DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Response to Arguments
In view of the amendments filed on 12/17/2025, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, cited in the office action of 10/7/2025, are moot.
Applicant’s arguments with respect to claim(s) 1-2 and 4-20 have been considered, but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 4, and 6-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Solovay (Pat. No. US 6,482,227 B1).
Solovay discloses the following regarding claim 1: a method of implanting a prosthetic medical device, comprising: advancing a first prosthetic medical device (10) through a subject's vasculature to a target implantation site (Fig. 16; col. 10, lines 65-col. 11, lines 21), wherein the first prosthetic medical device comprises a coil (15) having an inflow end portion (upper portion), wherein the first prosthetic medical device further comprises a foam gasket (30) disposed around the coil (Figs. 2-3; col. 5, lines 60-col. 6, lines 28), an outflow end portion (lower portion), and a central longitudinal axis (central axis extending vertically through the coil) extending from the inflow end portion to the outflow end portion (Figs. 1-3); expanding the first prosthetic medical device from a compressed state to an expanded state to engage native vascular tissue at the target implantation site (Fig. 16; col. 6, lines 53-col. 7, lines 4; col. 10, lines 65-col. 11, lines 33); delivering a second prosthetic medical device (80(a) and/or 80(b)) to the first prosthetic medical device after expanding the first prosthetic medical device (Figs. 16-18; col. 10, lines 65-col. 11, lines 21); and docking the second prosthetic medical device within the first prosthetic medical device (Figs. 18-20; col. 10, lines 65-col. 11, lines 33).
Solovay discloses the following regarding claim 2: the method of claim 1, wherein the target implantation site includes a native aorta (Figs. 16-20; col. 11, lines 22-33).
Solovay discloses the following regarding claim 4: the method of claim 1, wherein the foam gasket is disposed on a radially facing outer surface of the coil (Figs. 2-3; col. 5, lines 60-col. 6, lines 28).
Solovay discloses the following regarding claim 6: the method of claim 1, wherein the coil has at least one loop (Fig. 3).
Solovay discloses the following regarding claim 7: the method of claim 1, wherein the coil of the first prosthetic medical device comprises a first end (medial end portion) and a second end (lateral end portion), wherein the first end is spaced from the second end (Figs. 2-3).
Solovay discloses the following regarding claim 8: the method of claim 1, wherein the first prosthetic medical device is expanded from the compressed state to the expanded state in a radial direction substantially perpendicular to the central longitudinal axis (Figs. 23-25; col. 6, lines 53-col. 7, lines 4; col. 10, lines 65-col. 11, lines 33).
Solovay discloses the following regarding claim 9: the method of claim 1, wherein at least a portion of the first prosthetic medical device is self-expandable (col. 5, lines 20-45).
Solovay discloses the following regarding claim 10: the method of claim 9, wherein the self-expandable portion of the first prosthetic medical device is fabricated from a shape memory material (col. 5, lines 46-59).
Solovay discloses the following regarding claim 11: the method of claim 10, wherein the shape memory material is Nitinol (col. 5, lines 46-59).
Solovay discloses the following regarding claim 12: a method of implanting a surgical implant device, comprising: advancing a delivery apparatus (300) and a first surgical implant device (10) releasably coupled to a distal portion of the delivery apparatus through a subject's vasculature to a target implantation site (Figs. 16-25; col. 10, lines 28-col. 11, lines 21), wherein the first surgical implant device comprises an annular body (12) having an inflow end portion (upper portion), wherein the first surgical implant device further comprises a foam gasket (30) disposed around the annular body (Figs. 2-3; col. 5, lines 60-col. 6, lines 28), an outflow end portion (lower portion), and defines a lumen (central opening) extending from the inflow end portion to the outflow end portion (Figs. 1-3); deploying the first surgical implant device to an expanded state to engage walls of native tissue at the target implantation site (Fig. 16; col. 6, lines 53-col. 7, lines 4; col. 10, lines 65-col. 11, lines 33); and inserting a second surgical implant device (80(a) and/or 80(b)) into the lumen of the first surgical implant device (Figs. 18-20), wherein inserting the second surgical implant into the lumen of the first surgical implant occurs after deploying the first surgical implant to the expanded state (Figs. 16-18; col. 10, lines 65-col. 11, lines 21).
Solovay discloses the following regarding claim 13: the method of claim 12, wherein the annular body forms a loop in a circumferential direction (Figs. 1-3) and has a first end (medial end portion) and a second end (lateral end portion).
Solovay discloses the following regarding claim 14: the method of claim 13, wherein the first end of the loop is spaced radially from the second end of the loop (Figs. 1-3).
Solovay discloses the following regarding claim 15: the method of claim 14, wherein the first end of the loop is spaced circumferentially from the second end of the loop (Figs. 1-3).
Solovay discloses the following regarding claim 16: the method of claim 12, wherein at least a portion of the first surgical implant device is self-expandable (col. 5, lines 20-45).
Solovay discloses the following regarding claim 17: a method of implanting a prosthetic medical device, comprising: advancing a delivery apparatus (300) and a docking implant (10) releasably coupled to a distal end portion thereof through a subject's vasculature to a target implantation site (Figs. 16-25; col. 10, lines 28-col. 11, lines 21), wherein the docking implant comprises a self-expanding circumferential implant body (12) (col. 5, lines 20-45) having a proximal end portion (upper portion), and distal end portion (lower portion), and a central longitudinal axis (central, vertical axis) extending from the proximal end portion to the distal end portion (Figs. 1-3); deploying the docking implant from the delivery apparatus such that the circumferential implant body self-expands from a compressed state to an expanded state such that the circumferential implant body engages native vascular tissue at the target implantation site (Fig. 16; col. 5, lines 20-45; col. 6, lines 53-col. 7, lines 4; col. 10, lines 65-col. 11, lines 33); delivering a prosthetic medical device (80(a) and/or 80(b)) to the docking implant after deploying the docking implant from the delivery apparatus (Figs. 16-18; col. 10, lines 65-col. 11, lines 21); and docking the prosthetic medical device within the docking implant (Figs. 18-20; col. 10, lines 65-col. 11, lines 33).
Solovay discloses the following regarding claim 18: the method of claim 17, wherein the docking implant further comprises a covering (30) disposed on a radially outer surface of the circumferential implant body (Figs. 2-3; col. 5, lines 60-col. 6, lines 28).
Solovay discloses the following regarding claim 19: the method of claim 18, wherein the delivery apparatus comprises a sheath (332) and a lumen (central opening in the sheath) disposed at the distal end portion of the delivery apparatus (Figs. 23-25), wherein the lumen contains the docking implant in the compressed state prior to deployment (Figs. 23-25; col. 10, lines 32-col. 11, lines 21).
Solovay discloses the following regarding claim 20: the method of claim 19, wherein the circumferential implant body comprises a loop (Figs. 1-3) having a first end portion (medial end portion) and a second end portion (lateral end portion), wherein the first end portion is spaced apart from the second end portion (Figs. 1-3).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solovay in view of Goicoechea et al. (Pub. No.: US 2002/0019659 A1; hereinafter “Goicoechea”).
Solovay discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the first prosthetic medical device further comprising a fabric covering disposed around the coil. Goicoechea teaches that it is well known in the art that a vascular implant comprises fabric coverings (paras. 0023-0030, 0153), for the purpose of protecting the implant and preventing embolization. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Solovay to comprise a fabric covering, as taught by Goicoechea, in order to help protect the implant and prevent embolization. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774
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