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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to a delivery apparatus/assembly, classified in A61F2/2466.
II. Claims 17-22, drawn to a method of delivery, classified in A61F2/243.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process as claimed can be practiced by another and materially different apparatus, such as a stent or graft and does not require the prosthetic heart valve (e.g. another apparatus).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions listed above requires different text searches.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve 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 restriction 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 upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions 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 inventions 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 invention.
This application contains claims directed to the following patentably distinct species:
Figures 3-5
Figures 6-9
Figures 10-11
Figures 12A-12B
The species are independent or distinct because the species shows different actuator assembly of a delivery apparatus that is removably coupled to the prosthetic device using a threaded rod 126 coupled to an actuator assembly 300; species b is directed to an actuator assembly comprising a driver the driver head is configured to engage a rod of the frame and a sleeve comprises a first and second extensions, the first extension is longer and extend distal to the second extension, the first extension extend over a first side of the post of the frame and a second extension extends over the opposite, second side of the post of the frame, wherein the first extension engages a retaining element; species c is directed to an actuator assembly having two extensions with similar length, wherein both extensions engage a retaining element in o . 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, no claim appears to be 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 require different text search.
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 Thursday, 09/17/2026 a provisional election was made without traverse to prosecute the invention of group I, drawn to a delivery apparatus/assembly and species c, Figures 10-11, claim1-3, 5-7 and 10-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4, 8-9 and 15-22 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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Allowable Subject Matter
Claims 2-3, 5-7 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 2, the prior art fails to teach nor render obvious wherein the retaining element comprises a head portion including a second aperture and two legs spaced apart from one another and extending from the head portion, wherein the two legs are configured to flex between the first position and the second position. Claims 6 and 7 depends from claim 2.
Regarding Claim 3, the prior art fails to teach nor render obvious wherein the extension of the outer sleeve is a first extension, and wherein the outer sleeve comprises a second extension extending from an opposite side of the tube portion of the outer sleeve than the first extension, the first and second extensions spaced apart from one another. Claim 5 depends from claim 3.
Claims 12-14 are allowed.
Regarding Claim 12, Maimon et al. discloses an assembly (as seen in Figures 1 and 8-9) comprising: a prosthetic heart valve 14 comprising: a radially expandable and compressible frame 22, 604, the frame comprising at least one actuation mechanism 612 comprising: a first frame member having a first inner bore and a second frame member having a second inner bore (as seen in Figure 18), the first and second frame members being spaced apart axially from one another; and a threaded rod 610 extending through the first and second inner bores; and a delivery apparatus comprising: a handle 70 (as seen in Figures 1 and 8-9); and at least one actuator assembly extending from the handle (as seen in Figure 1), the actuator assembly 608 comprising: an outer sleeve 634 having a tube portion abutting an outflow end portion of the second frame member and a first extension 632 that extends distally from the tube portion and over the second frame member; a driver (rod/cable, see paragraph [0209]) extending through the tube portion of the outer sleeve 634 and engaging an end of the threaded rod, the driver configured to rotate the threaded rod to radially expand and/or compress the frame and a retaining element 1410 configured to hold the outer sleeve in engagement with the second frame member (as seen in Figures 42-43). However, the prior art does not teach nor render obvious a retaining element extending through a first aperture in the first extension of the outer sleeve and a second aperture in the second frame member, wherein the retaining element is configured to flex and release from the first and second apertures in response to a pulling force applied to an end portion of the retaining element.
Regarding Claim 13, the prior art fails to teach nor render obvious wherein the retaining element comprises a head portion and two legs spaced apart from one another extending from the head portion, wherein the legs are configured to flex under external force toward or away from one another, and wherein the first aperture and the second aperture are shaped to receive the legs therethrough. Claim 14 depends from claim 13.
Claim Rejections - 35 USC § 102
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.
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, 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maimon et al. U.S. Publication 2020/0297482 A1.
Regarding Claim 1, Maimon et al. discloses a delivery apparatus 600 in Figures 18-25 and 42-43 for a radially expandable prosthetic device, comprising: an actuator assembly 611 comprising: an outer sleeve 634 comprising a tube portion and an extension 632 that extends distally from the tube portion (as seen in Figure 18 and 42-43), the extension 632 comprising a first aperture 1416 in its distal end (as seen in Figure 42 and paragraph [0272]); an actuation member extending through the tube portion of the outer sleeve; and a retaining element 1410 configured to extend through the first aperture 1416 in the extension of the outer sleeve 634 and hold the outer sleeve 634 against an end portion of a frame of a prosthetic device (as seen in Figures 42-43 and paragraph [0271-0272]), wherein the retaining element 1410 is biased into a first position where it holds the outer sleeve in engagement with the frame (paragraphs [0271-0272]), and is configured to flex in response to a pulling force into a second position that enables the retaining element 1410 to be released from the first aperture 1416, thereby enabling disengagement of the outer sleeve from the end portion of the frame of the prosthetic device (paragraph [0271] and as seen in Figures 42-43).
Regarding Claim 10, Maimon et al. discloses a handle 70 (as seen in Figures 1 and 13), and wherein the actuator assembly extends distally from the handle 70 (as seen in Figure 1 and paragraph [0137]).
Regarding Claim 11, Maimon et al. discloses further comprising a flexible element 76 extending from the handle 70 to an end portion of the retaining element and wherein the flexible element 72 is configured to apply the pulling force to the end portion of the retaining element in response to actuation of a control mechanism of the handle 70 (paragraphs [0138] and [0141] and as seen in Figures 8-9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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