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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-3 and 21-37 is/are pending. Claim(s) 22-27 is/are withdrawn. Claim(s) 4-20 is/are canceled.
Allowable Subject Matter
Claim(s) 1-3 and 21-37 are allowable over the prior art and would be allowable if the below rejections are addressed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art lacks an endovascular heart valve repair system, a valve repair leaflet grasping device, bailout suture, and an inverter bar, where the bailout suture is looped through the lateral ends of the inverter bar, in combination with the remaining claimed features.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/13/2026 is acknowledged.
Claims 4-20 would have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-V, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/2026. However, Applicant has canceled claims 4-20.
Applicant’s election of Species 1-3 and Species 2-1 in the reply filed on 7/13/2026 and 8/5/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has added new claims 21-37 in the reply on 7/13/2026 and remaining on 8/5/2026. Due to Applicant’s amendments, the following changes to the restriction requirement structure are necessary for Groups I-V. The above elected groups and species content are maintained as follows.
Group A: endovascular heart valve repair systems
Former claims 1-3, 7-11
Group B: methods for expelling valve leaflets from a valve repair leaflet grasping device
Former claims 4-6
Group C: an endovascular heart valve prosthesis
Former claims 12-16
Group D: a method for deploying an endovascular heart valve
Former claims 17-20
Upon election of Group A, an election must be made from the following species of endovascular heart valve repair systems.
Species A-1: an endovascular heart valve repair system of former claims 1-3 (former Group I)
Secondary suture, #93, e.g. Figures 8D, 9A-B, 10A-B
Current claims: 1-3, 21, 28-37
Species A-2: an endovascular heart valve repair system with a hub and a spacer of former claims 7-11 (former Group 3)
Hub, no reference number, [00178], only instance in specification
Figures 27-29
Spacer, #s 264, 268, 270, 272, 274, 276
Figures 25-26, 31-36, 52 (#352); Figures 27-29
Current Claims: 1, 21-37
Here, Applicant’s election covers Group A, Species A-1.
Overall, new claims 22-27 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups B-D, Species A-2, Species 1-1, 1-2, 1-4, 1-5, and Species 2-2, 2-3, 2-4, 2-5, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/2026 and 8/5/2026.
Claim Objections
Claims 32 and 36-37 are objected to because of the following informalities:
Claim 32 recites “a dip or pot-hole or grove”, which should be “a dip a pot-hole or a groove”.
Claim 36 recites “a distal expandable funnel, coil, or fan”, which should be “a distal expandable funnel, a coil, or a fan”.
Claim 37 recites “and actuator rod-gripper”, which should be “and an actuator rod-gripper”.
Appropriate correction is required.
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.
Claim 37 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 37 recites “a corresponding implant pair,” “an implant-rod,” and “an implant-gripper.” It is unclear if these are the same as the “a first pair of leaflet capture arms,” “a first inner arm,” and “a first outer arm” introduced in claim 1 or if they are additional elements as written. As written, the specification lacks support for a combination of an inner/outer arm pair and an implant rod/gripper pair. Therefore, the combination of these two pairs of elements is new matter.
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 1-3, 28, 31, 33-34, and 37 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.
Claim 1, line 13 and Claim 28 each recites “valve leaflets”. It is unclear if these are the same or different than those introduced earlier in claim 1, line 2. For purposes of examination the Examiner considers this language to be “the coapting heart valve leaflets”.
Claim 2 recites the limitation "the bailout suture loop". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner is interpreting the following in claim 1, line 12: “and looped through opposite lateral ends of the inverter bar, forming a bailout suture loop, so that two ends of the …”.
Claim 3 recites "the bailout loop". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner is interpreting the following in claim 1, line 12: “and looped through opposite lateral ends of the inverter bar, forming a bailout suture loop, so that two ends of the …”. Further, for purposes of examination the Examiner considers this language to be “the bailout suture loop” to be consistent with claim 2.
Claim 31 recites the limitation "the patient’s ventricle". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a patient’s ventricle”.
Claims 33 and 34 each recites “leaflets”. It is unclear if these are the same or different than those introduced earlier in claim 1. For purposes of examination the Examiner considers this language to be “the coapting heart valve leaflets”.
Claim 37 recites “a corresponding implant pair,” “an implant-rod,” and “an implant-gripper.” It is unclear if these are the same as the “a first pair of leaflet capture arms,” “a first inner arm,” and “a first outer arm” introduced in claim 1. If these are the intended references, then the terms in claim 37 should be corrected to refer to the names used in claim 1. If they are different elements, then see 35 USC 112(a) rejection above.
Claims(s) 21, 29-30, 32, and 35-36 is/are rejected as being dependent from a rejected claim.
Relevant Prior Art
US 2013/0066341 to Ketai, et al teaches a heart valve leaflet grasping device having bailout suture (e.g. Figures 18-19), but lacks an inverter bar distal of the grasping device.
US 2006/0020275 to Goldfarb, et al teaches a heart valve leaflet grasping device having bailout suture (e.g. Figures 3, 18 A, 18B), but lacks an inverter bar distal of the grasping device and having the bailout suture through both ends.
US 2004/0049207 to Goldfarb, et al teaches a heart valve leaflet grasping device having bailout suture and distal inverter bar (e.g. Figures 18, 48), but lacks the bailout suture through both ends of the inverter.
US 2019/0021852 to Delgado, et al teaches a heart valve leaflet grasping device having bailout suture and distal inverter bar (e.g. Figures 13, 42-43), but lacks the bailout suture through both ends of the inverter.
AU 2002/316473 A1 to Dell, et al teaches a valve leaflet repair device having an inverter bar with a suture through both of its lateral ends (e.g. Figure 11C), a gripping structure embodiment (e.g. Figures 17D, 21A), but lacks a combination of a gripping device, a bailout suture, and an inverter with the bailout suture looped through its ends.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 9/1/2026
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