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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
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 application, U.S. Provisional Application No. 63/476,878, fails 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. More specifically, this provisional application fails to disclose the subject matter recited in claims 3, 5, 7, and 8.
The Examiner notes that support for claims 3, 5, 7, and 8 has been found in U.S. Provisional Patent Application No. 63/584,358. As such, Examiner will be taking the priority date for these claims for the purposes of examination as 9/21/2023, this being the filing date of U.S. Provisional Application No. 63/584,358. Examiner will be taking the priority date for the remaining claims in this instant application for the purposes of examination as 12/22/2022, this being the filing date of U.S. Provisional Application No. 63/476,878.
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 16-20 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 16 and 19 recite the limitation “the distal face defining at least one aperture and including two symmetrical openings distinct from the at least one aperture”. However, there does not appear to be sufficient support for this specific claim limitation (e.g., symmetrical openings that are distinct from the aperture) in Applicant’s disclosure. Applicant is encouraged to amend the claims to clarify that the ‘aperture is composed of two distinct symmetrical openings’ (or something comparable).
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 4, 5, and 16-20 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.
Claims 4 and 5 recite the limitation "an aperture" in line 2. The antecedent basis for this limitation in the claims is confusing, since it’s unclear how/whether this ‘aperture’ is related to the previously-recited ‘aperture’.
Claims 16 and 19 are found to be indefinite because Examiner is unsure of what is meant by the limitation “located on opposite sides of the radiofrequency active plate [electrode] relative to the at least one aperture” (see lines 8 and 7, respectively). This renders the scope of the claims unclear. Appropriate correction is required.
Claims 16 and 19 recite the limitation "the distal portion of the elongate member" in lines 14 and 11 (respectively). There is insufficient antecedent basis for this limitation in the claim, since the previously-claimed “distal portion” was never linked to the “elongate member”.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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.
Claim(s) 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woloszko, U.S. 6,991,631 (hereinafter Woloszko).
Regarding claim 16, Woloszko discloses (note figs. 56A-C) an electrosurgical device comprising: an elongate member defining a lumen (extending proximally from ‘1840’) for fluid; a distal portion which includes a radiofrequency ‘active plate electrode’ (1820) and a distal face, the radiofrequency active plate electrode being located centrally on the distal face (note fig. 56B); the distal face defining at least one aperture (1840) and including two symmetrical openings distinct from the at least one aperture (as best understood) and located on opposite sides of the radiofrequency active plate electrode relative to the at least one aperture (note fig. 56B); the distal portion including at least one non-cutting portion (1808) and at least one cutting portion (1820) configured to deliver energy for puncturing the tissue wherein a distal surface of the radiofrequency active plate electrode forms the at least one cutting portion; and an ‘area of the distal portion of the elongate member’ necessarily defining an ‘arched-taper profile’ (see ‘1810’) located about the at least one aperture. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 17, Woloszko discloses (see above) an electrosurgical device wherein the radiofrequency active plate electrode is ‘permanently affixed’ to an electrically conductive portion (‘1821’; note col. 62, line 40) of the elongate member.
Regarding claim 18, Woloszko discloses (see above) an electrosurgical device wherein the two symmetrical openings are necessarily dimensioned to allow (i.e., capable of permitting) passage of a guidewire.
Regarding claim 19, Woloszko discloses (note figs. 56A-C) an electrosurgical device comprising: an elongate member defining a lumen (extending proximally from ‘1840’) for fluid; a distal portion which includes an electrode (1820) and a distal face, the electrode formed by a radiofrequency ‘active plate’ and ‘permanently affixed centrally upon the distal face’ (note fig. 56B); the distal face defining at least one aperture (1840) and including two symmetrical openings distinct from the at least one aperture (as best understood) and located on opposite sides of the radiofrequency active plate relative to the at least one aperture (note fig. 56B), the openings capable of allowing unimpeded passage therethrough; the distal portion including at least one non-cutting portion (1808) and at least one cutting portion (1820) formed by the radiofrequency active plate for puncturing the tissue; and the ‘distal portion of the elongate member’ necessarily defining an ‘arched-taper profile’ (see ‘1810’) located about the at least one aperture. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 20, Woloszko discloses (see above) an electrosurgical device wherein the distal face forms the ‘arched-taper profile’ (see ‘1810’), and the radiofrequency active plate is located at a distal-most location of the elongate member (note fig. 56A).
Allowable Subject Matter
Claims 1-3 and 6-15 are allowed.
Claims 4-5 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.
Response to Arguments
Applicant’s arguments, filed March 25, 2026, with respect to Ellman have been fully considered and are persuasive. The corresponding rejections have been withdrawn.
Applicant's arguments with respect to Woloszko have been fully considered but they are not persuasive. More specifically, Examiner asserts that the cited claims have been met as they are currently written, due to the breadth of limitations such as “active plate electrode,” “distal portion,” “elongate member,” “arched-taper profile,” “permanently affixed centrally upon the distal face” (see above rejections for updated interpretation). Therefore, Examiner maintains that the cited claims are still met in view of Woloszko, as can be seen above.
Conclusion
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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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