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 16-20 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 16 is rendered definite by the limitation “the recess”, in line 5, since is it unclear which recess is being referred to. For examination purposes, Examiner interprets “the recess” as “the at least one recess” defined in line 4.
Claim 17 is rendered definite by the limitation “the recess”, in line 3, since is it unclear which recess is being referred to. For examination purposes, Examiner interprets “the recess” as “the at least one recess” defined in lines 4-5 of claim 16.
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.
Claims 1-2 and 4-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajpara et al. (US 2017/0056149).
Regarding claim 1, Rajpara discloses an assembly (See Fig. 1) comprising: a packaging tray (at 100 in Fig. 1) comprising a plurality of recesses (See Fig. 1 labeled below) capable of receiving components of a prosthetic valve delivery system, wherein the tray has a length, a first end portion (left end portion of 100 in Fig. 1) extending along a third of the length, a second end portion (right end portion of 100 in Fig. 1), opposite the first end portion, extending along a third of the length, and a middle portion (middle section of 100 in Fig. 1) extending along a third of the length from the first end portion to the second end portion; a delivery apparatus (at 400 in Figs. 1 and 2) disposed within a set of one or more first recesses of the plurality of recesses of the tray such that a shaft of the delivery apparatus has a curved section (left-most portion of 400 at 418 in Fig. 1) forming a 180-degree bend along a distal half of the shaft, wherein the curved section is positioned within the first end portion of the tray (as shown in Fig. 2); and a crimping device (tapered surface of 620 crimps the device held therein – See [0083]) configured to be received within a second recess (See Fig. 1 labeled below) of the plurality of recesses that is positioned within the middle portion of the tray, wherein a valve mounting portion (near 10 in Fig. in Fig. 1) of the delivery apparatus is adjacent the crimping device when the crimping device is positioned within the second recess (as shown in Fig. 2).
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Regarding claim 2 Rajpara discloses the curved section of the shaft is positioned entirely within the first end portion of the tray (as shown in Fig. 2).
Regarding claim 4, Rajpara discloses a handle (portion between reference numerals 400 and 420 in Fig. 1) of the delivery apparatus is positioned entirely within the second end portion of the tray.
Regarding claim 5, Rajpara discloses the tray comprises a first side (bottom side in Fig. 3) and a second side (top side in Fig. 3) opposite the first side, the first side and the second side extending along the length of the tray, and wherein the handle is disposed adjacent the first side and the valve mounting portion is disposed adjacent the second side. The term “adjacent” is relatively broad and can be defined as “lying near, close, or contiguous; adjoining; neighboring” [Collins Dictionary]. Furthermore, element 10 is close to the second side of Rajpara. With respect to the art rejections, in accordance with MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, 367 F.3d 1359, 70 USPQ2D 1827, 1834 (Fed. Cir. 2004).
Regarding claim 6, Rajpara discloses a proximal half of the shaft is positioned within the second end portion of the tray and the middle portion of the tray (See Fig. 2).
Regarding claim 7, Rajpara discloses at least one first recess of the one or more first recesses comprises a pair of opposing retaining features (at 144/142 in Fig. 1) configured to hold a portion of the shaft within the at least one first recess, the pair of opposing retaining features spaced apart from one another and extending toward one another from opposite sides of the at least one first recess.
Regarding claim 8, Rajpara discloses the second recess comprises one or more retaining features (at 116) extending outward from the second recess, wherein the one or more retaining features are configured to hold the crimping device within the second recess in a specified horizontal and longitudinal orientation when the crimping device is positioned within the second recess.
Regarding claim 9, Rajpara discloses the one or more retaining features include protrusions extending outward, in a vertical direction, from a base of the second recess and one or more retaining features extending outward, from a sidewall of the second recess.
Regarding claim 10, Rajpara discloses a packaging assembly (See Fig. 1) capable of storing a delivery system for a prosthetic valve, comprising: a tray (at 100) comprising a plurality of recesses (See Fig. 1 labeled above), wherein the tray comprises a first end portion (right end portion of 100 in Fig. 1) and a second end portion (left end portion of 100 in Fig. 1) opposite the first end portion, the first end portion defining a first end of the tray and the second end portion defining a second end of the tray; and a delivery apparatus (at 400) disposed within a set of one or more first recesses of the plurality of recesses of the tray such that a handle portion (portion between reference numerals 400 and 420 in Fig. 1) of the delivery apparatus is positioned within the first end portion of the tray, a distal half of a shaft of the delivery apparatus has a curved section (at 418 in Fig. 1) forming a 180-degree bend positioned within the second end portion of the tray, and a valve mounting portion (at 420) of the delivery apparatus is positioned within the tray closer to the second end than the first end.
Regarding claim 11, Rajpara discloses the handle portion is positioned adjacent a first side (bottom side in Fig. 3) of the tray and the valve mounting portion is positioned adjacent a second side (top side in Fig. 3) of the tray that is opposite the first side, and wherein the first and second sides define a length of the tray. The term “adjacent” is relatively broad and can be defined as “lying near, close, or contiguous; adjoining; neighboring” [Collins Dictionary]. With respect to the art rejections, in accordance with MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, 367 F.3d 1359, 70 USPQ2D 1827, 1834 (Fed. Cir. 2004).
Regarding claim 12, Rajpara discloses the curved section of the shaft is positioned entirely within the second end portion of the tray and extends along and adjacent to the second end of the tray that extends between the first and second sides.
Regarding claim 13, Rajpara discloses a proximal half of the shaft is substantially straight and extends along and adjacent to the first side of the tray.
Regarding claim 14, Rajpara discloses the handle portion of the delivery apparatus is positioned entirely within the first end portion of the tray, and wherein a first recess of the set of one or more first recesses that is configured to receive the handle portion has a length that is longer than the handle portion such that the handle portion can slide within the first recess.
Regarding claim 15, Rajpara discloses a proximal half of the shaft is positioned within the first end portion of the tray and a middle portion of the tray that extends between the first end portion and the second end portion.
Claims 16 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramsey (US 2017/0056122).
Regarding claim 16, Ramsey discloses a packaging assembly (See Fig. 11) capable of storing a prosthetic valve delivery apparatus, comprising: a tray (101) capable of receiving a prosthetic valve delivery apparatus, wherein the tray includes at least one recess (at 161 in Fig. 11); and a removable bowl (at 162 in Fig. 11) disposed in the recess, wherein the bowl is capable of receiving a liquid.
Regarding claim 19, Ramsey discloses the removable bowl comprises one or more coupling features (at 163) that are configured to couple to complementary coupling features disposed in the tray adjacent to the recess (See [0144]).
Regarding claim 20, Ramsey discloses the removable bowl comprises one or more mating features (at 163) that are configured to mate with complementary mating features on a sidewall of the recess (See [0144]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rajpara et al. (US 2017/0056149) as applied to claim 1 above, in view of WO 2022/268220 [hereinafter “WO ‘220]. As described above, Rajpara discloses the claimed invention except for the strap. However, WO ‘220 teaches a tray (at 1 in Fig. 28) comprising a curved shaft (at 260 in Fig. 28) held within a recess (at 110 in Fig. 28) of the tray, wherein the tray includes a strap (at 120) that extends over the curved shaft when the curved shaft is positioned within the recess, wherein the strap couples to coupling features (at 122) on a surface of the tray, for the purpose of retaining the curved shaft within the recess of the tray. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the tray of Rajpara with a strap as taught by WO ‘220 in order to better secure the shaft within the tray.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey (US 2017/0056122) as applied to claim 16 above, in view of Terzibashian (US 9,744,333). As described above, Ramsey discloses the removable bowl having a bowl portion (at 148 in Fig. 11), but does not disclose the holder portion. However, Terzibashian teaches an assembly (at 20 - See Fig. 4) comprising a bowl portion (at 50) and a holder portion (at 80) that are foldable relative to one another (foldable along 77 in Fig. 4), wherein the holder portion comprises one or more coupling features (at 90/92) at an end of the holder portion that are configured to mate with complementary coupling features (at 74) of the bowl portion when the holder portion is folded over the bowl portion, for the purpose of closing the bowl portion. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the bowl portion of Rajpara with a holder portion as taught by Terzibashian in order to close the open top of the bowl portion. Furthermore, Ramsey-Terzibashian discloses the bowl portion is positioned in the recess and the holder portion is foldable over an open top of the bowl portion, and wherein the holder portion is capable of receiving and suspending a prosthetic valve within the bowl portion when folded over the bowl portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735
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