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 Objections
Claims 1-10 are objected to because of the following informalities: The preamble of the claims refer to a “PRN” adapter. However, the acronym “PRN” is not defined in any of the claims, is not a commonly used acronym in the art, and represents a Latin phrase (according to paragraph [0003] of the disclosure). Because this acronym does not appear to limit the scope of the claim in any manner, it is suggested to remove the acronym from the preamble of every claim. Appropriate correction is required.
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 1-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKinnon et al. (PG PUB 2008/0027398).
Re claim 1, McKinnon discloses a PRN adapter 10 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) comprising: a casing 20; and an elastomeric member 22 coupled to the casing (as seen in Fig 2), the elastomeric member (Para 56, “silastic material”) forming a septum (labeled in Fig B below) and a male luer taper (labeled in Fig B below; the portion of the elastomeric member 22 that resides within the male luer member of casing 20 (Claim 23, “closed luer access device”)).
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Re claim 2, McKinnon discloses the casing forms a hollow interior (extending from the proximal-most end of the casing (labeled in Fig B above) to the distal-most end of the casing (labeled in Fig B above) having a proximal opening (labeled in Fig B above) and a distal opening (the lumen within the luer member of casing 20, labeled in Fig B above).
Re claim 3, McKinnon discloses that the septum of the elastomeric member is positioned at the proximal opening of the hollow interior (as seen in Fig 2) and the male luer taper extends to the distal opening of the hollow interior (as seen in Fig 2).
Re claim 4, McKinnon discloses that the casing includes a rim (labeled in Fig B above) that forms the proximal opening (as seen in Fig 2 and Fig B above).
Re claim 5, McKinnon discloses that the septum forms a distally facing lip (labeled in Fig B above) that overlaps a proximal face (facing upward in Fig 2) of the rim (as seen in Fig 2 and Fig B above).
Re claim 6, McKinnon discloses that the elastomeric member includes a retaining member (labeled in Fig B above) that is spaced from the septum by a neck (labeled in Fig B above).
Re claim 7, McKinnon discloses that a proximal face (facing upward in Fig 2 and Fig B) of the retaining member abuts a distal face (labeled in Fig B above) of the rim (as seen in Fig 2 and Fig B above).
Re claim 9, McKinnon discloses that the elastomeric member forms a lumen (when opened, as seen in Fig 4) that extends from the septum through the male luer taper (as seen in Fig 4).
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon et al. (PG PUB 2008/0027398) in view of Miller et al. (PG PUB 2008/0287859).
Re claim 8, McKinnon discloses that the casing includes threads (as seen in Fig 2 and labeled in annotated Fig B above), but due to the distal-most end of the luer member extending distally past the distal-most end of the sheath (labeled in annotated Fig B above), these threads are not in the hollow interior; accordingly, McKinnon fails to disclose that the hollow interior includes threads. Miller, however, teaches an adaptor 90 (Fig 6) comprising a substantially similar casing comprising a proximal portion (directed upward in Fig 6), and a distal portion (directed downward in Fig 6) comprising an internal luer member 99 and a surrounding sheath (unlabeled but comprising threads 92) comprising threads 92 (as seen in Fig 6), wherein the distal-most end of the luer member ends proximal to the distal-most end of the sheath and within the sheath (as seen in Fig 6), resulting in the casing forming a hollow interior that includes not only the pathway within the luer member but also the space defined within the circular wall of the sheath; Miller teaches that providing the sheath longer than the luer member allows the adaptor to connect with a corresponding threads of a device to which it is intended to be attached (Para 73). Since this is the same purpose and achieves the same result as McKinnon’s distal portion design, these arrangements (wherein the luer member ends distal to the sheath and wherein the luer member ends within the sheath) were art-recognized equivalents at the time the invention was made; therefore, it would have been obvious to one of ordinary skill in the art to substitute the distal portion arrangement of Miller in place of that of McKinnon since it has been held that substituting parts of an invention involves only routine skill in the art. This modification would result in the “hollow interior” including the space between the luer member and the sheath and, thus, including the threads.
Re claim 10, McKinnon discloses that the casing forms a hollow interior (extending from the proximal-most end of the casing (labeled in Fig B above) having a proximal opening (labeled in Fig B above) and a distal opening (the lumen within the luer member of casing 20, labeled in Fig B above), the proximal opening being formed by a rim (labeled in Fig B above) (as seen in Fig 2 and Fig B above), and wherein the elastomeric member includes a retaining member (labeled in Fig B above) that is spaced from the septum by a neck (labeled in Fig B above) (as seen in Fig 2 and Fig B above), the elastomeric member also forming a lumen (when opened, as seen in Fig 4) that extends from the septum through the male luer taper (as seen in Fig 4), the septum of the elastomeric member being positioned at the proximal opening of the hollow interior (as seen in Fig 2) and the male luer taper extending to the distal opening of the hollow interior (as seen in Fig 2), the septum forming a distally facing lip (labeled in Fig B above) that overlaps a proximal face (facing upward in Fig 2) of the rim when a proximal face (facing upward in Fig 2) of the retaining member abuts a distal face (labeled in Fig B above) of the rim (as seen in Fig 2 and Fig B above). McKinnon discloses that the casing includes threads (as seen in Fig 2 and labeled in annotated Fig B above), but due to the distal-most end of the luer member extending distally past the distal-most end of the sheath (labeled in annotated Fig B above), these threads are not in the hollow interior and do not extend from the distal opening; accordingly, McKinnon fails to disclose that the hollow interior includes threads that extend from the distal opening. Miller, however, teaches an adaptor 90 (Fig 6) comprising a substantially similar casing comprising a proximal portion (directed upward in Fig 6), and a distal portion (directed downward in Fig 6) comprising an internal luer member 99 and a surrounding sheath (unlabeled but comprising threads 92) comprising threads 92 (as seen in Fig 6) that extend from a distal opening ( defined by the space surrounding the internal luer member), wherein the distal-most end of the luer member ends proximal to the distal-most end of the sheath and within the sheath (as seen in Fig 6), resulting in the casing forming a hollow interior that includes not only the pathway within the luer member but also the space defined within the circular wall of the sheath; Miller teaches that providing the sheath longer than the luer member allows the adaptor to connect with a corresponding threads of a device to which it is intended to be attached (Para 73). Since this is the same purpose and achieves the same result as McKinnon’s distal portion design, these arrangements (wherein the luer member ends distal to the sheath and wherein the luer member ends within the sheath) were art-recognized equivalents at the time the invention was made; therefore, it would have been obvious to one of ordinary skill in the art to substitute the distal portion arrangement of Miller in place of that of McKinnon since it has been held that substituting parts of an invention involves only routine skill in the art. This modification would result in the “hollow interior” including the space between the luer member and the sheath and, thus, including the threads and the threads extending from the distal opening.
Conclusion
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783