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 .
Response to Amendment
The amendment filed 07/24/2026 has been entered. Claims 1-10, 21-28, and 30 remain pending in the application and claims 11-20 and 29 are cancelled. Applicant’s amendments to the claims have overcome the 112(b) rejection, claim objections, and prior art rejections with respect to claims 21 and 30 previously set forth in the Non-Final Office Action mailed 04/24/2026, however has not overcome the prior art rejection with respect to claim 1 (see rejection below).
Response to Arguments
Applicant's arguments filed 07/24/2026 have been fully considered but they are not persuasive with respect to claim 1. Applicant argues on pages 8-9 that the proposed combination of Gilmore and Lee fails to disclose, teach, or suggest “wherein, after detachment, the detached hemostasis element is positioned in a passage in the heart wall.” The Office respectfully disagrees. The limitation is functional, and since there are no structures precluding the hemostasis element 203/205 from being positioned within a passage of the heart, Gilmore’s hemostasis element 203/205 is capable of being put in any type of passage of the heart after being detached. Therefore, the rejection is maintained.
Applicant’s arguments, see “Remarks”, filed 07/24/2026, with respect to claims 21 and 30 have been fully considered and are persuasive. The rejection of Gilmore has been withdrawn.
Claim Objections
Claims 2-3, 22, and 24-25 are objected to because of the following informalities:
Claim 2 line 2 “a heart wall” is suggested to read “the one or more walls” for better antecedent basis. Claim 3 is objected due to being dependent on claim 2.
Claim 22 line 5 “an elongated delivery state” is suggested to read “the elongated state” for better antecedent basis and claim language consistency.
Claim 22 line 7 “a curved deployed state” is suggested to read “the curved, deployed state” for better antecedent basis.
Claim 24 line 2 “a heart wall” is suggested to read “the one or more walls” for better antecedent basis. Claim 25 is objected due to being dependent on claim 24.
Appropriate correction is required.
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 1-3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gilmore in view of Lee (US PGPub 2014/0236127), hereinafter known as “Lee.”
With regards to claim 1, Gilmore discloses (Figures 1A-1B, 10E, and 11A) a device for remodeling a shape of one or more walls of a human heart, the human heart having an internal chamber (Abstract; page 97 lines 7-14 and 20-30), the device comprising:
an anchoring portion 20/128/450 having an elongated anchor body with a distal anchor end portion and a proximal anchor end portion opposite the distal anchor end portion (figures 1A and 11A);
a joint portion 122/124 configured to allow between 180 degrees and 720 degrees of rotation of the joint portion 122/124 (page 73 lines 19-29 and page 35 line 26 – page 36 line 8);
wherein the joint portion 122/124 has a distal joint end portion 244A fixedly attached to the proximal anchor end portion and a proximal joint end portion 244B opposite the distal joint end portion 244A (figure 1B);
a hemostasis element 203/205 having a distal hemostasis end portion detachably connected to the proximal joint end portion 244B (page 73 lines 19-29 and page 78 lines 9-17);
wherein the device is configured to receive an elongating device 494 through an inner passage in the device;
wherein when the elongating device 494 is received in the inner passage through the anchoring portion 20/450, the anchoring portion 20/450 is held in an elongated delivery state (figure 11A);
wherein when the elongating device 494 is removed from the inner passage of the anchoring portion 20/450, the anchoring portion 20/450 forms a curved deployed state (figure 10E; page 97 lines 7-14);
wherein the distal hemostasis end portion 203/205 is detachably connected to the proximal joint end portion 244B by an attachment portion 205 movable between a coupling position and a release position (page 73 lines 19-29 and page 78 lines 9-17); and
wherein, after detachment, the detached hemostasis element 203/205 is positioned in a passage in the heart wall (functional limitation - page 73 lines 19-29 and page 78 lines 9-17 – the hemostasis element 203/205 is detachably connected and therefore is capable of being positioned in a passage in the heart wall).
Gilmore is silent wherein the attachment portion includes a plurality of projections and a plurality of recesses, wherein each of the plurality of recesses is configured to receive a respective projection of the plurality of projections.
However, in a similar field of endeavor of tissue anchors, Lee teaches (Figures 12-13) wherein the attachment portion 116/120 includes a plurality of projections 120/130 and a plurality of recesses 116/136, wherein each of the plurality of recesses 116/136 is configured to receive a respective projection 120/130 of the plurality of projections 120/130 (paragraphs 57-58).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the attachment portion of Gilmore for the attachment portion of Lee. The difference between the prior art and the claimed invention is that Gilmore does not teach a plurality of projections and a plurality of recesses. Lee teaches (see Figs. 12-13) a similar attachment portion comprising a plurality of projections and a plurality of recesses. Accordingly, the prior art references teach that it is known that the attachment portion of Gilmore and the attachment portion of Lee are elements that are functional equivalents for providing coupling. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the attachment portion taught by Lee for the attachment portion of Gilmore because both elements were known equivalents and would have resulted in the predictable results of providing coupling to the device.
With regards to claim 2, Gilmore further discloses wherein the elongating device 494 is configured to pierce a heart wall to form a passage therein (functional limitation – page 97 lines 7-14 – claim language is functional, therefore the rod is capable of piercing a heart wall to form a passage therein as it is inserted into the channel of the tissue anchor 450 and seen extending past the anchor 450 with a beveled tip in figure 11A).
With regards to claim 3, Gilmore further discloses wherein the elongating device 494 is a wire (page 97 lines 7-14 – rod 494 is interpreted as a wire).
With regards to claim 5, Gilmore further discloses wherein the joint portion 122/124 is integrally formed with the anchoring portion 20/128/450 (page 72 lines 17-18);
With regards to claim 6, the combination of Gilmore/Lee disclose the device as claimed in claim 1. The combination discloses wherein the plurality of projections (120/130 of Lee) of the attachment portion include a pair of projections (120/130 of Lee) extending proximally from a cylindrical sidewall of the hemostasis portion (203/205 of Gilmore; akin to 118 of Lee)) and wherein the plurality of recesses (116/136 of Lee) of the attachment portion includes a pair of recesses (116/136 of Lee) extending proximally in a cylindrical sidewall of the joint portion (122/124 of Gilmore; akin to 116 of Lee). The device is silent wherein the attachment portion include a pair of projections extending proximally from a cylindrical sidewall of the joint portion and a pair of recesses extending proximally in a cylindrical sidewall of the hemostasis element.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have a reversal of parts so that the attachment portion include a pair of projections (120/130 of Lee) extending proximally from a cylindrical sidewall of the joint portion (122/124 of Gilmore; akin to 116 of Lee) and a pair of recesses (116/136 of Lee) extending proximally in a cylindrical sidewall of the hemostasis element (203/205 of Gilmore; akin to 118 of Lee) as supported by MPEP 2144.04 VI A. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification).
With regards to claim 7, as rejected above, it would have been obvious to substitute the attachment portion of Lee for the attachment portion of Gilmore. Lee further discloses wherein each of the plurality of projections 120/130 includes a shape memory alloy (paragraph 39 – male coupler constructed of PTFE) and each of the plurality of projections 120/130 is shape set to the release position (figure 13; paragraph 57). Thus, when incorporating the attachment portion of Lee, the claimed limitation is considered obvious.
With regards to claim 8, the combination of Gilmore/Lee disclose the device as claimed in claim 7. The combination discloses wherein the attachment portion include a pair of projections (120/130 of Lee) extending proximally from a cylindrical sidewall of the hemostasis portion (203/205 of Gilmore; akin to 118 of Lee)) and a pair of recesses (116/136 of Lee) extending proximally in a cylindrical sidewall of the joint portion (122/124 of Gilmore; akin to 116 of Lee); and wherein, in the release position (figure 13 of Lee), each of the plurality of projections 120/130 bend radially inward (paragraph 57). The device is silent wherein each of the plurality of projections extends proximally from a cylindrical sidewall of the joint portion.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have a reversal of parts so that the attachment portion include a pair of projections (120/130 of Lee) extending proximally from a cylindrical sidewall of the joint portion (122/124 of Gilmore; akin to 116 of Lee) and a pair of recesses (116/136 of Lee) extending proximally in a cylindrical sidewall of the hemostasis element (203/205 of Gilmore; akin to 118 of Lee) as supported by MPEP 2144.04 VI A. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification).
With regards to claim 9, as rejected above, it would have been obvious to substitute the attachment portion of Lee for the attachment portion of Gilmore. Lee further discloses wherein each of the plurality of projections 120/130 is held in the coupling position (figure 12) by the elongating device 122 (akin to rod 494 of Gilmore) when the elongating device 122 is positioned in the inner passage and extending through the attachment portion (figure 12). Thus, when incorporating the attachment portion of Lee, the claimed limitation is considered obvious.
With regards to claim 10, Gilmore further discloses wherein the anchoring portion 20/128/450 includes a shape memory alloy (page 85 lines 15-20) and the anchoring portion 20/128/450 is shape set to the curved deployed state (figure 10E).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gilmore in view of Lee, and further in view of Yellin et al. (US PGPub 2013/0226290), hereinafter known as “Yellin.”
With regards to claim 4, Gilmore/Lee disclose the device as claimed in claim 1. The combination is silent wherein the elongated anchor body includes a series of cuts traverse to a longitudinal axis along the elongated anchor body.
However, in a similar field of endeavor of tissue anchors, Yellin teaches (Figures 1-2) wherein the elongated anchor body 102 includes a series of cuts 200 traverse to a longitudinal axis along the elongated anchor body 102 (paragraphs 69-70).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Gilmore/Lee to include wherein the elongated anchor body includes a series of cuts traverse to a longitudinal axis along the elongated anchor body as taught by Yellin for the purpose of allowing for increased expansion and/or contraction in regions of the hypotube, and for allowing increased flexibility or bending of the internal body member (paragraph 70 of Yellin).
Allowable Subject Matter
Claims 21, 23, 26-28 and 30 are allowed.
The following is an examiner’s statement of reasons for allowance:
With regards to claims 21, 23, and 26-28, the allowable subject matter is in the context of the claims. Specifically, the prior art of records fails to disclose or make obvious the claimed device for remodeling a shape of one or more walls of a human heart, comprising, inter alia,
“a joint portion configured to allow between 180 degrees and 720 degrees of rotation of the joint portion;
wherein the joint portion has a distal joint end portion fixedly attached to the proximal anchor end portion and a proximal joint end portion opposite the distal joint end portion;
wherein the joint portion is integrally formed with the anchoring portion; and
wherein the anchoring portion and the joint portion each comprise a series of cuts configured to allow the anchoring portion and the joint portion to move between an elongated state and a curved, deployed state.”
The closest prior art of Gilmore et al. (WO 2016/189391) discloses a device for remodeling a shape of one or more walls of a human heart in figures 1A-1B, 10E, and 11A; however is silent to “wherein the anchoring portion and the joint portion each comprise a series of cuts configured to allow the anchoring portion and the joint portion to move between an elongated state and a curved, deployed state.” The interpretation of the joint portion 122/124 of Gilmore is not structurally part of the anchoring portion 20/128/450 as the joint portion 122/124 is its own separate element related to delivery of the anchoring portion 20/128/450, and thus cannot be modified to comprise a series of cuts configured to allow the joint portion to move between an elongated state and a curved, deployed state. The prior art fails to disclose or make obvious the claimed subject matter of the joint portion. Therefore, the claims are allowable over all prior art.
With regards to claim 30, the allowable subject matter is in the context of the claims. Specifically, the prior art of records fails to disclose or make obvious the claimed device for remodeling a shape of one or more walls of a human heart, comprising, inter alia,
“a hemostasis element having a distal hemostasis end portion detachably connected to the proximal joint end portion, the hemostasis element comprising a plurality of cuts configured to facilitate bending of the hemostasis element, each of the cuts being slanted relative to a longitudinal axis of the device;
wherein the distal hemostasis end portion is detachably connected to the proximal joint end portion by an attachment portion movable between a coupling position and a release position;
wherein movement of the attachment portion to the release position disconnects the joint portion from the hemostasis element such that the joint portion and the anchoring portion remain together and the hemostasis element is positioned in a passage in the heart wall.”
The closest prior art of Gilmore et al. (WO 2016/189391) discloses a device for remodeling a shape of one or more walls of a human heart in figures 1A-1B, 10E, and 11A; however is silent to “the hemostasis element comprising a plurality of cuts configured to facilitate bending of the hemostasis element, each of the cuts being slanted relative to a longitudinal axis of the device… wherein movement of the attachment portion to the release position disconnects the joint portion from the hemostasis element such that the joint portion and the anchoring portion remain together and the hemostasis element is positioned in a passage in the heart wall.” The interpretation of the hemostasis element 203/205 of Gilmore is not structurally part of the anchoring portion 20/128/450, as the hemostasis element is its own separate element related to delivery of the anchoring portion 20/128/450 and thus cannot be modified to comprise a plurality of cuts configured to facilitate bending of the hemostasis element, each of the cuts being slanted relative to a longitudinal axis of the device. The prior art fails to disclose or make obvious the claimed subject matter of the hemostasis element. Therefore, the claims are allowable over all prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 10/02/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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