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(s) 4-7 and 13 is/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 4 recites the limitation "the first band opening…the second band opening" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “wherein at least one of the first opening and the second opening includes an actuation portion and a locking portion”. It appears the actuation portions and locking portions are located on the band openings (see Fig. 3-4) and not the openings of the main body (opening area where Lumen 114 is located). However, it’s a bit unclear to the examiner which openings applicant may be referring to.
Claim 13 recites the limitation "the one or more band openings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 1-3, 12-13 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maimon et al. US 2013/0152659.
PNG
media_image1.png
314
488
media_image1.png
Greyscale
PNG
media_image2.png
282
426
media_image2.png
Greyscale
Maimon discloses a crimping device (200) comprising: a housing comprising a base (214) and a main body (212), wherein the main body extends from the base and comprises a lumen (opening formed by 212) configured to receive a mechanically expandable prosthetic heart valve (216), the main body further comprising a first opening and a second opening, wherein the first opening and the second opening are spaced apart and extend from an inner surface of the main body that defines the lumen to an outer surface of the main body (see Figs. 15 and 17); and a crimping band (210) comprising a first end portion (211), a second end portion (213), and a loop (see Fig. 16) disposed between the first and second end portions.
PNG
media_image3.png
270
373
media_image3.png
Greyscale
As for claim 2, Maimon discloses wherein the first end portion (211) of the crimping band is fixedly coupled to the housing (212, see Fig. 17 above).
As for claim 3, Maimon discloses wherein the first end portion (211) of the crimping band is movably coupled to the housing (214, see fig. 17 above, movable by adjustable threaded screw knob 215).
As for claim 12, Maimon discloses a locking mechanism (threaded spindle and knob, 215 and movable jaw 214 relative to 212) coupled to the housing and configured to restrict relative movement between the crimping band and the housing.
As for claim 13, Maimon discloses wherein the locking mechanism is disposed adjacent to the one or more band openings (see Fig. 15).
As for claim 20, Maimon discloses wherein, when in the first configuration, the loop of the crimping band (210) has a first diameter and is configured such that the prosthetic heart valve (216) in a radially expanded configuration can be positioned radially within the loop, and when in the second configuration, the loop of the crimping band has a second diameter less than the first diameter (adjust threaded spindle 215 and jaws 212, 214; ¶0039).
Claim(s) 1-4, 12-13 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. WO 01/21110.
Brown discloses a crimping device (150, pg. 7, lines 26-33 and pg. 8, lines 1-9) comprising: a housing comprising a base (see Fig. 11 below, 150) and a main body (162), wherein the main body extends from the base and comprises a lumen (166) configured to receive a mechanically expandable prosthetic heart valve (130, 134), the main body further comprising a first opening (front open end of 166) and a second opening (back open end of 166), wherein the first opening and the second opening are spaced apart and extend from an inner surface of the main body that defines the lumen to an outer surface of the main body (see Fig. 11 below); and a crimping band (110) comprising a first end portion (122), a second end portion (122), and a loop (114, see Figs. 10-11) disposed between the first and second end portions.
PNG
media_image4.png
442
640
media_image4.png
Greyscale
As for claim 2, Brown discloses wherein the first end portion (122) of the crimping band (110) is fixedly coupled to the housing (154, 158).
As for claim 3, Brown discloses wherein the first end portion (122) of the crimping band (110) is movably coupled to the housing (movable through openings 170 and movable blocks 154; pg. 7, lines 26-33 and pg. 8, lines 1-9).
As for claim 4, Brown discloses wherein the first end portion (122) of the crimping band (110) is extends through a first band opening (170), and wherein the second end portion (122) of the crimping band extends through a second band opening (170).
As for claim 12, Brown discloses a locking mechanism (Pulling member 158 locks position of movable block 154) coupled to the housing and configured to restrict relative movement between the crimping band (110) and the housing (150, 162).
As for claim 13, Brown discloses wherein the locking mechanism is disposed adjacent to the one or more band openings (170, see Fig. 11 above).
As for claim 20, Brown discloses wherein, when in the first configuration, the loop of the crimping band (110) has a first diameter and is configured such that the prosthetic heart valve (130, 134) in a radially expanded configuration can be positioned radially within the loop, and when in the second configuration, the loop of the crimping band has a second diameter less than the first diameter (pg. 7, lines 26-33 and pg. 8, lines 1-9).
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) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. WO 01/21110.
As for claims 8-9, Brown discloses all the limitations as recited above and further illustrates and recites wherein the loop of the crimping band is adjustable to contact an axial length of a prosthetic valve stent (130, 134). Brown does not specify wherein the loop of the crimping band is configured to contact less than one fourth of the axial length of the prosthetic heart valve or less than one eighth of the axial length of the prosthetic heart valve. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date, that the crimping band of Brown would inherently have the dimensions to meet the claimed limitation. Furthermore, it would have been obvious
through routine engineering and/or optimization to modify the thickness of the crimping band such that the band only contacts less than one fourth to one eight of the axial length of the prosthetic heart valve as claimed.
Allowable Subject Matter
Claims 5-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10-11 and 14-19 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYRONE V HALL JR whose telephone number is (571)270-5948. The examiner can normally be reached Mon.-Fri. 7:30am-3:30pm.
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, Monica Carter can be reached at (571) 272-4475. 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.
/TYRONE V HALL JR/Primary Examiner, Art Unit 3723
Prosecution Insights