DETAILED ACTION
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 (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.
Information Disclosure Statement
Examiner notes that the IDS submitted on 26 August 2024 and 20 March 2025 lists U.S. Application numbers. It is impractical for the examiner to consider the ongoing prosecution of an application. Examiner’s initials indicates only the abstract, drawings, specification and claims were reviewed. The entire prosecution history of these applications was NOT reviewed.
Claim Rejections - 35 USC § 102
(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.
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 and 3-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hacohen (US Patent Application 2011/0137410).
Claim 1: Hacohen’410 discloses an apparatus (20) for use with a prosthetic valve that is configured to be deployed within a native atrio-ventricular valve of a heart of a subject (paragraph [0044]), the native atrio-ventricular valve including a valve annulus, valve leaflets, and chords (paragraph [0044]), the apparatus comprising:
a valve frame (36, 38, 24, 46, 48) configured to support the prosthetic valve within the native atrio-ventricular valve, the valve frame comprising:
a frame body comprising:
an atrial part (36, 38) configured to be positioned, when the valve frame is deployed, such that at least a portion of the atrial part is disposed on an atrial side of the native atrio-ventricular valve (paragraph [0049]; and
a ventricular part (24, 46, 48) configured to be positioned, when the valve frame is deployed, such that at least a portion of the ventricular part is disposed within a ventricle of the subject (paragraph [0048], [0050]); and
at least one arm (32) configured to extend from the ventricular part of the frame body (paragraph [0048]), the at least one arm being configured to deploy among the chords of the native atrio-ventricular valve (paragraph [0059], and the at least one arm being configured such that when the at least one arm is deployed among the chords and is rotated, the at least one arm pulls the native atrio-ventricular valve radially inward toward the valve frame and twists the native atrio-ventricular valve around the valve frame (paragraph [0059]; Figure 4), by recruiting and deflecting at least a portion of the chords,
the frame body of the valve frame being configured to trap the native valve leaflets in a partially closed and twisted configuration by radially expanding, to thereby at least partially seal a space between the native atrio-ventricular valve and the prosthetic valve (paragraph [0059], [0060]).
Claim 3: Hacohen’410 discloses a protruding member shaped to protrude from the at least one arm (32), and configured to bar the portion of the chords that are recruited by the at least one arm from exiting the at least one arm (see annotated copy of figure below).
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Claim 4: Hacohen’410 discloses the native atrio-ventricular valve includes a mitral valve, and the valve frame is configured to support the prosthetic valve within the native mitral valve (paragraph [0005]
Claim 5: Hacohen’410 discloses the frame body of the valve frame is configured to trap the native valve leaflets in the partially closed and twisted configuration by the atrial part radially expanding against the at least one arm, such as to trap the native valve leaflets between the atrial part and the at least one arm (paragraph [0060]).
Claim 6: Hacohen’410 discloses the atrial part comprises a cylindrical portion that is configured to extend through an annular level of the native atrio-ventricular valve (Figure 2 shows the atrial part 36, 38 is cylindrical), and
wherein the cylindrical portion of the atrial part is configured to radially expand toward the at least one arm, such as to trap the native valve leaflets between the cylindrical portion of atrial part and the at least one arm (Figure 4; paragraph [0060]).
Claim 7: Hacohen’410 discloses the at least one arm (32) is configured to twist the leaflets of the native valve, such that the leaflets of the native valve are shaped into overlapping configurations with respect to each other (the arm is configured to twist the leaflets into an overlapping configuration because the prosthetic valve is disclosed as being rotated during delivery into the native valve), and
the frame body of the valve frame is configured to seal the space between the native atrio-ventricular valve and the prosthetic valve by trapping the leaflets of the native valve in the overlapping configurations with respect to each other (paragraph [0060]).
Claim 8: In the device of Hacohen’410, the at least one arm (32) is configured to seal commissures between the leaflets of the native atrio-ventricular valve by the twisting the leaflets of the native valve into the overlapping configurations with respect to each other (since Hacohen’410’s device is rotating in the ventricular part of the native valve with arms engaging the chordae, as recited in the claims, it would similarly be expected to seal the commissures between the leaflets of the native valve; see MPEP 2112 and 2114).
Claim 9: In Hacohen’410, the device (20) is configured so the at least one arm (32) is configured to deploy among the chords of the native atrio-ventricular valve to a distance sufficient to recruit and deflect at least primary and secondary chords of the native atrio-ventricular valve (Hacohen’410’s device fully expands in the native atrio-ventricular valve; as such, it is configured to engage both the primary and secondary chords because typically these chords do not extend beyond the periphery of the native valve.)
Claim 10: In Hacohen’410, the device (20) is configured so the at least one arm (32) is configured to deploy among the chords of the native atrio-ventricular valve to a distance sufficient to further recruit and deflect tertiary chords of the native atrio-ventricular valve (Hacohen’410’s device fully expands in the native atrio-ventricular valve; as such, it is configured to engage the tertiary chords because typically these chords do not extend beyond the periphery of the native valve.)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, 10-16, 18, 19, 21-26 of U.S. Patent No. 10,292,816. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘816 patent, as outlined in the chart below:
Claims of present application 18/814988
Anticipated by claims of 10,292,816
1
1, 16
2
1, 16
3
7, 18
4
8, 19
5
10, 21
6
11, 22
7
12, 23
8
13, 24
9
14, 25
10
15, 26
Claims 1-5, 7, 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8, 12, 16, 18, 20, 22, 23 of U.S. Patent No. 11,065,114. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘114 patent, as outlined in the chart below:
Claims of present application 18/814988
Anticipated by claims of 11,065,114
1
1, 12, 22, 23
2
1, 12, 22, 23
3
6, 16
4
9, 12, 23
5
8, 18
7
20
8
4, 20
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,779,459. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘459 patent, as outlined in the chart below:
Claims of present application 18/814988
Anticipated by claims of 11,779,459
1
9
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 10-16, 18, 19, 21-25 of U.S. Patent No. 12,097,114. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘114 patent, as outlined in the chart below:
Claims of present application 18/814988
Anticipated by claims of 12,097,114
1
1, 16
2
1, 16
3
7, 18
4
8, 19
5
10, 21
6
11, 22
7
12, 23
8
13, 24
9
14, 25
10
15
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Allowable Subject Matter
Claim 2 is 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 and if a terminal disclaimer were filed to overcome the double patenting rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 19 December 2025
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771