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 48, 50-58, drawn to an apparatus, classified in A61F2/2418.
II. Claims 49, 59-69, drawn to a method of using an apparatus, classified in A61F2/2427.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product such as delivering an adjustable annuloplasty ring that has ends that can be opened to adjust the size and shape of the annuloplasty device.
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 CPC and keyword search.
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.
During a telephone conversation with Darby Chan on Thursday, 12/11/2025 a provisional election was made without traverse to prosecute the invention of Group I, drawn to an apparatus, claims 48, 50-58. Affirmation of this election must be made by applicant in replying to this Office action. Claims 48, 59-69 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.
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) 48, 50-52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richter et al. U.S. Publication 2013/0310917 A1.
Regarding Claim 48, Richter et al. discloses an apparatus as seen in Figure 1-14A comprising a cardiac valve system comprising: a split-frame cardiac valve 10, which comprises: an axially-split tubular stent having two free longitudinal edges 28a, 28b and two end edges 21, 22 (as seen in Figures 1 and 14A); and two or more prosthetic leaflets 15, which are coupled to the tubular stent 10 (paragraph [0053]); and a delivery catheter 85 in which the split-frame cardiac valve is removably disposed with the axially-split tubular stent radially compressed in a three-dimensional spiral configuration (as seen in Figures 5-6B), with one of the free longitudinal edges disposed distal-most in the delivery catheter and the other of the free longitudinal edges disposed proximal-most in the delivery catheter (as seen in Figures 6A-6B), wherein the split-frame cardiac valve is configured such that when the split-frame cardiac valve is in a radially expanded configuration upon delivery from the delivery catheter and the two free longitudinal edges are coupled together (as seen in Figures 7a-9A), the axially-split tubular stent assumes a tubular shape in which: the two free longitudinal edges are axially-oriented and the two end edges are disposed at respective axial ends of the tubular stent (as seen in Figures 1, 4A-4B, 9A and 14A) and the prosthetic leaflets are configured to assume open and closed states, and to coapt with one another when in the closed states.
Regarding Claim 50, Richter et al. discloses an apparatus comprising a cardiac valve system comprising: a split-frame cardiac valve 10, which comprises: an axially-split tubular stent having first and second free longitudinal edges and proximal and distal end edges; and two or more prosthetic leaflets 15 (as seen in Figure 1), which are coupled to the tubular stent 10 (as seen in Figure 1, 8A, 9A); and a delivery catheter 85 in which the split-frame cardiac valve 10 is removably disposed with the axially-split tubular stent radially compressed in a rolled configuration defining more than one turn (as seen in Figure 5), in which the first and the second free longitudinal edges 28a, 28b are axially-oriented parallel to each other and to a central longitudinal axis of the delivery catheter 85 (as seen in Figure 6A-6B), and the first free longitudinal edge 28b is disposed more distally than the second free longitudinal edge 28b, wherein the split-frame cardiac valve 10 is configured such that when the split-frame cardiac valve is in a radially expanded configuration upon deployment from a distal end of the delivery catheter and the first and the second free longitudinal edges are coupled together (as seen in Figures 7A-7E and 14A and paragraphs [0019], [0040], [0058]), the axially-split tubular stent assumes a tubular shape in which: the first and the second free longitudinal edges are axially-oriented and the proximal and the distal end edges are disposed at respective axial ends of the tubular stent, and the prosthetic leaflets 15 are configured to assume open and closed states, and to coapt with one another when in the closed states (paragraphs [0011-0013], [0018], [0040-0042], [0058]).
Regarding Claim 51, Richter et al. discloses wherein the split-frame cardiac valve 10 is removably disposed within the delivery catheter with the axially-split tubular stent radially compressed in the rolled configuration in which a proximal end of the first free longitudinal edge 28a is disposed more distally than a distal end of the second free longitudinal edge 28b (as seen Figures 5 and paragraphs [0014], [0040-0042], [0047], [0058], [0064]).
Regarding Claim 52, Ritcher et al. discloses wherein the split-frame cardiac valve 10 is removably disposed within the delivery catheter 85 with the axially-split tubular stent radially compressed in the rolled configuration in which a distance between the proximal end of the first free longitudinal edge and the distal end of the second free longitudinal edge equals at least 25% of a length of the first free longitudinal edge (based on Figures 6A-6B, the distance between the proximal end of the first longitudinal edge and the distal end of the second longitudinal edge would equal at least 25% of the length of the first free longitudinal edge).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 53-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritcher et al. U.S. Publication 2013/0310917 A1.
Regarding Claim 53, 55, 56, in the embodiment used in the rejection above, Figures 1-9A does not expressly disclose wherein the split-frame cardiac valve further comprises: a shaft, which is coupled to the first free longitudinal edge; and a shaft receptacle, which is coupled to the second free longitudinal edge, and is configured to slidingly accept the shaft, such that upon insertion of the shaft into the shaft receptacle after deployment of the split-frame cardiac valve from the distal end of the delivery catheter, the first and the second free longitudinal edges are coupled together by the shaft and the shaft receptacle, wherein the shaft receptacle is at least partially cylindrical and wherein the shaft receptacle is shaped as a partial cylinder that defines a longitudinal slot there along. In an alternative embodiment as seen in Figure 13A-13B, Ritcher et al. discloses a first free longitudinal edge 128a coupled to a shaft 65a and a second longitudinal edge 128b which is coupled to a shaft receptacle 66 which is cylindrical and comprises a groove/slot (paragraphs [0076-0077]) which is configured to slidingly accept the shaft which allows the first and second free longitudinal edges to be coupled together by the shaft and the shaft receptacle for the purpose of attaching the longitudinal edges together to lock the sides of the valve module together and form the tubular structure (paragraph [0077-0078]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the longitudinal edges of Figures 1-9A to further include a shaft and shaft receptacle as taught in Figures 13A-13B for the purpose of attaching the longitudinal edges together to lock the sides of the valve module together and form the tubular structure.
Regarding Claim 54, Figures 1-9A discloses a deployment wire 80 which is removably coupled to a proximal end of the shaft 135 and the delivery catheter when the split-frame cardiac valve is removably disposed within the delivery catheter (as seen in Figures 7A-7E and 9A). However, in the embodiment used in the rejection above, Figures 1-9A does not expressly disclose a deployment wire passes through the shaft receptacle. In an alternative embodiment as seen in Figure 13A-13B, Ritcher et al. discloses a first free longitudinal edge 128a coupled to a shaft 65a and a second longitudinal edge 128b which is coupled to a shaft receptacle 66 and a deployment wire 80 is removably coupled to a proximal end of the shaft (as seen in Figure 13A) which would passes through the shaft receptable and the delivery catheter (as seen in taught in Figures 7A-7E and 9A) for the purpose of maintaining proper alignment of the wire relative to the valve frame when deploying the valve frame from the catheter (paragraph [0057]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the longitudinal edges of Figures 1-9A to further include a shaft receptable as seen in Figure 13A-13B, wherein the deployment wire passes through the shaft and delivery catheter (as seen in Figure 9A) and through a shaft receptacle for the purpose of maintaining proper alignment of the wire relative to the valve frame when deploying the valve frame from the catheter.
Regarding Claims 57, 58, in the embodiment used in the rejection above, Figures 1-9A does not expressly disclose wherein the shaft is shaped so as to define one or more couplers that are configured to engage the shaft receptacle to prevent decoupling of the shaft from the shaft receptacle after insertion therein, wherein a distal end of the shaft comprises a stopper, which limits advancement of the shaft into the shaft receptacle. In an alternative embodiment as seen in Figure 13A-13B, Ritcher et al. discloses a first free longitudinal edge 128a coupled to a shaft 65a and a second longitudinal edge 128b which is coupled to a shaft receptacle 66 and at least one coupler 63 (prongs forming a groove creating a snap lock, see Figure 12A and paragraph [0076]) that is configured to engage the shaft receptacle 66 to prevent decoupling of the longitudinal edges (paragraphs [0075-0076]) and a stopper 69 which limits the advancement of the shaft to the shaft receptacle 66 (paragraph [0076]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the longitudinal edges of Figures 1-9A to further include a shaft, shaft receptacle and a stopper to prevent decoupling of the longitudinal edges and limit the distance in which the shaft move along the shaft receptable and create a snap fit connection.
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