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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/24/2025. As directed by the amendment: claims 1, 10, 12, and 16 have been amended, claims 18-20 have been cancelled and claims 21-23 have been added. Thus, claims 1-17 and 21-23 are presently pending in this application.
Election/Restrictions
Claims 12-17 and 22 are withdrawn as being drawn to non-elected species II. Elected species I is a primary covering over at least a portion of a frame and a secondary cover that covers parts of the frame not covered by the primary covering. Claim 12 has been amended to recite “the primary covering partially overlaps the secondary covering” which is not part of elected species I.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 11/24/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mellmann and Hewitt.
Claim Rejections - 35 USC § 103
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 was made.
Claims 1-11, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Mellmann et al. (US 20170258475 A1) in view of Hewitt et al. (US 20160249934 A1).
Regarding claim 1 Mellmann discloses (fig. 1-7A) an implantable medical device, comprising: an expandable frame 1 defining a profile of the implantable medical device (see fig. 3b and [0083]-[0085]), the expandable frame 1 movable between a collapsed configuration (fig. 3b) for delivery and an expanded configuration (fig. 5b) for deployment (see [0051] and [0053]), the expandable frame including a proximal portion (portion adjacent 3), a distal portion (portion adjacent 2) and an intervening intermediate portion (portion therebetween, see fig. 4b); a primary covering (4+6) extending over the proximal portion of the expandable frame (see fig. 4b and [0091]-[0092]); and a secondary covering 7 extending over parts of the expandable frame not covered by the primary covering (see fig. 4b and [0091]-[0092]).
Mellmann further teaches that the primary covering can be stiffer / less elastic than the secondary covering (see [0101]). Mellmann fails to expressly disclose the primary covering has a first density and the secondary covering has a second density less than the first density.
However Hewitt, in the same filed of endeavor, teaches (fig. 56 and 58) of a primary covering 1304 on proximal side of the device and a secondary covering 1302 on the distal portion of the device (see fig. 56, 58, and [0290]), wherein the primary covering 1304 has a first density (BD.sub.avg2) and the secondary covering 1302 has a second density (BD.sub.avg1) less than the first density (see [0290]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Mellmann to have the primary covering has a first density and the secondary covering has a second density less than the first density as taught by Hewitt, for the purpose of having a higher density portion to block blood flow into the defect and a lower density portion to be able to collapse the distal end of the device to a smaller diameter to improve delivery (see Hewitt [0290] and [0292]).
Regarding claim 2, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) the secondary covering 7 extends over the intermediate portion of the expandable frame (see fig. 4b).
Regarding claim 3, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) the secondary 7 covering extends over the distal portion (portion adjacent 2) of the expandable frame (see fig. 4b).
Regarding claim 4, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) the expandable frame comprises a plurality of proximal anchors 8 disposed about a first periphery of the expandable frame (see fig. 3b and [0092]).
Regarding claim 5, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 4. Mellmann further discloses (fig. 1-7A) the expandable frame comprises a plurality of distal anchors 9 disposed about a second periphery of the expandable frame, the second periphery displaced axially from the first periphery (see fig. 3b).
Regarding claim 6, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Mellmann further discloses (fig. 1-7A) the primary covering 4+6 is secured in place relative to the expandable frame via interactions between the primary covering and the plurality of proximal anchors 8 (see fig. 3b and [0092]).
Regarding claim 7, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Mellmann further discloses (fig. 1-7A) the secondary covering 7 is secured in place relative to the expandable frame via interactions between the secondary covering and the plurality of distal anchors 9 (see fig. 3b and [0092]).
Regarding claim 8, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) the secondary covering 7 is secured in place relative to the expandable frame 1 via sutures 9 extending between the secondary covering and the expandable frame (see fig. 3b and [0092]).
Regarding claim 9, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) the secondary covering 7 is secured in place relative to the expandable frame via sutures 70 extending between the primary covering and the secondary covering (see fig. 3b and [0092]).
Regarding claim 10, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann as modified teaches the primary covering has a first thickness and the secondary covering has a second thickness less than the first thickness. (Hewitt teaches the section where fewer filaments overlap results in a reduced thickens, see [0304], and the secondary covering 1302 has less filaments overlapping than the primary covering 1304 resulting in a second thickness less than the first thickness, see fig. 56. Mellmann is modified to have the secondary covering have a lower density which also results in the secondary covering having less overlapping filaments).
Regarding claim 11, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) an LAAC (left atrial appendage closure) device (see abstract).
Regarding claim 21, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses the primary covering is a fabric, the secondary covering is a fabric (see [0101]).
Mellmann as modified is silent regarding the primary covering having a first Denier rating of 20 to 25 and the secondary covering having a second Denier rating of 10 to 15.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mellmann as modified to have the primary covering having a first Denier rating of 20 to 25 and the secondary covering having a second Denier rating of 10 to 15 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Mellmann as modified would not operate differently with the claimed Denier as the covers would still perform their function of occluding. Further, applicant places no criticality on the range claimed, indicating simply that the Denier “may” be within the claimed ranges (specification [0067]).
Regarding claim 23, Mellmann as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Mellmann further discloses (fig. 1-7A) the primary covering (4+6) has a first knit pattern (woven) and the second covering 7 has a second knit pattern (knitted) different from the first knit pattern (see [0101]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771