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 20-25, 28, and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,452,628. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are otherwise similar to the claims of ‘628 as set forth below except for the well-known difference set forth below, with reference to Column/Line numbers of the ‘628 patent:
Regarding current claim 20, ‘628 claim 1 recites: a loading system for an expandable and collapsible prosthetic heart valve device (C9L33-34), comprising: a loading funnel (C9L35) including a conical portion (a funnel shape inherently comprises at least a conical portion) and a cylindrical portion (see note below), the loading funnel being configured to hold the prosthetic heart valve device therein (C9L35-36); a receptacle configured to be coupled to the loading funnel to define a watertight interior (C9L39-41); a fluid infusion line, wherein, in operation, biocompatible fluid is transmitted to the watertight interior through the fluid infusion line to fill the watertight interior with biocompatible fluid to immerse the prosthetic heart valve device and to eliminate air from the watertight interior (C10L1-7); a delivery catheter configured to be removably engaged with the loading funnel to position a lumen of the delivery catheter in fluid communication with a lumen of the loading funnel (C10L8-12); and a pull wire configured to be removably connected with the prosthetic heart valve device (C10L13-14), wherein, in operation, the pull wire extends through the lumen of the delivery catheter and beyond a distal end of the delivery catheter (C10L13-17); wherein: the pull wire is configured to pull the prosthetic heart valve device through the loading funnel and into the delivery catheter (C10L18-22).
With respect to the funnel including a cylindrical portion in addition to a conical portion, this is a well-known and routine configuration for loading funnels for stented devices as set forth at US 2013/0190859 A1 to Hillukka at Fig. 5 (conical: 206; cylindrical: 216); US 2012/0083875 A1 to Johnson at Fig. 10 (conical: 312; cylindrical: 310); US 2011/0295216 A1 to Miller at Fig. 14 (conical: 1316; cylindrical: 1320); US 2010/0298931 A1 to Quadri at Fig. 14B (conical: 246; cylindrical: 250); and US 2010/0043197 A1 to Abbate at Figs. 18A/B (conical: 1802; cylindrical: 1804); and therefore the Examiner takes Official notice that it would have been well known and routine, and thus not patentably distinct, to modify '628's claim 1 loading system funnel to have a cylindrical portion in addition to the conical portion.
Further, there is correspondence between dependent claims of the current application and claims of the ‘628 patent as follows:
Current application claim #
21
22
23
24
25
28
32
33
34
‘628 patent claim #
1
1
1
1
1
1
1
3
1
Claims 20-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,232,991. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are otherwise similar to the claims of ‘991 as set forth below except for the well-known difference set forth below, with reference to Column/Line numbers of the ‘991 patent
Regarding current claim 20, ‘991 claim 1 recites: a loading system for an expandable and collapsible prosthetic heart valve device (C9L36-37), comprising: a loading funnel (C9L38-39) including a conical portion (a funnel shape inherently comprises at least a conical portion) and a cylindrical portion (see note below), the loading funnel being configured to hold the prosthetic heart valve device therein (C9L38-39); a receptacle configured to be coupled to the loading funnel to define a watertight interior (C9L40-41); a fluid infusion line, wherein, in operation, biocompatible fluid is transmitted to the watertight interior through the fluid infusion line to fill the watertight interior with biocompatible fluid to immerse the prosthetic heart valve device and to eliminate air from the watertight interior (C9L42-47); a delivery catheter configured to be removably engaged with the loading funnel to position a lumen of the delivery catheter in fluid communication with a lumen of the loading funnel (C9L48-51); and a pull wire configured to be removably connected with the prosthetic heart valve device, wherein, in operation, the pull wire extends through the lumen of the delivery catheter and beyond a distal end of the delivery catheter (C9L52-56); wherein: the pull wire is configured to pull the prosthetic heart valve device through the loading funnel and into the delivery catheter (C9L57-60).
With respect to the funnel including a cylindrical portion in addition to a conical portion, this is a well-known and routine configuration for loading funnels for stented devices as set forth at US 2013/0190859 A1 to Hillukka at Fig. 5 (conical: 206; cylindrical: 216); US 2012/0083875 A1 to Johnson at Fig. 10 (conical: 312; cylindrical: 310); US 2011/0295216 A1 to Miller at Fig. 14 (conical: 1316; cylindrical: 1320); US 2010/0298931 A1 to Quadri at Fig. 14B (conical: 246; cylindrical: 250); and US 2010/0043197 A1 to Abbate at Figs. 18A/B (conical: 1802; cylindrical: 1804); and therefore the Examiner takes Official notice that it would have been well known and routine, and thus not patentably distinct, to modify '991's claim 1 loading system funnel to have a cylindrical portion in addition to the conical portion.
Further, there is correspondence between dependent claims of the current application and claims of the ‘991 patent as follows:
Current application claim #
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
‘991 patent claim #
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
Allowable Subject Matter
Claims 20-38 would be allowable when the non-statutory double patenting rejections set forth above are overcome.
The following is a statement of reasons for the indication of allowable subject matter: The current claims are similar in scope to parent application 17/893,446 and broader than but similar in scope to the claims of parent application 16/848,328; and contain similar subject matter which was found to be allowable in both the '446 and '328 applications. As set forth in the Notices of Allowance dated 10/17/2024 for '446 and 05/24/2022 for '328, the combination of US 2014/0277403 A1 to Peter; US 2008/0281398 to Koss et al.; and US 2011/0319988 A1 to Schankereli et al. are considered the closest prior art of record. The base claim requires that the watertight interior of the funnel be filled with fluid to immerse the valve and to eliminate any air in the watertight interior. As discussed by Peter at [0038], the fluid used to immerse the valve is specifically disclosed as filling a substantial volume, but not an entirety of the chamber, so that an air cavity is generated at the top so that a volumetric expansion of air in the chamber can occur to remove air bubbles from the liquid. Thus, it is clear from Peter that the air chamber is necessary to the mode of operation of the device, and modifying Peter to remove the air in the watertight interior would change the principle of operation of the device. Accordingly, there is no reason or motivation to modify Peter to arrive at the claimed invention. Moreover, none of the other prior art of record, alone or in combination, teaches or suggests the limitations of the base claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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