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 .
Election/Restrictions
Applicant’s election without traverse of Species I in the reply filed on 06/07/2026 is acknowledged.
Claims 7 – 13, 19, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/07/2026. (Examiner’s note: claim 21 recites openings that face the occluding disk, and as best understood by the Examiner Species I does not include openings that face the occluding disk when positioned on the fixing disk; therefore, claim 21 is being withdrawn from consideration).
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites “one hook portion” in line 1 and “each first positioning hole” in line 2”, although the lines are understood by the Examiner to mean “one hook portion of the hook portions” and “each of the first positioning holes” as previously defined, the Examiner suggests the lines be amended to read “one hook portion of the hook portions” and “each of the first positioning holes” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1 – 6, 14 – 17, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "the hook portion is formed by” in line 11 renders the claim indefinite because it is unclear whether Applicant is intending for only one of the “hook portions” to be formed by the proceeding means or if Applicant is intending for the line to mean “the hook portions is formed by” such that all of the hook portions are formed by the proceeding means. For the purpose of examination, the Examiner will read the claim to mean that all of the hook portions are formed by the proceeding means.
Regarding claim 2, the phrase "one of the first-direction wire and the second-direction wire is threaded through the first positioning holes, and the other of the first-direction wire and the second-direction wire is threaded through the second positioning holes" renders the claim indefinite because it is unclear if Applicant is now intending for the claim to require the “first-direction wire” and the “second-direction wire” when the “first-direction wire” and the “second-direction wire” were previously only functionally required. For the purpose of examination, the Examiner will read claim 2 as positively requiring the occluder and thus positively requiring the “first-direction wire” and the “second-direction wire” that comprise said occluder. However, if Applicant is intending the former, the recitation of the “first-direction wire” and the “second-direction wire” renders claim 3 indefinite (see below)
Regarding claim 3, the phrase “a value of the included angle beta is equal to a value of an included angle between the first-direction wire and the second-direction wire” renders the claim indefinite because it is unclear if Applicant is now intending for the claim to require the “first-direction wire” and the “second-direction wire” when the “first-direction wire” and the “second-direction wire” were previously only functionally required. For the purpose of examination, the Examiner will read claim 3 in the same manner claim 2 is being read (see above).
Regarding claim 4, the phrase “wherein there are two first positioning holes” renders the claim indefinite because it is unclear if Applicant is intending for the phrase “two first positioning holes” be narrowing down the amount of holes of “at least two first positioning holes” previously defined or if the “two first positioning holes” are additional “first positioning holes” to the “at least two first positioning holes”, such that the claim requires at least 4 first positioning holes. For the purpose of examination, and based on Applicant’s disclosure, the Examiner will read the claim to mean that the “at least two first positioning holes” comprises two first positioning holes.
Regarding claims 14 and 15, the phrase "the projection of the hook portion” in line 11 renders the claim indefinite because it is unclear whether Applicant is intending for the projection of only one of hook portion out of the [plurality of] hook portions to be at the claimed position, or if Applicant is intending for the projections of each of the hook portions to be at the claimed position. For the purpose of examination, the Examiner will read the claim to mean the former.
Regarding claim 17, the phrases "the first hooks” and “the second hooks" followed by the phrases “the first hook” and “the second hook” render the claim indefinite because it is unclear if Applicant is intending to claim a plurality of “first hooks” and a plurality of “second hooks” or if Applicant is intending to claim a singular “first hook” and a singular “second hook”. Based on Applicant’s disclosure, particularly Fig. 13, the Examiner will read the claim to require a singular first hook and a singular second hook.
Claims 2 – 6, 14 – 17, and 22 are rejected as being indefinite for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inouye et al (US 2020/0008812 A1).
Regarding claim 1, Inouye discloses a hook (fixation member 16) used for being fixed to an occluder (implant 14) (abstract, paragraphs [0068 – 0075], and Figs. 1 – 4), wherein the occluder is formed by interweaving a first-direction wire (first filament 25) and a second-direction wire (second filament 27) (paragraph [0069]), and the hook (fixation member 16) comprises a positioning body (fixation member 16) and hook portions (projections 41 and 43), wherein
the positioning body is provided with a first positioning portion (first engagement member 37) and a second positioning portion (second engagement member 39);
the first positioning portion (first engagement member 37) is configured to limit the hook (fixation member 16) to one of the first-direction wire (first filament 25) and the second-direction wire (second filament 27) (paragraph [0078] and Fig. 3), and the second positioning portion (second engagement member 39) is configured to limit the hook (fixation member 16) to the other of the first-direction wire (first filament 25) and the second-direction wire (second filament 27) (paragraph [0078] and Fig. 3);
or the first positioning portion (first engagement member 37) and the second positioning portion (second engagement member 39) are configured to limit, in different directions of force (left and right and/or up and down), the hook in an axial direction to the first-direction wire or the second-direction wire (paragraph [0078] and Fig. 3);
the limitation “the hook portion[s] is formed by bending the positioning body” is considered to be product by process claim limitations (only limited to structure of implied step) "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, forming the projections 41 and 43 by bending the positioning body produces no structural differences between the structure of instant application and the prior art as both result in a hook portion; additionally, forming the projections 41 and 43 in the manner claimed would result in the desired structure, i.e. by bending the positioning body, such that the intended use of the hook portions remains the same, i.e. to engage the surrounding tissue. Therefore the product of the prior art encompasses the product-by-process as claimed.
the hook portion[s] have an included angle (see annotated Fig. 4) is formed between a projection (tip of projections 41 and 43) of the hook portion (projections 41 and 43) on the positioning body and an axis of the positioning body (see annotated Fig. 4), and the included angle a is in a range of greater than 0 degrees and less than 90 degrees (see annotated Fig. 4) (Examiner’s note: because the projection is bent relative to the straight body portion and is not shown to be extending fully perpendicular to the longitudinal axis of the straight body portion nor is it shown to be extending parallel to the straight body portion, the angle ‘alpha’ has to be a degree between 0 and 90; therefore, Inouye discloses the angle as claimed).
Annotated Figure 4 of Inouye
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Regarding claim 14, Inouye discloses wherein the projection of the hook portion on the positioning body is located on a first side or a second side of the axis of the positioning body (see annotated Fig. 4), wherein the first side is an opposite side of the second side (see annotated Fig. 4).
Regarding claim 15, Inouye discloses when the projection of the hook portion on the positioning body is located on the second side of the axis of the positioning body (see annotated Fig. 4), the first positioning portion is configured to limit the hook in the axial direction to the second-direction wire (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art is capable of functioning in the manner claimed. With that said, the first positioning portion is capable of being used in the claimed manner).
Claims 1, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jayaraman (US 2022/0175392 A1).
Regarding claim 1, Jayaraman discloses a hook (hook 140A/B) used for being fixed to an occluder (device 100) (abstract, paragraphs [0094 – 0098], and Figs. 34 - 38), wherein the occluder is formed by interweaving a first-direction wire and a second-direction wire (Figs. 34,35), and the hook (hook 140A/B) comprises a positioning body (body of hook 140A/B) and hook portions (barbs 142A), wherein
the positioning body is provided with a first positioning portion (left / upper half of the hook 140A/B) and a second positioning portion (right / lower half of the hook 140A/B) (Figs. 37,38);
the first positioning portion (left / upper half of the hook 140A/B) is configured to limit the hook (hook 140A/B) to one of the first-direction wire and the second-direction wire and the second positioning portion (second engagement member 39) is configured to limit the hook (hook 140A/B) to the other of the first-direction wire and the second-direction wire (Examiner’s note: as shown in Figs. 34,35 each half of the hooks 140A/B limit the body by attaching to multiple cross-stitched wires);
the limitation “the hook portion[s] is formed by bending the positioning body” is considered to be product by process claim limitations (only limited to structure of implied step) "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, forming the barbs 142A by bending the positioning body produces no structural differences between the structure of instant application and the prior art as both result in a hook portion; additionally, forming the barbs 142A in the manner claimed would result in the desired structure, i.e. by bending the positioning body, such that the intended use of the hook portions remains the same, i.e. to engage the surrounding tissue. Therefore the product of the prior art encompasses the product-by-process as claimed.
the hook portion[s] have an included angle (angle between the longitudinal axis of the body and the point of inclination of the barbs) is formed between a projection (tip 150) of the hook portion (barbs 142A) on the positioning body and an axis (longitudinal) of the positioning body (Figs. 37A,38), and the included angle a is in a range of greater than 0 degrees and less than 90 degrees (Figs. 37A,38) (Examiner’s note: because the barbs are bent relative to the straight body portion and is not shown to be extending fully perpendicular to the longitudinal axis of the straight body portion nor are they shown to be extending parallel to the straight body portion, the angle ‘alpha’ has to be a degree between 0 and 90; therefore, Jayaraman discloses the angle as claimed).
Regarding claim 16, Jayaraman discloses an occluder (device 100 / anchor 120) formed by interweaving a first-direction wire and a second-direction wire (abstract, paragraphs [0065], [0068], [0069], [0094 – 0098], and Figs. 13, 34 – 38), comprising:
a fixing disc (anchor 120), provided with several hooks (hooks 140A/B) (see Fig. 13, where the anchor 120 has multiple hooks which equate to the hooks 140A/B – paragraph [0080] and [0104]) according to claim 1 and used for being fixed in a left atrial appendage through the hooks (paragraph [0102]); and
an occluding disc (cover 160) having a diameter greater than the fixing disc and configured to occlude the left atrial appendage (Figs. 13 – 15,28,30,31).
Regarding claim 17, Jayaraman discloses wherein the hooks (hooks 140A/B) are provided on the first-direction wire and the second-direction wire of the fixing disc (Figs. 13-15), hanging directions of the hooks are the same (Figs. 13-15), and the hooks comprise first hooks and second hooks (hooks on the left half of the occluder and hooks on the right half of the occluder, respectively);
wherein, the first hook is limited to the first-direction wire through the first positioning portion and the second hook is limited to the second-direction wire through the first positioning portion (Examiner’s note: as shown in Figs. 34,35 each of the hooks is limited (i.e., fixed) to each of the first and second wires (i.e., all of the wires) via the sutures that suture the hooks to the wires on each of the first half and second half of the hooks (i.e., the first and second positioning portions), and
the hook portions of the first hook and the hook portions of the second hook are oriented in the same direction (Examiner’s note: as shown in Fig. 37 all of the hook portions are oriented in the same direction, therefore, the first and second hooks (i.e., the left and right hooks in Fig. 13) would also comprise the same hook portion orientation).
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2022/0175392 A1) as applied to claim 16 above, and further in view of Tischler et al (US 2022/0117608 A1).
Regarding claim 22, as discussed above, Jayaraman discloses the device of claim 16.
However, Jayaraman is silent regarding (i) wherein the hooks are in a wavy line along a circumferential direction of the fixing disk.
As to the above, Tischler teaches, in the same field of endeavor, an occluder (occluder / implant 200) comprising a fixing disk (implant 200) with a plurality of hooks (first row and second row of anchors 250), wherein the hooks (first row and second row of anchors 250) are in a wavy line around the circumference of the fixing disk for the purpose of providing improved fixation strength, improved apposition to adjacent tissue, a reduced profile in a first, constrained position, reduced force required to remove the plurality of anchors 250 from the tissue (compared to placing all of the anchors in a single row) since only a portion of the total anchors is removed at a time, and reduced force required to retrieve the implant 200 back into a delivery catheter for repositioning (compared to having all of the anchors in a single row) (abstract, paragraphs [0046 – 0047] and Fig. 5).
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 hooks of Jayaraman to be positioned in a wavy (i.e., staggered) pattern along the circumference, as taught by Tishler, for the purpose of providing improved fixation strength, improved apposition to adjacent tissue, a reduced profile in a first, constrained position, reduced force required to remove the plurality of anchors 250 from the tissue (compared to placing all of the anchors in a single row) since only a portion of the total anchors is removed at a time, and reduced force required to retrieve the implant 200 back into a delivery catheter for repositioning (compared to having all of the anchors in a single row) (paragraph [0047] – Tischler).
Examiner’s Note
Claims 2 – 6 would be allowable, with the Examiner’s interpretation for claim 2 (disclosed in the 112(b) rejection above), if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Related Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Morin et al (US 2022/0280166 A1) teaches LAA anchors with openings.
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.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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