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 .
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18152551 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims read on the instant claims. “The introducer shaft” in the 551 application was changed to “the introducer sheath” to correct for the same antecedent basis issue as the instant claims for the same terminology (See 112 rejection below).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-20 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 1, “the introducer shaft” has no antecedent basis. The Applicant possibly means introducer sheath. Additionally, there is insufficient antecedent basis for “the hub connector” and “the hub”. Is this the introducer hub or a different hub? Further clarification is needed.
Claims 2-20 are dependent on claim 1 and do not remedy the issue. Therefore, they are also rejected.
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 a wwas made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Toellner (US 10874781 B2).
Regarding claim 1, Toellner discloses A system for inserting a collapsible blood pump into a patient, the system comprising: (eg. Abstract, Col. 2, Ln. 15-25) an introducer, the introducer comprising an introducer hub and an introducer sheath extending distally from the introducer hub (Eg. Fig. 1-2, Col. 8, Ln. 3-50, sheath with a tubular portion 11 connected proximally to a valve 13), the introducer sheath comprising an introducer sheath lumen (eg. Col. 8, Ln. 3-50, tubular portion 11 defines lumen L1 which has inner diameter d11), the introducer hub comprising a hub connector and a distal hub lumen surrounding a proximal end of the introducer shaft (eg. Col. 8, Ln. 3-50, widened proximal region is the distal hub lumen surrounding proximal end of the sheath and valve housing is connector interface); and a transfer tool comprising a transfer sheath, the transfer sheath comprising a transfer sheath lumen (eg. Col. 2, Ln. 64 – Col. 3, Ln. 30, Col. 8, Ln. 43-50, Col. 10, Ln. 25-40, Col. 12, Ln. 20-40) having a diameter substantially equal to a diameter of the introducer sheath lumen (eg. multiple embodiments, Col. 4, Ln. 25-35) and a transfer tool connector adapted to connect to the hub connector, a distal portion of the transfer sheath extending into the hub when the transfer tool connector is connected to the hub connector (eg. Col. 2, Ln. 64 – Col. 3, Ln. 30, Col. 8, Ln. 13-50, Col. 10, Ln. 25-40, Col. 12, Ln. 20-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ratio of diameters of the first and second sheath lumens to be between 1:1 and 1:1.2 as taught by Toellner since it would have been obvious resizing of elements in to yield desired lumen dimensions (see MPEP 2144.04).
Regarding claim 2, Toellner discloses the distal portion of the transfer sheath extends into the distal hub lumen when the transfer tool connector is connected to the hub connector (eg. Col. 8, Ln. 17-25).
Regarding claim 3, Toellner discloses the distal end of the transfer sheath abuts a proximal end of the introducer sheath when the transfer tool connector is connected to the hub connector (eg. Col. 2, Ln. 64 – Col. 3, Ln. 3, requires the ends to meet each other).
Regarding claim 4, Toellner discloses the introducer hub further comprises a tapered surface extending proximally and radially outwardly from the distal hub lumen (eg. Col. 4, Ln. 40 – Col. 5, Ln. 3, Col 8, Ln. 25-40, Col. 11, Ln. 34-57, one of ordinary skill could adjust the shape as desired to guide the device into a smaller lumen, see MPEP 2144.04).
Regarding claim 11, Toellner discloses the transfer tool further comprises a proximal hub surrounding a proximal portion of the transfer sheath (eg. Col. 3, Ln. 30 – Col. 4, Ln. 24, Col. 5, Ln. 10-51, Col. 11, Ln. 5-20).
Regarding claim 12, Toellner discloses the transfer tool proximal hub comprises a central lumen, the proximal portion of the transfer sheath being disposed in the central lumen, the central lumen having a reduced diameter portion proximal to a proximal end of the transfer sheath (eg. Col. 4, Ln. 40 – Col. 5, Ln. 3, Col 8, Ln. 25-40, Col. 11, Ln. 34-57, one of ordinary skill could adjust the shape as desired to guide the device into a smaller lumen, see MPEP 2144.04).
Claim(s) 5-7, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Toellner (US 10874781 B2) in view of Edwards (EP 1441801 B1).
Regarding claim 5, Toellner discloses the invention of claim 1, but does not disclose the introducer further comprises a one-way valve disposed in the introducer hub proximal to the introducer sheath lumen and configured to seal against vascular pressure.
Edwards teaches a one-way duckbill valve and sealing valve combination for sealing in one direction (eg. Para. 4-6, 10-12, 17-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Toellner with a duckbilled and sealing valve combo as taught by Edwards to provide the predictable result of providing a seal around a tool or catheter while preventing flow of blood through the introducer.
Regarding claim 6, the combined invention of Toellner and Edwards discloses the introducer further comprises a seal disposed in the introducer hub proximal to the introducer sheath and configured to seal against vascular pressure around a range of diameters of devices inserted through the seal (eg. Edwards, Para. 5-10, 15-17, 22-21, 28-29).
Regarding claim 7, the combined invention of Toellner and Edwards discloses the introducer further comprising a disc valve disposed in the introducer hub proximal to the introducer sheath and configured to seal against vascular pressure around a range of diameters of devices inserted through the valve (eg. Edwards, Para. 5-10, 15-17, 22-21, 28-29).
Regarding claim 14, the combined invention of Toellner and Edwards discloses the transfer tool proximal hub further comprises a seal adapted to seal around a catheter portion of a blood pump (eg. Edwards, Para. 5-10, 15-17, 22-21, 28-29).
Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Toellner (US 10874781 B2) in view of Agrawal (US 2018/0126142 A1).
Regarding claim 8, Toellner discloses the invention of claim 1, but does not disclose the introducer hub further comprises a purge fluid port in fluid communication with the distal hub lumen.
Agrawal teaches a hemostasis valve for an introducer sheath that has a side port for connection to a flush/injection tube (eg. Para. 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Toellner with the side port as taught by Agrawal since side ports are well-known in the art for providing the predictable result of connecting flushes or injection tubes.
Regarding claim 13, the combined invention of Toellner and Agrawal discloses the transfer tool proximal hub further comprises a purge fluid port communicating with the central lumen (eg. Agrawal, Para. 57, one of ordinary skill would have been able to use a commonly known fluid port in the art for flushing/injecting as desired).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Toellner (US 10874781 B2) in view of Fantuzzi (US 11197690 B2).
Regarding claim 9, Toellner discloses the invention of claim 1, but does not disclose the hub connector comprises threads disposed on the introducer hub.
Fantuzzi teaches a medical device introducer that various types of connections such as threaded connections between hubs to couple them together (Eg. Col. 3, Ln. 48-55, Col. 9, Ln. 40-62, Col. 10, Ln. 3-47, Col. 13, Ln. 12-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Toellner with the threaded connections as taught by Fantuzzi because both are related to medical introducers and threaded connections are commonly used in the art.
Regarding claim 10, the combined invention of Toellner and Fantuzzi discloses the hub connector and transfer tool connector are configured to provide an axial force to move the transfer sheath and introducer sheath toward each other (Eg. Col. 3, Ln. 48-55, Col. 9, Ln. 40-62, Col. 10, Ln. 3-47, Col. 13, Ln. 12-31).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Toellner (US 10874781 B2) in view of Huddleston (US 116548114 B2)
Regarding claim 15, Toellner discloses the invention of claim 1, but does not disclose the transfer tool further comprises a handle surrounding the transfer sheath.
Huddleston teaches a device for percutaneous delivery of a radially collapsible implant through a separately placed sheath with a handle (eg. Fig. 1, Abstract, Col. 5, Ln. 15 – Col. 6, Ln. 21, Col. 7, Ln. 10-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Toellner with the handle as taught by Huddleston to provide the predictable result of having a graspable body for better handling.
Regarding claim 16, the combined invention of Toellner and Huddleston discloses the handle extends proximally from the transfer tool connector (eg. Huddleston Fig. 1, 11, Abstract, Col. 5, Ln. 15 – Col. 6, Ln. 21, Col. 7, Ln. 10-67).
Regarding claim 17, the combined invention of Toellner and Huddleston discloses a proximal hub, the handle extending from the transfer tool connector to the proximal hub (eg. Huddleston Fig. 1, 11, Abstract, Col. 5, Ln. 15 – Col. 6, Ln. 21, Col. 7, Ln. 10-67).
Regarding claim 18, the combined invention of Toellner and Huddleston discloses the transfer tool connector comprises threads disposed at a distal end of the handle, the distal portion of the transfer sheath extending distally beyond the transfer tool connector (eg. Huddleston, Fig. 11, Col. 5, Ln. 17-47, threading is used. One of ordinary skill would have used threading to connect the parts since threading is commonly used in the art).
Regarding claim 19, the combined invention of Toellner and Huddleston discloses the transfer tool connector comprises a rotatable ring with internal threads (eg. Huddleston Fig. 1, 11, Abstract, Col. 5, Ln. 15 – Col. 6, Ln. 21, Col. 7, Ln. 10-67, internally threaded ring).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Toellner (US 10874781 B2) in view of Schaeffer (US 7534250 B2).
Regarding claim 20, Toellner discloses the invention of claim 1, but does not disclose the distal portion of the transfer sheath is radially expandable.
Schaeffer teaches an introducer sheath that is radially expandable (eg. Abstract, Col. 1, Ln. 60 – Col. 2, Ln. 45, Col. 3, Ln. 30 – Col. 4, Ln. 30, Col. 6, Ln. 61 – Col. 7, Ln. 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Toellner to make the sheath expandable as taught by Schaeffer to provide the predictable result of having the ability to adjust to different diameters as desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/ Examiner, Art Unit 3796
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