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 .
Claim Objections
Claims 2-4 are objected to because of the following informalities: Claims 2-4 each are respectively dependent off of claim 1 which is a device claim directed to a shunt configured to be deployed in a first/second body cavity. Each of claims 2-4 recites the first/second body cavities are defined by a heart chamber/atrium/blood vessels. Since the claims are device claims, they cannot positively recite tissue. In order to avoid any 101 issues, claims 2-4 should be amended to recite the cavities defines the chamber/atriums/vessels in a functional manner. Appropriate correction is required.
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.
Claims 1-10, 12-14, 17, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,744,589. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to claim 1, the reference patent claims a device for modifying blood flow within a patient (claim 1), the device comprising: a shunt (claim 1, the device) configured to transition between a compressed delivery state and an expanded deployed state (claim 1), the shunt comprising a middle region (claim 1), a first end region (claim 1) extending from a first end of the middle region and configured to be deployed in a first body cavity, a second end region (claim 1) extending from a second end of the middle region and configured to deployed in a second body cavity of the patient, and a lumen (claim 1) extending therethrough and defining the passage between the first and second cavities, wherein select portions of the first and second end regions configured to be independently, selectively deformable to different angles relative to a longitudinal axis of the shunt upon actuation of one or more forces thereto (claim 1); the different angles of the select portions of the first and/or second end regions configured to be maintained in the expanded deployed state upon release of the one or more forces to thereby change a flow rate of blood through the passage defined by the lumen between the first and second body cavities (claim 1), thereby changing a coefficient of discharge of the shunt (claim 1).
As to the instant application’s claim 2, see reference patent claim 1.
As to the instant application’s claim 3, see reference patent claim 1.
As to the instant application’s claim 4, 5, see reference patent claim 1. Since the blood vessels cannot be positively claimed, the reference patent can read on being used on cavities defined by blood vessels.
As to the instant application’s claim 6, see reference patent claim 2.
As to the instant application’s claim 7, see reference patent claim 4.
As to the instant application’s claim 8, see reference patent claim 8.
As to the instant application’s claim 9, see reference patent claim 9.
As to the instant application’s claim 10, see reference patent claim 16.
As to the instant application’s claim 12, see reference patent claim 7.
As to the instant application’s claim 13, 14, see reference patent claim 6.
As to the instant application’s claim 17, the reference patent claims a method for modifying blood flow within a patient (claim 20) the method comprising: selecting a shunt (claim 20, the device) comprising a middle region (claim 20), a first end region (claim 20) extending form a first end of the middle region, a second end region (claim 20) extending from a second end of the middle region, and a lumen (claim 20) extending therethrough; delivering the shunt in a compressed delivery state through the patient’s vasculature such that the first end region is disposed within a first body cavity (claim 20), the second region is disposed within a second body cavity (claim 20), the middle region is positioned within a tissue between the first and second body cavities (claim 20) and the lumen defining the passage between the first and second body cavities (claim 20); applying one or more forces to the first and/or second end regions to independently, selectively deform select portions of the first and/or second end regions to different angles relative to the longitudinal axis of the shunt (claim 20), activating the first and/or second end regions to independently, selectively deform select portions of the first and/or second end regions to different angles relative to a longitudinal axis of the shunt (claim 20), wherein, upon release of the one or more, the different angles of the select portions of the first and/or second end regions are maintained in the expanded deployed state to thereby change a flow rate of blood through the passage defined by the lumen between the first and second body cavities, thereby changing a coefficient of discharge of the shunt (claim 20, 21).
As to claim 18, see reference patent claim 20.
Claims 1-18, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,349,912. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to claim 1, the reference patent claims a device for modifying blood flow within a patient (claim 1), the device comprising: a shunt (claim 1, the device) configured to transition between a compressed delivery state and an expanded deployed state (claim 1), the shunt comprising a middle region (claim 1), a first end region (claim 1) extending from a first end of the middle region and configured to be deployed in a first body cavity, a second end region (claim 1) extending from a second end of the middle region and configured to deployed in a second body cavity of the patient, and a lumen (claim 1) extending therethrough and defining the passage between the first and second cavities, wherein select portions of the first and second end regions configured to be independently, selectively deformable to different angles relative to a longitudinal axis of the shunt upon actuation of one or more forces thereto (claim 1); the different angles of the select portions of the first and/or second end regions configured to be maintained in the expanded deployed state upon release of the one or more forces to thereby change a flow rate of blood through the passage defined by the lumen between the first and second body cavities (claim 1), thereby changing a coefficient of discharge of the shunt (claim 1).
As to the instant application’s claim 2, see reference patent claim 1.
As to the instant application’s claim 3, see reference patent claim 1.
As to the instant application’s claim 4, 5, see reference patent claim 1. Since the blood vessels cannot be positively claimed, the reference patent can read on being used on cavities defined by blood vessels.
As to the instant application’s claim 6, see reference patent claim 3.
As to the instant application’s claim 7, see reference patent claim 4.
As to the instant application’s claim 8, see reference patent claim 6.
As to the instant application’s claim 9, see reference patent claim 8.
As to the instant application’s claim 10, see reference patent claim 7.
As to the instant application’s claim 11, see reference patent claim 12.
As to the instant application’s claim 12, see reference patent claim 13.
As to the instant application’s claim 13, see reference patent claim 14.
As to the instant application’s claim 14, see reference patent claim 15.
As to the instant application’s claim 15, see reference patent claim 1.
As to the instant application’s claim 16, see reference patent claim 9.
As to the instant application’s claim 17, the reference patent claims a method for modifying blood flow within a patient (claim 16) the method comprising: selecting a shunt (claim 1) comprising a middle region (claim 16), a first end region (claim 16) extending form a first end of the middle region, a second end region (claim 16) extending from a second end of the middle region, and a lumen (claim 16) extending therethrough; delivering the shunt in a compressed delivery state through the patient’s vasculature such that the first end region is disposed within a first body cavity (claim 16), the second region is disposed within a second body cavity (claim 16), the middle region is positioned within a tissue between the first and second body cavities (claim 16) and the lumen defining the passage between the first and second body cavities (claim 16); applying one or more forces to the first and/or second end regions to independently, selectively deform select portions of the first and/or second end regions to different angles relative to the longitudinal axis of the shunt (claim 16), activating the first and/or second end regions to independently, selectively deform select portions of the first and/or second end regions to different angles relative to a longitudinal axis of the shunt (claim 16), wherein, upon release of the one or more, the different angles of the select portions of the first and/or second end regions are maintained in the expanded deployed state to thereby change a flow rate of blood through the passage defined by the lumen between the first and second body cavities, thereby changing a coefficient of discharge of the shunt (claim 16).
As to the instant application’s claim 18, see reference patent claim 16.
As to the instant application’s claim 20, see reference patent claim 16.
Claims 11, 15, 16, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,744,589 in view of U.S. Patent 6,616,675 to Evard.
As to the instant application’s claim 11, the reference patent is silent about the hourglass shape of the shunt. Evard teaches a similar device (devices for maintaining connections, abstract), having a shunt in an hourglass shape in the expanded deployed state (figure 2, col. 8 ll. 57-64). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the shunt of the reference patent claims be hourglass shape as taught by Evard in order for engaging the anatomical tissue on opposite sides of the passageway.
As to the instant application’s claim 15, the reference patent is silent about the one or more expansion devices. Evard teaches a similar a similar system (devices for maintaining connections, abstract) having one or more expansion devices (28,30) configured to be actuated to apply one or more forces to the first and/or second end regions to independently, selectively deform select portions of the first and/or second end regions to different angles relative to the longitudinal axis of the shunt, wherein, and releasing of the one or more forces by the one or more expansion devices to allow the device to be maintained (col. 11 II. 10-45) in order for cause select portions to splay to the desired angle. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the one or more expansion devices of Evard in the system of the reference patent claim for in order to cause the select portions to splay to the desired angle.
As to the instant application’s claim 16, see Evard figure 3”’, col. 11 ll. 10-45, col. 2 ll. 42-47).
As to instant application’s claim 20, the reference patent is silent about actuating the one or more expansion devices to apply the one or more forces. Evard teaches a similar method (devices for maintains connections, abstract) having the method step of activating one or more expansion devices (28,30) to apply one or more forces to the first and/or second end regions to independently, selectively deform select portions of the first and/or second end regions to different angles relative to the longitudinal axis of the shunt (col. 11 ll. 10-45) in order for cause the select portions to splay to the desired angle. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the one or more expansion devices of Evard in the method of the reference patent claim in order to cause the select portions to splay to the desired angle.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,744,589 in view of U.S. Patent Publication 2002/0165606 to Wolf
As to the instant application’s claim 19, the reference patent is silent about the first region is dispose within a blood vessel and the second region is disposed within a heart chamber, the middle region is positioned within tissue between the blood vessel and the heart chamber, and the lumen defines the passage between the blood vessel and the heart chamber. Wolf teaches a similar method (bypass) where the first region is disposed within a blood vessel and the second region is disposed within a heart chamber, the middle region is positioned within tissue between the blood vessel and the heart chamber, and the lumen defines the passage between the blood vessel and the heart chamber (paragraph 2, 28, 36, 38, figure 1a) for the purpose of allowing communication of fluids from similar portions of human tissue to another. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method comprise the first, second, middle region, and lumen be within the blood vessel and heart chamber in order for allowing communication of fluids from similar portions of human tissue to another.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,349,912 in view of U.S. Patent Publication 2002/0165606 to Wolf
As to the instant application’s claim 19, the reference patent is silent about the first region is dispose within a blood vessel and the second region is disposed within a heart chamber, the middle region is positioned within tissue between the blood vessel and the heart chamber, and the lumen defines the passage between the blood vessel and the heart chamber. Wolf teaches a similar method (bypass) where the first region is disposed within a blood vessel and the second region is disposed within a heart chamber, the middle region is positioned within tissue between the blood vessel and the heart chamber, and the lumen defines the passage between the blood vessel and the heart chamber (paragraph 2, 28, 36, 38, figure 1a) for the purpose of allowing communication of fluids from similar portions of human tissue to another. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method comprise the first, second, middle region, and lumen be within the blood vessel and heart chamber in order for allowing communication of fluids from similar portions of human tissue to another.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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