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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 05, 2025 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Center et al. (US 2015/0005810 A1) in view of Edmiston et al. (US 2017/0156840 A1).
Regarding claim 1, Center discloses an embolic apparatus 760 (Fig. 35B) comprising: a main body portion 765 extending in a longitudinal direction (Fig. 35B); a plurality of first frame portions 762 foldably connected to the main body portion; a plurality of second frame portions 764 foldably connected to an end opposite to the other end of the main body portion connected to the plurality of first frame portions (Fig. 35B); and a blocking film portion 768 connecting the plurality of first frame portions and covering the plurality of first frame portions (Fig. 36A); wherein the plurality of first frame portions and the plurality of second frame portions extend in directions away from each other (i.e., in opposing directions; Fig. 35B), wherein each of the plurality of second frame portions comprises: a fixing frame having (see Fig. 35B reproduced below) a bent portion thereon (i.e., bending from 765); and a contact frame (see Fig. 35B reproduced below) extending from and intersecting with the fixing frame (Fig. 35B); and a hole portion formed in the fixing frame to extend longitudinally (i.e., each hole is formed between segments); wherein the fixing frame is formed to be concave in an outward direction from the main body portion, and the contact frame is formed to be convex in the outward direction from the main body portion (Fig. 35B reproduced below), wherein the contact frame extends beyond the fixing frame (i.e., Fig. 35B distally). Center also discloses mechanically limiting penetration depth of the bent portion by providing a physical stop 765 (i.e., at least since penetration would continue until reaching the proximal end which is closed by 765 such that the depth would be limited by way of the structure).
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Center doesn’t directly disclose:
the contact frame extends through the fixing frame; and wherein the contact frame passes completely through the hole portion and is coupled to the fixing frame.
wherein the contact frame is configured to contact an inner circumferential surface of a target object.
Regarding (i):
In the same field of endeavor, namely medical devices for modification of left atrial appendages and related systems, Edmiston et al. discloses a similar device to Center including an embolic apparatus 20 comprising a main body portion 104 and a plurality of second frame portions (Fig. 2), the plurality of second frame portions comprises: a fixing frame 24; and a contact frame 26 extending from and intersecting with the fixing frame (Fig. 2; para. [0083]); and a hole portion 62 formed in the fixing frame (Fig. 2; para. [0083]). Edmiston also discloses the contact frame extends through the fixing frame (Fig. 2 and 19; para. [0081] such that the eyelets are each directly interlocked such that each contact and fixing frame would pass entirely through the other); and wherein the contact frame passes completely through the hole portion and is coupled to the fixing frame (Fig. 19 and as disclosed in para. [0081] such that the eyelets are each directly interlocked such that each contact and fixing frame would pass entirely through the other. ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Center to have the eyelets 62 of Edmiston such that the contact frame passes through the eyelets for purposes of providing a hinged coupling arrangement for the contact from to pivot relative to the fixing portion (para. [0083]).
Regarding (ii):
The device of Center is fully capable of having the contact frame configured to contact an inner circumferential surface of a target object if one desired to do so at least since the purpose of the anchor portion is to anchor the occlusive device at an implant location (para. [0005]) and there is provided a stop just distal to 765 that limits the penetration depth by way of the bent portion such that the frame is crimped at 765 and implantation depth cannot be more proximal- note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 4, Center and Edmiston disclose the embolic apparatus of claim 1. Although Center doesn’t directly disclose wherein the fixing frame and the contact frame are weldably coupled at a region in which the fixing frame intersects with the contact frame. However, para. [0119] disclose that the frames may be made from nitinol, steel, stainless steel, or any other biocompatible material, which are known to be weldable materials. Therefore, the fixing frame and the contract frame are fully capable of being welded (note: the term “weldably coupled” under the broadest reasonable interpretation only requires that the components are capable of being coupled via welding and doesn’t positively recite being coupled via a weld).
Regarding claim 5, Edmiston discloses an embolic apparatus 760 (Fig. 35B) comprising: a main body portion 765 extending in a longitudinal direction (Fig. 35B); a plurality of first frame portions 762 foldably connected to the main body portion; a plurality of second frame portions 764 arranged to face the plurality of first frame portions (Fig. 35B), extending in a direction away from the plurality of first frame portions (Fig. 35B), and foldably connected to the main body portion (Fig. 35B); a blocking film portion 768 provided in plural to each independently cover the plurality of first frame portions and the plurality of second frame portions (Fig. 36A discloses a single blocking film, however); and a bent portion on a distal end of one of the plurality of second frame portions (i.e., at least one of the plurality of second frame portions bends from 765), wherein the distal end is opposite to a proximal end of the second frame portion connected to the main body portion (Fig. 35B); wherein one of the plurality of second frame portions comprises: a fixing frame having a bent portion thereon (see Fig. 35B reproduced below) a contact frame (see Fig. 35B reproduced below) extending from and intersecting with the fixing frame (Fig. 35B); and a hole portion formed in the fixing frame to extend longitudinally (i.e., each hole is formed between segments), wherein the fixing frame is formed to be concave in an outward direction from the main body portion (Fig. 35B reproduced above), and the contact frame is formed to be convex in the outward direction from the main body portion (Fig. 35B produced above). Center also discloses mechanically limit penetration depth of the bent portion by providing a physical stop 765 (i.e., at least since penetration would continue until reaching the proximal end which is closed by 765 such that the depth would be limited by way of the structure).
Center doesn’t directly disclose:
the contact frame extends through the fixing frame; and wherein the contact frame passes completely through the hole portion and is coupled to the fixing frame.
wherein the contact frame is configured to contact an inner circumferential surface of a target object.
Regarding (i):
In the same field of endeavor, namely medical devices for modification of left atrial appendages and related systems, Edmiston et al. discloses a similar device to Center including an embolic apparatus 20 comprising a main body portion 104 and a plurality of second frame portions (Fig. 2), the plurality of second frame portions comprises: a fixing frame 24; and a contact frame 26 extending from and intersecting with the fixing frame (Fig. 2; para. [0083]); and a hole portion 62 formed in the fixing frame (Fig. 2; para. [0083]). Edmiston also discloses the contact frame extends through the fixing frame (Fig. 2; para. [0083] via eyelets 62); and wherein the contact frame passes completely through the hole portion and is coupled to the fixing frame (para. [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Center to have the eyelets 62 of Edmiston such that the contact frame passes through the eyelets for purposes of providing a hinged coupling arrangement for the contact from to pivot relative to the fixing portion (para. [0083]).
Regarding (ii):
The device of Center is fully capable of having the contact frame configured to contact an inner circumferential surface of a target object if one desired to do so at least since the purpose of the anchor portion is to anchor the occlusive device at an implant location (para. [0005]) and there is provided a stop just distal to 765 that limits the penetration depth by way of the bent portion such that the frame is crimped at 765 and implantation depth cannot be more proximal- note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 6, Center and Edmiston disclose the embolic apparatus of claim 5. Center also discloses each of the other plurality of second frame portions (Figs. 37B-37C) includes a respective bent portion on a respective distal end thereof (i.e., see 773 and 775 of Figs. 37B and 37C), wherein each respective distal end is opposite to a respective proximal end connected to the main body portion (Figs. 37B-37C).
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered but they are not persuasive.
In response to Applicant's first argument that there is no teaching in Center or Edmiston that the fixing frame is formed to be concave in an outward direction and a contact frame formed to be convex in the outward direction. Examiner disagrees and points to Fig. 35B above which shows at least a portion of the fixing frame being concave in an outward direction and the contact frame being convex in the outward direction.
Just because Applicant argues that the specific curvature is critical, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant also argues that the amended claims recite that the contact frame passes “completely through” the hole portion and extends “beyond” the fixing frame. Edmiston discloses that the contact frame passes completely through the hole portion at least by way of coupling the eyelet as shown clearly in Figs. 2 and 19 and as disclosed for example in para. [0081] such that the eyelets are each directly interlocked such that each contact and fixing frame would pass entirely through the other. Regarding the contact frame extending beyond the fixing frame, since the contact frame is attached to the distal end of the fixing frame in both references, it therefore extends beyond the fixing frame.
Regarding Applicant’s argument that the contact frame is configured to mechanically limit the penetration depth of the bent portion by providing a physical stop is not taught by Center or Edmiston, Examiner disagrees. Examiner notes that under BRI, a physical stop can be any structure preventing further penetration depth. As such, both Edmiston (i.e., via bent portion distally as shown in Fig. 19) and Center (i.e., via 756 of Fig. 35B) are both capable as acting as a stop to limit the penetration depth.
Applicant also argues that Center and Edmiston must recognize the technical problem and teach the solution that the invention requires, but this is not a requirement. Instead, case law and the MPEP dictate that a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's arguments that the device has specific advantages not contemplated by Center or Edmiston, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771