DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 28 April 2026.
Notice of 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 .
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 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.
Response to Arguments
Claim 1 was amended to recite “wherein said interconversion from said first shape to said second shape comprises a movement of said anchoring element in relation to said arm”. Applicant argues this overcomes Dolan’420 because the anchoring element 116 does not move relative to the arm 114 as the device moves between the first and second shapes (Figures 2 and 4, respectively). This argument is persuasive. However, upon further search and consideration, a new ground of rejection follows below.
Claim 16 was amended to recite “wherein the sharp distal end is additionally and separately joined to a second of the plurality of base regions through a separate elongated member.” Applicant argues this overcomes Alon’645 because the claim requires two separate joints to two separate parts. This argument is not persuasive. The claim only requires the elastic member and elongated member to be separate, which they are, not the base regions. Alon’645 describes the proximal end of element 16 as having two shoulders 44 in paragraph [0097]. For this reason, the rejection is maintained.
Regarding the rejection to claim 16 under McGuckin’441, Applicant argues McGuckin’441 fails to disclose an anchoring element connected to a first part via an elastic member and then, a second, different part via an elongated member. This argument is not persuasive. The claim only requires the elastic member and the elongated member to be separate, which they are. The base members are also separate and connect to a single anchor mounting portion.
Claim Objections
Claims 1 and 16 are objected to because of the following informalities:
The preamble of claim 1 recites a “tissue anchoring mechanism configured to deploy from an arm” but line 4 positively recites the arm as part of the invention. Therefore, there is disagreement between the preamble and the body of the claim.
Claim 16 raises similar issues: The preamble recites a “tissue anchoring mechanism configured to deploy from an arm” but lines 4-5 recite the anchor element is attached to the arm, meaning the arm is part of the invention. Therefore, there is disagreement between the preamble and the body of the claim.
Claims 1 and 16 are interpreted such that the arm is a positively recited element of the invention.
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.
Claim 7 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 pre-AIA the applicant regards as the invention.
Claim 7 recites the limitation "an elastic member" in line 5. This limitation is unclear because independent claim 1 introduces “an elastic member” in line 8. It is unclear if the “elastic member” introduced in claim 7 is a second/different elastic member or the same elastic member introduced in claim 1. For the purpose of examination, Examiner will assume it is the same elastic member introduced in claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Solem et al. (US Patent Publication 2007/0270943).
Claim 1: Solem’943 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device, the anchoring mechanism comprising:
an arm (147), including an anchor-mounting portion (149; paragraph [0074]);
an anchoring element (132) having a sharp distal end (distal end of 138), and a proximal end (136) engaged with the anchor-mounting portion (paragraph [0074]);
wherein, together, the proximal end and anchor-mounting portion form an assembly (Figure 10d), the assembly having an elastic member (142) which relaxes to interconvert the assembly between a first shape (Figure 9a, 10a, 10b) and a second shape (Figure 9b, 10d); and
the first shape is collapsed to position a distal portion of the sharp distal end of the anchoring element relatively close to a longitudinal axis of the arm (Figure 9a, 10a, 10b), compared to the second shape (Figures 9b, 10d);
wherein said interconversion from said first shape to said second shape comprises a movement of said anchoring element in relation to said arm (distal end of anchoring element 138 is angled relative to the arm 147 in the second shape – see Figure 10d).
Claim 2: In Solem’943, the elastic member (142) is tensioned in the first shape, and relaxed in the second shape (paragraph [0070], [0072]).
Claim 3: In Solem’943, interconversion between the first shape (Figure 9a, 10a, 10b) and the second shape (Figures 9b, 10d) moves the distal portion of the sharp distal end of the anchoring element longitudinally along the longitudinal axis, and further away from the longitudinal axis (see Figures 9a, 9b, 10a, 10b, 10d).
Claim 4: In Solem’943, the elastic member (142) comprises a spring formed into the anchoring element (paragraph [0068]);
wherein the anchoring element comprises a piece cut from sheet stock, and the elastic member is a part of the piece (paragraph [0068]).
Claim 6: Solem’943 discloses the anchoring element (132) and the anchor mounting portion (149) comprise separate interlocking pieces (paragraph [0074]).
Claim 1-4, 9 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Nayak et al. (US Patent Publication 2005/0256532)
Claim 1: Nayak’532 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device, the anchoring mechanism comprising:
an arm (33), including an anchor-mounting portion (unlabeled loop at the free end of 32 in Figure 3a);
an anchoring element (35) having a sharp distal end (36), and a proximal end (opposite end of element 36) engaged with the anchor-mounting portion (Figure 3a)
wherein, together, the proximal end and anchor-mounting portion form an assembly (Figure 3a), the assembly having an elastic member (33 is elastic; paragraph [0049]) which relaxes to interconvert the assembly between a first shape (Figure 4) and a second shape (Figure 3a); and
the first shape is collapsed to position a distal portion of the sharp distal end of the anchoring element relatively close to a longitudinal axis of the arm (Figure 9a, 10a, 10b), compared to the second shape (Figures 3a);
wherein said interconversion from said first shape to said second shape comprises a movement of said anchoring element in relation to said arm (see Figures 4 and 5).
Claim 2: In Nayak’532, the elastic member (33) is tensioned in the first shape, and relaxed in the second shape (paragraph [0049]).
Claim 3: In Nayak’532, interconversion between the first shape (Figure 4) and the second shape (Figures 3a or 5) moves the distal portion of the sharp distal end (42) of the anchoring element (4) longitudinally along the longitudinal axis, and further away from the longitudinal axis (see Figures 3a, 4 and 5).
Claim 4: In Nayak’532, the elastic member comprises a spring formed into the anchoring element 4 (paragraph [0049]).
The limitation "the anchoring element comprises a piece cut from sheet stock" is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In this case, the elastic member (i.e. middle of anchoring element 33) is part of the anchoring element (4).
Claim 9: Nayak’532 discloses the implantable device is a suturing clip (it could hold sutures) comprising a plurality of arms (spokes 33) extending from a core (34) each provided with a corresponding anchoring element 35 (Figure 3a).
Claim 14: In Nayak’532, the elastic member (length of 33) is part of the anchor mounting portion (loop at the distal end of the 33; all of 33 disclosed as elastic in paragraph [0049]); and
The elastic member (33) terminates in a recess (loop at free end of 33; see Figure 3 for example) shaped to engage with the anchoring element (35).
Claim 1, 3, 4, 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cartier et al. (US Patent Publication 2005/0288704).
Claim 1: Cartier’704 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device, the anchoring mechanism comprising:
an arm (18), including an anchor-mounting portion (6, 23);
an anchoring element (9) having a sharp distal end (12), and a proximal end (7) engaged with the anchor-mounting portion (Figures 3a-3c show this);
wherein, together, the proximal end (7) and anchor-mounting portion (6, 23) form an assembly (Figure 3a-c), the assembly having an elastic member (paragraph [0042] discloses elements 2 and 3 are formed from shape memory tubes) which relaxes to interconvert the assembly between a first shape (Figure 1) and a second shape (Figure 3a-c) and
the first shape is collapsed to position a distal portion of the sharp distal end of the anchoring element relatively close to a longitudinal axis of the arm (Figure 1), compared to the second shape (Figures 3a-3c);
wherein said interconversion from said first shape to said second shape comprises a movement of said anchoring element (9) in relation to said arm (18) (Figures 1 and 3a-3c).
Claim 3: In Cartier’704, interconversion between the first shape (Figure 1) and the second shape (Figures 3a-c) moves the distal portion of the sharp distal end of the anchoring element longitudinally along the longitudinal axis, and further away from the longitudinal axis (see Figures 1, 3a-c).
Claim 4: In Cartier’704, the elastic member comprises a spring formed into the anchoring element (paragraph [0042]);
wherein the anchoring element comprises a piece cut from sheet stock, and the elastic member is a part of the piece (paragraph [0042]).
Claim 6: Cartier’704 discloses the anchoring element (9) and the anchor mounting portion (6, 23) comprise separate interlocking pieces (Figure 3b; Figures 6, 7).
Claims 1, 3, 4, 6, 10, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sixto et al. (US Patent Publication 2007/0010715).
Claim 1: Sixto’715 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device, the anchoring mechanism comprising:
an arm (32), including an anchor-mounting portion (“non-illustrated bore”, paragraph [0142]);
an anchoring element (4) having a sharp distal end (42), and a proximal end (41; paragraph [0142]) engaged with the anchor-mounting portion (Figures 27);
wherein, together, the proximal end (41) and anchor-mounting portion (“non-illustrated bore”, paragraph [0142]) form an assembly (Figure 27), the assembly having an elastic member (paragraph [0102] discloses 4 is formed from a memory material exhibiting elastic behavior) which relaxes to interconvert the assembly between a first shape (Figure 27) and a second shape (Figure 40) and
the first shape is collapsed to position a distal portion of the sharp distal end of the anchoring element relatively close to a longitudinal axis of the arm (Figure 27), compared to the second shape (Figures 40);
wherein said interconversion from said first shape to said second shape comprises a movement of said anchoring element (4) in relation to said arm (32) (Figures 27, 40).
Claim 3: In Sixto’715, interconversion between the first shape (Figure 27) and the second shape (Figures 40) moves the distal portion of the sharp distal end (42) of the anchoring element (4) longitudinally along the longitudinal axis, and further away from the longitudinal axis (see Figures 27, 40).
Claim 4: In Sixto’715, the elastic member comprises a spring formed into the anchoring element 4 (paragraph [0102]).
The limitation "the anchoring element comprises a piece cut from sheet stock" is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In this case, the elastic member (i.e. middle of anchoring element 4) is part of the anchoring element (4).
Claim 6: Sixto’715 discloses the anchoring element (4) and the anchor mounting portion (“non-illustrated bore” of element 32) comprise separate interlocking pieces (paragraph [0142]).
Claim 10: In Sixto’715, the sharp distal end (42) is held away from the anchor mounting portion (“non-illustrated bore”, paragraph [0142]) the arm (32) by an elongated member (length of anchoring element 4), wherein a longitudinal axis of the elongated member extends away from a longitudinal axis of the arm at an approximate right angle in the second shape (Figure 40), and at an oblique angle in the first shape which is at least 45° different than the approximate right angle shape ((Figure 27 shows the elongated member is slightly bent in the first shape).
Claim 12: In Sixto’715, the elastic member (4) is part of the proximal end of the anchoring element (4); and
the elastic member (4) terminates in a recess (bore 41) shaped to engage with the anchor-mounting portion (“non-illustrated bore”, paragraph [0142]).
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leewood et al. (US Patent Publication 2012/0022638).
Claim 1: Leewood’638 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device, the anchoring mechanism comprising:
an arm (110), including an anchor-mounting portion (distal end of 110, near 130);
an anchoring element (120) having a sharp distal end (125), and a proximal end (proximal end of 120; near 130) engaged with the anchor-mounting portion (Figure 1);
wherein, together, the proximal end (proximal end of 120) and anchor-mounting portion (distal end of 110) form an assembly (Figure 1), the assembly having an elastic member (paragraph [0024] discloses 120 is a shape memory alloy) which relaxes to interconvert the assembly between a first shape (paragraph [0024]: “In an undeployed configuration of the barb 105, the penetrating element 120 preferably extends in a longitudinal direction from the body portion 110 so as to have a low-profile configuration. ) and a second shape (Figure 1; paragraph [0024]) and
the first shape is collapsed to position a distal portion of the sharp distal end of the anchoring element relatively close to a longitudinal axis of the arm (paragraph [0024]), compared to the second shape (Figure 1; paragraph [0024]);
wherein said interconversion from said first shape to said second shape comprises a movement of said anchoring element (120) in relation to said arm (110) (paragraph [0024]).
Claim 2: In Leewood’638, the elastic member is tensioned in the first shape, and relaxed in the second shape (paragraph [0024]).
Claim 3: In Leewood’638, interconversion between the first shape (straight configuration described in paragraph [0024]) and the second shape (Figures 1) moves the distal portion of the sharp distal end (125) of the anchoring element (120) longitudinally along the longitudinal axis, and further away from the longitudinal axis (Figure 1; paragraph [0024])
Claim 4: In Leewood’638, the elastic member comprises a spring formed into the anchoring element 120 (paragraph [0032]).
The limitation "the anchoring element comprises a piece cut from sheet stock" is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In this case, the elastic member is part of the anchoring element (120).
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alon (US Patent Publication 2016/0120645).
Claim 16: Alon’645 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm (24) of an implantable device (Figure 2; this device is configured for implantation because it is inserted in the body and could be left there), the anchoring mechanism comprising:
an anchoring element (16) terminating in a sharp distal end (46) and attached, through a plurality of base regions (shoulders 44; paragraph [0097]) on its proximal side, to an anchor-mounting portion (42) of the arm;
wherein the sharp distal end (46) is joined to a first of the plurality of base regions (shoulder 44) through an elastic member; and
wherein the sharp distal end (46) is additionally and separately joined to a second of the plurality of base regions (second shoulder 44; paragraph [0097]) through a separate elongated member (see annotated copy of Figure 7 below).
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Claims 16, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin et al. (US Patent Publication 2005/0165441).
Claim 16: McGuckin’441 discloses a self-expanding tissue anchoring mechanism configured to deploy from an arm of an implantable device (Figure 11g), the anchoring mechanism comprising:
an anchoring element terminating in a sharp distal end (356a; Figure 11g) and attached, through a plurality of base regions (see annotated copy of Figure 11g) on its proximal side, to an anchor-mounting portion of the arm (see annotated copy of Figure 11g);
wherein the sharp distal end is joined to a first of the plurality of base regions through an elastic member (paragraph [0078] teaches the filter is made of nickel-titanium shape memory alloy, which is a superelastic material); and
wherein the sharp distal end is additionally and separately joined to a second of the plurality of base regions through a separate elongated member (annotated copy of Figure 11g below).
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Claim 17: McGuckin’441 discloses the elastic member (base) bends, moving the sharp distal end from a collapsed position nearer to a longitudinal axis of the anchor-mounting portion of the arm, to an expanded position further from the longitudinal axis (Figure 11e, 11f shows the collapsed position; Figure 11g shows the expanded position).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 6, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Leewood’638, as applied to claim 1, further in view of Roeder et al. (US Patent 8,394,139).
Claim 6: Leewood’638 does not teach the anchoring element and anchor mounting portion are separate interlocking elements.
Like Leewood’638, Roeder’139 teaches a barb for attachment to an implantable device. Roeder’139 teaches an anchoring element (13) with a sharp distal end 11 and a proximal end (14, 18) for engagement with an anchor mounting portion of an implantable device (column 5, lines 19-21).
Roeder’139 teaches this arrangement is advantageous because it allows the sharp barb to be attached to a preferred location on the implantable device without limiting the location based on the geometry or manufacturing the implantable device (column 1, lines 15-35).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Leewood’638 by providing the anchoring element with a region that engages with an anchor mounting portion, , as taught by Roeder’139, in order to allow the barb to be attached to an implantable device at a preferred location.
Claim 7: Leewood’638 does not disclose a plurality of base regions engaged with the anchor mounting portion.
Like Leewood’638, Roeder’139 teaches a barb for attachment to an implantable device. Roeder’139 teaches an anchoring element (13) with a sharp distal end 11 and a proximal end having a plurality of base regions (free ends of elements 14 and 18; see annotated copy of Figure 1c below) for engagement with an anchor mounting portion of an implantable device (column 5, lines 19-21).
The sharp distal end (11) is joined to a first base region (free end of 14) through an elastic member (see annotated copy of Figure 1c below). The sharp distal end (11) is additionally and separately joined to a second of the base regions (free end of 18) through a separate elongate member (see annotated copy of Figure 1c below).
Roeder’139 teaches this arrangement is advantageous because it allows the sharp barb to be attached to a preferred location on the implantable device without limiting the location based on the geometry or manufacturing the implantable device (column 1, lines 15-35).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Leewood’638 by providing the anchor mounting portion with a plurality of base regions, as taught by Roeder’139, in order to allow the barb to be attached to an implantable device at a preferred location.
Allowable Subject Matter
Claims 26, 27, 30 and 31 are allowed.
Claims 18-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771
20 July 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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