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 .
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) 1-3, 5-9 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fantuzzi et al (US 20170312492) hereafter known as Fantuzzi.
Independent claim:
Regarding claim 1:
Fantuzzi discloses
A graft system [see Fig. 1 element 10 and para 64… “a graft system 10”] comprising:
a graft [see Fig. 1 element 110 and para 64… “The graft 110”];
a hemostasis valve operably coupled to a proximal end of the graft [see Fig. 1 element 310 and paras 64 and 66-67… “the hemostasis valve 310 and the clamp 210 to allow the introduction of a medical device without the risk of blood loss.”]; and
a clamp disposed around the proximal end of the graft and configured to hold the hemostasis valve in place relative to the graft [see Fig. 1 element 210 and paras 64 and 66-67… “the hemostasis valve 310 and the clamp 210 to allow the introduction of a medical device without the risk of blood loss.”]
Independent claim:
Regarding claim 16:
A kit [see Figs. 15-17 element 910 and para 83… “The graft system 910” and “In some implementations, the graft 110, the proximal clamp 713, and the proximal hemostasis valve sheath 716 are provided in a kit.”], comprising:
a graft [see Figs. 15-17 element 110 and para 83… “the graft 110”];
a hemostasis valve configured to be operably coupled to a proximal end of the graft [see Figs. 15-17 element 711 and para 84… “Following graft anastomosis to a vascular vessel or a body cavity per standard medical procedure, the proximal hemostasis valve 711 may be inserted inside the graft 110 and secured in place using the proximal clamp 713. Subsequently, the distal hemostasis valve sleeve 922 may be inserted through the proximal hemostasis valve slit membrane 715 and advanced to a desired depth inside the graft 110 as shown in FIG. 17.”]; and
a clamp configured to be disposed around the proximal end of the graft and hold the
hemostasis valve in place relative to the graft [see Figs. 15-17 element 713 and para 84… “Following graft anastomosis to a vascular vessel or a body cavity per standard medical procedure, the proximal hemostasis valve 711 may be inserted inside the graft 110 and secured in place using the proximal clamp 713.”]
Dependent claims:
Regarding claim 2, see para 64 of Fantuzzi [see “The graft 110 is typically a porous soft medical fabric as described in U.S. Pat. No. 3,953,566 and is intended for use as a conduit in contact with blood and biological tissue.”] which discloses porous soft medical fabric which is understood to include woven and/or knitted fabrics as claimed.
Regarding claim 3, see Fig. 1 and paras 17, 22 and 66 of Fantuzzi [see “The system preferably further comprises at least one clamp configured to be disposed around the graft's tubular body and having a first configuration that allows insertion of the valve's introducer sheath into the distal end of the graft's tubular body and a second configuration that allows clamping of the graft against the valve's introducer sheath, when inserted in the graft's tubular body.”] which discloses clamping as having different configurations (i.e. attachments relative to the graft) indicating a removable attachment.
Regarding claims 5-7, see para 20 of Fantuzzi [see “The system further comprises at least one valve configured to be attached to the distal end of the graft's tubular body, the valve comprising a housing, the housing including a flexible membrane having at least one of a passage extending through the membrane and a weakened area to allow a medical device to be inserted through the membrane into said vascular graft. The valve further comprises an introducer sheath that is configured to be inserted into the distal end of the graft's tubular body.”] and para 67 of Fantuzzi [see “The hemostasis valve 310 comprises a slit membrane 314, an introducer sheath 315 and a housing 311. The housing 311 comprises two distinct halves 311A, 311B joined by two seams 312A, 312B that travel the entire length of the hemostasis valve 310.”] which disclose a housing with two portions and seams, a slit membrane and an introducer sheath as recited in these claims.
Regarding claims 8-9, see Fig. 3 elements 313 (first and second handles) and para 67 of Fantuzzi [see “The housing 311 comprises two distinct halves 311A, 311B joined by two seams 312A, 312B that travel the entire length of the hemostasis valve 310. The seams 312A, 312B are intended to thin the wall of the hemostasis valve 310 to provide a preferential breaking line in the event that the hemostasis valve 310 is split in two halves resulting in two separate halves 311A, 312B. Handles 313 are intended to assist the user in handling the hemostasis valve 310 as well as providing a handle to assist in separating the hemostasis valve 310 into two separate halves. In this embodiment, seams 312A, 312B travel the middle of the handles 313 in order to facilitate breaking the handles 313 into two halves.”] which discloses a preferential breaking line and handles as recited in claims 8 and 9.
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) 4 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi.
Regarding claim 4:
Fantuzzi discloses the invention substantially as claimed including all the limitations of claim 1 as outline above.
However, Fantuzzi discloses releasable attachment of the clamp and the graft [see paras 17, 22 and 66 of Fantuzzi] and thus, fails to disclose “wherein the clamp is permanently attached to the graft” as recited by claim 4.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Fantuzzi by making the clamp permanently attach to the graft because there are a limited number of ways to attach the clamp to the graft (i.e. permanently attached or releasably attached) and permanently attached is one of those limited number of ways.
Regarding claim 17:
Fantuzzi discloses the invention substantially as claimed including all the limitations of claim 16 as outlined above. Additionally, Fantuzzi discloses the kit as including a ruler to help with cutting grafts accurately [see para 83… “The kit may include a ruler having length increments and graft angle bevel markings to help a user prepare and cut grafts accurately. A ruler with markings indicating lengths and angles can allow a user to tailor the graft 100 to the patient and situation.”]
However, Fantuzzi fails to disclose the kit as including “a tool configured to cut the graft”.
It would have been obvious to one skilled in the art at the time the invention was filed to modify the kit by providing a tool to cut the graft so as to ensure the grafts are cut accurately as this will help with the known process of cutting grafts performed by the kit.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi in view of Dudnik et al (US 20090035388) hereafter known as Dudnik.
Fantuzzi discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Fantuzzi fails to disclose “wherein the graft includes a coating comprising cellulose” as recited by claim 10.
Dudnik discloses in the analogous art of medical devices [see para 3… “The invention also contemplates methods of making such composition, methods of forming coatings on medical materials and medical materials coated with the coating composition.”] that adding a hydrophilic coating of cellulose to a graft can help make the material lubricious [see para 36… “In further aspects, the medical material has a hydrophilic coating to which the anti-microbial photo-stable coating composition of the invention is applied thereon. The hydrophilic coating also makes the medical material lubricious.” And para 59… “The hydrophilic coating can be provided in a variety of configurations for different surfaces. The chemically inert polymers for use in the invention are those that are used and desirable to fabricate various types of in-dwelling devices. Examples of in-dwelling devices include but are not limited to implants, catheters, stents, vascular grafts, wound dressings, cardiac valves, pins, clamps, tubings and the like can be used in the practice of the invention. Polymers that can be surface modified according to the present invention include all polymeric substrates such as polyurethanes, polyamides, polyesters, polyethers, polyorganosiloxanes, polysulfones, polytetrafluoroethylene, polysiloxanes, carbohydrate materials including cellulose fibers such as cotton and chitosan;”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Fantuzzi by adding a hydrophilic coating of cellulose to the graft similarly to that disclosed by Dudnik as this provide the advantage of making the graft lubricious.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi in view of Kume et al (US 20220193321) hereafter known as Kume.
Fantuzzi discloses the invention substantially as claimed including all the limitations of claim 16 as outlined above.
However, Fantuzzi fails to disclose the kit as “comprising a Y-connector” as claimed.
Kume discloses in the analogous art of grafting and arterial devices [see abstract… “Methods, devices, and systems establish and facilitate arterial access for interventional procedures, such as stenting, angioplasty, grafting, replacement valve therapy, and atherectomy.”] that Y-connectors are standard connectors used in arterial devices [see para 91… “The coupler 107 can be configured for attachment to standard connectors (e.g., syringe, stopcocks, hemostasis valve, Y-connector, or other type of connector).”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Fantuzzi by including Y-connectors in the kit because these are standard connectors and therefore by providing the standard pieces in the kit, one of ordinary skill in the art would expect to the kit to include the elements needed to cover a wide range of common procedures.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi in view of Foley et al (US 20030176765) hereafter known as Foley.
Fantuzzi discloses the invention substantially as claimed including all the limitations of claim 1.
However, Fantuzzi uses a clip to attach a valve and graft together [see abstract… “The at least one clamp (210) is configured to be disposed around the graft's tubular body and has a first configuration that allows insertion of the valve's introducer sheath (615) into the distal end (110B) of the graft's tubular body and a second configuration that allows clamping of the graft (110) against the valve's introducer sheath (615), when inserted in the graft's tubular body.”] and fails to disclose the graft system as “further comprising a grommet, where one end of the grommet is coupled to an end of the graft” as recited by claim 11, “wherein the grommet includes one or more threads” as recited by claim 12, or “at least one ring configured to be operably coupled to the grommet via the one or more threads” as recited by claim 13.
Foley discloses in the analogous art of medical devices that adhere, hold and/or stabilize different organs to help aid treatment [see para 2… “The invention relates to devices capable of providing adherence to organs of the body for purposes of medical diagnosis and treatment. More particularly, the invention relates to devices capable of adhering to, holding, moving, stabilizing or immobilizing an organ.”] a known way to mate two different medical components together includes using a grommet [see Fig. 7 element 150] with threads [see Fig. 7 element 158] that couple with a locking ring [see Fig. 7 element 154 and see paras 52-56].
Since Fantuzzi discloses one way of connecting two different medical components in the form of a graft and valve (i.e. using a clamp) and Foley discloses another way of connecting two different medical components (i.e. using a grommet with threads and a ring), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Fantuzzi by including a grommet with threads and a locking ring similarly to that disclosed by Foley (i.e. thereby reciting the limitations of claims 11-13) to connect the graft and the valve, because this is a combination of two independent ways to connect medical components which one of ordinary skill would expect to produce better connection than either independent way alone.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foley.
Independent claim:
Regarding claim 19:
Foley discloses:
A device [see Fig. 7 and para 27… “FIG. 7 is a cross-sectional side view of an alternative embodiment of a manipulating device”], comprising:
a grommet [see Fig. 7 element 150 and para 54… “a fastener such as grommet 150 may surround the interface between cup-like member 16 and vacuum tube 20”]; and
a sheath having a distal end coupled to a proximal end of the grommet [see Fig. 7 element 20 (i.e. sheath) relative to element 150 (i.e. grommet) and para 54… “Grommet 150 may provide a more secure connection between shaft member 142 and vacuum tube 20”]
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi in view of Nix et al (WO 2023105001) hereafter known as Nix.
Fantuzzi discloses
A method for anastomosis [see para 84… “Following graft anastomosis to a vascular vessel or a body cavity per standard medical procedure, the proximal hemostasis valve 711 may be inserted inside the graft 110 and secured in place using the proximal clamp 713.”], comprising:
providing a graft system of claim 1 [see rejection to claim 1 above];
However, Fantuzzi focuses on the steps after the anastomosis and therefore is silent as to all the details of the anastomosis. Therefore, Fantuzzi fails to disclose the steps of: “creating an opening in a vessel” or “gluing a graft of the graft system to the vessel” as claimed.
Nix discloses in the analogous art of cardiovascular surgery [see pg. 3 lines 1-10… “The present disclosure relates to a surgical guide tube, a kit, a system, and a clamp-ing unit for as well as a method of fixing a medical device, in particular a catheter of an intravascular blood pump, to a patient.”] that opening the patients skin to get access to the vessel and then gluing the graft to the vessel (i.e. “creating an opening in a vessel” or “gluing a graft of the graft system to the vessel”) are known steps for anastomosis [see pg. 43 lines 5-15… “The first method steps are the same as in the previously described embodiments. That is, in a first step the patient's skin is opened to get access to the vessel, next a vascular graft is connected to the vessel by anastomosis, wherein the seam generated by suturing the graft to the vessel may be enforced with a glue, and then the medical device is inserted through the graft into the vessel so that the catheter extends through the graft out of the patient with its proximal end.”]
Since Fantuzzi is understood to include a method of anastomosis, but is silent as to all the details of the anastomosis and Nix discloses a creating an opening in a vessel and glueing the graft to the vessel are known steps of anastomosis, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Fantuzzi by creating an opening in a vessel and gluing the graft of the graft system to the vessel similarity to that disclosed by Nix (i.e. thereby reciting the missing limitations of claim 29) because these are known steps of anastomosis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEBASTIAN X LUKJAN whose telephone number is (571)270-7305. The examiner can normally be reached Monday - Friday 9:30AM-6PM.
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, NIKETA PATEL can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights