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 .
Claim amendments filed 10/31/2025 are acknowledged. Claims 1-11 are pending.
Response to Arguments
The arguments filed 10/31/2025 have been considered.
The applicant argues that “the method as claimed by claim 1 differs from Tsuruta in that the claimed method does not require the presence of the antechamber 14, the sterilization chamber 15, the ventilation chamber 16, and the filling and packaging chamber 17 of the Tsuruta reference.” The claims do not prevent the existence of these components in Tsuruta.
The applicant continues to argue limitations or benefits of the disclosed invention that are not required by the claim language. Nothing prevents the use of more than one chamber in the prior art. Additionally, hindsight only applied to 103 obviousness rejections. The rejection of claim 1 as anticipated by Tsuruta is maintained. Tsuruta teaches the added limitations as fig 7 illustrates the sterilization step in the start up process (para [0020]). As can be seen in fig 7, the film is wrapped around the nozzle 35a and closed at the bottom (pinched and sealed by rollers 38 and sealer 37). Thus, Tsuruta teaches the claim limitations as amended.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsuruta (US 2019/0300219).
With regards to claim 1, Tsuruta teaches a method to sterilize a packaging machine (11; abstract; fig 5) with a feed circuit (collection of supply lines; fig 2) comprising providing a first feed line (material feed through line L14 and L13) configured to feed a first flow of product (material), providing a second feed line (L1 and L5) configured to feed a second flow of sterilizing solution (hydrogen peroxide water), and providing a third feed line (outside air line from 30 through L3) configured to feed a third flow of gaseous fluid (outside air), and a forming and filling station (filling device 35 at packaging chamber 17) equipped with a nozzle (injection pipe 35a) fluidically connected to the feed lines and around which it is provided to form a tubular wrapping (plastic film bag 1 in a tubular shape) of heat sealable film (film is heat sealed; para [0073]) (fig 2; para [0072]). The film is closed longitudinally around the nozzle and closed transversely below the nozzles so that the nozzle is at least partly contained in the tubular (the film is pinched and sealed by rollers 38 and sealer 37 around and below the nozzle 35a prior to the sterilization as it is seen in startup sterilization substep in fig 7). Tsuruta teaches a start-up step (start-up process) with a sterilization sub-step (S2) (fig 5). During the sterilization sub step said second flow of sterilizing solution is fed to the first feed line (at least to L13) (fig 7; para [0079).
With regards to claim 2, in the sterilization sub step the second flow is fed into the third feed line (portion of third feed line from V2 and through L3) (fig 7; para [0079]).
With regards to claim 3, Tsuruta teaches further providing a sub step of forming the tubular wrapping of heat sealable film around the delivery member (fig 7 showing the start-up sterilization process shows the tubular wrapping around the bottom of delivery member 35a), wherein the tubular wrapping is closed downstream of the delivery member (shown closed at the bottom at 37) and said sub step of forming the tubular wrapping is performed before the sterilization sub step (since the tube is shown in place in fig 7 showing the sterilization step 52 configuration, a tubular wrapping forming step must have occurred before it)(fig 7; para [0020]).
With regards to claim 4, after the sterilization sub-step, a purging sub step occurs in which the third flow (outside air) is fed into the first (fed to L13 via L12 and to 35a) and third feed lines (taken from outside and fed all the way through L3 (para [0080]; fig 8).
With regards to claim 6, Tsuruta teaches a packaging machine (11; abstract; fig 2) with a feed circuit (collection of supply lines; fig 2) comprising a first feed line (material feed through line L14 and L13) configured to feed a first flow of product (material), a second feed line (L1 and L5) configured to feed a second flow of sterilizing solution (hydrogen peroxide water), and a third feed line (outside air line from 30 through L3) configured to feed a third flow of gaseous fluid (outside air), and a forming and filling station (filling device 35 at packaging chamber 17) equipped with a nozzle (injection pipe 35a) fluidically connected to the feed lines and around which it is provided to form a tubular wrapping (plastic film bag 1 in a tubular shape) of heat sealable film (film is heat sealed; para [0073]) (fig 2; para [0072]). The film is closed longitudinally around the nozzle and closed transversely below the nozzles so that the nozzle is at least partly contained in the tubular (the film is pinched and sealed by rollers 38 and sealer 37 around and below the nozzle 35a prior to the sterilization as it is seen in startup sterilization substep in fig 7). The first feed line is fluidically connected to the to the second feed line by means of the third feed line (sterilant travels from L1 of the second feed line through L2 to L3 of the third feed line (at intersection between V2 and 33) and then through L12 and finally into L13 of the first feed line (fig 7; para [0079]).
With regards to claim 7, at least one valve (valve 4) is disposed on the first feed line and directly downstream of the first source (material), so as to selectively isolate it from the first feed line (closes off the downstream portion of the first line at L13) (arrangement in fig 7).
With regards to claim 8, one or more other closing members (V3 and V1) are configured to selectively isolate the third feed line from the first line (V3 shuts off connection path L12) and the second feed line (V1 shuts off the connection path L2) (fig 2).
With regards to claim 9, Tsuruta teaches a duct (L2) fluidically connected both to the second and also the third feed lines in order to reciprocally connect the second and third feed lines (fluid can flow either way) and a duct (L12) which fluidically connects the third feed line to the first feed line in order to reciprocally connect the first and third feed lines (fluid can flow either way) (fig 7).
With regards to claim 10, the ducts each comprise a respective valve (V1 and V3) so as to be able to isolate each feed line from the other (V3 shuts down connection L12 and V1 shuts down connection L2) (fig 7).
With regards to claim 11, Tsuruta teaches a method to sterilize a packaging machine (11; abstract; fig 5) with a feed circuit (collection of supply lines; fig 2) comprising providing a first feed line (material feed through line L14 and L13) configured to feed a first flow of product (material), providing a second feed line (L1 and L5) configured to feed a second flow of sterilizing solution (hydrogen peroxide water), and providing a third feed line (outside air line from 30 through L3) configured to feed a third flow of gaseous fluid (outside air), and a forming and filling station (filling device 35 at packaging chamber 17) equipped with a nozzle (injection pipe 35a) fluidically connected to the feed lines.
Tsuruta taches feeding a heat sealable film to the forming and filling station (para [0073]) where the film is wound around the nozzle (see fig 7); forming a tubular wrapping (plastic film bag 1 in a tubular shape) of heat sealable film (film is heat sealed; para [0073]) (fig 2; para [0072]). The film is closed longitudinally around the nozzle and closed transversely below the nozzle (downstream) so that the nozzle is at least partly contained in the tubular (the film is pinched and sealed by rollers 38 and sealer 37 around and below the nozzle 35a prior to the sterilization as it is seen in startup sterilization substep in fig 7). Tsuruta teaches a start-up step (start-up process) with a sterilization sub-step (S2) (fig 5). During the sterilization sub step said second flow of sterilizing solution is fed to the first feed line (at least to L13) (fig 7; para [0079). The forming of the tubular wrapping is performed before the sterilization step (shown in fig 7; also a restarting process would have had a complete process before it in which a tube was formed as well).
Claim Rejections - 35 USC § 103
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsuruta (US 2019/0300219).
With regards to claim 5, Tsuruta does not teach a substep of cleaning or sanitizing the feed circuit followed by a drying step that occurs before the sterilization step (S2). Tsuruta does be a drying step (dehumidification and preheating step S1) that occurs before the sanitization step (S2). Tsuruta also teaches a drying step after the sterilization step (first aeration step S3) (fig 5). A person having ordinary skill in the art would have found it obvious to have repeated the start up sterilization process in order to achieve additional sterilization and insure the sterility. This would result in a second sanitizing step of the feed circuit followed by a drying step that both occur before the already introduced sterilization step.
Additionally, it would be obvious to repeat the entire process of fig 5 on each start up after a shut down to ensure aseptic filling. The first sterilizing step (S2) of the first start up is thus a sanitizing step followed by a drying step (either the first start up first aeration step (S3) or the dehumidification and preheating step of the second/subsequent start up (S1)) that occur before the sterilizing step mapped in claim 1 (the sterilization step S2 of the second or subsequent start up).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONALD R SPAMER whose telephone number is (571)272-3197. The examiner can normally be reached Monday to Friday from 9-5.
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/DONALD R SPAMER/Primary Examiner, Art Unit 1799