DETAILED ACTION
Currently, claims 1-3, 5-11, and 14-22 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.
Claim Rejections - 35 USC § 112
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 15 and 17-22 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.
Claim 15 is found to be indefinite for its improper recitation of a Markush claim. Applicant is encouraged to replace “or” with -and- in line 2 of the claim
Claim 17 recites the limitation "each of the opposing arms having a distal end" in lines 12-13. The antecedent basis for these limitations is confusing, since it’s unclear how/whether they are related to the previously-recited ‘opposing arm distal ends’.
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) 17, 18, and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yahagi, U.S. 9,033,978 (hereinafter Yahagi).
Regarding claim 17, Yahagi discloses (note figs. 1 and 3) a system, comprising: an elongate shaft (2) having a proximal end portion, a distal end portion, a longitudinal axis extending therebetween, 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 (3A-B) deployable from the lumen between a retracted position and an extended position (note col. 4, line 9), the opposing arms having distal ends positioned apart from each other in the extended position (see fig. 3); and a cutter (5/5A) extending between the opposing arms at a location proximal to respective distal ends of the opposing arms and spanning a gap between the opposing arms, the location being between the distal end portion and the distal ends of the opposing arms, each of the opposing arms having a distal end extending distally beyond the cutter, each of the opposing arms defining a length between the respective distal end and the cutter, the opposing arms tapered toward each other along the length to define a funnel shape configured to direct tissue toward the cutter (see fig. 3), wherein the opposing arms are capable of being used in the claimed manner.
Regarding claim 18, Yahagi 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. 4, line 9; fig. 3), and the opposing arms are configured to approach one another as the opposing arms are retracted towards the retracted position (see figs. 1-2A).
Regarding claim 20, Yahagi discloses (see above) a system wherein the cutter includes a wire (5/5A) extending between the opposing arms and is tensioned between the opposing arms when the arms are in the extended position (see fig. 3).
Regarding claim 21, Yahagi discloses (see above) a system wherein the opposing arms are necessarily ‘rigid’ (at least somewhat) and taper inwardly (see fig. 3) from the distal ends thereof towards the lumen of the elongate shaft when in the extended position.
Regarding claim 22, Yahagi discloses (see above) a system wherein the cutter is capable of being energized with RF energy to cut tissue (note abstract; col. 4, line 9).
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) 1-3, 5-9, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dormann, U.S. 2017/0143363 (hereinafter Dormann) in view of Vakharia, U.S. 7,833,223 (hereinafter Vakharia).
Regarding claims 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. However, the system of Dormann fails to explicitly disclose a slot defined in an outer wall of the at least one arm extending between the distal end portion and the arm distal end portion, wherein the cutter is recessed within the slot and the outer wall of the at least one arm in the delivery condition, and wherein the cutter extends outside of the slot and the outer wall across the gap in the cutting condition. Vakharia teaches (note figs. 1A-C) a similar system comprising an elongate shaft (proximal portion of ‘112’), an arm (distal portion of ‘112’), and cutters (122/123/124), as well as slots (136/137/138) defined in an outer wall of the arm extending between the elongate shaft and a distal end portion of the arm, wherein each cutter is recessed within its respective slot and the outer wall of the arm in a delivery condition (note fig. 1A), and wherein each cutter extends outside of its respective slot and the outer wall in a respective cutting condition (note fig. 1C). This configuration, which enables performing tissue cuts in multiple directions without having to reposition the device, has been utilized in order to minimize unnecessary device movement and increase safety, efficiency, and versatility. 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 multiple cutters having respective slots defined in an outer wall of the arm extending between the distal end portion and the arm distal end portion, wherein each cutter is recessed within its respective slot and the outer wall of the arm in the delivery condition, and wherein each cutter extends outside of its respective slot and the outer wall across the gap in a respective cutting condition. This modification would enable performing tissue cuts in multiple directions without having to reposition the device, thereby minimizing unnecessary device movement and resulting in increased safety, efficiency, and versatility.
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 in view of Vakharia teaches (see above) a system wherein the cutter is configured to be deployed from the slot to extend away from an apex of the hook in the cutting condition (note fig. 1C of Vakharia).
Regarding claims 6 and 8, Dormann in view of Vakharia teaches (see above) a system comprising a shaft, an arm (defining a hook), and a cutter. However, this combination of references fails to expressly teach 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 further 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).
Regarding claim 7, Dormann in view of Vakharia teaches (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 abstracts of Dormann and Vakharia).
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 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 in view of Vakharia teaches (see above) a system wherein the cutter extends proximally from the distal end portion of the elongate shaft along an insulated (necessarily) lumen within the elongate shaft to the proximal end portion.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dormann in view of Vakharia as applied to claims 1-3, 5-9, and 14-16 above, and further in view of Wilder, U.S. 2020/0214764 (hereinafter Wilder).
Regarding claims 10-11, 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 further 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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yahagi.
Regarding claim 19, Yahagi discloses (see above) a system comprising a shaft, a cutter, and a pair of deployable opposing arms. However, Yahagi fails to explicitly disclose 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 modified Yahagi 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).
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2006/0064113 (Nakao).
U.S. 5,437,665 (Munro).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
Prosecution Insights