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 . Claims 1-20 are pending examination below.
Election/Restrictions
Applicant’s election without traverse of claims 1-16 in the reply filed on May 06, 2026 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 06, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: various reference numbers in the 300 level found in Figs. 7-11 are not listed in the specification, such as but not limited to refs. 310, 320, 321, 322, 324, and 350. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 10-12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 20130072847 A1 (hereinafter, "Schutz").
In regards to claim 1, Schutz teaches an access port (Fig. 1, access port, 1, para 0039), comprising an annular ring (Fig. 2, coupling member, 2, para 0047), a central opening passing through the annular ring (Fig. 2, outlet nozzle, 24, para 0039), an optional tubular projection extending from the annular ring and coaxial with the central opening (Fig. 1 and 2, connection member, 23, para 0039 and 0046), an annular skirt on a distal surface of the annular ring and co-axial with the central opening Fig. 2, wall portion, 22, para 0039); a plurality of tissue openings passing axially through the annular ring and spaced apart about a circumference of the annular ring (Fig. 2, traversing holes, 61, para 0039); and a plurality of tissue anchors configured to axially pass into and through the plurality of tissue openings (para 0039, discloses use with screws), the annular skirt, and into anatomic tissue to exert an axially compressive force to the annular ring and the access skirt against the anatomic tissue (Fig. 7, bone, 9, para 0042).
In regards to claim 2, Schutz teaches, further comprising an annular access cap (Fig. 1, first valve system, 7, para 0045) having a central opening co-axial with the central opening of the annular ring (see above, annotated Fig. 1).
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In regards to claim 3, Schutz further teaches, wherein the annular access cap further comprises a first annular cap member (Fig. 1, valve housing, 75, para 0045) that removably engages with the annular ring of the access port (Fig. 1, valve housing, 75, and access port, 1, para 0045), a second annular cap member (Fig. 1, protective cap, 10, para 0053) coupled to the first annular cap member, wherein the first annular access cap member (Fig. 1, first valve system, 7, para 0045) and the second annular access cap member (Fig. 1, second valve system, 8, para 0045) each have a central opening defining the central opening of the annular access cap (see above, annotated Fig.1, central opening).
In regards to claim 4, Schutz further teaches, wherein further comprising a seal disposed within the central opening (Fig. 8 and 9, sleeve portion, 232 and flexible blades, 231, para 0055, act as a seal compressing the internal conduit, 3 against the connection member, 23).
In regards to claim 5, Schutz further teaches, wherein the tissue anchors are selected from the group of tissue screws, expandable pins, and expandable anchors (Fig. 2, traversing holes, 61, para 0039, adapted to carry screws not shown).
In regards to claim 6, Schutz further teaches, wherein the annular access cap further comprises a tubular projection disposed in the central opening of the annular access cap (Fig. 1 and 2, connection member, 23, para 0039 and 0046).
In regards to claim 7, Schutz further teaches, wherein the tubular projection (Fig. 7, internal conduit, 3, para 0042) is configured to project distally (Fig. 7, coupling member, 2, para 0042) from the central opening of the annular access cap and pass into and through a penetration into the anatomic tissue (Fig. 7, trench, 92, and bone, 9, para 0042).
In regards to claim 10, Schutz further teaches wherein the annular access cap further comprises a valve (Fig. 1, first valve system, 7, para 0043).
In regards to claim 11, Schutz further wherein the valve (Fig. 1, first and second valve system, 7 and 8, para 0039) is a one-way valve (Fig. 1, passageways, 70 and 71, and sealing membranes, 80 and 81, para 0047) configured to pass medical instruments and/or medical devices therethrough (para 0051, open when external conduit is inserted, closed sealing when removed).
In regards to claim 12, Schutz further teaches a sealing plug (Fig. 1, sealing membranes, 80 and 81, para 0047) passing through the one-way valve (Fig. 1, passageways, 70 and 71, para 0047) the sealing plug being retained by the one-way valve and the second annular cap member (Fig. 1, clipping member, 814 para 0047).
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.
Claims 8-9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schutz in view of WO 2022173972 A1, (hereinafter, "Mitchell").
In regards to claim 8, Schutz further teaches, wherein the annular access cap (Fig. 1, first valve system, 7, para 0039) further comprises a sealing plug (Fig. 1, sealing membranes, 80 and 81, para 0047, see also Fig. 12, plug, 702, para 0058). However Schutz does not explicitly state the sealing plug projects distally from the central opening of the annular access cap.
Mitchell teaches an annular access port (Fig. 2, apical cuff, 200, para 0080) projecting distally from the central opening of the annular access cap (Fig. 18, plug member, 374, para 00104). Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the annular access cap of Schutz with the sealing plug of Mitchell to prevent bleeding through the cored area of the heart and assess the hemostasis of the region (Mitchell, para 00104).
In regards to claim 9, Schutz further teaches that the access port (Fig. 1, access port, 1, para 0039)). However Schutz does not explicitly teach the sealing plug has a length less than or equal to a thickness of the anatomical tissue.
Mitchell further teaches, wherein the sealing plug (Fig. 18, plug member, 374, para 00104). Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the annular access cap of Schutz with the sealing plug of Mitchell to entirely occlude the cored opening of the heart in order to create the seal (Mitchell, para 00104).
Mitchell has a length but is silent as to the sealing plug having a length less than or equal to a thickness of the anatomical tissue. Mitchell discloses (para 00104) that the plug member is able to partially or entirely occlude the cored opening. As seen in Fig. 18, the plug protrudes from the handle near the distalmost end of the plug tool and as such the length of the distal end of the device is disclosed to be a result effective variable in that changing the length of the distal end changes the seal of the heart muscle which affects occlusion and sealing effective variable, adjust the length of Mitchell to be the length less than or equal to, the length relates to occluding in order to perform the same function. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Mitchell device to have a length within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. 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 device of Mitchell by making the length of the distal portion be a length less than or equal to a thickness of the anatomic tissue as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 13, Schutz further teaches the access port (Fig. 1, access port, 1, para 0039) and a central bore passing along an entire longitudinal axis (see below, annotated Fig. 1, central openings).
However, Schutz does not explicitly teach the access port delivery system comprising a drive input sub-system, a synchronous drive gear subsystem, a synchronous drive gear subsystem, and a driver sub-system. Mitchell further teaches the access port delivery system (Fig. 20, delivery tool, 300, para 0087) comprising a drive input sub-system (Fig. 20, driver, tool, 350, para 0087), a synchronous drive gear subsystem (Fig. 15, delivery tool, 500, para 0092), and a central bore passing along an entire longitudinal axis (Fig. 2, central opening, 22, para 0076) of the access port delivery system and open at opposing ends thereof (Fig. 18, para 0015), wherein the access port is removably coupled to the driver sub-system (Fig. 20 and 21, delivery tool, 500 and driver may be removed). Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the central bore of Schutz with the drive system of Mitchell in order to implant the access port into the heart muscle achieving a hemostatic seal (Mitchell, para 00103).
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In regards to claim 14, Schutz further teaches the tissue anchors (Fig. 2, traversing holes, 61, para 0039, adapted to carry screws not shown). However, Schutz does not explicitly teach the driver sub-system. Mitchell further teaches wherein the tissue anchors (Fig. 13, tissue anchors, 30, para 0087) are removably coupled to the driver sub-system (Fig. 13, driver tool, 350, para 0087). Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue anchors of Schutz to include the driver sub -system of Mitchell to drive the tissue anchors through the skirt and ultimately delivering the device for implantation (Mitchell, para 0087).
In regards to claim 15, Schutz further teaches the central bore (see above, annotated Fig. 1, central openings). However Schutz does not explicitly teach the access port delivery system comprising a rotational member coupled to the drive input sub-system and the central bore passes through the rotational member and is accessible there through. Mitchell further teaches the access port delivery system (Fig. 20, delivery tool, 300, para 0087, see also Fig. 15, delivery tool, 500) comprising a rotational member coupled to the drive input sub-system (Fig. 20, handle, 340, para 0099) and the central bore passes through the rotational member and is accessible there through. Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue anchors of Schutz to include the driver sub -system of Mitchell to drive the tissue anchors through the skirt and ultimately delivering the device for implantation (Mitchell, para 0087).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schutz in view of R. Fontana, G.Tortora, M. Silvestri, M. Vatteroni, P.Dario, M.G. Trivella, A portable system for autoregulation and wireless control of sensorized left ventricular assist devices, Biocybernetics and Biomedical Engineering, Volume 36, Issue 2, 2016, Pages 366-374, ISSN 0208-5216, https://doi.org/10.1016/j.bbe.2016.02.001. (hereinafter, "Fontana") .
In regards to claim 16, Schutz further teaches the access port (Fig. 1, access port, 1, para 0039). However, it does not explicitly teach the access port comprising at least one sensor and/or power source. Fontana which teaches a left ventricular assist device (Abs.) also teaches the need to have a sensorized platform for the VAD (Section B., Implementation of a sensorized Bench Platform). Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue anchors of Schutz to include the sensorized VAD of Fontana in order to control the pump speed and flow level rate (Results and Conclusion).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/J.M.S./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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