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 .
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.
Claims 5 and 18 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 5 recites the limitation "the tricuspid leg" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation to be the tricuspid valve arm.
Claim 18 recites the limitation "the tricuspid leg" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation to be the tricuspid valve arm.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5 and 12-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim WO 2021/064689 A1.
Regarding Claim 1, Kim discloses a mitral valve cerclage assembly (abstract) comprising: a cerclage tube (identified as sheath, paragraph [0059] and see Figure 9) comprising a stem 14 comprising a hinge 16 and a pre-hinge segment having a curve shape (the segment extending from 14 towards 16, see Figure 2), wherein the pre-hinge segment spans proximally from the hinge 16; a coronary sinus arm 21 (paragraph [0043-0045]), a tricuspid valve arm 31 (paragraph [0046-0047]); a stopper 40 located at a distal end of the tricuspid valve arm 31 (paragraph [0048-0049]); a cerclage rope 50 passing through the cerclage tube (see Figure 6 and paragraphs [0045], [0050], through the stem 14 out of the coronary sinus arm 21 (as seen in Figures 6-7), through the tricuspid valve arm 31 to form a loop, and back through the stem 14 (as seen in Figures 6-8).
Regarding Claim 2, Kim discloses wherein the pre-hinge segment has a length in the range of 0.5-3.5 cm long (see Figure 16, paragraph [0059]).
Regarding Claim 3, Kim discloses wherein the pre-hinge segment has a length in the range of 0.7-2.0 cm long (see Figure 16, paragraph [0059]).
Regarding Claim 4, Kim discloses wherein the tricuspid valve arm is longer than the coronary sinus arm (paragraph [0047]).
Regarding Claim 5, Kim discloses wherein the stopper 40 is wider or has a greater diameter than the distal end of the tricuspid valve arm 31 (see Figure 2 and paragraph [0048]).
Regarding Claim 12, Kim discloses a method of treating mitral valve regurgitation in a patient's heart (abstract and paragraph [0007]), comprising: having a cerclage rope 50 (paragraph [0059]) having a first end 55 and a second end 56 (as seen in Figures 6-9 and paragraph [0059]); a cerclage tube (identified as sheath, see Figures 6-9 and paragraph [0059]) comprising a stem 14 comprising a hinge 16 and a pre-hinge segment having a curve shape (the segment extending from 14 towards 16, see Figure 2), wherein the pre-hinge segment spans proximally from the hinge 16; a coronary sinus arm 21 (paragraph [0043-0045]), a tricuspid valve arm 31 (paragraph [0046-0047]); a stopper 40 located at a distal end of the tricuspid valve arm 31 (paragraph [0048-0049]); inserting the cerclage rope at a vascular entry site through a femoral vein (paragraph [0007], [0055-0056], [0062]), advance up into an inferior vena cava, into a coronary sinus, through a great cardiac vein, out into a right ventricle, through a tricuspid valve, back into the right atrium, back down the inferior vena cava, back through the femoral vein, and exit back out of the vascular entry site such that both the first end and the second end exit out of the vascular entry site (paragraphs [0059], [0062]); inserting the first end of the cerclage rope into the coronary sinus arm (see Figure 9 and paragraph [0059]); inserting the second end of the cerclage rope into the tricuspid valve arm 31 (paragraph [0054], [0056] and [0059]); inserting the cerclage tube into the femoral vein and advance up into the inferior vena; pointing the distal end of the pre-hinge segment towards the coronary sinus, the tricuspid valve, or a point therebetween; advancing the coronary sinus arm into the coronary sinus (paragraph [0059], [0062]); advancing the tricuspid valve arm through the tricuspid valve (paragraphs [0006], [0036], [0040], [0042], [0047-0048] and [0056]); applying tension to the cerclage rope (as seen in Figure 13 and paragraphs [0006-0007], [0043], [0047-0048]) .
Regarding Claim 13, Kim discloses the method further comprises positioning the stopper 40 against a wall of the right ventricle (as seen in Figure 13 and paragraph [0026]).
Regarding Claim 14, Kim discloses wherein the cerclage tube further comprises a lock 58 that fastens together a segment of the first end of the cerclage rope to a segment of the second end of the cerclage rope (as seen in Figure 6), and the method further comprises locking the two segments together (paragraphs [0061-0062]).
Regarding Claim 15, Kim discloses wherein the path taken by the cerclage rope makes a cerclage loop (paragraphs [0002], [0062] as seen in Figures 6-9).
Regarding Claim 16, Kim discloses wherein the pre-hinge segment has a length in the range of 0.5-3.5 cm long (see Figure 16, paragraph [0059]).
Regarding Claim 17, Kim discloses wherein the tricuspid valve arm is longer than the coronary sinus arm (as seen in Figures 1-2 and paragraph [0036]).
Regarding Claim 18, Kim discloses wherein the stopper 40 is wider or has a greater diameter than the distal end of the tricuspid valve arm 31 (see Figure 2, paragraph [0048]).
Regarding Claim 20, Kim discloses a cerclage kit for treating mitral valve regurgitation (as seen in Figures 1-16 and abstract, paragraphs [0036-0062]), comprising: a cerclage rope 50 (paragraphs [0003], [0007], [0045], [0050]); a cerclage tube (identified as sheath, paragraph [0059] and see Figure 9) comprising a stem 14 comprising a hinge 16 and a pre-hinge segment having a curve shape (the segment extending from 14 towards 16, see Figure 2), wherein the pre-hinge segment spans proximally from the hinge 16; a coronary sinus arm 21 (paragraph [0043-0045]), a tricuspid valve arm 31 (paragraph [0046-0047]); a stopper 40 located at a distal end of the tricuspid valve arm 31 (paragraph [0048-0049]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6-11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim WO 2021/064689 A1.
Regarding Claim 6, Kim discloses wherein the stopper 40 has a width that is larger in diameter of the tricuspid valve arm 31 (paragraph [0049]). However, Kim does not expressly disclose wherein the stopper has a width or diameter in the range of 2-6 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Tau’s stopper to have a width or diameter in the range of 2 to 6 mm for the purpose of having a stopper that is larger in diameter than the tricuspid valve arm and can have size and shape that is designed specific to patient’s anatomy (paragraph [0049]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Tau’s stopper to have a width or diameter in the range of 2 to 6 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It would have been obvious to one having ordinary skill in the art to modify the width or diameter of the stopper to better conform to the patient’s anatomy.
Regarding Claims 7, 19, Tau discloses wherein the coronary sinus arm 21 has a length paragraph [0045]), wherein Kim discloses the arm length vary as needed from patient to patient and the length is determined based on prior imaging of the patient, wherein the length of the arm portion prevents direct contact with the cerclage rope and protects the coronary sinus and its surrounding tissue from damage. However, Tau et al. does not expressly disclose the length in the range of 1.2-5.0 cm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Tau’s coronary sinus arm length to be in the range of 1.5 to 5.0 cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It would have been obvious to one having ordinary skill in the art to modify the length of the coronary sinus arm to better conform to the length of the coronary sinus of the patient to allow the device to be best suited to protect the surrounding tissue from damage.
Regarding Claims 8, 9, Tau discloses wherein the tricuspid valve arm 31 has a length paragraph [0047]), wherein Kim discloses the arm length vary as needed from patient to patient based on prior imaging of the patient, wherein the length of the arm portion maintains the preformed shape (paragraph [0047]). However, Kim does not expressly disclose wherein the tricuspid valve arm has a length in the range of 4.0-11 cm, wherein the tricuspid valve arm has a length in the range of 5.5-9.0 cm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Tau’s tricuspid valve arm to have a length in the range of 4.0 to 11 cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It would have been obvious to one having ordinary skill in the art to modify the length of the tricuspid valve arm to maintain a preformed shape that conforms to the length of the patient’s anatomy and aid in the proper placement of the arm.
Regarding Claims 10, 11, Tau discloses the pre-hinge segment having a curve shape (the segment extending from 14 towards 16, see Figure 2) between the main longitudinal axis of the stem and the longitudinal axis of the tricuspid valve arm, wherein the curve shape forms a bend that forms an angle (see Figures 6 and 11). However, Tau does not expressly disclose the pre-hinge segment causes a bend that forms an angle between the main longitudinal axis of the stem and the longitudinal axis of the tricuspid valve arm, wherein the angle is the range of 45-135° and wherein the angle A is the range of 60-120°. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Tau’s pre-hinge segment to have a bend that forms an angle in the range of 45-135° or 60-120° for the purpose of closely conforming to the natural curvature of the patient’s heart and allowing improved navigation of the cerclage assembly around the tortuous regions of the heart.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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