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.
Claim 42 and its dependent claims 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 42 recites the limitation "the distal tip" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 31, 32, 34-37, 39, 41, 42, and 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Pub. No.: US 2017/0128203 A1; hereinafter “Zhang”).
Zhang discloses the following regarding claim 31: a method of delivering an anchor of a valve prosthesis (paras. 0130-0143), the method comprising: advancing a distal end of a delivery device (300) to a first side of a native valve (paras. 0130-0140); deploying an anchor (e.g., 120) from a delivery configuration to a deployed configuration on the first side of the native valve (paras. 0130-0143), the anchor comprising an echogenic portion (paras. 0151, 0164-0165);
advancing the anchor in the deployed configuration from the first side of the native valve to a second side of the native valve (paras. 0140-0143); rotating the anchor in the deployed configuration around one or more structures on the second side of the native valve (paras. 0092-0097, 0113-0116); identifying the echogenic portion in an ultrasound image to confirm that the anchor has been fully rotated around the one or more structures (paras. 0092-0097, 0151, 0164-0165); and releasing the anchor from the distal end of the delivery device (paras. 0130-0143).
Zhang discloses the following regarding claim 32: the method of claim 31, further comprising identifying the echogenic portion with ultrasound during the rotating step (paras. 0151, 0164-0165).
Zhang discloses the following regarding claim 34: the method of claim 31,wherein identify the echogenic portion in the ultrasound further comprises confirming a planarity of the anchor (paras. 0151, 0164-0165).
Zhang discloses the following regarding claim 36: the method of claim 31,further comprising deploying a frame (e.g., 110) of the valve prosthesis within the native valve and within the anchor (Fig. 6; para. 0081).
Zhang discloses the following regarding claim 37: the method of claim 31, further comprising capturing the one or more structures on the second side of the heart using with an outwardly radially extending grabber arm (e.g., 200, 202, 204) of the anchor (paras. 0089-0091).
Zhang discloses the following regarding claim 39: the method of claim 31,wherein the echogenic portion is at least a distal tip of the anchor (para. 0092), wherein identifying the echogenic portion includes identifying a location of at least the distal tip of the anchor (paras. 0092, 0151, 0164-0165).
Zhang discloses the following regarding claim 41: the method of claim 31,wherein the echogenic portion is at least a portion of an outwardly radially extending grabber arm (e.g., 200, 202, 204) of the anchor (paras. 0100-0101), wherein identifying the echogenic portion includes identifying a location of at least the portion of the grabber arm of the anchor (paras. 0151, 0164-0165).
Zhang discloses the following regarding claim 42: the method of claim 31,wherein the echogenic portion comprises a wire wound around the distal tip (interpreted to be the distal tip of the anchor) (para. 0092).
Zhang discloses the following regarding claim 44: the method of claim 31,further comprising releasing the anchor from the delivery device after anchor placement is confirmed (paras. 0130-0143).
Claim Rejections - 35 USC § 103
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.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Rowe et al. (Pub. No.: US 2010/0256751 A1; hereinafter “Rowe”).
Zhang discloses the limitations of the claimed invention, as described above. However, it does not explicitly disclose using ultrasound imaging for advancing the delivery device. Rowe teaches that it is well known in the art that imaging techniques, including ultrasound, are used to guide and determine the accurate positioning of the delivery catheter and its associated implants (paras. 0071-0073). It would have been obvious to one having ordinary skill in the art to modify the invention of Zhang to use ultrasound, as taught by Rowe, in order to accurately guide and position the delivery catheter within the patient. Such a modification would be made with a reasonable expectation of success.
Claim(s) 38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Tremulis et al. (Pub. No.: US 2004/0049211 A1; hereinafter “Tremulis”).
Zhang discloses the limitations of the claimed invention, as described above. Regarding claim 40, Zhang teaches that the echogenic portion is at least a portion of a main body of the anchor (para. 0092), and identifying the echogenic portion includes identifying a location of at least the portion of the main body of the anchor (paras. 0151, 0164-0165). However, it does not explicitly disclose the anchor having a spiral shape. Tremulis teaches that it is well known in the art that a heart valve anchor comprises a spiral shape (e.g., Figs. 8A-9, 68; paras. 0049-0050, 0115), for the purpose of providing the anchor with the desired size and configuration needed to suit the implantation site and allow for proper valve function. It would have been obvious to one having ordinary skill in the art to modify the invention of Zhang to comprise a spiral anchor, as taught by Tremulis, in order to provide the anchor with the desired size and configuration needed to suit the implantation site and allow for proper valve function. Such a modification would be made with a reasonable expectation of success.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Miller et al. (WO 2009/082479 A2; hereinafter “Miller”).
Zhang discloses the limitations of the claimed invention, as described above. However, it does not explicitly disclose the echogenic portion comprising reflective elements each having an arrangement of reflective surfaces that reflect ultrasound. Miller teaches that it is well known in the medical devices such as heart valve comprise echogenic portions with reflective elements each having an arrangement of reflective surfaces that reflect ultrasound (paras. 0006, 0207), for the purpose of enhancing the implant’s visibility using imaging techniques. It would have been obvious to one having ordinary skill in the art to modify the invention of Zhang to use reflective elements, as taught by Miller, in order to enhance the implant’s visibility using imaging techniques. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774