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 .
Election/Restrictions
This application contains claims directed to the following patentably distinct species of actuation assemblies for a prosthetic valve.
Specie A: Fig. 7
Specie B: Fig. 8
Specie C: Figs. 10A-11
The species are independent or distinct because the actuators have different fastening mechanisms with the claims to the different species recite the mutually exclusive characteristics of such species, such as the two bolts of some species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, none are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Jeffrey Haendler on 07/30/26 a provisional election was made without traverse to prosecute the invention of Specie A; Fig. 7, claims 1,2,4-13,15-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3, 14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 8,9 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.
In claim 8, the recitation of "less than ….0.55 mm" raises an issue of indefiniteness because it is not evident of how small the diameter can be because one does not know the lower limit or dimension the diameter can be as it could even encompass 0 according to the scope of less than 0.55 mm because it is an open-ended limitation. Additionally the limitation in claim 9, of “greater than …..0.6 mm is not clear what the upper limit is. Since the limitation of "greater than" encompasses values for a diameter beyond 0.55 mm, one does not know the maximum dimension of a diameter for the bolt. It must be noted that MPEP 2173.05(c) states open-ended ranges can raise an issue of indefiniteness by lacking clear boundaries.
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) 1,2, 4,7,10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Cartledge et al. (2013/0046373) or, in the alternative, under 35 U.S.C. 103 as obvious over Dobbrunz (5333976). Cartledge et al. show (Fig. 121) a prosthetic valve, comprising: a radially expandable frame comprising a plurality of interconnected struts 12040, wherein the frame is radially expandable between a radially compressed state and a radially expanded state, paragraph 260. Fig. 135 shows how a frame includes a valvular structure 13542 disposed within frame and configured to regulate the flow of blood through the frame in one direction. Additionally it can be seen in Fig. 121 that at least one an actuation assembly operatively coupled to the frame, wherein the actuation assembly comprises first and second bolts aligned end-to-end relative to each other, wherein an end portion of the first bolt 12022 is coupled to an adjacent end portion of the second bolt 12020, wherein the first and second bolts are rotatable together (paragraph 259) in a first rotational direction to produce radial expansion of the frame from the radially compressed state to the radially expanded state, paragraph 189. Please note the examiner is taking the position the referencing of the two elements with different numbers (12022 and 12020) implies two separate bolts that are coupled together as they are also shown with different diameters to also suggest separate elements. However, in the alternative Cartledge et al. did not explicitly state an end portion of the first bolt is coupled to an adjacent end portion of the second bolt. Dobbrunz teaches that (Fig. 8) that threaded bolts can be joined or coupled together with an end portion of the first bolt 16 is coupled to an adjacent end portion of the second bolt 14. It would have been obvious to one of ordinary skill in the art to provide first and second bolts with an end portion of the first bolt is coupled to an adjacent end portion of the second bolt as taught by Dobbrunz with the stent valve actuation assembly of Cartledge et al. such that it provides adjustability between elements above a surface, see col. 2 of Dobbrunz. With respect to claim 2, Fig. 121 of Cartledge also shows the first bolt 12022 having threads extend to the second bolt 12020 and thus it can be construed that due to the different diameters, the threaded section of the end portion of the first bolt is tightened into a threaded bore of the second bolt. Further Dobbrunz teaches (col. 5, lines 3-5) the second bolt comprises a threaded bore in the adjacent end portion of the second bolt, wherein a threaded section of the end portion of the first bolt is tightened into the threaded bore of the second bolt. Regarding claim 4, Fig. 121 shows the frame comprises at least one vertically oriented post 12014 with a channel extending therethrough, and wherein the first bolt extends through the channel. With respect to claim 7, Fig. 121 shows the first bolt 12022 has a first diameter and the second bolt 12020 has a second diameter, wherein the second diameter is greater than the first diameter. Regarding claim 10, Cartledge et al. further disclose (paragraph 28) a head portion of the first bolt is configured to be releasably connected to a component of a delivery apparatus actuator. Additionally Cartledge shows (Figs. 135,136) there can be a valvular structure 13540 disposed within frame and configured to regulate the flow of blood through the frame in one direction.
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) 5,6, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (2013/0046373) alternatively in view of Dobbrunz (5333976) and in view of Matsumoto (4880343). Cartledge et al. as alternatively modified with Dobbrunz is explained supra. However, Cartledge in view of Dobbrunz did not explicitly disclose a washer disposed between the second bolt and the vertically oriented post, wherein the washer has an aperture and the end portion of the first bolt extends through the aperture. Matsumoto teaches (Fig. 5A) that a bolt extends through an aperture of a washer 21 that is disposed between two threaded receiving structures 22,20. It would have been obvious to one of ordinary skill in the art to use a washer as taught by Matsumoto with the prosthetic heart valve actuation assembly of Cartledge et al. alternatively modified with Dobbrunz such that it provides the ability to secure the bolt once established in its deployed position and then lock, see Matsumoto col. 5, lines 16-51. Regarding claim 6, Matsumoto teaches (Fig. 5B) the washer 21 is to extend axially into the channel 23 of a threaded receiving member 22. Matsumoto further teaches (3D) a washer can have upward structure 14 but not explicitly an annular sleeve disposed around the aperture of the washer. However, Matsumoto also did teach modifications could be made to the upward structures, col. 4, lines 63-65. Thus, it would have been obvious to one of ordinary skill in the art to alternatively provide the washer as an annular sleeve disposed around the aperture and extending axially into the channel per the teaching of Matsumoto with the prosthetic heart valve actuation assembly of Cartledge et al. as alternatively modified with Dobbrunz such that it effectively locks the bolt in its deployed location and the washer provides the necessary space. With respect to claim 17, Figs. 120-124 show prosthetic heart valve, comprising: a frame 12010 having a first end, a second end, and a longitudinal axis extending between the first end and the second end, wherein the frame is radially expandable between a radially compressed state and a radially expanded state (paragraphs 260,269), and wherein the frame comprises a plurality of vertical posts 12014 extending parallel to the longitudinal axis and a plurality of angled struts 12040 arranged in circumferentially extending rows of angled struts. Additionally it can be seen in Fig. 121 that at least one an actuation assembly comprising a first bolt 12022 and a second bolt 12020 aligned end-to-end, wherein the first bolt extends through a channel in a first vertical post of the plurality of vertical post 12014 wherein an end portion of the first bolt is coupled to an adjacent end portion of the second bolt, and wherein the first and second bolts are rotatable together (paragraph 259) in a first rotational direction to produce radial expansion of the frame from the radially compressed state to the radially expanded state, paragraph 189. Please note the examiner is taking the position the referencing of the two elements with different numbers (12022 and 12020) implies two separate bolts that are coupled together as they are also shown with different diameters to also suggest separate elements. However, in the alternative Cartledge et al. did not explicitly state an end portion of the first bolt is coupled to an adjacent end portion of the second bolt. Dobbrunz teaches that (Fig. 8) that threaded bolts can be joined or coupled together with an end portion of the first bolt 16 is coupled to an adjacent end portion of the second bolt 14. It would have been obvious to one of ordinary skill in the art to provide first and second bolts with an end portion of the first bolt is coupled to an adjacent end portion of the second bolt as taught by Dobbrunz with the stent valve actuation assembly of Cartledge et al. such that it provides adjustability between elements above a surface, see col. 2 of Dobbrunz. As already mentioned above, similar for claim 5 limitation, claim 17 reciting “a washer disposed between the adjacent end portion of the second bolt and the first vertical post” was not explicitly taught by Cartledge alternatively modified with Dobbrunz. Matsumoto teaches (Fig. 5A) that a bolt extends through an aperture of a washer 21 that is disposed between two threaded receiving structures 22,20. It would have been obvious to one of ordinary skill in the art to use a washer as taught by Matsumoto with the prosthetic heart valve actuation assembly of Cartledge et al. alternatively modified with Dobbrunz such that it provides the ability to secure the bolt once established in its deployed position and then lock, see Matsumoto col. 5, lines 16-51. Regarding claim 18, see explanation above for claim 6 as it is the same limitation and scope, thus the combined teachings of Cartledge as modified with Dobbrunz and Matsumoto render the claim obvious with the same rationale already detailed above. With respect to claim 19, Fig. 121 of Cartledge also shows the first bolt 12022 having threads extend to the second bolt 12020 and thus it can be construed that due to the different diameters, the threaded section of the end portion of the first bolt is tightened into a threaded bore of the second bolt. Further Dobbrunz teaches (col. 5, lines 3-5) the second bolt comprises a threaded bore in the adjacent end portion of the second bolt, wherein a threaded section of the end portion of the first bolt is tightened into the threaded bore of the second bolt. Thus, it would be obvious to provide the second bolt with a threaded bore in the adjacent end portion of the second bolt, such that a threaded section of the end portion of the first bolt is tightened into the threaded bore of the second bolt per the teaching of Dobbrunz in the actuation assembly bolts of Cartledge to provide greater adjustability. With respect to claim 20, Fig. 121 shows the first bolt 12022 has a first diameter and the second bolt 12020 has a second diameter, wherein the second diameter is greater than the first diameter.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (2013/0046373) alternatively in view of Dobbrunz (5333976) and in view of Gifford et al. (WO 2021/195664). Cartledge et al. as alternatively modified with Dobbrunz is explained supra. However, Cartledge in view of Dobbrunz did not explicitly disclose diameter of the first bolt is less than or equal to 0.55 mm. Gifford et al. teach (Figs. 1,10) that a prosthetic heart valve with stent framework is delivered via a catheter system. Gifford et al. also teach (paragraph 123) the stent strut diameter or thickness is less than or equal to 0.55mm. It would have been obvious to one of ordinary skill in the art to utilize a diameter for the strut elements of a heart valve that has a diameter that can be less than or equal to 0.55mm as taught by Gifford et al. with the prosthetic heart valve of Cartledge et al. as alternatively modified with Dobbrunz such that the bolt is of a diameter to fit within the channel lumen of the strut in the heart valve frame. Such a modification only involves routine skill in the art in optimizing the stent framework flexibility with respect to diameter dimension affecting material properties and matching cooperating structures disposed therein.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (2013/0046373) alternatively in view of Dobbrunz (5333976) and in view of Fogarty et al. (8747463). Cartledge et al. as alternatively modified with Dobbrunz is explained supra. However, Cartledge in view of Dobbrunz did not explicitly disclose diameter for a second bolt. Fogarty et al. teach (Fig. 23) that a channel 62 for an actuation or insertion element (Figs. 52-55) is provided with a diameter to accommodate the actuation or insertion element can be greater than 0.6mm (col. 8, lines 20-23). It would have been obvious to one of ordinary skill in the art to utilize a diameter for an insertion element used with a heart valve that has a diameter that can be greater than 0.6mm as taught by Fogarty et al. with the prosthetic heart valve of Cartledge et al. as alternatively modified with Dobbrunz such that the bolt is not too large but can be accommodated in a small diameter lumen to not interfere with the profile of the valve structure.
Claim(s) 11,12,15,16 are rejected under 35 U.S.C. 103 as obvious over Cartledge et al. (2013/0046373) in view of Rogers (5336223). Cartledge et al. show (Fig. 121) a prosthetic valve, comprising: a radially expandable frame comprising a plurality of interconnected struts 12040, wherein the frame is radially expandable between a radially compressed state and a radially expanded state, paragraph 260. Fig. 135 shows how a frame includes a valvular structure 13542 disposed within frame and configured to regulate the flow of blood through the frame in one direction. Additionally it can be seen in Fig. 121 that at least one an actuation assembly operatively coupled to the frame, wherein the actuation assembly comprises first and second bolts aligned end-to-end relative to each other, wherein an end portion of the first bolt 12022 is coupled to an adjacent end portion of the second bolt 12020, wherein the first and second bolts are rotatable together (paragraph 259) in a first rotational direction to produce radial expansion of the frame from the radially compressed state to the radially expanded state, paragraph 189. Please note the examiner is taking the position the referencing of the two elements with different numbers (12022 and 12020) implies two separate bolts that are coupled together as they are also shown with different diameters to also suggest separate elements. However, in the alternative Cartledge et al. did not explicitly state an end portion of the first bolt is coupled to an adjacent end portion of the second bolt. Rogers teaches that (Fig. 1) that threaded bolts can be joined or coupled together with an end portion of the first bolt 5 is coupled to an adjacent end portion of the second bolt 10. It would have been obvious to one of ordinary skill in the art to provide first and second bolts with an end portion of the first bolt is coupled to an adjacent end portion of the second bolt as taught by Rogers with the stent valve actuation assembly of Cartledge et al. such that it provides adjustability between elements above a surface, see col. 2, lines 52-55 of Rogers. It is also noted that Cartledge et al. did not disclose with this embodiment (Fig. 121) at least one nut coupled to the actuation assembly. Rogers teaches (Fig. 1) a nut 6 coupled to an actuation assembly two threaded bolts (5,10) to provide adjustment, see col. 3, lines 48-50. It would have been obvious to one of ordinary skill in the art to incorporate a nut as taught by Rogers with an actuation assembly in the prosthetic valve apparatus of Cartledge such that it provides the user/surgeon the ability to make any adjustment with the bolts as necessary. Regarding claim 12, Fig. 121 of Cartledge shows a bore in one strut 12014 of the plurality of interconnected struts, which receives a component of the actuation assembly. Regarding claim 15, Cartledge also shows (Fig. 120) the frame comprises a first axially oriented post and a second axially oriented post, wherein the first axially oriented post and the second axially oriented post are axially aligned with each other, wherein a bore 12012 extends axially through both the first axially oriented post and the second axially oriented post and receives the first and second bolts. With respect to claim 16, Fig. 121 shows the first bolt 12022 has a first diameter and the second bolt 12020 has a second diameter, wherein the second diameter is greater than the first diameter. In addition it is noted that Rogers also teaches that first bolt 5 has a first diameter and the second bolt 10 has a second diameter, wherein the second diameter is greater than the first diameter
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/ Primary Examiner, Art Unit 3799
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