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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/10/2026 has been entered.
This office action is responsive to the amendment filed on 07/10/2026. As directed by the amendment: claims 1, 4-5, and 23 have been amended, claims 11 and 18-20 have been cancelled and claim 24 has been added. Thus, claims 1-10, 12-17, and 21-24 are presently pending in this application.
Election/Restrictions
Claim 1 has been amended to be directed to non-elected species II After re-evaluation of the species, The Office has decided to group species I and II into a single elected species. Therefore claims 12-17 and 22 will be examined as directed to the elected species.
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 1-5, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford et al. (US 20020143349 A1) in view of Larsen et al. (US 20190216468 A1).
Regarding claims 1, 4, and 5 Gifford discloses (see fig. 2-3 and 8-9) an implantable medical device, comprising:
an expandable frame 48 defining a profile of the implantable medical device (see fig. 3 and [0071]), the expandable frame 48 movable between a collapsed configuration for delivery (configuration of fig. 3) and an expanded configuration for deployment (configuration of fig. 9; see [0071]), the expandable frame 48 including a proximal portion (portion adjacent 53), a distal portion (portion adjacent 52) and an intervening intermediate portion (see fig. 3),
a primary covering 36 extending over the proximal portion of the expandable frame (see fig. 9 and [0069]); and
a secondary covering 42 extending over parts of the expandable frame not covered by the primary covering 36 (see fig. 9 and [0070]);
wherein the primary covering has a first density (fluid impermeable thus has more material per area and less, if any, openings) and the secondary covering has a second density (more openings as its mesh; see fig. 9) less than the first density (the more openings means there is less material per area thus is less dense);
wherein the primary covering 36 partially overlaps the secondary covering 42, thereby covering a proximal edge (bottom as viewed in fig. 9) of the secondary covering 42 (see fig. 8-9 and [0069]-[0070]).
Gifford is silent regarding the expandable framework including a plurality of anchors extending radially outward from the expandable framework; the plurality of anchors includes a plurality of proximal anchors disposed about a first periphery of the expandable frame; the plurality of anchors further includes a plurality of distal anchors disposed about a second periphery of the expandable frame, the second periphery displaced axially from the first periphery.
However Larsen, in the same field of endeavor, teaches (fig. 1) an expandable framework 12 including a plurality of anchors 16 extending radially outward from the expandable framework (see fig. 1 and [0061]); the plurality of anchors 16 includes a plurality of proximal anchors disposed about a first periphery of the expandable frame (see fig. 1 and [0063]); the plurality of anchors 16 further includes a plurality of distal anchors disposed about a second periphery of the expandable frame, the second periphery displaced axially from the first periphery (see fig. 1 and [0063]).
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 Gifford to have the expandable framework including a plurality of anchors extending radially outward from the expandable framework; the plurality of anchors includes a plurality of proximal anchors disposed about a first periphery of the expandable frame; the plurality of anchors further includes a plurality of distal anchors disposed about a second periphery of the expandable frame, the second periphery displaced axially from the first periphery as taught by Larsen, for the purpose of the anchors being able to help fix the device to the treatment location (see Larsen [0067]).
Regarding claim 2, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gifford further discloses (see fig. 2-3 and 8-9) the secondary covering 42 extends over the intermediate portion of the expandable frame (see fig. 9).
Regarding claim 3, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gifford further discloses (see fig. 2-3 and 8-9) the secondary covering 42 extends over the distal portion of the expandable frame (see fig. 9).
Regarding claim 23, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gifford further discloses (see fig. 2-3 and 8-9) the primary covering 36 has a first knit pattern (fluid impermeable material) and the second covering 42 has a second knit pattern (mesh) different from the first knit pattern (see fig. 9 and [0069]-[0070]).
Regarding claim 24, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gifford further discloses (see fig. 2-3 and 8-9) the implantable medical device includes only two coverings: the primary covering 36 and the secondary covering 42 (see fig. 9 and [0069]-[0070]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Larsen as applied to claim 5 above, and further in view of Inouye et al. (US 20200060849 A1).
Regarding claims 6-7, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Gifford as modified is silent regarding the primary covering is secured in place relative to the expandable frame via interactions between the primary covering and the plurality of proximal anchors; the secondary covering is secured in place relative to the expandable frame via interactions between the secondary covering and the plurality of distal anchors.
However Inouye, in the same filed of endeavor, teaches (fig. 3-4) an expandable frame 110 with a plurality of anchors 140 and a cover 120 (see fig. 3 and [0055]-[0056]), wherein the covering 120 is secured in place relative to the expandable frame 110 via interactions between the covering and the plurality of anchors 140 (see fig. 3 and [0059]).
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 Gifford as modified to have the primary covering is secured in place relative to the expandable frame via interactions between the primary covering and the plurality of proximal anchors; the secondary covering is secured in place relative to the expandable frame via interactions between the secondary covering and the plurality of distal anchors as taught by Inouye, for the purpose of being able to have the anchors extend to engage tissue and hold the covering between the tissue and the frame (see Inouye [0059]).
Claims 8, 9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Larsen as applied to claim 1 above, and further in view of Mellmann et al. (US 20170258475 A1).
Regarding claims 8-9, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gifford as modified is silent regarding the secondary covering is secured in place relative to the expandable frame via sutures extending between the secondary covering and the expandable frame; the secondary covering is secured in place relative to the expandable frame via sutures extending between the primary covering and the secondary covering.
However Mellmann, in the same filed of endeavor, teaches (fig. 1-7A) an expandable frame 1, a primary covering (4+6) and a secondary covering 7 that 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]); 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]).
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 Gifford as modified to have the secondary covering is secured in place relative to the expandable frame via sutures extending between the secondary covering and the expandable frame; the secondary covering is secured in place relative to the expandable frame via sutures extending between the primary covering and the secondary covering as taught by Mellmann, for the purpose of attaching the covers to the frame and each other to prevent separation of the different parts (see Mellmann [0092]).
Regarding claim 21, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 21. Gifford is silent regarding the primary covering is a fabric having a first Denier rating of 20 to 25 and the secondary covering is a fabric having a second Denier rating of 10 to 15.
However Mellmann, in the same filed of endeavor, teaches (fig. 1-7A) the primary covering 7 is a fabric, the secondary covering (4-6) is a fabric (see [0035]).
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 Gifford as modified to have the primary and secondary coverings be fabric as taught by Mellmann, for the purpose of having sufficient flexibility for delivery and sufficient stiffness for treatment (see Mellmann [0087]).
Gifford 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 Gifford 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 Gifford 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]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Larsen as applied to claim 1 above, and further in view of McCormick et al. (US 20070078506 A1).
Regarding claim 10, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Gifford further discloses the secondary covering 42 has a second thickness (see [0078]).
Gifford as modified is silent regarding the primary covering has a first thickness, the second thickness less than the first thickness.
However McCormick, in the same field of endeavor, teaches a covering with a first thickness (8 layers of film each having a 0.0125mm thickness for a total of 0.1mm thickness, see [0115]).
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 Gifford as modified to have the primary covering has a first thickness of 0.1mm thick as taught by McCormick, for the purpose of being able to have a cover with the desired mechanical and structural properties (see McCormick [0115]-[0116]).
Gifford as modified teaches the second thickness (0.003in which is 0.0762in; see Gifford [0078]) less than the first thickness (0.1mm).
Claims 12, 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Inouye et al. (US 20200060849 A1).
Regarding claims 12-13 Gifford discloses (fig. 2-3 and 8-9) a device capable of beins used as a left atrial appendage closure (LAAC) device (see note below), comprising:
an expandable frame 48 defining a profile of LAAC (see fig. 3 and [0071]), the expandable frame 48 movable between a collapsed configuration for delivery (configuration of fig. 3) and an expanded configuration for deployment (configuration of fig. 9; see [0071]), the expandable frame 48 including a proximal portion (portion adjacent 53), a distal portion (portion adjacent 52) and an intervening intermediate portion (see fig. 3),
a primary covering 36 extending over the proximal portion of the expandable frame (see fig. 9 and [0069]); and
a secondary covering 42 extending over a part of the expandable frame (see fig. 9 and [0070]);
wherein the primary covering has a first density (fluid impermeable thus has more material per area and less, if any, openings) and the secondary covering has a second density (more openings as its mesh; see fig. 9) less than the first density (the more openings means there is less material per area thus is less dense);
wherein the primary covering 36 partially overlaps the secondary covering 42 (see fig. 8-9 and [0069]-[0070]).
Note: The preamble, "a left atrial appendage closure (LAAC) device" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Gifford meets the structural limitations of the claim, and is capable of being used as a left atrial appendage device.
Gifford is silent regarding the expandable framework including a plurality of anchors extending about a periphery of the expandable frame; the primary covering interacting with the plurality of anchors; the secondary covering also interacts with the plurality of anchors.
However Inouye, in the same filed of endeavor, teaches (fig. 3-4) an expandable frame 110 with a plurality of anchors 140 extending about a periphery of the expandable frame (see fig. 3) and a cover 120 (see fig. 3 and [0055]-[0056]), wherein the covering 120 interacting with the plurality of anchors 140 (see fig. 3 and [0059]).
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 Gifford as modified to have the expandable framework including a plurality of anchors extending about a periphery of the expandable frame; the primary covering interacting with the plurality of anchors; the secondary covering also interacts with the plurality of anchors as taught by Inouye, for the purpose of being able to have the anchors extend to engage tissue and hold the covering between the tissue and the frame (see Inouye [0059]).
Regarding claim 16, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Gifford further discloses (see fig. 2-3 and 8-9) wherein the primary covering has a first density (fluid impermeable thus has more material per area and less, if any, openings) and the secondary covering has a second density (more openings as its mesh; see fig. 9) less than the first density (the more openings means there is less material per area thus is less dense).
Regarding claim 17, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Gifford further discloses (see fig. 2-3 and 8-9) the secondary covering 42 extends over the intermediate portion and the distal portion of the expandable frame (see fig. 9).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Inouye as applied to claim 12 above, and further in view of Mellmann.
Regarding claims 14-15, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Gifford as modified is silent regarding the secondary covering is secured in place relative to the expandable frame via sutures extending between the secondary covering and the expandable frame; the secondary covering is secured in place relative to the expandable frame via sutures extending between the primary covering and the secondary covering.
However Mellmann, in the same filed of endeavor, teaches (fig. 1-7A) an expandable frame 1, a primary covering (4+6) and a secondary covering 7 that 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]); 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]).
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 Gifford as modified to have the secondary covering is secured in place relative to the expandable frame via sutures extending between the secondary covering and the expandable frame; the secondary covering is secured in place relative to the expandable frame via sutures extending between the primary covering and the secondary covering as taught by Mellmann, for the purpose of attaching the covers to the frame and each other to prevent separation of the different parts (see Mellmann [0092]).
Claims 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Inouye as applied to claim 12 above, and further in view of McCormick.
Regarding claim 22, Gifford as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Gifford further discloses the secondary covering 42 has a second thickness (see [0078]).
Gifford as modified is silent regarding the primary covering has a first thickness, the second thickness less than the first thickness.
However McCormick, in the same field of endeavor, teaches a covering with a first thickness (8 layers of film each having a 0.0125mm thickness for a total of 0.1mm thickness, see [0115]).
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 Gifford as modified to have the primary covering has a first thickness of 0.1mm thick as taught by McCormick, for the purpose of being able to have a cover with the desired mechanical and structural properties (see McCormick [0115]-[0116]).
Gifford as modified teaches the second thickness (0.003in which is 0.0762in; see Gifford [0078]) less than the first thickness (0.1mm).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
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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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/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
Prosecution Insights