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 .
Information Disclosure Statement
The Information Disclosure Statement filed on May 2, 2024, does not fully comply with the requirements of 37 CFR 1.98(b) because the file copy of the German patent document (DE 10 2014 102650 A1) lacks an abstract in English. Since the submission appears to be bona fide, Applicant is given ONE (1) MONTH from the date of this notice to supply the above mentioned omissions or corrections in the information disclosure statement. NO EXTENSION OF THIS TIME LIMIT MAY BE GRANTED UNDER EITHER 37 CFR 1.136(a) OR (b). Failure to timely comply with this notice will result in the above mentioned information disclosure statement being placed in the application file with the noncomplying information not being considered (37 CFR 1.97(i)).
Specification
The disclosure is objected to because of the following informalities: In paragraph 0001, the status of the parent application needs to be updated. 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 70-71 and 73-81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11, 16, and 27 of U.S. Patent No. 11,833,034 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method steps would have followed from the functional language pertaining to the frame structure being “configured to be actuated from the unexpanded configuration to the expanded configuration within the anchor and adjacent a native valve in a patient” (patent claim 1 at column 49, lines 30-33) and the anchor being “configured to reside within a subvalvular plane of the heart when it anchors the frame structure to the native valve” (patent claim 3 at column 49, lines 41-43); attention is also directed to patent claim 27. Regarding claim 70, the anchor has a “flat spiral shape” (patent claim 1 at column 49, lines 25-26). Regarding claim 73, the anchor wraps around the frame structure in the deployed configuration (patent claim 1 at column 49, lines 30-32). Regarding claims 78-79, the locking mechanism features are described in patent claims 9 and 11. Regarding claim 80, the frame structure comprises “an expandable stent” (patent claim 16), for example. Regarding claim 81, “the anchor is configured to reside entirely within the subvalvular plane of the heart when it anchors the frame structure to the native valve” (patent claim 4). Other limitations are apparent (MPEP § 707) from language in the above listed patent claims.
Claim Rejections - 35 USC § 102
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.
Claims 70-89 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ortiz et al., US 2002/0173841 A1, which discloses a method for treating a diseased native valve in a patient (abstract; paragraphs 0002-0003, 0008), the method comprising advancing a frame structure and an anchor having a flat spiral shape (Figures 4, 12-13, 17, 29, 29A, 39A-39D, 41A-41B; paragraphs 0010, 0089) from a first side of a native valve to a second side of the native valve (Figures 1A, 2A-2C, 3, 6B, 10, 14-15, 27, 32, 42; paragraphs 0078, 0080); deploying the anchor adjacent the native valve (Figures 2A-2B, 6B, 15; paragraphs 0071, 0073); expanding the frame structure within the native valve from an unexpanded configuration to an expanded configuration (Figures 2B-2C, 10, 36-37; paragraphs 0010, 0012-0013, 0015, 0071, 0073, 0098); and anchoring the frame structure in the expanded configuration to the native valve with the anchor (Figures 2C, 3, 10, 16, 25, 27-28, 36-37, 41A-41B, 42; paragraphs 0015, 0076-0077, 0079, 0086, 0090, 0097, 0102). Under one interpretation, the frame structure corresponds to a spiral loop residing along the first side of the native valve following deployment (abstract; Figures 2C, 3, 8-9, 27, 41A-41B, 42; paragraphs 0010, 0012, 0015, 0071, 0073). Under another interpretation, the frame structure corresponds to replacement valve 260 expanded to engage upper coil 262a, with replacement valve optionally having a more structural or frame-like “coil or ring” for the “male-female coupling” [Figures 36-37; paragraphs 0012 (last sentence: “rings may be adjustable in diameter”), 0013 , 0098].
Regarding claims 71-72 and 74, the anchor is configured to coaxially wrap at least partially around a delivery device in the deployed configuration (Figures 14-15, 39A-39B; paragraphs 0080, 0100). Regarding claim 73, the anchor is configured to wrap at least partially around the frame structure in the deployed configuration (Figures 36-37; paragraph 0098). Regarding claims 77 and 80, various forms of actuation may be employed [paragraphs 0010 (shape memory alloys), 0073 (“pre-stressed coiled shape”), 0077 (“electric current”)]. Regarding claims 78-79 and 89, different nested locking mechanisms are shown and described (Figures 8-9, 25, 30, 41B; paragraphs 0010, 0015, 0077, 0086, 0090, 0102). Regarding claims 81-87, deploying the anchor occurs on both the first side (to define an intermediate deployed configuration: Figures 2B, 14-15) and the second side (to establish a final deployed configuration of a same outer anchor perimeter: Figures 2C, 3, 16, 36-37, 42) of the native valve via an opening (paragraphs 0012-0013, 0015, 0071, 0073, 0078, 0080). The further limitations of other claims are readily apparent (MPEP § 707) from the drawings in light of the discussion above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
Prosecution Insights