably apprised as to the amount of deflection allowed for by the terminology of “substantially prevented” so as to render the scope of the claim as indefinite. The Examiner notes that the rejection of claim 43 above discusses the deficiencies in the instant disclosure with respect to the lack of any recitation of deflection of the tapered tip relative to the guidewire. Claims 44-52 are rejected due to their dependency on claim 43. Appropriate correction is required.
Again, regarding claim 43, the claim presently sets forth a coil wire or braided wire that functions to “improve pushability” therein. This terminology is being interpreted as a relative term which renders the claim indefinite. The term “improve pushability” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant case, the Examiner is of the position that one of ordinary skill would not be reasonably apprised of a base amount of pushability for an intraseptal insertion part of an RF catheter nor is the degree of improvement of the pushability clearly defined or described in such a manner so as to render the scope of the claim as definite. Claims 44-52 are rejected due to their dependency on claim 43. Appropriate correction is required.
Regarding claim 45, the claim recites the limitation of “a tip lumen provided in the tapered tip is in close contact with the guidewire and thus there is no space therebetween”. Parent claim 43 provides for “a guidewire lumen extending through the tapered tip and configured to receive a guidewire” and with the guidewire lumen to be “dimensioned to closely receive the guidewire”. It is the Examiner’s position that the scope of claim 45 is indefinite given the substantial overlap in the claimed subject matter between the “guidewire lumen” and the “tip lumen, and further in view of that the claims fail to establish any manner of structural relationship between the claimed tip lumen and the guidewire lumen. Appropriate correction is required.
Regarding claim 46, the claim recites the limitation of “a tip lumen” therein. Parent claim 43 provides for “a guidewire lumen extending through the tapered tip and configured to receive a guidewire” and with the guidewire lumen to be “dimensioned to closely receive the guidewire”. It is the Examiner’s position that the scope of claim 46 is indefinite given the overlap in lumen location between the “guidewire lumen” and the “tip lumen, and further in view of that the claims fail to establish any manner of structural relationship between the claimed tip lumen and the guidewire lumen. Appropriate correction is required.
Regarding claim 50, the claim recites the limitation of “a cooling channel” therein. Parent claim 43 similar recites “a cooling channel”. The Examiner is of the position that the scope of claim 50 is indefinite given the substantial overlap in the claimed subject matter between each “a cooling channel”, and further in view of that the claims fail to establish any manner of structural relationship between each claimed cooling channel. Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see pages 5-6 of the Remarks filed February 20, 2026 with respect to the rejection of claim 43 under 35 U.S.C. 102(a)(1) as anticipated by Schaer (US Pat. No. 6,002,956) have been fully considered and are persuasive. In particular, Schaer fails to provide that the tapered tip of its device is functionally capable of being a needle to pierce a wall of a septal vein and penetrate an intraventricular septum as claimed. Said differently, there is no structurally evidence that the distal tip of Schaer at 17 can function to puncture tissue. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 43-52 are 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.
Claims 43-52 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Saadat et al. (US Pat. No. 6,120,520) provides for a plurality of the claimed features of an RF catheter assembly as claimed.
Hassett (US Pat. Pub. 2017/0020567 A1) provides for a catheter assembly including the use of a guidewire lumen to reach a desired location within the body.
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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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, 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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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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