DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 2, 6, 7, 9-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2011/0264202 to Murray in view of U.S. Patent Publication 2007/0293930 Wang.
As to claim 1, Murray discloses a delivery device for an implantable medical device (paragraph 10) having a plurality of retention members at an end thereof, the delivery device comprising: an inner shaft (54/80) extending in a longitudinal direction and defining a longitudinal axis (figure 3); an outer sheath (52/70) surrounding a portion of the inner shaft, the outer sheath being slidable relative to the inner shaft in the longitudinal direction (paragraph 37, 40); a compartment (62) defined inside the outer sheath and adapted to receive the medical device in an assembled condition (paragraph 39); an end of the compartment (proximal end of 62); and a spring (152 and/or 102, paragraph 56, 51 ) attached to the inner shaft (paragraph 55,40, both the release sleeve assembly 60 which comprises the biasing arms 152 and the capture assembly which comprises the biasing member 102 can be attached to the inner shaft 80) the spring being positioned distal to a proximal end of the compartment (figure 3, the “springs” 152,102 will be distal to the proximal end of the medical device which will be configured to engage the retainer), the spring being in a compressed condition when the outer sheath covers the compartment in the assembled condition (paragraph 51, 52, 56), the spring configured to release stored energy to push the medical device radially outwardly, thereby facilitating release of the plurality of retention members from the plurality of recesses when the outer sheath slides to uncover the compartment (paragraph 37, 51, 52, 59) but is silent about the retainer including a plurality of circumferentially spaced recesses, each of the recesses being adapted to receive a respective one of the retention members of the medical device in the assembled condition. Murray does disclose the medical device has elements at the proximal end that seems to be able to engage/interact with a retainer structure that will be proximally spaced from the spring (figure 1a, the ends of the stent have circular elements).
Wang teaches a similar device (implant delivery, abstract) having a retainer (27, paragraph 48) positioned at one end of a compartment (figure 2), the retainer including a plurality of circumferentially spaced recesses (recesses as seen in figure 7a,c, 8a-n), each of the recesses being adapted to receive a respective one of the retention members of the medical device in the assembled condition (paragraph 48) for the purpose of controlling movement of the medical device during delivery. The retainer as taught by Wang can be used in the device of Murray, where the device of Murray will have the structure to engage with the retainer. Further the recesses will be circumferentially spaced based on the structure of Wang, and the multiple elements, and circumferentially spaced elements of Murray (at least paragraph 76-78, figure 2, 3, 7a-c, 9, 9a). The retainer will be at the proximal end of the medical device of Wang to engage the proximal interlocking structures, which will allow the springs to be distally spaced from the retainer. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the retainer with the circumferentially spaced recesses, where each of the recesses being adapted to receive a respective one of the retention members of the medical device in the assembled condition in the device of Murray in order for controlling movement of the medical device during delivery.
As to claim 2, with the device of Murray and Wang above, Murray discloses the spring is a single coiled leaf spring attached to and extending around the inner shaft (figure 3, 4b, paragraph 51, 53, 56).
As to claim 6, with the device of Murray and Wang above, Murray discloses the spring is a plurality of curved leaf springs, each of the plurality of curved leaf springs attached to and extending partially around the inner shaft (figure 3, 4b, paragraph 51, 53, 56).
As to claim 7, with the device of Murray and Wang above, Murray discloses the plurality of curved leaf springs includes at least to curved leaf springs (figure 3, 4b).
As to claim 9, with the device of Murray and Wang above, Murray discloses the spring is a plurality of straight or curved leaf springs attached to the inner shaft and extending in the longitudinal direction of the inner shaft (figure 3, 4b, paragraph 51, 53, 56).
As to claim 10, with the device of Murray and Wang above, Murray discloses wherein the plurality of straight or curved leaf springs extend in the longitudinal direction of the inner shaft for part of a length of the compartment (figure 3, 4b, paragraph 51, 53, 56).
As to claim 11, with the device of Murray and Wang above, Murray discloses the plurality of straight or curved leaf springs extend in the longitudinal direction of the inner shaft for an entire length of the compartment (figure 3, 4b, paragraph 51, 53, 56). The length that the springs extend will be the “entire length of the compartment”.
As to claim 12, with the device of Murray and Wang above, Murray discloses the plurality of straight or curved leaf springs are attached to the inner shaft at a plurality of respective circumferential locations around the inner shaft (figure 3, 4b, paragraph 51, 53, 56).
As to claim 13, Murray as modified by Wang above discloses each of the plurality of respective circumferential locations circumferentially aligns with a respective one of the plurality of recesses (figure 3, 4b, paragraph 51, 53, 56). The springs 102 are aligned with the interlocking structure at the distal end. Wang teaches that the proximal and distal structure can be in alignment (figure 2) so the plurality of respective circumferential locations circumferentially can align with a respective one of the plurality of recesses.
As to claim 14, Murray as modified by Wang above discloses the plurality of straight or curved leaf springs includes three straight or curved leaf springs (figure 3, 4a,b of Murray), and the plurality of recesses includes three recesses (figure 5a of Wang). The device can have least three leaf springs as disclosed by Murray and three recesses that will align with the interlocking structure.
As to claim 15, with the device of Murray and Wang above, Murray discloses the plurality of straight or curved leaf springs are biased to extend a radial distance from the longitudinal axis of the inner shaft so that the plurality of straight or curved leaf springs extend farther radially outward than bottom surfaces of the plurality of recesses (figure 4a).
As to claim 16, Murray as modified by Wang above discloses the plurality of straight or curved leaf springs includes six straight or curved leaf springs (figure 3, 4a,b of Murray, the springs 102 and 152 can include a total of six), and the plurality of recesses includes three recesses (figure 5a of Wang). If it would not be known that the springs 102 152 can read on the six straight or curved leaf springs, Murray does disclose that the number of posts 40 and therefore the number of biasing members can be four or any other number (paragraph 35). The number of posts will affect the deployment of the device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of leaf springs as applicant appears to have placed no criticality on the claimed number of springs (see paragraph 87 of the specification of the present invention indicating there can be more or less springs).
As to claim 17, Murray as modified by Wang discloses every other one of the plurality of straight or curved leaf springs is circumferentially aligned with a respective one of the three recesses. The modified device can have six leaf springs and at least three recesses. Further the springs can align with the recesses based on the springs 102 aligning with interlocking structure at the distal end of the stent, which can align with interlocking structure at the proximal end of the stent, which can align with the recesses of the retainer. Every other leaf spring may not be rendered obvious to not align with the three recesses, but every other leaf spring can align with a respective one of three recesses.
As to claim 18, Murray as modified by Wang discloses a system comprising the delivery device of claim 1 and the medical device (figure 3).
As to claim 19, with the system of Murray and Wang above, Murray discloses the medical device is a prosthetic heart valve (figure 1a, paragraph 35).
As to claim 20, with the device of Murray and Wang above, Murray discloses the prosthetic heart valve includes a stent and a valve assembly mounted within the stent, the plurality of retention members being extensions of the stent (figure 1a).
Allowable Subject Matter
Claims 3-5, 8 are 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.
Of note: A call was made to the applicant for an examiner’s amendment (the springs are leaf springs that circumferentially extend around the inner shaft within the medical device in the compressed condition) to place the application in condition for allowance but an agreement was not reached.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 6,468,298 to Pelton, U.S. Patent 6,582,460 to Cryer, U.S. Patent Publication 2002/0120323 to Thompson (as cited Publication Reference 2 in the IDS filed 04/15/2025), U.S. Patent Publication 2004/0093063 to Wright (as cited Publication Reference 8 in the IDS filed 04/15/2025), and U.S. Patent Publication 2011/0270374 to Orr all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
Prosecution Insights