DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of Invention I, claims 1-16 in the reply filed on 28 July 2026 is acknowledged. The traversal is on the ground(s) that Inventions I and II are not distinct because the apparatus claim recites a controller that is configured to perform the process of claim 1. This is not found persuasive because restriction between process and apparatus claims only requires one-way distinctness to be proper (see MPEP 806.05(e)). The restriction requirement provided the reasonable example that the process as claimed can be practiced by a conventional autoclave with no pressurized air connection, heating jacket, and/or cooling jacket. Seeing that the steps of the process involve adjusting pressure, temperature, and humidity inside a steam sterilization device, which can be achieved by opening valves from a pressurized steam source and an ambient air environment as desired, the process does not appear to require the specific device of claims 17-18. See prior art rejections below.
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 28 July 2026.
Priority
4. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 12 July 2024 and 21 August 2024 are being considered by the examiner.
Specification
6. The disclosure is objected to because of the following informalities:
In par 0005, “Microbial Barrier” and “Log Reduction Value” need not be capitalized.
In par 00038, “pressure ps which at least” should read --pressure ps of at least-- in both instances where it occurs.
In par 00040, “helps reducing the stress” should read –helps to reduce the stress--.
Appropriate correction is required.
Claim Objections
7. Claim 1 is objected to because of the following informalities: in part c), “constant to the predetermined pressure” should read –constant at the predetermined pressure--. Appropriate correction is required.
8. Claim 11 is objected to because of the following informalities: in the second line, “the inner or outer surface” should read –an inner surface or an outer surface--, for clarity, as no surfaces have been previously defined for the primary packaging.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-16 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.
11. Claim 1 recites the limitation "the steam" in the fourth line. There is insufficient antecedent basis for this limitation in the claim, as it is unclear whether this refers to the steam supplied in step b) or to some other steam already present within the device during step a).
Claim 1 further recites the limitation “according to Ph. Eur. 5.1.1” in the eleventh line. That particular citation to the European Pharmacopoeia is understood to refer to the 11th edition (per Specification par 00023) of a standard validation procedure for sterilization processes, but it is unclear from the “according to” invocation by the claim whether this validation procedure is to be read into the claim scope. If the validation procedure for the claimed SAL is important to the scope of the claim, the claim should positively recite what specific steps are required. Alternatively, if the validation procedure is not intended to be read into the claim scope, deleting this limitation would cure the issue by simply referring to “a sterility assurance level of equal to or less than 10-6 ”, which is understood as having a one-in-one-million chance of a micro-organism surviving the sterilization process and thus would be definite on its own.
12. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05(c). In the present instance, claim 1 recites in the sixteenth line broadly reducing the drying pressure “by at most 75 hPa or by at least 5 hPa”. The claim(s) are considered indefinite because there is a question or doubt as to what pressure reduction range is required by the claim, i.e., whether a pressure of less than 5 hPa or greater than 75 hPa would be included in the claim scope since the limitations are introduced in the alternative.
13. Claims 2-16 are indefinite by virtue of their dependence on indefinite claim 1.
Claim Rejections - 35 USC § 103
14. 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
15. Claims 1, 3-7, 9-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Akerman (“Steam Sterilisation of BFS containers in Autoclaves”, seminar given March 2018, www.bfsioa.org/media/f2fd332d-f869-4260-b0fa-e862074d67f8/ufwArg/2018 accessed 02 September 2026) as evidenced by European Pharmacopoeia 5.1.1 (www.uspbpep.com/ep50/5.1.1.%20Methods%20of%20preparation%20of%20sterile%20products.pdf accessed 02 September 2026).
16. Regarding claim 1, Akerman discloses a process for steam sterilization of primary packaging in a steam sterilization device (Steam Sterilisation of BFS containers in Autoclaves, Title), the process comprising the steps of:
a) pre-heating the primary packaging in the steam sterilization device to a temperature Tₚ (Heating with dry air to a temperature below 100º C, then Final heating to sterilisation temperature 121º C by combined steam and air mixture, Slide 22) at least equal to 15 °C below a dew point temperature Tdp of the steam at a predetermined pressure ps and predetermined temperature Tₛ at which the steam sterilization is to be performed (steam sterilization performed at saturated steam temperature of 121 °C, Slides 16 and 22; constant pressure applied during sterilisation phase, Slide 18);
b) adjusting the pressure and temperature in the steam sterilization device to the predetermined pressure pₛ and the predetermined temperature Tₛ (Final heating to sterilisation temperature 121º C by combined steam and air mixture, Slide 22; pressure gradually increased when temperature increases, Slide 18) and performing the sterilization by supplying steam to the steam sterilization device for at least a time tₛ (moist heat sterilisation at minimum 121.1 ºC for 15 min, Slide 13) sufficient to ensure a sterility assurance level of equal to or less than 10⁻⁶ according to Ph. Eur. (Slide 13); and
c) in a drying phase reducing a relative humidity in the steam sterilization device (drying phase in combination with a slow cooling down, Slide 22) and reducing the drying pressure in the steam sterilization device from the predetermined pressure ps (Gradually decreasing pressure during cool-down, which also allows efficient drying, Slide 18) before adjusting in a cooling phase the pressure and temperature in the steam sterilization device to ambient pressure and a temperature of ≤ 75 °C (Final cooling phase to below 40 ºC, Slide 22).
Akerman does not specifically teach that the gradual pressure decrease would reduce the pressure by at most 75 hPa or by at least 5 hPa, nor does Akerman specifically teach that the drying phase would specifically reduce the humidity to <50%. Akerman does teach the use of dry air circulating in the preheating phase (Slide 22), and that products should be completely dry after processing (Slide 20), motivating the use of dry air for drying. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II). Because humidity reduction and pressure reduction rate are considered result-effective variables such that determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, a person having ordinary skill in the art could reasonably come upon the claimed ranges in optimization of the sterilization method.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, in step c) to reduce the pressure by at most 75 hPa or by at least 5 hPa and to reduce the humidity to <50% as generally taught by Akerman, because choosing such operating ranges would be expected to provide the gradual pressure decrease and drying results extolled by Akerman and simply involves routine optimization within prior art conditions.
Akerman references the European Pharmacopoeia in Slides 12-13 but does not specifically teach that the sterility assurance level of <= 10-6 is attained according to Ph. Eur. 5.1.1. The 2005 edition of the European Pharmacopoeia 5.1.1 referenced above establishes validation guidelines to ensure a sterility assurance level of 10-6 or better for steam sterilisation processes (page 445, right column) and as such represents the relevant Ph. Eur. standard for the sterility assurance level taught by Akerman, with no modification to the process necessary.
17. Regarding claim 3, Akerman teaches the process as recited in claim 1 wherein the pre-heating in step a) is executed for a time period that can be readily evaluated by a skilled user (critical parameters to evaluate include Time to reach phase transition 1, Time to reach phase transition 2, Total heat up time, Slide 36).
Akerman does not specifically teach a heat up time of 0.5 h to 3 h. Akerman does, however, teach the general range of times for the sterilization process (15 min to over 5h, Slide 15), further lending to the expectation that preheating time is a variable to be readily optimized by a person having ordinary skill in the art. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II). Because preheating cycle time is considered a result-effective variable such that determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, a person having ordinary skill in the art could reasonably come upon the claimed ranges in optimization of the sterilization method.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to execute preheating step a) of the process of Akerman for 0.5 to 3 hours, because this time range would predictably provide the gradual temperature ramp to prevent damage to the packaging as preferably taught by Akerman (Slides 20 and 22-23) and could be readily achieved through routine optimization.
18. Regarding claim 4, Akerman teaches the process as recited in claim 1 wherein in step a) the primary packaging is pre-heated to a temperature Tₚ of at least 60 °C (Heating with dry air to a temperature below 100º C, then Final heating to sterilisation temperature 121º C by combined steam and air mixture, Slide 22).
19. Regarding claim 5, Akerman teaches the process as recited in claim 1 wherein the steam sterilization in step b) is executed at a temperature Tₛ in the range of from 120 °C to 127 °C (Sterilisation at constant conditions at 121º C, Slides 13 and 22).
20. Regarding claim 6, Akerman teaches the process as recited in claim 1 wherein the steam sterilization in step b) is executed at a pressure ps which is above ambient pressure (Slides 18 and 23).
21. Regarding claim 7, Akerman teaches the process as recited in claim 1 wherein the adjusting of the pressure in the cooling phase in step c) is executed gradually (Gradually decreasing pressure during cool-down, which also allows efficient drying, Slide 18). Akerman does not specifically teach a pressure reduction at a rate of at most 500 hPa/min. Though no limits on a gradual rate are established, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II). Because pressure reduction rate is considered a result-effective variable such that determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, a person having ordinary skill in the art could reasonably come upon the claimed ranges in optimization of the sterilization method.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, in step c) to reduce the pressure at a rate of at most 500 hPa/min as generally taught by Akerman, because choosing such operating ranges would be expected to provide the gradual pressure decrease and drying results extolled by Akerman and simply involves routine optimization within prior art conditions.
22. Regarding claim 9, Akerman teaches the process as recited in claim 1 wherein during the drying phase in step c) the temperature in the steam sterilization device is reduced from Ts gradually from 121 °C at first then finally to a temperature of 40 °C (Slide 22), which necessarily involves reduction to a temperature in the range of from 120 °C to 90 °C.
23. Regarding claim 10, Akerman teaches the process as recited in claim 1 wherein at the beginning of step c) the pressure begins being reduced gradually to allow efficient drying (Slide 18), such that the first moment of gradual pressure reduction reads upon wherein between step b) and step c) the pressure in the steam sterilization device is reduced from ps by at most 75 hPa.
24. Regarding claim 12, Akerman teaches the process as recited in claim 1 wherein the preheating includes preheating to the dew point temperature Tdp (Heating with dry air to a temperature below 100º C, then Final heating to sterilisation temperature 121º C by combined steam and air mixture, Slide 22).
25. Regarding claim 13, Akerman teaches the process as recited in claim 1 wherein the preheating includes preheating to at least 50 °C (Heating with dry air to a temperature below 100º C, then Final heating to sterilisation temperature 121º C by combined steam and air mixture, Slide 22).
26. Regarding claim 14, Akerman teaches the process as recited in claim 1 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced gradually (Gradually decreasing pressure during cool-down, which also allows efficient drying, Slide 18). Akerman does not specifically teach a pressure reduction by at most 75 hPa and by at least 5 hPa. Though no limits on a gradual rate are established, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II). Because pressure reduction rate is considered a result-effective variable such that determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, a person having ordinary skill in the art could reasonably come upon the claimed ranges in optimization of the sterilization method.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, in step c) to reduce the pressure by at most 75 hPa and by at least 5 hPa as generally taught by Akerman, because choosing such operating ranges would be expected to provide the gradual pressure decrease and drying results extolled by Akerman and simply involves routine optimization within prior art conditions.
27. Regarding claim 15, Akerman teaches the process as recited in claim 1 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced gradually (Gradually decreasing pressure during cool-down, which also allows efficient drying, Slide 18). Akerman does not specifically teach a pressure reduction by at most 50 hPa and by at least 10 hPa. Though no limits on a gradual rate are established, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II). Because pressure reduction rate is considered a result-effective variable such that determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, a person having ordinary skill in the art could reasonably come upon the claimed ranges in optimization of the sterilization method.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, in step c) to reduce the pressure by at most 50 hPa and by at least 10 hPa as generally taught by Akerman, because choosing such operating ranges would be expected to provide the gradual pressure decrease and drying results extolled by Akerman and simply involves routine optimization within prior art conditions.
28. Regarding claim 16, Akerman teaches the process as recited in claim 1 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced gradually (Gradually decreasing pressure during cool-down, which also allows efficient drying, Slide 18). Akerman does not specifically teach a pressure reduction by at most 50 hPa and by at least 20 hPa. Though no limits on a gradual rate are established, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II). Because pressure reduction rate is considered a result-effective variable such that determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, a person having ordinary skill in the art could reasonably come upon the claimed ranges in optimization of the sterilization method.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, in step c) to reduce the pressure by at most 50 hPa and by at least 20 hPa as generally taught by Akerman, because choosing such operating ranges would be expected to provide the gradual pressure decrease and drying results extolled by Akerman and simply involves routine optimization within prior art conditions.
29. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Akerman as applied to claim 1 above, and further in view of Patel et al (US 20180221564 A1).
Regarding claim 2, Akerman teaches the process as recited in claim 1 wherein the primary packaging is further packaged in a secondary packaging container (ampoules loaded into pallets, Slides 21, 28, 31) but does not teach that this secondary package is sealed with a non-woven.
Patel teaches an analogous method for sterilizing using steam (pars 0030 and 0033-0034) wherein a pre-filled syringe i.e. similar single use medical container is placed within a protective container and sealed (pars 0034-0035, FIG. 1) wherein the seal can be a conventional non-woven sterilization wrap (pars 0070-0072), the secondary package beneficially preventing microbial penetration after sterilization (par 0070).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further package the primary packaging of Akerman in a secondary package sealed with a non-woven as taught by Patel, because this secondary packaging would predictably prevent microbial penetration post-sterilization in the same manner and simply involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
30. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Akerman as applied to claim 1 above, and further in view of Kang et al (US 20160187309 A1).
Regarding claim 8, Akerman teaches the process as recited in claim 1. Although Akerman hints that the process may be carried out in a traditional vacuum autoclave (Slide 16), Akerman does not specifically teach wherein between step a) and step b) the pressure in the steam sterilization device is reduced to a range of 100 hPa to 1,000 hPa.
Kang teaches an analogous steam sterilization method with moisture indication and reduction (Abstract, pars 0037-0039) wherein the steam sterilization process can include conventional methods known in the art including pre-vacuum to an exemplary vacuum depth of 0.8 bar or 800 hPa (par 0039), which falls within the claimed range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include between step a) and step b) of the process of Akerman a pre-vacuum step reducing the pressure in the steam sterilization device to between 100 hPa and 1,000 hPa as taught by Kang, because such a pressure reduction would predictably remove air or other gas present in the chamber in the same manner (Kang par 0038) and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
31. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Akerman as applied to claim 1 above, and further in view of Jurgens (US 4718463 A).
Regarding claim 11, Akerman teaches the process as recited in claim 1 but does not teach wherein before step a) an additional washing step is executed including a rinsing of the inner or outer surface of the primary packaging with water or a polar organic solvent.
Jurgens teaches an analogous method of producing sterilized plastic syringes (Abstract) comprising washing the tips and barrels of the syringe with a multiplicity of jets of water to remove debris (col 3 lines 13-28, FIG. 3), or alternatively using liquid freon (col 3 lines 29-40), before passing to respective autoclave steps where they are heated by steam under pressure similarly to a temperature in the range from 120-125 °C to destroy viable microorganisms (col 3 lines 41-46).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add before the steam sterilization process of Akerman an additional washing step including a rinsing of the inner or outer surface of the primary packaging with water or a polar organic solvent as taught by Jurgens, because such a rinsing step would predictably remove debris or contaminants in the same manner and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
Double Patenting
32. 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
33. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-32 of copending Application No. 18/786,660 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference appears to be that the reference application recites that the primary packaging be “silicone coated”. This recitation results in no manipulative difference to the process from the instant claims; thus, the instant claims are anticipated by the narrower scope of the reference claims as compared below:
Present
U.S. Application No. 18/786,660
1. A process for steam sterilization of primary packaging in a steam sterilization device, the process comprising the steps of:
a) pre-heating the primary packaging in the steam sterilization device to a temperature Tₚ
at least equal to 15 °C below a dew point temperature Tdp of the steam at a
predetermined pressure ps and predetermined temperature Tₛ at which the steam sterilization is to be performed;
b) adjusting the pressure and temperature in the steam sterilization device to the
predetermined pressure ps and the predetermined temperature Tₛ and performing the sterilization by supplying steam to the steam sterilization device for at least a time ts sufficient to ensure a sterility assurance level of equal to or less than 10⁻⁶ according to Ph. Eur. 5.1.1; and
c) in a drying phase reducing a relative humidity in the steam sterilization device to < 50 % and either maintaining a drying pressure in the steam sterilization device constant to the predetermined pressure ps or reducing the drying pressure in the steam sterilization device from the predetermined pressure ps by at most 75 hPa or by at least 5 hPa, before adjusting in a cooling phase the pressure and temperature in the steam
sterilization device to ambient pressure and a temperature of ≤ 75 °C.
2. The process as recited in claim 1 wherein the primary packaging is further packaged in a secondary packaging container sealed with a non-woven.
3. The process as recited in claim 1
wherein the pre-heating in step a) is executed for 0.5 h to 3 h.
4. The process as recited in claim 1 wherein in step a) the primary packaging is pre-heated to a temperature Tₚ of at least 60 °C.
5. The process as recited in claim 1 wherein the steam sterilization in step b) is executed for a time tₛ of at least 1.5 h or at a temperature Tₛ in the range of from 120 °C to 127 °C.
6. The process as recited in claim 1 wherein the steam sterilization in step b) is executed at a pressure ps which is above ambient pressure.
7. The process as recited in claim 1 wherein the adjusting of the pressure in the cooling phase in step c) is executed at a rate of at most 500 hPa/min.
8. The process as recited in claim 1 wherein between step a) and step b) the pressure in the steam sterilization device is reduced to a range of 100 hPa to 1,000 hPa.
9. The process as recited in claim 1 wherein during the drying phase in step c) the temperature in the steam sterilization device is reduced from Ts to a temperature in the range of from 120 °C to 90 °C or the pressure in the steam sterilization device is held constant.
10. The process as recited in claim 1 wherein between step b) and step c) the pressure in the steam sterilization device is reduced from ps by at most 75 hPa.
11. The process as recited in claim 1 wherein before step a) an additional washing step is executed including a rinsing of the inner or outer surface of the primary packaging with water or a polar organic solvent.
12. The process as recited in claim 1 wherein the preheating includes preheating to the dew point temperature Tdp.
13. The process as recited in claim 1 wherein the preheating includes preheating to at least 50 °C.
14. The process as recited in claim 1
wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced by at most 75 hPa and by at least 5 hPa.
15. The process as recited in claim 1 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced by at most 50 hPa and by at least 10 hPa.
16. The process as recited in claim 1
wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced by at most 50 hPa and by at least 20 hPa.
16. A process for steam sterilization of silicone coated primary packaging in a steam sterilization device, the process comprising the steps of:
a) pre-heating the silicone coated primary packaging in the steam sterilization device to a temperature Tp at least equal to 15 °C below a dew point temperature Tdp of the steam at a predetermined pressure ps and predetermined temperature Ts at which the steam sterilization is to be performed;
b) adjusting the pressure and temperature in the steam sterilization device to the predetermined pressure ps and the predetermined temperature Ts and performing the sterilization by supplying steam to the steam sterilization device for at least a time ts sufficient to ensure a sterility assurance level of equal to or less than 10-6 according to Ph. Eur. 5.1.1; and
c) in a drying phase reducing a relative humidity in the steam sterilization device to < 50 % and either maintaining a drying pressure in the steam sterilization device constant to the predetermined pressure ps or reducing the drying pressure in the steam sterilization device from the predetermined pressure ps by at most 75 hPa or by at least 5 hPa, before adjusting in a cooling phase the pressure and temperature in the steam sterilization device to ambient pressure and a temperature of ≤ 75 °C.
17. The process as recited in claim 16 wherein the silicone coated primary packaging is further packaged in a secondary packaging container sealed with a non-woven.
18. The process as recited in claim 16 wherein the pre-heating in step a) is executed for 0.5 h to 3 h.
19. The process as recited in claim 16 wherein in step a) the silicone coated primary packaging is pre-heated to a temperature Tp of at least 60 °C.
20. The process as recited in claim 16 wherein the steam sterilization in step b) is executed for a time ts of at least 1.5 h or at a temperature Ts in the range of from 120 °C to 127 °C.
21. The process as recited in claim 16 wherein the steam sterilization in step b) is executed at a pressure ps which is above ambient pressure.
22. The process as recited in claim 16 wherein the adjusting of the pressure in the cooling phase in step c) is executed at a rate of at most 500 hPa/min.
23. The process as recited in claim 16 wherein between step a) and step b) the pressure in the steam sterilization device is reduced to a range of 100 hPa to 1,000 hPa.
24. The process as recited in claim 16 wherein during the drying phase in step c) the temperature in the steam sterilization device is reduced from Ts to a temperature in the range of from 120 °C to 90 °C or the pressure in the steam sterilization device is held constant.
25. The process as recited in claim 16 wherein between step b) and step c) the pressure in the steam sterilization device is reduced from ps by at most 75 hPa.
26. The process as recited in claim 16 wherein before step a) an additional washing step is executed including a rinsing of the inner or outer surface of the silicone coated primary packaging with water or a polar organic solvent.
27. The process as recited in claim 16 wherein the preheating includes preheating to the dew point temperature Tdp.
28. The process as recited in claim 16 wherein the preheating includes preheating to at least 50 °C.
29. The process as recited in claim 16 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced by at most 75 hPa and by at least 5 hPa.
30. The process as recited in claim 16 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced by at most 50 hPa and by at least 10 hPa.
31. The process as recited in claim 16 wherein the drying pressure in the steam sterilization device from the predetermined pressure ps is reduced by at most 50 hPa and by at least 20 hPa.
34. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
35. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reshef et al (US 20260183440 A1) teaches a steam sterilizer system (Abstract) with a steam sterilization cycle including the steps of preheating, sterilizing at constant temperature, and cooling in a similar manner (pars 0035, 0050, 0056).
36. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Talbert whose telephone number is (703)756-5538. The examiner can normally be reached Mon-Fri 8:00-5:00 Eastern Time.
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/ERIC TALBERT/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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