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 .
Examiner’s Note
The Examiner attempted to get into contact with Applicant’s representative on 12/16/2025, 01/06/2026, and 01/14/2026. The Examiner left a detailed voicemail proposing an amendment to claim 15 for the purpose of putting the application in condition for Allowance. However, no response has been received, and thus the Examiner has elected to send out a Final Rejection. See the section under “Allowable Subject Matter” for the Examiner’s proposed amendment.
Response to Amendment
This Office action is in response to the applicant’s communication filed 12/09/2025.
Status of the claims:
Claims 15 and 17 – 19 are pending in the application.
Claim 15 was amended.
Specification
The objections to the specification in the previous action dated 09/11/2025 have been withdrawn in light of the Applicant’s amendments filed 12/09/2025. Specifically, the objection to the specification, regarding the claimed “flatten ball shape”, has been withdrawn as the specification has been amended to include the language necessary.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 15 and 17 – 19 under U.S.C 35 112(a) for failing to comply with the written description requirement, recited in the previous action dated 09/11/2025 have been withdrawn in light of the Applicant’s amendments filed 12/09/2025. Specifically, the rejection of claim 15, regarding the phrase “flattened ball shape”, and the rejection of claims 17 – 19 for being dependent on a claim rejected under 112(a) have been withdrawn as the Specification has been amended to describe the ”flattened ball shape”.
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.
The rejection of claims 15 and 17 – 19 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 09/11/2025 have been withdrawn in light of the Applicant’s amendments filed 12/09/2025. Specifically, the rejection of claim 15, regarding the lack of clarity in the phrase “wherein an entirety of the medical device includes only two collars”, has been withdrawn as the appropriate corrections have been made.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15 and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Center et al (US 2015/0005810 A1) (previously cited) and in view of Greenhalgh et al (US 7,648,532 B2) (previously cited).
Regarding claim 15, Center discloses a medical device for left atrial appendage closure (abstract, paragraphs [0002], [0094], [0097] and Fig. 25) (Examiner’s note: as discussed in paragraph [0169] Center states that the occlusive device frame 602 corresponds to any anchor frames disclosed previously, which includes the anchor frame 102. Therefore, although the Examiner is relying upon the embodiment of Fig. 25, the Examiner may cite to other passages within the disclosure as they relate to frame 102 and thus frame 602) comprising:
a support frame including a plurality of struts, the support frame having a proximal end region with only one proximal collar, a medial region, and a distal end region with only one distal collar (see third and fourth iterations of annotated Fig. 25), wherein the support frame is actuatable from a first constrained delivery configuration to a second deployed configuration in which at least the medial region is radially expanded to engage an inner wall of the left atrial appendage (paragraphs [0097] and [0099]), wherein the support frame in the second deployed configuration defines a flattened ball shape with a circumferential side wall and proximal and distal faces extending transverse to a longitudinal axis extending through the proximal and distal collars (Fig. 25);
an engagement element including a (first) plurality of atraumatic members extending distally beyond a distal end point of the support frame (see third and fourth iterations of annotated Fig. 25), the plurality of atraumatic members configured to engage the inner wall of the left atrial appendage and prevent the support frame from sliding along the inner wall during implantation (Examiner’s note: the preceding limitation only requires that the structure of the prior art be capable of functioning in the manner claimed; with that said the designated engagement elements in the third and fourth iterations of annotated Fig. 25 extend outward and are capable of engaging an inner surface of the left atrial appendage and prevent the frame from sliding).
However, the above embodiment of Center is silent regarding (i) a membrane on at least a proximal end region of the support frame and (ii) wherein at least some of the (first) plurality of atraumatic members are first wires fixed directly to the plurality of struts on the distal face of the support frame, spaced radially inward from the circumferential side wall.
As to (i), Center further teaches, in paragraph [0169] wherein the device of Fig. 25 is an occlusive device, and teaches in paragraph [0100] wherein any of the occlusion frames of the disclosure can be used as a filter device and comprise a covering that is configured to modulate the passage of blood or thrombus through the covering to occlude the flow of blood.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment of Fig. 25 (both iterations) to incorporate a covering (i.e., membrane) on the frame for the purpose of further occluding the passage of blood and modulate the passage of blood or thrombi (paragraph [0100]).
As to (ii), Greenhalgh teaches a medical device (device 300) for a left atrial appendage closure (col. 4 lines 23 – 26, col. 11 lines 29 – 39, and Fig. 30A) comprising a support frame (frame 305) with a plurality of struts (leg segments 310 and 312; which equate to the struts of Center designated by the Examiner in the third iteration of annotated Fig. 25), a proximal end region with a proximal collar (second collar member 324), a distal end region with a distal collar (first collar member 314) (col. 13 line 41 – col. 14 line 2 and Fig. 30A), an engagement member including a plurality of atraumatic members / first wires (anchors 326 and 328) fixed directly to the struts (leg segments 310 and 312) in the distal end region and extending distally beyond a distal end point of the frame (frame 305) (Examiner’s note: as stated in col. 13 lines 60 – 65 and shown in Fig. 30A the anchors 326 and 328 (i.e., the atraumatic wires / first wires) are fixed directly to the leg segments 310 and 312 (i.e., the struts) and extend beyond the frame 305).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device (both iterations) of Center to incorporate the anchors of Greenhalgh, wherein the anchors are attached to / fixed to the inner surface struts in the distal region of the frame, as taught by Greenhalgh, for the purpose of providing additionally means of retaining the occlusion device of Center in the desired location, as the anchors will engage tissue and resist movement of the occlusion device. It should be understood that Greenhalgh makes obvious attaching the anchors 326 and 328 to the inner surface of the struts of Center as Greenhalgh discloses attaching the anchors 326 and 328 to the struts of the frame of Greenhalgh; therefore the combination encompasses the orientation of the anchors as shown in the third and fourth iterations of annotated Fig. 25 of Center.
Annotated Figure 25 of Center modified by Greenhalgh
(third iteration)
PNG
media_image1.png
809
858
media_image1.png
Greyscale
Annotated Figure 25 of Center modified by Greenhalgh
(fourth iteration)
PNG
media_image2.png
773
730
media_image2.png
Greyscale
Regarding claim 17, as discussed above, the device of Center in view of Greenhalgh makes obvious the device of claim 15. Additionally, Center further discloses wherein at least some of the plurality of atraumatic members are second wires fixed directly to the distal collar and extending distally therefrom (see third iteration of annotated Fig. 25).
Regarding claim 18, as discussed above, it would have been obvious to modify the device of Center to incorporate the additional anchors of Greenhalgh. Additionally, the combination teaches wherein at least some of the (first) plurality of atraumatic members are additional wires (anchors 326 and 328 of Greenhalgh) passing through an interior of the support frame and extending through / around the distal end region (Examiner’s note: as shown in both the third and fourth iterations of annotated Fig. 25, the “first wires” (i.e., the anchors of Greenhalgh) are also “additional” wires as they are additions added on to the device of Center; furthermore, as shown in the third and fourth iterations of annotated Fig. 25 the “first wires” / the “additional wires” are attached to an inner surface of the struts (of Center) and therefore pass through an interior of the support frame and though / around the distal end region of the frame. It is noted that the claims as currently written do not require that the “additional wires” be different from any of the other previously claimed plurality of atraumatic wires).
Regarding claim 19, as discussed above, the device of Center in view of Greenhalgh makes obvious the device of claim 15. Additionally, Center further discloses wherein at least some of the (first) plurality of atraumatic members are fixed to a proximal face of the distal collar and extend proximally from the distal collar then curve around an outer edge of the distal collar to extend distally of the distal collar (Examiner’s note: as shown in the third iteration of annotated Fig. 25 the loop atraumatic members are fixed and extend as claimed).
Examiner’s note
The claims as currently written only require each of the proximal and distal regions to have a single collar, the claims as currently written do not require the medical device to comprise only one proximal collar and only one distal collar.
The following claim 15 drafted by the examiner and considered to distinguish patentably over the art of record in this application, is presented to applicant for consideration:
15. (Currently Amended) A medical device for a left atrial appendage closure, comprising:
only one proximal collar and only one distal collar;
a support frame including a plurality of struts, the support frame having a proximal end region with the only one proximal collar, a medial region, and a distal end region with the only one distal collar, wherein distal ends of all of the plurality of struts are coupled directly to the distal collar, wherein the support frame is actuatable from a first constrained delivery configuration to a second deployed configuration in which at least the medial region is radially expanded to engage an inner wall of the left atrial appendage, wherein the support frame in the second deployed configuration defines a flattened ball shape with a circumferential side wall and proximal and distal faces extending transverse to a longitudinal axis extending through the proximal and distal collars;
a membrane disposed on at least the proximal end region of the support frame; and
an engagement element including a plurality of atraumatic members extending distally beyond a distal endpoint of the support frame, the plurality of atraumatic members configured to engage the inner wall of the left atrial appendage and prevent the support frame from sliding along the inner wall during implantation, wherein at least some of the plurality of atraumatic members are first wires fixed directly to the plurality of struts on the distal face of the support frame, spaced radially inward from the circumferential side wall.
Response to Arguments
Applicant’s arguments, filed 12/09/2026, with respect to the 112(a) and 112(b) rejections have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejections of the claims has been withdrawn in light of said amendments.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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, Elizabeth Houston can be reached on 571-272-7134. 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.
/Andrew Restaino/Primary Examiner, Art Unit 3771