DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
(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, 6-14, 21, and 22, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blatter (US 6265002).
Regarding claims 1, 6, 9, 10, 11, 12, Blatter discloses packaging that is fully capable of housing a medical device, the medical device packaging comprising:
a first packaging member and a second packaging member attached to the first packaging member (col. 7:24-27, two sheets pressed together to form seal areas to form a cavity/interior volume, col. 3: 40-45) with a gas- permeable seal via path indicated by line at 434, fig. 4E, the inner cavity disclosed by Blatter is fully capable of housing medical device, the gas-permeable seal 434 including, reference annotated Fig. 4E of Blatter:
a first seal track including a first opening and
a second seal track spaced apart from the first seal track and more proximal to the inner cavity than the first seal track,
the second seal track including a second opening offset from the first opening by a distance,
a third seal track that is spaced apart from the second seal track, the third seal track being located more proximal to the inner cavity than the second seal track,
the gas-permeable seal including a channel formed from the first and second seal tracks and the first and second openings, the channel being a single and only path through the gas-permeable seal that permits gas passage from an external environment to the inner cavity.
The packaging disclosed by Blatter is capable of permitting gas sterilization because there is nothing about the package of Blatter that would not allow sterilization by gas. Further regarding claim 9, the Length of the seal disclosed by Blatter is 110 mm (0.11 meters), col. 7:38-42. With this in mind, the channel is greater than 1x10-7 meters in length. In addition, it is known in the art that a tortuous path causes bacteria and microorganisms to collect in the corners of the path, as such, the tortuous path disclosed by Blatter inherently impedes microorganisms from entering into the cavity by some degree.
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Regarding claim 3, it is understood that because of the lack of disclosure of any reason for using two materials, the first and second sheets of Blatter are understood to be formed of the same material, (flexible wrapping material is cellophane, col. 1: 40-42.
Regarding claim 7, as seen in fig. 4E, referencing the uppermost seal line as the first seal, the seal line that is third from the top as the second seal, and the bottom most seal line as the third seal, the limitation of claim 7 is met:
a spacing between the first seal track and the second seal track is different than a spacing between the second seal track and the third seal track.
Regarding claim 8, as seen in fig. 4E, referencing the seal line that is second from the top as the first seal, the seal line that is third from the top as the second seal, and the bottom most seal line as the third seal, the limitation of claim 8 is met:
a spacing between the first seal track and the second seal track is substantially the same as a spacing between the second seal segment and the third seal track.
Regarding claim 13, as seen in fig. 4E (upper embodiment), Blatter discloses the first distance between the first opening and the second opening is different than the second distance between the second opening and the third opening.
Regarding claim 14, as seen in fig. 4E (lower embodiment), the first distance between the first opening and the second opening is substantially the same as the second distance between the second opening and the third opening.
Regarding claims 21 and 22, as seen in fig. 4E of Blatter the channel extends in left-to-right and right-to-left directions through the openings in the seal.
Claim Rejections - 35 USC § 103
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Blatter as applied to claim 1 above, and further in view of Schuster (US 4203520).
Regarding claim 2, the references applied above teach all of claim 1, as applied above. Blatter does not mention the transparency of the packaging. The packaging of Blatter is taught as being cellophane.
Schuster is analogous art in regard to in regard to heat sealed packaging for articles and having a tortuous path, fig. 1-3 and 9, col. 4: 1-15. Schuster further teaches that the packaging be made transparent for unobstructed view of the contents housed in the packaging, col. 3: 15-19.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Blatter to provide transparent packaging material in order to allow unobstructed view of the contents of the packaging as per the teaching of Schuster.
Allowable Subject Matter
Claims 4 and 5 is 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.
Regarding claim 5, the closest available prior art is Jamison (US 5419638) who teaches a 0.03 inch diameter which provides a cross-sectional area of 0.456 sq mm, which is equal to 4.56 x 10-7 sq meters, col. 6: 30-35 of Jamison.
Claims 15-17 are allowed.
Regarding claims 4 and 15, The closest available art is (KR 20250106559) but the reference does not qualify as prior art.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLIE L IMPINK whose telephone number is (571)270-1705. The examiner can normally be reached Monday-Friday (7:30-3:30).
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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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MOLLIE LLEWELLYN IMPINK
Primary Examiner
Art Unit 3799
/MOLLIE IMPINK/Primary Examiner, Art Unit 3799
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