DETAILED ACTION
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 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.
Claim(s) 4-7,23-25,27-28 and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klocke et al. (U.S. Pub. No. 2017/0247131).
Regarding claim 33: Klocke discloses a method for producing and filling an administration packaging for a pharmaceutic product, the method comprising the following steps:
at least partially heating a plastic sheet (Fig. 2; via 10/11),
forming a bottom part of the administration packaging having a cavity for receiving the pharmaceutic product and a rim surrounding the cavity by stretching the plastic sheet onto and/or into a molding tool, see for example (Fig. 2; via 12/13 and/or along the use of another device poisoned upstream of heating plates 10/11; “slot or groove 7 as a predetermined breaking point. This device is positioned upstream from the upper heating plate 10 and the lower heating plate 11”),
filling the cavity with the pharmaceutic product, (Fig. 2; via 14), and
covering the cavity with a cover and fixing the cover to the rim so that the cavity is completely closed (via cover 4 and/or closing-sealing 15/16).
Klocke may not disclose the claimed step of generating a predetermined breaking zone to take place in the bottom part with the molding tool and/or the exact timing to be during the step of forming the bottom part. However, the it would have been obvious to one having ordinary skill in the art, before the effective filing date to have modified Klocke’s method by having the step of generating a predetermined breaking zone to take place during the step of forming the bottom part instead of being upstream of the bottom forming step, since it has been held that rearranging parts or steps of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 4: further comprising forming the predetermined breaking zone as or comprising a groove on an outer or an inner surface of the administration packaging, (Figs. 1 & 6; via slot or groove 7).
Regarding claim 5: further comprising forming the predetermined breaking zone comprising a projection opposite the groove (via inherently groove 7 will form a projection portion).
Regarding claim 6: further comprising forming the predetermined breaking zone as a region which has at least essentially the same thickness as a region of the bottom part surrounding the predetermined breaking zone, see for example (Figs. 1 & 6; via breaking zone 7 appears to be with the same thickness as the bottom part 2 of the package).
Regarding claim 7: further comprising forming the predetermined breaking zone as a kink in a wall of the bottom part (“breaking point can be a slot or a groove in the thermoforming film, or even a pinched area”; inherently pinching area will result on forming kink portion).
Regarding claim 23: wherein the step of generating the predetermined breaking zone comprises stretching the plastic sheet onto a forming device of the modeling tool, see for example (paragraph 0015; “”during thermoforming” means that the forming die allows pre-stretching of the material into the mold”); wherein the forming device is formed by or comprises an elevation and/or an indentation on a surface of a mold of the molding tool; (“a device for production the slot or groove 7…positioned upstream from the upper heating plate 10 and the lower heating plate 11”; inherently this device would have an elevated portion on the pressing member to form a groove).
Regarding claim 24: wherein the step of generating the predetermined breaking zone comprises stretching the plastic sheet onto a forming device of the modeling tool, see for example (paragraph 0015; “”during thermoforming” means that the forming die allows pre-stretching of the material into the mold”), further comprising providing the forming device as an adjustable and/or exchangeable component of the molding tool (inherently those devices are changeable and adjustable; paragraph 0020; “In order to minimize production costs...work with interchangeable molds”).
Regarding claim 25: further comprising providing the molding tool with a negative mold and a positive mold (inherently to shape 3-D shape the provided molds 12/13 have to be in male/female structure),
Klocke does not specifically clear regarding the step of providing the negative mold and the positive mold having complementary shaped surfaces, and generating a kink in the wall of the bottom part as predetermined breaking zone by means of the negative mold and the positive mold. However, it is known that the use of male/female molds to form 3-D shaped container is very inherently. It is noted that, having those male/female molds to form and generate a kink in the wall of the web or sheet are very old and known in the art and would be obvious.
Further, see for example (Figs. 3-4; via the shown molding plates; while having the predetermined breaking zone formed upstream of those plates, yet complete formation takes place at the final molding plates).
Regarding claim 27: further comprising providing venting holes in the molding tool and forming the bottom part comprising deformations from the venting holes (via “venting ducts 20”).
Regarding claim 28: further comprising providing the molding tool with one or multiple venting holes that are arranged at or formed in the forming device, see for example (Figs. 2-5; via the venting means 20 formed along with the formation of the entire package using same tools 12/13).
Regarding claim 31: further comprising forming a cross-section reduction or nozzle of an administration channel of the cavity in the predetermined breaking zone (paragraph 0007; “must also have an exceptionally small cross-section so that the solution contained in the chamber of the application package is only discharged from the open-tipped application duct”).
Regarding claim 32: further comprising forming the predetermined breaking zone such that the predetermined breaking zone extends only over the cavity or an administration channel of the cavity, see for example (Fig. 6; via breaking zone 7 over cavity/duct 6).
Allowable Subject Matter
Claims 1 and 34-45 are allowed.
The prior art of record fails to disclose the combination of the claimed method for producing and filling an administration packaging with a step of generating a predetermined breaking zone in the bottom part cut-free and/or without using a cutting tool, see for example (filed specification; Summary of the Inventio section; paragraphs 0023-0024; “the predetermined breaking zone is generated cut-free and/or without a cutting step”, while the Description of Related Art section; paragraph 0006 is referring to the known art as “The deep-drawing film…is generated by cutting through the PP layer”). Further the latest filed remarks on 09/02/2025, pages 1-2 is providing more detailed explanation to the novelty of the specific claimed steps of generating the “cut-free” breaking zone vs the known and applied art of applying a cut through the PP layer.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,4-7,23-25,27-28 and 31-45 have been considered but are moot because the new ground of rejection adjusted to address the filed new amendments and newly added claims.
In respect to applicant’s arguments and has been addressed above having a specific arrangement of the step of generating a predetermined breaking zone to take place in the bottom part with the molding tool and/or at the exact timing during the step of forming the bottom part would be nothing more than a matter of rearranging parts or steps of an invention, which involves only routine skill in the art. In re Japikse, 86 USPQ 70.
In respect to the argued and amended portion of having a step of forming the predetermined breaking zone to be a cut-free and/or without using a cutting tool, was found to be novel in combination of the other claimed steps.
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 SAMEH TAWFIK whose telephone number is (571)272-4470. The examiner can normally be reached Mon-Fri. 8:00 AM - 4:00 PM.
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/SAMEH TAWFIK/Primary Examiner, Art Unit 3731
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