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
The applicant’s election of group I directed to claims 1, 2 and 4-30 with traverse is acknowledged.
However, the arguments are not found convincing and the restriction is therefore maintained. The applicant argues that the prior art discloses a valved conduit prosthesis and not a heart valve. Claim 1 does not require a heart valve and accordingly the argument is moot. Only shared technical features must be found for unity of invention. The applicant argues that prior art Dzemeshkevich further fails to teach “a conduit lumen and slot therethrough” and “at least one leaflet having an external portion coupled to the exterior surface of the conduit”. In the restriction the slot is interpreted as the space between leaflets which can form a slot depending on the leaflet position. Leaflet coupled to an exterior surface does not require the leaflet itself to be on the exterior surface. While the claims are read in light of the specification, the limitations from the specification are not read into the claims. Additionally, please see the rejection of claim 1.
The nonelected claims can be rejoined at allowance if they contain all the features of an allowed claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape. Adhesive film is anticipates adhesive.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape. Adhesive film is anticipates adhesive.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape. Adhesive film is anticipates adhesive.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape. Adhesive film is anticipates adhesive.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape. Adhesive film is anticipates adhesive.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12186182B2 in view of Dienno (2016/0175095A1). It has been held that a species anticipates a genus, and the instant patent anticipates each and every aspect of the claim except reciting an opening instead of a slot. Dienno teaches the opening comprises a slot 217. It would have been obvious to one of ordinary skill in the art to make the opening a slot because this fits the shape of the leaflet passing through (see fig 3E) since the leaflet is a flat shape. Adhesive film is anticipates adhesive.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12186182B2. It has been held that a species anticipates a genus and the patent claim anticipates each and every aspect of the instant claim despite slightly different wording.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12186182B2. It has been held that a species anticipates a genus and the patent claim anticipates each and every aspect of the instant claim despite slightly different wording.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12186182B2. It has been held that a species anticipates a genus and the patent claim anticipates each and every aspect of the instant claim despite slightly different wording. Any directional indicator is capable of indicating a direction of blood flow by providing an orientation of the device.
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 attachment section includes a first portion and a second portion, and the first portion is attached to the proximal portion of the exterior surface of the conduit, and the second portion is attached to the distal portion of the exterior surface of the conduit”. must be shown or the feature(s) canceled from the claim(s). If the claimed subject matter is present please label accordingly or point out where this feature is labeled in the figures.
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 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(s) 4-7, 13, 16-17, 20, 26-27, 30 is/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 regard to claims 4-5, the claims directly or indirectly depend from cancelled claim 3.
In regard to claim 4, “the adhesive film” lacks proper antecedent basis.
In regard to claim 6, “the flexible film” and “the adhesive film” lack proper antecedent basis. It appears the applicant may have intended the claim to depend from a different base claim.
Claim 7 recites the limitation "the flexible film" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. It appears the applicant may have intended claim 7 to depend off a different claim than claim 1.
In regard to claim 13, “optionally” makes it unclear if the limitations following optionally are intended to be positively recited. For examination purposes the option without the limitations following is selected. Further, TFE-PMVE and ePTFE should be written in full form to avoid confusion.
In regard to claim 16, “the inflow end” lacks proper antecedent basis.
In regard to claim 17, “the inflow portion” lacks proper antecedent basis. It is further unclear if the inflow portion is part of the leaflet or the conduit due to the lack of antecedent basis.
In regard to claim 20, it is unclear what “lands” comprise. While the disclosure refers to lands as element 112 it is still unclear to the examiner what element this actually refers to. No further clarification is present in the instant disclosure. It appears this may be an incorrect translation of another term.
In regard to claim 26, “optionally” makes it unclear if the limitations following optionally are intended to be positively recited. For examination purposes the option without the limitations following is selected. Further, TFE-PMVE and ePTFE should be written in full form to avoid confusion.
In regard to claim 27, “the outflow portion” lacks proper antecedent basis. It is not clear if this terminology is referring to the outflow portion of the valve or conduit.
In regard to claim 30, “the inflow portion” lacks proper antecedent basis. It is not clear if this terminology is referring to the inflow portion of the valve or conduit.
All claims that depend from the rejected claims are also rejected under 112b.
Due to the large number of 112s please check the claims in their entirety for further issues.
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) 1-2, 4-7, 9-21, 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dienno (2016/0175095A1).
In regard to claim 1, Dienno teaches a valved conduit prosthesis comprising:
a conduit 101 having an exterior surface and an interior surface defining a conduit lumen and a slot 217 therethrough;
and at least one leaflet 310 having an external portion coupled to the exterior surface of the conduit 204 and an internal portion arranged within the interior surface of the conduit (within 202; see fig 3E) so as to be operable as a one-way valve, the leaflet 310 defining a valve structure [0152: in an assembled valve].
However, the embodiment of figure 3 of Dienno does not teach a conduit as intended by the applicant.
In the interest of compact prosecution, Dienno teaches that the valve may be a conduit 402 with a lumen (see lumen within 402 in fig 20A) and a slot (slot at 404d in fig 20c) [0097: other embodiments include valved conduits]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the valve in the embodiment of figures 2-3 of Dienno a conduit as taught by Dienno because this allows for a smoother inner surface transition to improve hemodynamics and provide less irregular surfaces to reduce thrombus formation [0097].
It is recommended the applicant further clarify the claim limitations regarding the conduit since conduit is simply defined as a natural or artificial channel. It appears the applicant may be using a different definition but the instant disclosure does not provide any clarification.
In regard to claim 2, Dienno meets the claim limitations as discussed in the rejection of claim 1, but does not teach the external portion of the at least one leaflet 310 is coupled to the exterior surface of the conduit by adhesive, thermal bonding or chemical bonding.
Dienno teaches other elements secured by thermal bonding [0194: film coupled to the conduit with an adhesive agent through thermal bonding]
It would have been obvious to one of ordinary skill in the art of medical bonding and connections at the time the invention was filed to use the thermal bonding of Dienno to bond the attachment section to the external surface of the conduit as an additional or backup attachment for additional security against coming detached.
In regard to claim 4, Dienno meets the claim limitations as discussed in the rejection of claim 3, and teaches the conduit 402 in the embodiment of figure 20 as discussed in the rejection of claim 1. Dienno further teaches wherein the adhesive film is arranged about a circumference of the conduit 402. [0198: the film can comprise an adhesive that facilitates securement of the valve collar 416 to the conduit; 0208: laminating the film to the second conduit such that the first frame is sealed; 0209: wrapping a tubular film about the second conduit prior to heating]
In regard to claim 5, Dienno meets the claim limitations as discussed in the rejection of claim 4, and further teaches a flexible film arranged about the circumference of the conduit and the adhesive film. [0233: wrapped by a layer of FEP followed by ten layers of PTFE/FEP film]
In regard to claim 6, Dienno meets the claim limitations as discussed in the rejection of claim 1. Dienno further teaches the flexible film includes expanded polytetrafluoroethylene (ePTFE) and the adhesive film comprises fluorinated ethylene propylene (FEP). [0198: ePTFE]
In regard to claim 7, Dienno meets the claim limitations as discussed in the rejection of claim 1, and further teaches the conduit in the embodiment of figure 20 as discussed in the rejection of claim 1. Dienno further teaches a support frame 200 (224 in figure 20B) coupled to the conduit 402 by the flexible film. [0198: film facilitates securement of the valve collar to the conduit]
In regard to claim 9, Dienno meets the claim limitations as discussed in the rejection of claim 1, and further teaches at least one radiopaque marker arranged adjacent to the at least one leaflet. [0169: leaflet can comprise radiopaque markers]
However, Dienno does not teach that the marker is arranged on an exterior surface of the conduit specifically.
It has been held that a mere rearrangement of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to include markers on the exterior surface of the conduit in order to better visualize the entire prosthesis. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04VIC
In regard to claim 10, Dienno meets the claim limitations as discussed in the rejection of claim 1. As discussed in the rejection of claim 1, the embodiment of figure 20 teaches the conduit (402) and further teaches the interior surface of the conduit is diametrically constant (constant diameter, fig 20A) and free of any macroscopic interruptions. (fig 20A; the conduits themselves are smooth along at least a majority of their length; [0097: smoother transition])
In regard to claim 11, Dienno meets the claim limitations as discussed in the rejection of claim 1. As discussed in the rejection of claim 1, Dienno teaches the conduit in the embodiment of figures 20 and further teaches the at least one leaflet 310 is positioned within the conduit at a longitudinal location (402) along a length of the conduit, and the conduit 402 is diametrically constant at the longitudinal location (diametrically constant along the entire length as shown in figure 20A) where the at least one leaflet 310 is positioned and through adjacent proximal and distal portions of the conduit. (402) As shown in figure 20A-B; placed between positions of the conduit in figure 20B)
In regard to claim 12, Dienno meets the claim limitations as discussed in the rejection of claim 1, and further teaches the conduit in the embodiment of figure 20 as discussed in the rejection of claim 1.
Dienno further teaches the conduit 402 has an inflow portion defining an inflow end and an outflow portion defining an outflow end (fig 20A), wherein the at least one leaflet 310 is operable to open to allow flow from the inflow end to pass through the outflow end of the conduit in antegrade flow conditions, and is operable to close to restrict flow from flowing from the outflow end through the inflow end in retrograde flow conditions. This is how heart valve leaflets operate. [0076]
In regard to claim 13, Dienno meets the claim limitations as discussed in the rejection of claim 1, and further teaches the at least one leaflet 310 comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, [0078: composite material is a combination of fluoropolymer and an elastomer imbibed within a porous structure of the membrane; 0169: leaflet can comprise a composite material].
and optionally TFE-PMVE copolymer comprising from 27 to 32 weight percent perfluoromethyl vinyl ether and respectively from 73 to 68 weight percent tetrafluoroethylene on at least a portion of the composite material, (the option without is chosen)
and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE. (the option without is chosen)
In regard to claim 14, Dienno meets the claim limitations as discussed in the rejection of claim 12, and further teaches the conduit in the embodiment of figure 20 as discussed in the rejection of claim 1. Dienno further teaches the outflow portion defines a sinus 406 adjacent to the at least one leaflet 301. [0188]
In regard to claim 15, Dienno meets the claim limitations as discussed in the rejection of claim 14, and further teaches the conduit in the embodiment of figure 20 as discussed in the rejection of claim 1. Dienno further teaches the sinus 406 is operable for the surgical attachment of blood vessels and/or coronary arteries. This is a product by process limitation, patentable only based on the resulting structure. The conduit is capable of being operated on for surgical attachment given the right tools and therefore the limitations have been met.
In regard to claim 16, Dienno meets the claim limitations as discussed in the rejection of claim 1, and further teaches the inflow end defines an outward taper or is operable to be outwardly tapered. The inflow end is capable of being outwardly tapered by stretching or adjusting given the right tools. This is a statement of intended use, and must only be capable of being tapered.
In regard to claim 17, Dienno meets the claim limitations as discussed in the rejection of claim 1, and further teaches the conduit in the embodiment of figure 20 as discussed in the rejection of claim 1. Dienno further teaches the inflow portion (of conduit 402) is operable to be outwardly everted and rolled toward the valve structure defining a sewing cuff. This is intended use. The conduit is capable of being rolled and sewed.
Alternatively, Dienno teaches a sewing cuff 285. Rolling could be interpreted as a product by process limitation, patentable only based on the end structure of a sewing cuff.
In regard to claim 18, Dienno teaches a valved conduit prosthesis comprising:
a conduit 101 having an interior surface defining a conduit lumen, an exterior surface, a proximal portion, and a distal portion;
a leaflet attachment portion having an opening 217 between the interior surface and the exterior surface of the conduit 101;
and at least one leaflet 310 having an attachment section attached to the exterior surface of the conduit (end of 310; fig 3E), the at least one leaflet 310 defining a valve structure [0152: in an assembled valve].
However, the embodiment of figure 3 of Dienno does not teach a conduit as intended by the applicant.
In the interest of compact prosecution, Dienno teaches that the valve may be a conduit 402 with a lumen (see lumen within 402 in fig 20A) and an opening (opening at 404d in fig 20c) [0097: other embodiments include valved conduits]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the valve in the embodiment of figures 2-3 of Dienno a conduit as taught by Dienno because this allows for a smoother inner surface transition to improve hemodynamics and provide less irregular surfaces to reduce thrombus formation [0097].
It is recommended the applicant further clarify the claim limitations regarding the conduit since conduit is simply defined as a natural or artificial channel. It appears the applicant may be using a different definition but the instant disclosure does not provide any clarification.
In regard to claim 19, Dienno meets the claim limitations as discussed in the rejection of claim 18, and further teaches the at least one leaflet 310 includes three leaflets [0226: three leaflets were prepared; 0222: three leaflets], and the three leaflets are separated from one another within an interior of the conduit by commissure gaps 210. [0099: commissure posts flanked by leaflet window frames]
Dienno teaches the conduit 402 in the embodiment of figure 20 as discussed in the rejection of claim 18.
In regard to claim 20, Dienno meets the claim limitations as discussed in the rejection of claim 19, and further teaches the conduit 402 in the embodiment of figure 20a as discussed in the rejection of claim 18. Dienno further teaches the conduit 402 includes lands (interpreted as best understood from the instant disclosure to refer to legs) (see legs of posts 216 in figure 3B; [0145]) separating the leaflets 310 at the attachment section of each of the leaflets (ends of the leaflets) to form the commissure gaps between the three leaflets within the interior surface of the conduit 402.
In regard to claim 21, Dienno meets the claim limitations as discussed in the rejection of claim 19, but does not teach the attachment section is attached to the exterior surface of the conduit by adhesive, thermal or chemical bonding.
Dienno teaches other elements secured by thermal bonding [0194: film coupled to the conduit with an adhesive agent through thermal bonding]
It would have been obvious to one of ordinary skill in the art of medical bonding and connections at the time the invention was filed to use the thermal bonding of Dienno to bond the attachment section to the external surface of the conduit as an additional or backup attachment for additional security against coming detached.
In regard to claim 25, Dienno meets the claim limitations as discussed in the rejection of claim 18, and further teaches the conduit 402 as discussed in the rejection of claim 18. Dienno further teaches the conduit 402 has an inflow portion defining an inflow end and an outflow portion defining an outflow end, (fig 20a)
wherein the at least one leaflet 310 is coupled to the conduit are operable to open to allow flow from the inflow end to pass through the outflow end of the conduit in antegrade flow conditions, and are operable to close to restrict flow from flowing from the outflow end through the conduit inflow end in retrograde flow conditions. [0076]
In regard to claim 26, Dienno meets the claim limitations as discussed in the rejection of claim 18, and further teaches the at least one leaflet 310 comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, [0078: composite material is a combination of fluoropolymer and an elastomer imbibed within a porous structure of the membrane; 0169: leaflet can comprise a composite material].
and optionally TFE-PMVE copolymer comprising from 27 to 32 weight percent perfluoromethyl vinyl ether and respectively from 73 to 68 weight percent tetrafluoroethylene on at least a portion of the composite material, (the option without is chosen)
and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE. (the option without is chosen)
In regard to claim 27, Dienno meets the claim limitations as discussed in the rejection of claim 18, and further teaches the outflow portion (interpreted as best understood as the outflow portion of the conduit) defines a sinus 406 adjacent to the at least one leaflet. (fig 20A) [0188: near leaflets 310]
In regard to claim 28, Dienno meets the claim limitations as discussed in the rejection of claim 27, and further teaches the conduit 402 in the embodiment of figure 20A. Dienno further teaches the sinus 406 is operable for the surgical attachment of blood vessels and/or coronary arteries. The sinus is capable of having vessels surgically attached given the right tools.
In regard to claim 29, Dienno meets the claim limitations as discussed in the rejection of claim 18, and further teaches the inflow end defines an outward taper or is operable to be outwardly tapered. The inflow end is capable of being outwardly tapered by stretching or adjusting given the right tools. This is a statement of intended use, and must only be capable of being tapered.
In regard to claim 30, Dienno meets the claim limitations as discussed in the rejection of claim 18, and further teaches the conduit 402 in figure 20a as discussed in the rejection of claim 18. Dienno further teaches the inflow portion (of the conduit) is operable to be outwardly everted and rolled toward the valve structure defining a sewing cuff. The conduit is capable of being everted and rolled due to its material. [0115: puncturing a conduit; therefore capable of being sewed]
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dienno (2016/0175095A1) in view of Buchanan (6936067B2).
In regard to claim 8, Dienno meets the claim limitations as discussed in the rejection of claim 7, and further teaches the use of PEEK in the frame [0224: commissure post caps] but does not teach the use of PEEK in the support frame.
Buchanan teaches the support frame 10 is formed of polyether ether ketone (PEEK). (Col 2, lines 39-40)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the PEEK stent material of Buchanan to fabricate the stent of Dienno because PEEK is an equivalent biocompatible material (Col 2, lines 38-39; Col 4, lines 34-39) that allows the stent to be injection molded (Col 4, lines 35-40).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dienno (2016/0175095A1) in view of Kaiser (CN101932290A).
In regard to claim 24, Dienno meets the claim limitations as discussed in the rejection of claim 18, and teaches the conduit as disclosed in the embodiment of figure 20 as discussed in the rejection of claim 18.
However, Dienno does not teach the conduit comprises a directional indicator.
Kaiser teaches a directional indicator 54 on the exterior surface of the conduit to indicate a direction of blood flow within the conduit. [0046: may be installed on stent or conduit; 0102; claim 10: at least one position marker preferably arranged in an area of the proximal end] Since the indicators allow monitoring of the stent location, they are also capable of indicating a direction of blood flow within the conduit since they are only on one side of the stent.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the indicators of Kaiser on the exterior conduit surface of Dienno because this ensures the stent location is accurately located and monitored [0093; 0046].
Allowable Subject Matter
Claim(s) 22-23 is/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.
In regard to claim 22, Dienno all of the claimed limitations except “the second portion is attached to the distal portion of the exterior surface of the conduit” in combination with the other claimed limitations. However, please note there is a drawing objection regarding this feature currently.
In regard to claim 23, Dienno meets the claim limitations except “the leaflet attachment portion is a portion of the conduit and the leaflet attachment portion is denser than remaining portions of the conduit” in combination with the other claimed limitations. “Is a portion of the conduit” is interpreted as best understood to mean the leaflet attachment portion is part of the same piece of material as the conduit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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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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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
Prosecution Insights