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 .
Election/Restrictions
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 15th 2026.
Drawings
The drawings are objected to because Figures 1-13E are in poor quality and contain gray and black shading in Figures 3-4 rendering them ineligible and insufficient quality so that all details in the drawings are reproducible in the printed patent.
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.
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) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giordano et al. US 9788931 B2, herein referred to as Giordano.
Regarding claim 1, Giordano discloses a cuff management device (Fig 2, holder 1) for use when loading a prosthetic heart valve (Col 1, lines 61-63), the cuff management device comprising: a body (6) extending between a first end (Fig 2, proximal end) and a second end (Fig 2, distal end); a plurality of legs disposed at the first end (Fig 2, fingers 5); and one or more segments (Fig 2, 5c) disposed at the second end (Fig 2), the one or more segments having one or more protrusions on an interior surface thereof (Fig 2, 5b inward indent).
Regarding claim 2, Giordano discloses wherein the plurality of legs comprises three legs spaced apart from one another (Fig 2, Col 4 lines 35-40).
Regarding claim 3, Giordano discloses wherein the one or more segments comprises three segments separated by longitudinal slits (Annotated Fig 1 below).
PNG
media_image1.png
564
393
media_image1.png
Greyscale
Regarding claim 4, Giordano discloses wherein the plurality of legs defines a first quantity (Fig 2, Col 4 lines 35-40), and the one or more segments defines a second quantity (Fig 2, Col 4 lines 35-40), the first quantity and the second quantity being equal (Fig 2, Col 4 lines 35-40).
Regarding claim 5, Giordano discloses wherein compressing the plurality of legs radially inward causes the one or more segments to extend radially outward (Col 5, lines 54-60).
Regarding claim 6, Giordano discloses wherein each of the one or more segments (5c) includes a single one of the one or more protrusions (5b).
Regarding claim 7, Giordano discloses wherein the one or more protrusions comprises a plurality of protrusions (Fig 2b), and each of the one or more segments (Fig 2, 9) includes multiple protrusions (9a and 9b).
Regarding claim 8, Giordano discloses wherein the one or more protrusions comprises nine protrusions (Col 5, lines 54-60).
Regarding claim 9, Giordano discloses wherein the prosthetic heart valve includes a number of cells at a proximal-most row at an inflow end (Fully capable of being commensurate with recited heart valve cells; claim directed at intended use), and the one or more protrusions comprises an equal number of protrusions commensurate with the number of cells (Fully capable of being commensurate with recited).
Regarding claim 10, Giordano discloses further comprising a recessed channel defined at the second end (Fig 1, 9c).
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.
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giordano in view of Skemp et al. US 20140277428 A1, here in referred to as Skemp.
Regarding claim 11, Giordano discloses the invention substantially as claimed and as discussed above with respect to claim 10, an element (High Fig 6G, 248) disposed within1 the recessed channel (Fig 6G), but does not explicitly disclose comprising an elastic band.
Skemp teaches further comprising an elastic band (Fig 3E, foam 330, [0039] foam is inherently elastic) disposed within the recessed channel (Fig 3E).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Giordano to incorporate further comprising an elastic band (Fig 3E, foam 330, [0039] foam is inherently elastic) disposed within the recessed channel, as taught and suggested by Skemp in order to impart shape memory (Skemp [0039]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giordano in view of High et al. US 20190021856 A1, herein referred to as High.
Regarding claim 12, Giordano discloses the invention substantially as claimed and as discussed above with respect to claim 10, but does not explicitly disclose further comprising an elastic band disposed within the recessed channel.
High teaches wherein the one or more segments includes a plurality of braces (High Fig 6G, 234) coupled to portions of a terminal ring (Annotated Fig 6G below).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filling date of the claimed invention to modify Giordano to incorporate
segments having one or more protrusions on an interior surface thereof, as taught and
suggested in order to allow locking with other components (High [0045]).
PNG
media_image2.png
735
785
media_image2.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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, Melanie Tyson can be reached at (571) 272-9062. 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.
/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights