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 .
Status of Claims
This office action is responsive to claims filed on 05/17/2024.
Claims 1-7 are currently pending.
Due to the new grounds of rejection on amended and unamended claims herein; this office action is non-final.
Terminal Disclaimer
The terminal disclaimer filed on 05/05/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12161775 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rataj (US 20180085482 A1) in view of Robinson (US 20210222356 A1), and in further view of Bruso (US 4636472 A), and as further evidenced by Griesbach (US 6767509 B1).
Regarding claim 1, Rataj discloses a tote liner for use in a terminal sterilization process (Note: “A tote liner for use…” recites only an intended use), the tote liner comprising:
a permeable sleeve (10) that allows a fluid to permeate a material of the sleeve (10) during a pressurized cleaning cycle ([0024] “used in sterilization situations….and autoclaving fill line equipment”; see also [0026]-[0027] discloses the materials to be permeable “launderable material”), wherein the sleeve is sized and dimensioned to accommodate a plurality of breather bags containing respective items to be sterilized ([0025] “insertion and removal of equipment to be sterilized” with regards to the limitation “to accommodate plurality of breather bags” is considered intended use as the sleeve of Rataj is capable of accommodating multiple bags); and
a seal (zipper, 12) that closes the permeable sleeve to prevent contamination of the plurality of bags in the interior of the permeable sleeve ([0025]).
Rataj is silent regarding the (A) the sleeve is sized and dimensioned to accommodate a plurality of bags and (B) a biological indicator to indicate a level of sterility in the interior of the permeable sleeve.
Robinson in a related invention teaches a permeable sleeve (100, 102) sized and dimensioned to accommodate a plurality of bags (152w, 152g; Fig. 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Rataj permeable autoclave breather bad to the liner size and configuration of Robinson so that it can accommodate plurality of inner breather bags while still allowing sterilant to permeate the outer sleeve material during pressurized cycle.
Rataj as modified is silent regarding a biological indicator to indicate a level of sterility in the interior of the permeable sleeve.
Bruso teaches a biological indicator (26) positioned in the interior of a permeable structure to indicate a level of sterility after pressurized sterilization cycle (Fig. 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Rataj permeable sleeve as modified by incorporating a biological indicator as taught by Bruso to indicate the level sterility achieved inside after sterilization cycle.
Griesbach further supports placing a biological indicator inside a sealed sterilization pouch/package to confirm sterilization conditions have been achieved. Griesbach discloses biological indicator vials placed inside the package (including multiple items such gowns) that are later incubated to verify no growth (Col 8 lines 40-55 and Example 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Rataj permeable sleeve as modified by incorporating a biological indicator as taught by Griesbach to indicate the level sterility achieved.
Wherein an argument is made that Rataj’s seal does not close the permeable sleeve to prevent contamination of the plurality of bags in the interior of the permeable sleeve.
Griesbach further teaches a reclosable “Zipper type” seal to close the package after loading items (Col 4 lines 50-65; seal 17 may be a heat seal, a pressure adhesive seal, a reclosable zipper type seal or the like).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Rataj permeable sleeve as modified by incorporating a various type of sealing techniques as taught by Griesbach to prevent contamination of contents
Rataj as combined further teaches:
Regarding claim 3, Rataj as modified discloses the biological indicator but is silent regarding wherein the biological indicator is operative to indicate a level of sterility to at least a Sterility Assurance Level of 1 ppm.
It would have been obvious to one having ordinary skill in the art before the effective filing date to have the biological indicator of Rataj as modified to be operative to indicate a level of sterility to at least a Sterility Assurance Level of 1 ppm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Doing so achieves a conventional sterility assurance level.
Regarding claim 4, Rataj teaches a zipper closure on the autoclave breather bag (Fig. 3, zipper 12), but is silent regarding the use of a cleanroom-compatible coil zipper
However it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Rataj Zipper and select and use a coil Zipper, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 5, wherein the biological indicator is contained in an interior space within the sleeve (Fig. 1B of Griesbach and Fig. 2 of Bruso).
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rataj (US 20180085482 A1) in view of Robinson (US 20210222356 A1), in view of Bruso (US 4636472 A) and Griesbach (US 6767509 B1), and in further view of Witcher et al. (US 20200385778 A1).
Regarding claim 2, Rataj as modified discloses the biological indicator but is silent regarding wherein the biological indicator comprises specifically Bacillus atrophaeus.
Witcher in a related invention teaches a biological indicator (100) comprises specifically Bacillus atrophaeus ([0055]).
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 modified the biological indicator of Rataj as modified by incorporating biological indicator comprises specifically Bacillus atrophaeus as taught by Witcher in order to allow effectively determine the effectiveness of the sterilization cycle.
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rataj (US 20180085482 A1) in view of Robinson (US 20210222356 A1), and in further view of Bruso (US 4636472 A), and as further evidenced by Griesbach (US 6767509 B1) and in further view of Ludvig (US 20120205269 A1).
Regarding claim 6, Rataj as modified discloses the invention as explained above including wherein the biological indicator (26 of Bruso and/or Col 8 lines 40-55 and Example 1 of Griesbach). but is silent regarding the biological indicator is integrated into a structure of the sleeve.
Ludvig teaches an indicator material (ink trip or sensor) integrated into a structure of the pouch itself ([0011]-[0014], [0046]-[0048] and [0061]-[0062]).
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 modified the sleeve and the biological indicator of Rataj as modified by incorporating biological indicator that is integrated into the layered structure of the sleeve, as taught by Ludvig in order to provide more compact, and structurally integrated indicator while maintaining permeability for sterilant.
Allowable Subject Matter
Claim 7 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. None of the cited prior art teaches or render obvious the specific liquid hydrogen peroxide solution plus liquid permeation combination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS E IGBOKWE whose telephone number is (571)272-1124. The examiner can normally be reached on M-F 8 a.m. - 5 p.m..
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/NICHOLAS E IGBOKWE/Examiner, Art Unit 3731
/ANDREW M TECCO/Primary Examiner, Art Unit 3731
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