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 .
This action is in response to the documents received on June 2, 2025.
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 1-20 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.
Claim 1 recites the limitation "the one or more at least partially filled product containers" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, this phrase will be understood to be an introduction of the limitation of - - one or more at least partially filled product containers” as presented in the rejection below.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-4, 9, 11, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over HUSNU et al. (US 9,139,316).
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Diagram I
In reference to claim 1, HUSNU et al. discloses a method of producing sterile solution filled containers comprising: positioning a cartridge 300 onto a filling machine, the cartridge including a plurality of containers 400, 405, each of the plurality of containers having a stem extending between a volume of the container and a connection line (see Diagram I above); coupling the cartridge to a feed line (see Diagram I above) in fluid communication with a mix tank 1502; purging air (column 24 lines 11-40) from the connection line before at least partially filling the containers 400, 405; pumping (column 24 lines 41-46) fluid 110 through the feed line and the connection line, the connection line in fluid communication a reservoir coupled to the connection line (see Diagram I above); sealing (column 24 lines 41-47) the stem of each of the at least partially filled containers at a location 320 between the connection line and the volume of the at least partially filled containers; and separating each of the at least partially filled and sealed containers from the connection line.
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Diagram II
HUSNU et al. does not explicitly disclose including a filter assembly in the process referenced in figure 41. Figure 1 of HUSNU et al. discloses a process of operating an alternative sterile solution filling system wherein a filter assembly is in fluid communication with a feed line and connection line (see Diagram II above). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the process of HUSNU et al. figure 41 to include positioning a filter assembly in fluid communication with a feed line and connection line since column 9 lines 55-67 of HUSNU et al. suggests such a modification would ensure that the product filled into the containers is properly sterilized according to government regulation thereby ensuring the integrity of the product filled into the containers.
Regarding claim 2, figures 40-42 of HUSNU et al. disclose the mix tank upstream in the fluid communication with the reservoir, such that the reservoir is at least partially filled with product prior to at least partially filling the plurality of containers.
With respect to claim 3, the method of HUSNU et al. in figures 40-42 discloses activating a pump to at least partially fill the plurality of containers, but does not disclose the reservoir disposed between the pump and the filter assembly as modified in claim 1. Figure 2 of HUSNU et al. teaches a process of at least partially filling containers wherein a reservoir 260 is provided between a pump 200 and a filter assembly 270 . It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have further modified the purging process of HUSNU et al. to include a secondary reservoir between the pump and the filter assembly since column 8 lines 7-12 of HUSNU et al. suggests that such a modification provides means for diluting product that is fed to the containers.
In reference to claim 4, figures 40-42 of HUSNU et al. discloses the step of arranging at at least a portion of the plurality of containers in a first row when implementing the filling steps of claim 1.
Regarding claim 9, column lines of HUSNU et al. disclose puring air from the connection line by activating a pump 200 to deliver gas from the connection line to a reservoir 100 disposed above the connection line (see Diagram I above).
With respect to claims 11 and 17, figures 14-17 of HUSNU et al. discloses the step of coupling the plurality of containers to a cartridge that facilitate removal and attachment of the plurality of containers (vials) on the cartridge to a filling machine as shown in figure 33; wherein the cartridge includes position a plurality of containers that can be .
In reference to claim 19, figure 1 of HUSNU et al. discloses pumping fluid through two filters 270, 630 in series, such that it would have been obvious to one having ordinary skill in the art at the time of filing the invention to have further modified the purging process of figures 40-42 to include the provision of two filters in series since column 12 lines 26-31 of HUSNU et al. state such a modification would prevent any backflow of contaminants into the at least partially filled containers.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over HUSNU et al. (US 9,139,316) in view of KIRCHER et al. (US 2021/0309398).
Regarding claims 12-15, HUSNU et al. discloses the step of sealing the plurality of containers at a stem secured thereto, but does not disclose analyzing the seal of the plurality of containers as claimed. Figure 4 of KIRCHER et al. teaches a process of filling a plurality of containers 58 with product in sterilized condition comprising: capturing a stem of a container with a sealing device 138; analyzing data from a sensor associated with the seal of the stem 185 with a processor 28; identifying (paragraph [0221]) a status of the seal condition based on the sensor data and accepting/rejecting (indicator) the seal based on the analyzed data in comparison to stored (threshold) acceptable parameters of the seal. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified sealing step of HUSNU et al. to include the analyzing and identifying steps as it pertains to the seal for the purpose of ensuring a satisfactory seal of the containers as suggested by paragraph [0221] of KIRCHER.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over HUSNU et al. (US 9,139,316) in view of MAGGIORE (US 2019/0048303).
With respect to claim 16 and 18, HUSNU et al. discloses a method of at least partially filling containers in the form of vials in a sterilized manner with a bioactive product; not bags nor bladders. MAGGIORE teaches a method of at least partially filling containers in a sterilized manner with a bioactive product, wherein claim 20 teaches the equivalence of vials and bags in the art of packaging bioactive product. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the process of HUSNU et al. to include either vials or bags/bladders as the plurality of containers since claim 20 and figure 3 of MAGGIORE suggests the selection of either container would be equally sufficient to maintain a bioactive product in a sterilized packaged manner.
Allowable Subject Matter
Claims 5-8, 10 and 20 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to the attached PTO-892 for a notice of references cited and recommended for consideration based on their disclosure of limitations related to method of producing sterile solution filled containers.
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/GLORIA R WEEKS/Primary Examiner, Art Unit 3731
April 9, 2026