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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/25 has been entered.
Response to Arguments
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive.
On pages 6-7 Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the bridge comprising struts that taper toward each other and cross at a fixed junction must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: fixed junction.
Claim Objections
Claims 34-35 are objected to because of the following informalities:
Claims 34-35 are objected to for not further limiting the claim from which it depends.
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.
Claims 14, 17-19, 21-23, 28-30, 34-42 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 14 and 30 are rejected for having new matter for claiming the bridge comprises struts that taper toward each other and cross at a fixed junction. The originally filed disclosure fails to have support for the struts tapering towards each other. The figures do not show any bridge struts that taper towards one another, and tapering is not mentioned in the specification anywhere making this new matter. Further, the struts crossing (e.g. one going over/under the other) is also not supported. The figures do not show one strut crossing the other, since they appear to show the struts existing on a single plane, where they form an x-shape. This is accordingly also new matter.
Remaining claims are rejected for depending on a claim with new matter.
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.
Claim(s) 14, 17-19, 21-23, 28-30, 34-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Subramanian et al. (US 20100121435 A1) hereinafter known as Subramanian.
Regarding claim 14 Subramanian discloses a method comprising:
positioning a transvalvular intraanular bridge (50) relative to a valve annulus (28), the bridge comprising a first end (52), first anchoring portion (58), second end (54), second anchoring portion (60), and a central portion connecting the first and second anchoring portion (64), wherein the central portion comprises a convex arcuate shape (Figures 13, 24-27; [0111]); wherein the first end and second end are seated against the annulus without penetrating the annulus ([0112] the first 58 and second 54 ends have holes for sutures that secure the band to the annulus (sutures penetrate the annulus so the band does not)),
passing a first and second suture through the first and second anchoring portions respectfully to secure the first and second ends to the valve annulus ([0020], [0112]), so the first and second ends reside on a generally septal-lateral axis transverse to coaptive edges of valve leaflets when the bridge is attached to the annulus (Figures 29, 31; [0133]),
wherein the first and second ends are at least 75% thicker than the central portion, wherein the thickness of the first end and second end are in a direction perpendicular to the intraanular plane of the valve annulus (see at least Figure 55, where ends include projections which increase the thickness of the ends as compared to the central portion. Although not understood as being drawn exactly to scale, they are not understood to be completely inaccurate either. Accordingly, the person of ordinary skill in the art, in reading Subramanian, would view Figure 55 and understand the ends can obviously be at least 75% thicker than the central portion based on the illustrated figure), and wherein the bridge comprises struts that taper toward each other (Figure 18).
The Examiner notes that the prior art fails to teach the struts crossing at a fixed junction, but points out that this is new matter. See the 112 1st paragraph rejections above.
Regarding claim 17 Subramanian teaches the method of claim 1 substantially as is claimed,
wherein Subramanian further discloses the bridge withstands a load in cyclic fatigue without damage (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 18 Subramanian teaches the method of claim 1 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains an anterior-posterior diameter for early coaption ([0106]).
Regarding claim 19 Subramanian teaches the method of claim 1 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains a diameter to reduce regurgitation (Abstract: treating regurgitation is the goal of the invention).
Regarding claim 21 Subramanian teaches the method of claim 1 substantially as is claimed,
wherein Subramanian further discloses the bridge limits displacement from the septal-lateral plane (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 41 Subramanian teaches the method of claim 14 substantially as is claimed,
wherein Subramanian further discloses the bridge tolerates a septal-lateral displacement during a cardiac cycle (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 42 Subramanian teaches the method of claim 14 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains a diameter to facilitate left ventricular remodeling (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 22 Subramanian discloses Subramanian discloses a method comprising:
positioning a transvalvular intraanular bridge (50) relative to a valve annulus (28), the bridge comprising a first end (52), first anchoring portion (58), second end (54), second anchoring portion (60), and a central portion connecting the first and second anchoring portion (64), wherein the central portion comprises a convex arcuate shape (Figures 13, 24-27; [0111]);
passing a first and second suture through the first and second anchoring portions respectfully to secure the first and second ends to the valve annulus ([0020], [0112]), so the first and second ends reside on a generally septal-lateral axis transverse to coaptive edges of valve leaflets when the bridge is attached to the annulus (Figures 29, 31; [0133]),
wherein the bridge has a length between the first and second end, the bridge having a width along the first end, and a first thickness is perpendicular to the length and width, wherein the first thickness of the first end is at least 75% greater than a second thickness of the central portion (see at least Figure 55, where ends include projections which increase the thickness of the ends as compared to the central portion. Although not understood as being drawn exactly to scale, they are not understood to be completely inaccurate either. Accordingly, the person of ordinary skill in the art, in reading Subramanian, would view Figure 55 and understand the ends can obviously be at least 75% thicker than the central portion based on the illustrated figure), and wherein the bridge comprises struts that taper toward each other (Figure 18).
The Examiner notes that the prior art fails to teach the struts crossing at a fixed junction, but points out that this is new matter. See the 112 1st paragraph rejections above.
Regarding claim 23 Subramanian teaches the method of claim 22 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains a septal-lateral diameter for early coaptation ([0106]).
Regarding claim 28 Subramanian teaches the method of claim 22 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains a diameter to facilitate left ventricular remodeling (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 29 Subramanian teaches the method of claim 22 substantially as is claimed,
wherein Subramanian further discloses the bridge tolerates a septal-lateral displacement during a cardiac cycle (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 39 Subramanian teaches the method of claim 22 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains an anterior-posterior diameter for early coaptation (this is inherent: See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 40 Subramanian teaches the method of claim 22 substantially as is claimed,
wherein Subramanian further discloses the bridge withstands load in cyclic fatigue without damage (the Examiner understands the bridge to be capable of withstanding at least some small level of load in cyclic fatigue for some small amount of time, without damage).
Regarding claims 30 and 34-35 Subramanian discloses Subramanian discloses a method comprising:
positioning a transvalvular intraanular bridge (50) relative to a valve annulus (28), the bridge comprising a first end (52), first anchoring portion (58), second end (54), second anchoring portion (60), and a central portion connecting the first and second anchoring portion (64), wherein the central portion comprises a convex arcuate shape (Figures 13, 24-27; [0111]);
wherein the first anchoring portion comprises an aperture (62) which has a longitudinal axis therethrough (considered to extend into the plane of the page),
passing a first and second suture through the first and second anchoring portions respectfully to secure the first and second ends to the valve annulus ([0020], [0112]), so the first and second ends reside on a generally septal-lateral axis transverse to coaptive edges of valve leaflets when the bridge is attached to the annulus (Figures 29, 31; [0133]),
wherein the thickness of the first end is parallel to the longitudinal axis of the aperture, and the first and second ends are at least 75% thicker than the central portion (see at least Figure 55, where ends include projections which increase the thickness of the ends as compared to the central portion. Although not understood as being drawn exactly to scale, they are not understood to be completely inaccurate either. Accordingly, the person of ordinary skill in the art, in reading Subramanian, would view Figure 55 and understand the ends can obviously be at least 75% thicker than the central portion based on the illustrated figure),
wherein the bridge comprises struts that taper toward each other (Figure 18),
wherein the bridge maintains an anterior-posterior diameter and a septa-lateral diameter, and the bridge does not affect the size/shape of the annulus when operably attached thereto (this is inherent: See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
The Examiner notes that the prior art fails to teach the struts crossing at a fixed junction, but points out that this is new matter. See the 112 1st paragraph rejections above.
Regarding claim 36 Subramanian teaches the method of claim 30 substantially as is claimed,
wherein Subramanian further discloses the bridge withstands load in a cyclic fatigue without damage (the Examiner understands the bridge to be capable of withstanding at least some small level of load in cyclic fatigue for some small amount of time, without damage).
Regarding claim 37 Subramanian teaches the method of claim 30 substantially as is claimed,
wherein Subramanian further discloses the bridge tolerates a septal-lateral displacement during a cardiac cycle (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Regarding claim 38 Subramanian teaches the method of claim 30 substantially as is claimed,
wherein Subramanian further discloses the bridge maintains a diameter to facilitate left ventricular remodeling (this is inherent. See MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the structure, materials, and dimensions of the Applicant’s invention (e.g. Figures 12-13, 24-27, [0110]-[0113]) are identical to those of Subramanian (Figures 12-13, 24-27; [0111]-[0114]), and thus the bridge will function in the same manner).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/08/26
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