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 .
Applicant's election with traverse of Group I and species C, Figs. 13-16, and claims 1-18 are readable on Species C are acknowledged. The traversal is on the ground(s) that “a search of the relevant prior art for the claims of Species C would inherently cover a corresponding search for the claims of the other group and species. Thus, Applicants submit that there would be no additional burden to include claims 19-20 when examining this application.” and Applicants request that the restriction requirement be withdrawn. They are not found persuasive because the inventions are independent and distinct from each other and because examination of each invention will necessitate disparate searches which would clearly pose a serious burden as clearly shown by the Examiner in the restriction requirement. Applicants are not entitled to examination of multiple independent inventions in one application. Therefore, claims 19-20 are withdrawn from further consideration by the examiner, 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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) 1-4, 6-10 and 13-18 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by Gaschino et al. (9,114,010; hereinafter Gaschino) or, in the alternative, under 35 U.S.C. 103 as obvious over Gaschino in view of The Official Notice and/or O'Mahony et al. (12,458,482; hereinafter O'Mahony).
As to claim 1, Gaschino discloses an assembly (1A’) comprising a jar (J) having an open end and configured to receive a valve holder, a lid (240A’) configured to cover the open end of the jar, and a valve holder (2, 2A’, 24A’) including a base (5, 6, 14, 16), a column (12) connected to and extending axially away from the base, and a plurality of circumferentially spaced valve retention members (5) mounted on the base. Gaschino discloses the valve holder is configured to receive a prosthetic heart valve (4). The valve holder of Gaschino is inherently capable to hold the prosthetic heart valve in a partially compressed state within the jar.
To the extent that Gaschino fails to show the valve holder is configured to hold the prosthetic heart valve in a partially compressed state within the jar, The Official Notice is taken of an old and conventional practice of providing a valve holder which is configured to hold a prosthetic heart valve in a partially compressed state within a container. O'Mahony, is cited by way of example only, teaches an assembly (1; Fig. 3) comprising a outer container/jar (100) having an open end, a lid (102) configured to cover the open end of the jar, and a valve holder (50, 54) is configured to receive a prosthetic heart valve (10) and to hold the prosthetic heart valve in a partially compressed state (column 4, lines 6-9 & column 5, lines 1-3). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of The Official Notice and/or O'Mahony to modify the assembly of Gaschino so the assembly is constructed with the valve holder is configured to hold the prosthetic heart valve in a partially compressed state within the jar because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As to claim 2, the assembly of Gaschino as modified comprises the plurality of circumferentially spaced valve retention members (5) are inherently capable to hold the prosthetic heart valve under a radial compressive strain as claimed.
As to claim 3, to the extent that Gaschino fails to show the radial compressive strain is less than 6% as claimed, 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 assembly of Gaschino as modified so the assembly is constructed with the radial compressive strain is less than 6% because the selection of the specific percentage of the radial compressive strain such as less than 6% as claimed would appear to have been an obvious matter of design choice based upon conventional design considerations, such as to prevent the prosthetic heart valve from getting damage during storage and/or to better securing the prosthetic heart valve.
As to claim 4, Gaschino discloses a position of the plurality of circumferentially spaced valve retention members (5; Figs. 3-4). Gaschino further discloses the support member (6) may be releasably coupled the holder member (2; column 7, lines 1-5). To the extent that Gaschino fails to show the plurality of circumferentially spaced valve retention members is adjustable inwardly and outwardly relative to an outer circumference of the base, 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 assembly of Gaschino as modified so the assembly is constructed with the plurality of circumferentially spaced valve retention members is adjustable inwardly and outwardly relative to an outer circumference of the base for allowing the valve holder to holder various sizes of prosthetic heart valves.
As to claims 6 and 7, Gaschino discloses the column has an upper end portion connected to the lid. To the extent that Gaschino fails to show the upper end portion is removably attached to the lid, 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 assembly of Gaschino so the assembly is constructed with the upper end portion is either connected or removably attached to the lid because it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art or vice versa.
As to claim 8, Gaschino discloses the assembly comprising the jar, the lid and the valve holder as claimed (see claim 1).
As to claim 9, Gaschino discloses the valve holder comprises the plurality of valve retention members as above.
As to claim 10, Gaschino discloses the valve holder comprises the base and the column (see claim 1).
As to claims 13 and 14, Gaschino discloses the valve retention members (5) as above.
As to claim 15, Gaschino discloses each valve retention member comprises a radially facing recess (Figs. 3 & 4 show each valve retention member (5) comprises a radially facing recess)
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As to claim 16, see claim 7 above.
As to claims 17 and 18, see Fig. 15.
Allowable Subject Matter
Claims 5 and 11-12 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 LUAN K BUI whose telephone number is (571)272-4552. The examiner can normally be reached Generally M-F, 7-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Avilés can be reached on 571-270-5531 or orlando.aviles-bosques@uspto.gov. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUAN K BUI/
Primary Examiner, Art Unit 3736
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