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 .
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement filed 9/13/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein (specifically Foreign Patent Documents #1, #3-#14 and #16-#18 and NPL #29) has not been considered.
Claim Objections
Claims 1-3 and 5-21 are objected to because of the following informalities:
in line 4 of Claim 1, inset --the-- before “irradiation”;
in line 1 of Claim 2-3, 5-10 and 12-20, insert --of sterilizing biocontainers-- after “method”;
in line 4 of Claim 2, inset --the-- before “irradiation”;
in line 1 of Claim 3, inset --the-- before “calculating”;
in line 1 of Claim 5, inset --the-- before “measuring”;
in line 1 of Claim 6, inset --the-- before “measuring”;
in line 1 of Claim 8,
inset --the-- before “determining”, and
delete “the” before “shelf” and insert --a--;
in line 3 of Claim 8, inset --first-- before “ageing”;
in line 1 of Claim 9,
inset --the-- before “determining”, and
delete “the” before “shelf” and insert --a--;
in line 1 of Claim 10,
inset --the-- before “determining”, and
delete “the” before “shelf” and insert --a--;
in line 3 of Claim 11, insert --plurality of-- before “biocontainers”;
in line 7 of Claim 11, inset --the-- before “irradiation”;
in line 1 of Claim 12, inset --the-- before “calculating”;
in line 1 of Claim 13, inset --the-- before “calculating”;
in line 1 of Claim 14, inset --the-- before “measuring”;
in line 1 of Claim 15, inset --the-- before “measuring”;
in line 2 of Claim 15, insert --first-- before “film”;
in line 1 of Claim 16, inset --the-- before “measuring”;
in line 1 of Claim 18,
inset --the-- before “determining”, and
delete “the” before “shelf” and insert --a--;
in line 1 of Claim 19,
inset --the-- before “determining”, and
delete “the” before “shelf” and insert --a--;
in line 1 of Claim 20,
inset --the-- before “determining”, and
delete “the” before “shelf” and insert --a--;
in line 5 of Claim 21, inset --the-- before “irradiation”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 5-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claims 1, 11 and 21, it is not clear what the limitation “calculating a…ageing time … after irradiation based on … radiation dose received…” attempting to set forth, particularly the metes and bounds of the limitation is not clear as the “calculating” step appears to encompass more than just carrying out a mathematical operation/step in view of the Specification and appears to encompass steps/a process taken separately and prior to a sterilization process.
In Claim 2, it is not clear what the limitation “calculating a second ageing time … after irradiation based on the second radiation dose received…” attempting to set forth, particularly the metes and bounds of the limitation is not clear as the “calculating” step appears to encompass more than just carrying out a mathematical operation of a calculation in view of the Specification.
In Claim 3, it is not clear whether the limitation “being calculated to be less than the first ageing time” is attempting to require the calculation to produce a quantity for the second ageing time “to be less than the first ageing time”.
In Claim 5, it is not clear what is the metes and bounds of the limitation “similar to”.
In Claim 8, it is not clear whether “determining a quality…based on a measurement of the first sensor” is attempting to set forth that the quality is based on a step of taking a measurement of a property of the first sensor or based on a measurement taken by the first sensor.
In Claim 9, it is not clear whether “determining a quality…based on a measurement of the first sensor” is attempting to set forth that the quality is based on a step of taking a measurement of a property of the first sensor or based on a measurement taken by the first sensor.
Claim 11 recites the limitation "the respective biocontainer" in line 7. There is insufficient antecedent basis for this limitation in the claim.
In Claim 11, it is not clear how one can prevent “use of a first biocontainer of the plurality of biocontainers based on a first ageing time of the first biocontainer”
Claim 12 recites the limitation "the second radiation does" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the first radiation does" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the first radiation does" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the material" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the first radiation does" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the second radiation does" in line 2. There is insufficient antecedent basis for this limitation in the claim.
In Claim 18, it is not clear whether “determining a quality…based on a measurement of a first sensor” is attempting to set forth that the quality is based on a step of taking a measurement of a property of a first sensor or based on a measurement taken by a first sensor.
In Claim 19, it is not clear whether “determining a quality…based on a measurement of the first sensor” is attempting to set forth that the quality is based on a step of taking a measurement of a property of the first sensor or based on a measurement taken by the first sensor.
Claims 6-7, 10, 15, 17 and 20 are rejected due to their dependence on a rejected claim.
Allowable Subject Matter
Claims 1, 11 and 21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: while prior art such as Adriaansz (WO03048806) discloses a method comprising steps of irradiating (via 1) a first biocontainer (5) (see Figure 1); measuring (via 6) a first radiation doe received by the first biocontainer (5) (see entire document, particularly p. 2 lines 28-33); and calculating a factor which accounts for ageing (see entire document, particularly p. 3 lines 10-11, p. 4 – Claim 4), Adriaansz (‘806) does not specifically teach a step of calculating a first ageing time of the first biocontainer after the irradiation based on the first radiation dose received by the first biocontainer and the material forming the first biocontainer nor a step of preventing use of the first biocontainer before the first ageing time has elapsed. In addition, while prior art of Benyathiar et al. (Journal of Polymers and the Environment(2021)29:460-471) discloses that irradiation of a material such as PLA film at dosages of 1 to 30 kGy and after ageing/storage of up to 9 months affects various material properties of the material (see Figures 5-7), Benyathiar et al. does not specifically teach a specific step of “calculating …ageing time”. It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a method of sterilizing biocontainers comprised of steps as set forth in the claims, particularly a step of “calculating a…ageing time…after irradiation based on the … radiation dose received by the … biocontainer” and “the material forming the … biocontainer”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: 20200129649 (a method of determining impact of gamma irradiation and/or heating with ageing on a polymer material); Kehoe et al. Journal of Non-Crystalline Solids (a method of determining effect of radiation/irradiation or accelerated aging on several properties of a material); Briggs et al. Recent Progress in Materials (2021) (polyurethane foam utilized in the method was not affected/degraded by e-beam sterilization/aging).
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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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