DETAILED ACTION
Currently, claims 1-3 and 5-22 are being examined, while the remaining claims have been cancelled.
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 6, 2026 has been entered.
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 ‘arm deployable from the distal end portion lumen’ (from claim 12) in conjunction with the ‘shaft, arm, hook, and cutter configuration’ (from claim 1) 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.
Claims 12-13 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.
Claim 12 recites the limitation “the at least one arm deployable from the lumen”, and claim 13 recites the limitation “to draw the native heart valve leaflet against the cutter as the at least one arm is retracted towards the cutting condition”. Due to the chosen terminology, it appears as though Applicant is combining the embodiment depicted in figs. 10A-B (which is tied to claims 12-13) with the embodiment depicted in figs. 5 and 7 (which is tied to claim 1). However, there does not appear to be sufficient support for this specific combination of embodiments in Applicant’s disclosure. 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.
Claim 13 is 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 13 is found to be indefinite because Examiner is unsure of what is meant by the limitation “to draw the native heart valve leaflet against the cutter as the at least one arm is retracted towards the cutting condition”. More specifically, the scope of this limitation is unclear since it appears to contradict the independent claim, which describes the “cutting condition” as a deployed configuration (i.e., not a retracted configuration). Appropriate correction is required.
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) 1-3, 5, 7, 9, and 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dormann, U.S. 2017/0143363 (hereinafter Dormann).
Regarding claim 1, Dormann discloses (note figs. 1-2) a system comprising: an elongate shaft (proximal portion of ‘10’) having a proximal end portion, a distal end portion and a longitudinal axis extending therebetween, the distal end portion extending along the longitudinal axis in a first direction (see fig. 2), the elongate shaft capable of being used for transvascular delivery of the distal end portion to a native heart valve; at least one ‘arm’ (distal portion of ‘10’) extending from the distal end portion, the at least one arm ‘deployable’ between a ‘delivery’ (i.e., straight) condition and a ‘cutting’ (i.e., curved) condition (note abstract), the at least one arm in the cutting condition extending radially outward transverse to the longitudinal axis and having an arm distal end portion extending in a second direction opposite the first direction (see fig. 2) and being radially offset from the longitudinal axis to form a hook (see distal curvature of device in fig. 2) defining a gap between the distal end portion of the elongate shaft and the arm distal end portion (see fig. 2); and a cutter (conductive articulation wire ‘16’) extending across the gap and connected to the distal end portion and the arm distal end portion (see fig. 2), wherein the at least one arm is capable of being used in the claimed manner.
Regarding claim 2, Dormann discloses (see above) a system wherein the elongate shaft includes a steering mechanism (2) adapted to bend at least a portion of the elongate shaft in at least a first reference plane (via ‘16’ - note abstract, paragraphs 50 and 52), the steering mechanism including at least one cable extending along a length of the elongate shaft (proximal region of ‘16’), and wherein the cutter (distal region of ‘16’) is radially offset from the at least one cable when the elongate shaft is viewed in transverse cross section (note fig. 2).
Regarding claim 3, Dormann discloses (see above) a system wherein an arm length is defined between the distal end portion and the arm distal end portion (note fig. 2), the at least one arm in the delivery (i.e., straight) condition extending along the longitudinal axis, the at least one arm capable of being used in the claimed manner.
Regarding claim 5, Dormann discloses (see above) a system wherein a slot (‘12’ – note fig. 2) is defined in an outer wall of the at least one arm, the slot extending between the distal end portion and the arm distal end portion, and wherein the cutter is necessarily configured to be deployed from the slot to extend away from an apex of the hook in the cutting condition.
Regarding claim 7, Dormann discloses (see above) a system wherein the cutter is affixed to the arm distal end portion (i.e., the distal tip), and further wherein the cutter is configured to transition the at least one arm from the delivery condition to the cutting condition upon application of tension thereto (note abstract).
Regarding claim 9, Dormann discloses (see above) a system wherein the cutter is conductive and is capable of being energized with RF energy (note paragraphs 3 and 52).
Regarding claim 12, Dormann discloses (see above; as best understood by Examiner) a system wherein the distal end portion includes at least one ‘lumen’ defined therein (formed by outer perimeter of proximal portion of ‘10’), the at least one arm ‘deployable’ (i.e., able to be deployed) from the lumen between the delivery condition and the cutting condition.
Regarding claim 13, Dormann discloses (see above; as best understood by Examiner) a system wherein the hook is capable of being used in the claimed manner.
Regarding claim 14, Dormann discloses (see above) a system wherein the cutter (conductive articulation wire ‘16’) is disposed at the distal end portion of the elongate shaft.
Regarding claim 15, Dormann discloses (see above) a system wherein the cutter comprises a wire (16).
Regarding claim 16, Dormann discloses (see above) a system wherein the cutter is necessarily ‘connected’ to both the distal end portion of the elongate shaft and the arm distal end portion (see fig. 2).
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(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dormann.
Regarding claims 6 and 8, Dormann discloses (see above) a system comprising a shaft, an arm (defining a hook), and a cutter. However, Dormann fails to explicitly disclose the dimensions of the hook and cutter. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified Dormann accordingly, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It should also be noted that a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dormann in view of Wilder, U.S. 2020/0214764 (hereinafter Wilder).
Regarding claims 6 and 8, Dormann discloses (see above) a system comprising a shaft, an arm (defining a hook), and a conductive cutting wire (16) capable of being energized with RF energy (note paragraphs 3 and 52). However, Dormann fails to explicitly disclose whether this system can operate in either a monopolar or bipolar configuration. Wilder teaches a similar system comprising a shaft (proximal portion of ‘300/400’), an arm defining a hook (distal portion of ‘300/400’), and a conductive cutting wire capable of being energized in either a monopolar or bipolar configuration (note paragraph 30). It is well known in the art that this conductive cutting wire configuration would result in increased versatility and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Dormann to comprise a conductive cutting wire configured to be energized in either a monopolar or bipolar configuration in order to increase versatility and efficiency.
Claim(s) 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu, U.S. 9,962,215 (hereinafter Shimizu) in view of Chu, U.S. 9,974,553 (hereinafter Chu).
Regarding claim 17, Shimizu discloses (note figs. 1-3B) a system comprising: an elongate shaft (18) having a proximal end portion, a distal end portion and at least one lumen extending from the proximal end portion to the distal end portion, the elongate shaft capable of being used for transvascular delivery of the distal end portion to a native heart valve; two opposing arms (26’s) deployable from the lumen between a retracted position (see fig. 3A) and an extended position (see fig. 3B), the opposing arms having distal ends (i.e., distal-most faces) positioned apart from each other in the extended position (see fig. 3B); and a cutter (16) extending between the opposing arms at a location proximal to respective distal ends (as defined above; also see fig. 3A) of the opposing arms and spanning a gap between the opposing arms, each of the opposing arms necessarily defining a length between the respective distal end and the cutter, wherein the opposing arms are capable of being used in the claimed manner. However, Shimizu fails to explicitly disclose that the opposing arms are tapered toward each other along the length to define a funnel shape configured to direct tissue toward the cutter. Chu teaches (note fig. 5) a similar system comprising an elongate shaft (520) with opposing arms (518) and a cutter (522/552) extending therebetween at a location proximal to their respective distal ends, wherein each of the opposing arms necessarily define a length between the respective distal end and the cutter, and wherein the opposing arms are tapered toward each other along the length to define a funnel shape configured to direct tissue toward the cutter (see fig. 5). It is well known in the art that these different ‘opposing arm’ configurations (e.g., having straight inner-facing sides with a cutter stretched therebetween vs having inwardly-curved distal tips with a cutter stretched therebetween) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Shimizu (in view of Chu’s configuration, having straight inner-facing sides with a cutter stretched therebetween) to comprise opposing arms that are tapered toward each other along the length to define a funnel shape configured to direct tissue toward the cutter. This is because this modification would have merely comprised a simple substitution of interchangeable ‘opposing arm’ configurations in order to produce a similar result (see MPEP 2143). It should also be noted that a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 18, Shimizu discloses (see above) a system wherein the opposing arms are configured to spread away from one another as the opposing arms deploy from the retracted position toward the extended position (note col. 2, line 30), and the opposing arms are configured to approach one another as the opposing arms are retracted towards the retracted position (see fig. 3A).
Regarding claim 19, Shimizu in view of Chu teaches (see above) a system comprising a shaft, a cutter, and a pair of deployable opposing arms. However, this combination of references fails to expressly teach the claimed gap between these arms. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have further modified Shimizu accordingly, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It should also be noted that a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 20, Shimizu discloses (see above) a system wherein the cutter includes a ‘wire’ (16) extending between the opposing arms and is tensioned between the opposing arms when the arms are in the extended position (see fig. 3B).
Regarding claim 21, Shimizu discloses (see above) a system wherein the opposing arms are necessarily ‘rigid’ (note col. 7, line 10) and ‘taper’ inwardly (see fig. 3B) from the distal ends thereof towards the lumen of the elongate shaft when in the extended position.
Regarding claim 22, Shimizu discloses (see above) a system wherein the cutter is configured to apply RF energy to cut tissue (note col. 7, line 46).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they do not apply to the current rejections.
Conclusion
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.
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/THOMAS A GIULIANI/ Primary Examiner, Art Unit 3794