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 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 69-75, 79, 80, 82, 196 and 197 are 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.
The word: “the capsule” in claim 69, lines 8 and 9 place the claim indefinite. In line 5, the Applicant’s representative positively claims “a proximal capsule” and “a distal capsule”, therefore, the Examiner is not clear which capsule performed the axial movement or if both capsules performed the movement. 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 69 and 79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 7 of U.S. Patent No. 12,357,459. Although the claims at issue are not identical, they are not patentably distinct from each other because both cases disclose an apparatus for use at a heart of a subject, the apparatus comprising a delivery tool dimensioned for percutaneous delivery to the heart. The delivery tool having a distal portion that defines a distal portion axis and comprises a shaft, a proximal capsule and a distal capsule. Each of the capsules having a respective open end, the open end of the proximal capsule facing the open end of the distal capsule, and being coupled to the shaft in a manner that facilitates axial movement of the capsule with respect to the shaft, along the distal portion axis. A prosthetic valve comprising a tubular portion that defines a lumen; a plurality of prosthetic leaflets disposed within the lumen; an upstream support portion that extends from the tubular portion; and a plurality of flanges, each of the flanges: coupled to the tubular portion at a respective coupling point that is downstream of the upstream support portion, and extending from the coupling point to a respective flange end-portion of the flange. The prosthetic valve is restrainable in a compressed state by the delivery tool, such that the shaft and a downstream end of the tubular portion are disposed within the distal capsule, and the upstream support portion and the flange end-portions are disposed within the proximal capsule.
Allowable Subject Matter
Claims 90-101 and 104 are allowed.
The following is an examiner’s statement of reasons for allowance: After careful consideration of the Applicant’s remarks the Examiner has found the independent claims are allowable. There is no evidence in the prior art of a method for use at a heart of a subject, the method comprising transluminally advancing a delivery system to the heart. The delivery system including a delivery tool, the delivery tool having a distal portion that defines a distal portion axis, the distal portion comprising a proximal capsule and a distal capsule, each of the capsules having a respective open end, the open end of the proximal capsule facing the open end of the distal capsule; and an implant comprising a proximal-implant portion, a distal-implant portion, and a flange having a flange end-portion. The implant being restrained by the delivery tool such that the proximal-implant portion and the flange end-portion are disposed within the proximal capsule, and the distal-implant portion of the implant is disposed within the distal capsule; and deploying the implant at the heart by proximally retracting the proximal capsule, with respect to the implant, such that the flange end-portion is released from the proximal capsule, subsequently, proximally retracting the distal portion of the delivery tool, such that the flange end-portion contacts tissue of the heart, subsequently, further proximally retracting the proximal capsule, with respect to the implant, such that the proximal-implant portion is released from the proximal capsule, and subsequently, distally advancing the distal capsule, with respect to the implant, such that the distal-implant portion is released from the distal capsule.
The closet reference is US Patent Pub. 2018/0014930 disclosing a proximal and distal capsule, however, in this reference the distal capsule releases the flange end portion and not the proximal capsule. Additionally, the proximally retraction step of the Hariton et al reference cannot be performed without the previous released of the flange end portion as shown in Figs. 4C-D (Hariton et al).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 70-75, 80, 82, 196 and 197 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 2/3/26