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 12/06/2024.
Claims 1-7 are currently pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-18 of U.S. Patent No. US 12161775 B2 (Hereinafter referred to as ‘775). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass the same subject matter presented in the instant claims with only minor grammatical changes or synonym usage.
Regarding claim 1, ‘775 claims tote liner for use in a terminal sterilization process, the tote liner comprising (Col 15 lines 17-18 and Col 16 lines 9-10):
a permeable sleeve that allows a sterilant to permeate a material of the sleeve during a pressurized cleaning cycle, wherein the sleeve is sized and dimensioned to accommodate a plurality of breather bags containing respective items to be sterilized; and a biological indicator to indicate a level of sterility in the interior of the permeable sleeve; and a seal that closes the permeable sleeve to prevent contamination of the plurality of breather bags in the interior of the permeable sleeve (Col 15 lines 17-32 and Col 16 lines 9-31).
Regarding Claims 2-7: Claims 11-14 and 15-18 of US 12161775 B2 recite essentially each feature of the claims and/or the claimed features patentably indistinct in view of the claimed invention of Claims 1-4 of US 12161775 B2, in addition to them being rejected as being directly or indirectly dependent upon base claim 1.
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, and 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rataj (US 20180085482 A1) in view of Nelson Labs’ guidelines for radiation sterilization validation Non-Patent Literature attached, published November, 12 2019 (https://web.archive.org/web/20191112/https://www.nelsonlabs.com/testing/sterilization-validation-radiation/), and in further view of Griesbach et al. (US 6767509 B1).
Regarding claim 1, Rataj discloses a tote liner for use in a terminal sterilization process (Note: A tote liner is intended use, and the sleeve is interpreted as fully capable of being placed in a tote as a liner), the tote liner comprising:
a permeable sleeve (10) that allows a sterilant to permeate a material of the sleeve 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 (10) 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 (12) that closes the permeable sleeve (10) to prevent contamination of the plurality of breather bags in the interior of the permeable sleeve ([0025]).
Rataj doesn’t teach the sleeve is (A) sized and dimensioned to accommodate a plurality of breather bags (B) a biological indicator to indicate a level of sterility in the interior of the permeable sleeve.
With regards to (A); it is well-known in the art to use nested or double-bagging techniques in cleanroom sterilization to reduce contamination risks and false positives during validation, where an outer permeable bag (like a tote liner) holds multiple inner breather bags containing items (e.g., medical devices or garments). For example, Nelson Labs’ guidelines for radiation sterilization validation (see page 2) explicitly recommend double-bagging samples “prior to dosing” to provide “an extra barrier to take into the cleanroom and… reduce the potential for false positives” during sterility testing.
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Rataj sleeve to serve as an outer tote liner accommodating a plurality of inner breather bags, as this is a standard practice for maintaining sterility in multi-item cleanroom processes, enhancing contamination control without undue experimentation as taught by Nelsons lab guidelines for radiation sterilization.
With regards to (B); Griesbach teaches biological indicator (13) to indicate a level of sterility in the interior of a container (3; Col 5 lines 15-33, Col 8 lines 50-57, and Col 11 lines 44-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rataj sleeve as modified (as adapted for double-bagging per industry practice) by incorporating biological indicator as taught by Griesbach, because biological indicators provide a standard for confirming microbial kill (e.g., spore-based resistance testing) over chemical indicators, and Such indicators are useful for establishing effective chlorine dioxide concentrations, humidity levels, and exposure intervals for various size packages and for the various medical supplies contained therein. The Examples, along with additional testing using similar protocols, have indicated that a needed exposure time must be provided for proper sterilization (Col 11 lines 46-50).
Rataj as modified 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).
Regarding claim 4, wherein the seal comprises a cleanroom-compatible coil zipper (Rataj zipper (12) is cleanroom-compatible, attached with silicone-free thread to prevent particulates; [0024]-[0025], and [0029]).
Regarding claim 5, wherein the biological indicator is contained in an interior space within the sleeve (Fig. 1B of Griesbach).
Regarding claim 6, wherein the biological indicator is integrated into a structure of the sleeve (Fig. 1B of Griesbach; Integrated in the inner portion of the bag, 1).
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rataj (US 20180085482 A1) in view of Nelson Labs’ guidelines for radiation sterilization validation(https://web.archive.org/web/20191112/https://www.nelsonlabs.com/testing/sterilization-validation-radiation/), and Griesbach et al. (US 6767509 B1) and in further view of Witcher et al. (US 20200385778 A1).
Regarding claim 2, Rataj as modified discloses the biological indicator including the use of spores of various Bacillus species as biological indicators 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 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rataj (US 20180085482 A1) in view of Nelson Labs’ guidelines for radiation sterilization validation(https://web.archive.org/web/20191112/https://www.nelsonlabs.com/testing/sterilization-validation-radiation/), and Griesbach et al. (US 6767509 B1) and in further view of Ludvig (US 20120205269 A1).
Regarding claim 7, Rataj as modified discloses the invention as explained above including wherein the sleeve is constructed of a material to allow the solution to permeate ([0024] “used in sterilization situations….and autoclaving fill line equipment”). but is silent regarding wherein the sterilant comprises a solution comprising between 15% and 30% weight to volume of hydrogen peroxide.
Ludvig in a related invention teaches sterilant comprises a solution comprising of hydrogen peroxide ([0027], [0056] and claim 30).
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 sterilant of Rataj as modified by incorporating hydrogen peroxide as taught by Ludvig as obvious substitution of equivalent sterilant for cleanroom use, as H2O2 is standard for low-temperature processes.
Rataj as modified does not further teach a solution comprising between 15% and 30% weight to volume of H2O2.
It would have been obvious to one having ordinary skill in the art before the effective filing date to have the solution of Rataj as modified as discussed above to have the solution comprising between 15% and 30% weight to volume of H2O2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited. Those references not relied upon are directed mainly toward the general field of permeable sleeve that allows a sterilant to permeate a material of the sleeve.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached on (571) 270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS E IGBOKWE/Examiner, Art Unit 3731
/ANDREW M TECCO/Primary Examiner, Art Unit 3731