DETAILED ACTION
Applicant’s preliminary amendment, filed October 24, 2024, is fully acknowledged by the Examiner. Currently, claims 16-25 are pending with claims 1-15 cancelled, and claims 16-25 newly added. The following is a complete response to the October 24, 2024 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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under one or more of the above referenced sections as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. PCT/US2023/066712) and Application No. 63.364263, each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For reference, please see the rejection of claim 16 below under 35 U.S.C. 112(a) for failing to comply with the enablement requirement for a reasoning as to the deficiencies regarding enablement in each of the above listed application.
Accordingly, claims 16-25 are not entitled benefit from either of the above listed applications and the priority date for the instant application will be treated as October 24, 2024.
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, a) the requirement in claim 16 of “the loop of the cutting element is positioned around the cutting element and is retractable proximally relative to the cutting element” and b) the requirement of the electrodes on the wire portion of the cutting element as in each of claims 21 and 25 must be shown or the feature(s) canceled from the claim(s) 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the instant Specification fails to provide antecedent basis for the claim terminology of “the loop of the cutting element is positioned around the cutting element and is retractable proximally relative to the cutting element” as set forth in independent claim 16. Similarly, the Specification fails to provide for antecedent basis for the various shapes of the loop of the wire as in claim 22 in combination with the above cited language in claim 16.
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 16-25 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 16, the claim currently recites the limitation of “the loop of the cutting element is positioned around the cutting element and is retractable proximally relative to the cutting element” therein.
The Examiner has reviewed the instant disclosure but is of the position that such fails to provide for an enabling disclosure for the at-issue language. The Examiner readily appreciates that electrosurgical devices for treating within the heart are known and understood in the art, and that the level of predictability is generally straightforward. The Examiner has reviewed the instant disclosure but has failed to find any specific direction or working example of the loop of the cutting element to be positioned around itself and further being proximally retractable relative to itself. In specific, the Examiner has found no disclosure that the loop of the cutting element (“CE” as set forth throughout the Specification) being positioned around the cutting element. To this end, the term of “loop” only appears three times in the entirety of the disclosure with only paragraphs [0018] and [0074] of the filed Specification noting that the cutting element (CE) has a loop. These paragraphs provide general disclosure of the loop of the cutting element with no insight as to how a loop of a cutting element may be positioned around itself, or be retractable proximally relative to itself. Similarly, figures 9A-H and 11 provide for multiple arrangements of the loop with none extending around the cutting element itself.
Rather, the disclosure and the drawings display that the loop of the cutting element extends away from the shaft of the cutting element and, at no time extends around any portion of itself so as to reasonably convey to one of ordinary skill in the art as to how to make and/or use the claimed apparatus with “the loop of the cutting element is positioned around the cutting element and is retractable proximally relative to the cutting element”. Thus, the Examiner finds that the undue experimentation would be required to make the apparatus set forth in claim 16 as presently claimed.
Claims 17-25 are rejected due to their dependency on claim 16. Appropriate correction is required.
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 16-25 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 16, the claim presently recites “a cutting element comprising a wire portion in the shape of a loop … the loop of the cutting element is positioned around the cutting element and is retractable proximally relative to the cutting element”.
In particular, while the Examiner can understand that the cutting element includes “a wire portion in a shape of a loop”, the Examiner is of the position that the structural relationship required between the wire portion and the cutting element is indefinite due to the manner in which the wire portion is defined in relationship to the cutting element itself. Said differently, the cutting element comprises the wire portion and then the structural and functional features of the wire portion are defined relative to the entirety of the cutting element. Thus, the Examiner is unable to reasonably ascertain the scope of the claim when it is unclear how, for example, the loop of the cutting element is both a) positioned around the cutting element and retractable proximally relative to the cutting element.
Claims 17-25 are rejected due to their dependency on claim 16. Appropriate correction is required.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kappel et al. (US Pat. Pub. 2013/0172828 A1) is particularly relevant in provide for a number of limitations as set forth in claim 16 including a delivery catheter at 20, a leaflet crossing tool as in figures 13A/B with the tool at 210, a cutting element comprising a wire portion in a shape of a loop adapted for applying electrical cutting energy at 70.
Chu et al. (US Pat. No. 5,846,248) is particularly relevant at figure 19 for an apparatus for capturing and cutting tissue within the body.
Bahney (US Pat. Pub. 2009/0192510 A1) provides for a relevant device for capturing and cutting tissue within the body.
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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