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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/4/2026 has been entered.
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive. Regarding the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Hijlkema, applicant argues claim 1 is amended to recite “the at least one protector forms a hollowed-out internal space radially between the at least one protector and the inner tube, the hollowed-out internal space being configured to accommodate a valve leaflet to separate the implant from the valve leaflet”. Applicant argues in Hijlkema, pocket 340 (fig.8A) is an annular blind pocket defined by inner wall 341 and outer wall 343, and a stent is tightly pinched between these walls, therefore the internal space of the annular pocket is completely occupied by the stent struts and Hijlkema fails to disclose a “hollowed-out internal space” radially between an outer protector and the inner tube. These arguments are not persuasive because, as applicant explained, Hijlkema discloses an annular blind pocket, and this annular blind pocket is considered by the examiner to be a hollowed-out internal space. Applicant appears to be arguing with respect to a combination of a stent and inner tube assembly, but the claim only requires an inner tube assembly. While the example in Hijlkema shows a stent occupying the pocket/hollowed-out internal space, when there is no stent located within the inner tube assembly, Hijlkema discloses a hollowed-out internal space radially between the at least one protector and the inner tube. The hollowed-out internal space of the inner tube assembly of Hijlkema is capable of accommodating a valve leaflet to separate the implant from the valve leaflet. The implant and valve leaflet are not positively recited since the claim recites “being configured to accommodate”. The limitation “being configured to accommodate a valve leaflet to separate the implant from the valve leaflet” is a functional limitation directed to an intended use of the inner tube assembly and according to MPEP 2114, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Since Hijlkema discloses all the structural limitations as claimed by applicant it would follow that it would be capable of performing the recited functions. Furthermore, one of ordinary skill in the art at the time of the invention could have used the inner tube assembly of Hijlkema in order to achieve this function should they have desired. Finally, the claim does not specify any particular structure of the implant and valve leaflet or how exactly the valve leaflet is separated from the implant. Therefore, any of the protectors and hollowed-out internal spaces disclosed by Hijlkema could be used to separate an implant (the examiner assumes this means the implant frame) from its leaflet(s) in either a radial or axial direction. Separating the implant from the valve leaflet depends on implant structure (no specifics are claimed) and depends on how the protector is positioned with respect to the implant and the valve leaflet (no specifics are claimed). The protectors of Hijlkema are capable of being positioned with respect to an implant such that a hollowed-out internal space accommodates a valve leaflet to separate the implant from the valve leaflet. For example, the protectors of Hijlkema could be positioned between an implant frame and a valve leaflet which would separate the implant (frame) from the valve leaflet. Accordingly, the rejection in view of Hijlkema is maintained.
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 “hollowed-out internal space being configured to accommodate a valve leaflet to separate the implant from the valve leaflet” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. None of the figures of the application show valve leaflets. Because there are no figures showing a combination of the implant protection part and the valve leaflets, there are no figures showing a hollowed-out internal space configured to accommodate a valve leaflet to separate the implant from the valve leaflet.
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.
Claims 5, 6, and 8 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.
Regarding claim 5, claim 1 was amended to require that the implant protection part is connected to the inner tube, a connector is connected to the inner tube and to the at least one protector, and the fixing head and the connector are “spaced apart from each other along the inner tube”. Claim 1 was also amended to delete that the implant protection part is connected to the fixing head since “or the fixing head” was deleted. Therefore, claim 5 is unclear because line 2 states the implant protection part further comprises a second protector connected to the protector and line 4 recites “wherein one of the protector and the second protector is connected to the fixing head”, but claim 1 requires the implant protection part, which comprises at least one protector, is connected to the inner tube. In other words, how can the second protector (which is connected to “the protector”) or the protector, be connected to the fixing head when the implant protection part is connected to the inner tube?
Claim 6 is unclear for reasons similar to claim 5. Claim 1 deleted “or the fixing head” (lines 8-9) and requires the implant protection part is connected to the inner tube (see claim 1, line 8). Therefore, it is unclear how “the implant protection part is connected to the fixing head” as recited in line 4 of claim 6. Claim 6 is further unclear because claim 1 already requires a connector that is connected to the inner tube and to the at least one protector, while claim 6 requires a connector connected to the inner tube and the second protector is connected to the connector. Claim 6 should be amended to correspond with the amendments to claim 1 which require the implant protection part is connected to the inner tube, a connector is connected to the inner tube and to the at least one protector, and wherein the fixing head and the connector are spaced apart from each other along the inner tube.
Claim 6 is further unclear because claim 6 recites the limitation "the connector" in lines 10 and 11, but it is unclear which connector this refers to because claim 1 recites a connector of the implant protection part and claim 6 recites a connector of the second implant protection part.
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.
Claims 1, 5-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hijlkema et al. US 6,858,034 (hereafter referred to as Hijlkema).
Regarding claim 1, Hijlkema discloses an inner tube assembly of an implant conveying device (figs.3 and 6), comprising an implant protection part, the implant protection part including at least one protector 44 (fig.3), 242 (figs. 7A-7B), 342 (figs. 8A-8B), or 442 (fig.8C) in the shape of a circular ring sheet or a circular arc sheet (for fig.3 see the cylindrical shape described in col.6, lines 19-22 which holds stent 14 within pocket 40; figs. 7A-8C show outer ring shaped protectors), an inner tube 23 (col.1, lines 63-65 disclose central core 23 can guide the system over a guidewire therefore the central core must be a tube as is customary in the art) and a fixing head 20’, 120 connected to the inner tube 23 (figs.3 and 6), the fixing head having a recess 40’, 340 capable of receiving a lug of an implant (figs.3 and 8A show recesses 40’, 340; figs. 7A, 7B, and 8C show additional recesses between and within fingers 244, 441, and 443; col.7, line 67-col.8 line 3 says the docking sections 242, 342, and 442 can also be provided for the catheter tip), wherein the implant protection part is connected to the inner tube (figs.3 and 6), wherein the implant protection part further comprises a connector 16’, 116 that is connected to the inner tube and the at least one protector 44, 142 (figs. 3 and 6; the protector can also be any of the protectors shown in figs. 7A-8C), the implant protection part is configured to be in contact with the implant 14 to support the implant 14 (figs.3 and 6; col.6, lines 19-22; col.7, lines 32-37), wherein the fixing head 20, 120’ and the connector 16’, 116 are spaced apart from each other along the inner tube, an opening direction of the recess faces axially toward the connector, and the at least one protector 44, 242, 342, 442 extends axially from the connector toward the fixing head (figs. 3 and 6; see annotated fig.3 below for an example), wherein the at least one protector forms a hollowed-out internal space 40 radially between the at least one protector and the inner tube (figs. 3 and 6-8C; see annotated fig.3 below for an example), the hollowed-out internal space being capable of accommodating a valve leaflet to separate the implant from the valve leaflet (the implant and valve leaflet are not positively recited since the claim recites “being configured to accommodate”). The limitation “being configured to accommodate a valve leaflet to separate the implant from the valve leaflet” is a functional limitation directed to an intended use of the inner tube assembly and according to MPEP 2114, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Since Hijlkema discloses all the structural limitations as claimed by applicant it would follow that it would be capable of performing the recited functions. Furthermore, one of ordinary skill in the art at the time of the invention could have used the inner tube assembly of Hijlkema in order to achieve this function should they have desired. Finally, the claim does not specify any particular structure of the implant and valve leaflet or how exactly the valve leaflet is separated from the implant. Therefore, any of the protectors and hollowed-out internal spaces disclosed by Hijlkema could be used to separate an implant from its leaflet(s) in either a radial or axial direction. Separating the implant from the valve leaflet depends on implant structure (no specifics are claimed) and depends on how the protector is positioned with respect to the implant and the valve leaflet (no specifics are claimed). The protectors of Hijlkema are capable of being positioned with respect to an implant such that a hollowed-out internal space accommodates a valve leaflet to separate the implant from the valve leaflet. For example, the protector 341 (which col.7, lines 58-59 says can be a hollow cylinder), or 441 could be positioned between an implant frame and a valve leaflet which would separate the implant (frame) from the valve leaflet.
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Regarding claim 5, as best understood in light of the 112b issues discussed above, it appears “the implant protection part” of claim 5 is a second implant protection part comprising a second protector connected to a third protector (since the at least one protector of claim 1 is connected to the inner tube and connector, opposite the fixing head) wherein one of the second and third protectors is connected to the fixing head, and claim 5 is interpreted as such. See fixing head 120, which is a catheter tip, comprising docking section 142’ in fig.6 and see each of figs. 7A-8C showing at least second and third protectors 244, 341, 343, 441, 443 in the docking sections 242, 342, and 442. Col.7, line 67-col.8 line 3 says the docking sections 242, 342, and 442 can be provided for the catheter tip. Therefore, when any of 242, 342, or 442 are provided as the docking section of the catheter tip/fixing head 120, the implant protection part comprises a second protector and a third protector connected to each other (at least via their bases) and wherein both are connected to the fixing head/catheter tip 120.
Regarding claim 6, as discussed above, claim 6 is indefinite. As best understood, the claim appears to be trying to require an implant protection part at the fixing head and another implant protection part connected to the inner tube at an opposite end. Fig.6 shows wherein the inner tube assembly comprises an implant protection part 142’ connected to the fixing head and another implant protection part 116, 142, connected to the inner tube 23 and opposite the fixing head (fig.6). Figs. 7A-8C show connectors and protectors and col.7, line 67-col.8 line 3 says the docking sections 242, 342, and 442 can be provided for both pushers and the catheter tip. Therefore, selection of any of the protection parts 242, 342, and 442 in the embodiments shown in figs. 7A-8C in place of 142 and 142’ in fig.6 would meet the claim as best understood.
Regarding claim 7, see fig.6 for connector 116 being a cylinder with an opening 22 in the middle, and the connector 116 is circumferentially connected to the inner tube 23 at the opening 22.
Regarding claim 8, see at least fig.8A for a first protector 343 being in the shape of a circular ring sheet and second protector 341 being a circular arc sheet (col.7, lines 58-59 discloses inner wall 341 can be a hollow cylinder and a hollow cylinder forms a circular arc of 360 degrees).
Regarding claim 10, see fig. 6 for a catheter comprising an outer tube 12 and the inner tube assembly of claim 1 as discussed above.
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hijlkema as applied to claim 1 above, and further in view of Phillips US 2019/0282384 (hereafter referred to as Phillips). Hijlkema discloses the inner tube assembly of claim 1 as discussed above. Hijlkema further discloses an outer tube 12, the inner tube assembly passing through the outer tube (fig.6). However, Hijlkema does not disclose a handle, the handle being configured to drive the outer tube to axially move relative to the inner tube assembly.
Phillips teaches an implant conveying device, in the same field of endeavor, wherein handles 181 and 182 are configured to cause retraction or advancement of a sheath 14 relative to an inner member in order to control deployment of a stent (par.7; par.172).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a handle configured to drive the outer tube to axially move relative to the inner tube assembly as taught by Phillips to the device of Hijlkema in order to control delivery of the stent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Glazier US 2011/0301703, Peterson et al. US 2015/0336150, and Scheinblum et al. US 2018/0133000 each teach protectors being placed between leaflets and a frame to protect the leaflets during crimping.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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, Melanie Tyson can be reached 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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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