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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed on December 17, 2025, in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 5, 2025 has been entered.
Response to Amendment
Claims 1-3, 6-8, 12, 14-15, 17-19 and 26 have been amended. Claims 22-24 and 27-29 have been canceled. Claims 1-21 and 25-26 are pending and examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-21 and 25-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding independent claims 1 and 12, the specification does not describe the method step of sterilizing "for at least six hours" recited in both or the independent claims or the steps now recited in claim 1 of "visually inspecting whether distortion, ink smearing, or delamination of the lidding occurred during the sterilizing step; and based on the visual inspection, either: (i) rejecting the lidded container when distortion, ink smearing or delamination is detected, or (ii) accepting the lidded container" or the steps now recited in claim 12 of "visually inspecting whether distortion, ink smearing, or delamination of the lidding structure occurred during the sterilizing step; and if distortion, ink smearing or delamination is not detected, adhering the sterilized lidding structure to a rim of a container to form a lidded container."
As was noted in the Advisory Action filed December 2, 2025, Applicant has not provided an explanation of where these new claim limitations are supported by the specification as filed. Para [0018] describes a sterilization process that includes temperature ranges and peroxide concentrations, but is silent as to the sterilizing time period. Para [0019] describes a hot sterile air application for removal of hydrogen peroxide from the film that may also be understood as part of the sterilization process, but is also silent as to heating time. The only reference to a processing time period that the examiner could find is at para [0020], the penultimate paragraph of the specification, that also discusses distortion, ink smearing or delamination. Para [0020] is repeated below:
"[0020] ln an embodiment, the film material will survive in a heated peroxide bath as described herein for up to six hours, and, in some case, an excess of thirteen hours, with no distortion, ink smearing, or delamination. In contrast, a typical PET film lidding cannot survive more than about 2 to 4 hours in a heated peroxide bath without becoming distorted, smeared or delaminated."
Para [0020] amounts to a statement of advantages/results of the process described in paras [0018] and [0019]. In view of the future tense disclosure that the film material "will survive" in a heated peroxide bath, para [0020] appears to be directed to a testing process performed outside of the inventive method steps of making the film lidding structure described in paras [0018]-[0019], thus not clearly directed to a process that requires a six hour application of hydrogen peroxide. Furthermore, the specification provides no guidance as to when a visual inspection is performed and the sterilized article is accepted or rejected. Thus, the new recitation in claim 12 of visually inspecting the lidding prior to adhering the lidding to a container rim is not supported by the specification. The examiner found no other support for the newly recited steps. Thus, the new process steps appear to be an addition to what was originally filed and therefore not supported thereby.
Claims 2-11, 13-21 and 25-26 are rejected under Section 112(a) in view of their dependency from claim 1 or claim 12.
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.
Claim 12 is 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.
Regarding claim 12, at line 4, the phrase "the HDPE" lacks antecedent basis and should be amended to recite "the at least one HDPE."
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.
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.
Claims 1-21 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Francklow et al., US 2023/0088010 (hereafter Francklow) in view of Wuest et al., US 2004/0043238 (hereafter Wuest), made of record at the end of the previous office action.
Regarding claim 1, Francklow teaches a film lidding structure (Abstract) and method of making (paras [0016]-[0040]) used in the food, drink and medical industries (para [0002])).
A method of Francklow includes:
providing at least one high-density polyethylene (HDPE) flexible film layer (paras [0011] and [0016] teach a lidding film that comprises an "oriented" polyethylene film a), oriented polyethylene understood to be flexible, and para [0031] teaches the oriented polyethylene comprises HDPE; also as to the new limitation that the layer is flexible, at para [0012] Francklow defines its "lidding film" as a "flexible" piece of material for use as a closure on a package comprising a tray, thus necessarily also teaching that the oriented HDPE film layer component of the film must also be "flexible;" the examiner notes the subjective nature of the term “flexible” and that in the absence of quantification, such subjective terminology fails to exclude the prior art from consideration as such);
laminating the at least one HDPE flexible film layer to at least one base layer to form a lidding (para [0011] teaches bonding the film (a) (i.e., oriented HDPE film layer) to a non-oriented polyethylene (b) (i.e., a base layer) that may be performed by laminating using an adhesive; para [0035] teaches the non-oriented polyethylene (b) (i.e., base layer) may comprise low-density polyethylene (LDPE)); and
adhering the at least one base layer to a rim of a container to form a lidded container (para [0036] teaches the non-oriented polyethylene (i.e., the LDPE base layer) softens during heat sealing such that a bond of desired strength is formed to a surface, such as a surface of a tray (i.e., a container); para [0038] teaches such tray surface may be the top edge of the tray so as to enclose a recess of the tray between the tray and the lidding film (i.e., form a lidded container)).
Francklow is silent as to the sterilizing, drying and inspection steps now recited in claim 1. With respect to these new steps, please see the Section 112(a) rejection above.
Wuest teaches a multilayer packaging film and process for aseptic packaging applications (Abstract). The packaging film is flexible, Wiest teaching the film may be formed into packages of various sizes (para [0040]). Wuest teaches that it is directed to providing a film suitable for contact with foodstuff or medicinal product; providing a film with physical integrity; providing a film having the ability to be sterilized and be compatible with the method of sterilization used, i.e., heat, chemical or radiation; and providing a film having adequate barrier protection to maintain product quality until the product is used (paras [0002]-[0003]). The packaging film of Wuest includes an inner polymeric layer that may be HDPE, LDPE or a polypropylene-ethylene copolymer (para [0031]), an intermediate oxygen barrier layer (para [0032]) and an outer layer that may be HDPE (para [0033]). Wuest teaches that its outer layer provides peroxide resistance to the packaging film (para [0033]). Wuest further defines its inner and outer film layers as having a Vicat Softening Point greater than 90°C (claim 1 of Wuest).
Wuest teaches a sterilization method wherein the film is first irradiated to kill internally entrapped microorganisms, followed by exposing both outwardly facing surfaces of the film to hydrogen peroxide, followed by removal of the hydrogen peroxide (para [0044]). Wuest further teaches that in typical processes, the sterilizing unit is an aseptic bath, such as a concentrated solution of hydrogen peroxide and water (para [0004]) and the sterilizing agent is usually maintained at a high temperature of approximately 70°C (para [0005]). Wuest teaches that packaging film issuing from the sterilizing bath may then be subjected to drying using hot-air jets to remove any residual sterilizing agent (para [0006]).
In Example 1 of Wuest (paras [0046]-[0059]), film samples were placed in containers filled with 35% hydrogen peroxide solution and placed into a constant temperature oven set at 160°F (71°C) for one hour (para [0057]). Wuest teaches a step of visually inspecting the samples after the sterilization treatment for signs of delamination and/or blistering along the edges, or in the ink areas (para [0057]). Wuest then teaches that unacceptable films for aseptic packaging will exhibit severe delamination at less than 8 hours of exposure to a heated hydrogen peroxide sterilization solution (para [0058]).
Thus, in view of the Section 112(a) rejection above, Wuest is understood to teach the same results taught in para [0020] of the specification as filed, thus rendering obvious the recited method steps of sterilizing for at least six hours, drying using hot sterile air and the visual inspection steps that include rejecting a film that exhibits distortion, ink smearing or delamination while accepting a film that does not include such defects.
Although Wuest is not directed to providing a lidding structure, it is understood as applicable analogous art, being in the same field of endeavor as the claims of the application, that of sterilizing a packaging structure used for food or medicinal materials. Wuest is also understood as applicable analogous art as it is reasonably pertinent to the problem faced by the inventor, that of suitably sterilizing packaging made from HDPE using hydrogen peroxide and heat.
It would have been obvious to one of ordinary skill in the art at the time of effective filing of the claims of the invention to modify the method of Francklow to provide its lidding structure with an outer HDPE film layer having a Vicat Softening Point greater than 90°C as taught by Wuest, thus advantageously providing a packaging material in the form of a lidding structure that may be sterilized in a hydrogen peroxide bath at elevated temperature and inspected as taught by Wuest, the resulting sterilized product advantageously free of defects such as distortion and delamination.
Regarding claim 2, Francklow teaches reverse printing at paras [0018]-[0019]. Wuest also teaches reverse printing at para [0034]).
Regarding claim 3, Francklow teaches surface printing with an over lacquer at paras [0020]-[0022].
Regarding claim 4, Francklow teaches it is known in the art to include polypropylene as a substrate material for a lidding film in view of the desirable properties of good clarity, rigidity and heat resistance (para [0005]). Although LDPE is a preferred material in the base of Francklow (see rejection of claim 1 above), it would have been obvious to one of ordinary skill in the art at the time of effective filing of the claims of the invention to modify the lidding film of Francklow to include a polypropylene inner layer in those instances wherein, for example, additional rigidity or heat resistance is desired.
Regarding the recitation of the polypropylene being “cast,” Francklow teaches its lidding layers may be stretched by techniques known in the art, including blown, cast or tenter processes (para [0033]).
Regarding claim 5, see the rejection of claim 2 above discussing Francklow teaching a reverse printed HDPE film layer. See the rejection of claim 1 discussing the Francklow teaching of laminating its film layers using adhesive. See the rejection of claim 4 above of cast polypropylene being an obvious component of a base layer. Finally, see para [0004] of Francklow teaching that a metal foil lidding film layer is known in the prior art, rendering predictable and thus obvious the recited structure of HDPE, ink, adhesive, foil, adhesive, and cast polypropylene.
Regarding claim 6, see para [0033] of Francklow teaching a blown film process.
Regarding claim 7, see the Abstract and para [0016] of Francklow teaching the oriented polyethylene film of Francklow being machine direction oriented.
Regarding claim 8, see Francklow para [0033] teaching a cast tentered process.
Regarding claims 9 and 10, see the rejection of claim 1 above and the Wuest teaching of sterilizing with 35% hydrogen peroxide solution at para [0057].
Regarding the claim 11 recitation of wherein the elevated temperature comprises between about 50°C and about 75°C, see the rejection of claim 1 above discussing Wuest teaching sterilizing at approximately 70°C (para [0005]) and Example 1 teaching sterilizing at 71°C (para 0057]).
Regarding claim 12, Francklow teaches a film lidding structure (Abstract) and method of making (paras [0016]-[0040]) used in the food and drink and medical industries (para [0002]).
A method of Francklow includes:
providing at least one high-density polyethylene (HDPE) flexible film layer ((paras [0011] and [0016] teach a lidding film that comprises an "oriented" polyethylene film a), oriented polyethylene understood to be flexible, and para [0031] teaches the oriented polyethylene comprises HDPE; also as to the new limitation that the layer is flexible, at para [0012] Francklow defines its "lidding film" as a "flexible" piece of material for use as a closure on a package comprising a tray, thus necessarily also teaching that the oriented HDPE film layer component of the film must also be "flexible;" the examiner notes the subjective nature of the term “flexible” and that in the absence of quantification, such subjective terminology fails to exclude the prior art from consideration as such);
laminating the at least one HDPE flexible film layer to at least one base layer to form a lidding (para [0011] teaches bonding the film (a) (i.e., HDPE film layer) to a non-oriented polyethylene (b) (i.e., a base layer) that may be performed by laminating using an adhesive; para [0035] teaches the non-oriented polyethylene (b) (i.e., base layer) may comprise low-density polyethylene (LDPE)); and
adhering the lidding structure to a rim of a container to form a lidded container (para [0036] teaches the non-oriented polyethylene (i.e., the LDPE base layer) softens during heat sealing such that a bond of desired strength is formed to a surface, such as a surface of a tray (i.e., a container); para [0038] teaches such tray surface may be the top edge of the tray so as to enclose a recess of the tray between the tray and the lidding film (i.e., form a lidded container)).
Francklow is silent as to the sterilizing and inspection steps recited in claim 12. With respect to these new steps, please see the Section 112(a) rejection above.
Wuest teaches a multilayer packaging film and process for aseptic packaging applications (Abstract). The packaging film is flexible, Wiest teaching the film may be formed into packages of various sizes (para [0040]). Wuest teaches that it is directed to providing a film suitable for contact with foodstuff or medicinal product; providing a film with physical integrity; providing a film having the ability to be sterilized and be compatible with the method of sterilization used, i.e., heat, chemical or radiation; and providing a film having adequate barrier protection to maintain product quality until the product is used (paras [0002]-[0003]). The packaging film of Wuest includes an inner polymeric layer that may be HDPE, LDPE or a propylene-ethylene copolymer (para [0031]), an intermediate oxygen barrier layer (para [0032]) and an outer layer that may be HDPE (para [0033]). Wuest teaches that its outer layer provides peroxide resistance to the packaging film (para [0033]). Wuest further defines its inner and outer film layers as having a Vicat Softening Point greater than 90°C (claim 1 of Wuest).
Wuest teaches a sterilization method wherein the film is first irradiated to kill internally entrapped microorganisms, followed by exposing both outwardly facing surfaces of the film to hydrogen peroxide, followed by removal of the hydrogen peroxide (para [0044]). Wuest further teaches that in typical processes, the sterilizing unit is an aseptic bath, such as a concentrated solution of hydrogen peroxide and water (para [0004]) and the sterilizing agent is usually maintained at a high temperature of approximately 70°C (para [0005]). Wuest teaches that packaging film issuing from the sterilizing bath may then be subjected to drying using hot-air jets to remove any residual sterilizing agent (para [0006]).
In Example 1 of Wuest (paras [0046]-[0059]), film samples were placed in containers filled with 35% hydrogen peroxide solution and placed into a constant temperature oven set at 160°F (71°C) for one hour (para [0057]). Wuest teaches a step of visually inspecting the samples after the treatment for signs of delamination and/or blistering along the edges, or in the ink areas (para [0057]). Wuest then teaches that unacceptable films for aseptic packaging will exhibit severe delamination at less than 8 hours of exposure to a heated hydrogen peroxide sterilization solution (para [0058]).
Thus, in view of the Section 112(a) rejection above, Wuest is understood to teach the same results taught in para [0020] of the specification as filed, thus rendering obvious the recited method steps of sterilizing for at least six hours and the visual inspection steps that include rejecting a film that exhibits distortion, ink smearing or delamination while accepting a film that does not include such defects.
Although Wuest is not directed to providing a lidding structure, it is understood as applicable analogous art, being in the same field of endeavor as the claims of the application, that of sterilizing a packaging structure used for food or medicinal materials. Wuest is also understood as applicable analogous art as it is reasonably pertinent to the problems faced by the inventor, that of suitably sterilizing packaging made from HDPE using hydrogen peroxide and heat.
It would have been obvious to one of ordinary skill in the art at the time of effective filing of the claims of the invention to modify the method of Francklow to provide its lidding structure with an outer HDPE film layer having a Vicat Softening Point greater than 90°C as taught by Wuest, thus advantageously providing a packaging material in the form of a lidding structure that may be sterilized in a hydrogen peroxide bath at elevated temperature and inspected as taught by Wuest, the resulting sterilized product advantageously free of defects such as distortion and delamination.
Regarding the claim 13 recitation of wherein the at least one base layer is adhered to the rim of the container, see the discussion in the rejection of claim 12 above of Francklow teaching adhering the lidding structure to a rim of a container to form a lidded container (para [0036], the non-oriented polyethylene (i.e., the LDPE base layer) softening during heat sealing such that a bond of desired strength is formed to a surface, such as a surface of a tray (i.e., a container); para [0038] teaching such tray surface may be the top edge of the tray so as to enclose a recess of the tray between the tray and the lidding film (i.e., form a lidded container).
Regarding claim 14, Francklow teaches reverse printing at paras [0018]-[0019]. Wuest also teaches reverse printing at para [0034]).
Regarding claim 15, Francklow teaches surface printing with an over lacquer at paras [0020]-[0022].
Regarding claim 16, see the rejection of claim 14 above discussing Francklow teaching a reverse printed HDPE film layer. See the rejection of claim 12 above discussing the Francklow teaching of laminating its film layers using adhesive. See the rejection of claim 4 above, Francklow teaching cast polypropylene being an obvious component of a base layer. Finally, see para [0004] of Francklow teaching that a metal foil lidding film layer is known in the prior art, rendering predictable and thus obvious the recited structure of HDPE, ink, adhesive, foil, adhesive, and cast polypropylene.
Regarding claim 17, see para [0033] of Francklow teaching a blown film process.
Regarding claim 18, see the Abstract and para [0016] teaching the oriented polyethylene film of Francklow being machine direction oriented.
Regarding claim 19, see para [0033] of Francklow teaching a cast tentered process.
Regarding claim 20, see the rejection of claim 12 above discussing Example 1 of Wuest (paras [0046]-[0059]) that teaches sterilization using a 35% hydrogen peroxide solution.
Regarding claim 21,Wuest teaches hydrogen peroxide sterilization at approximately 70°C (para [0005]) and also in an oven set at 160°F (para [0057]). These temperatures are close to the recited "about 65°C" and because the specification contains no disclosure of either the critical nature of this requirement or any unexpected results arising therefrom, the temperature of "about 65°C" is considered arbitrary and therefore obvious. Applicant must show that this requirement is critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 25 and 26, see the rejection of claims 1 and 12 above discussing the Wuest teaching of the packaging film issuing from the sterilizing bath being subjected to drying, e.g., by hot-air jets (para [0006]), thus teaching a drying process that does not include rinsing.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA L SCHALLER whose telephone number is (408)918-7619. The examiner can normally be reached Monday-Friday 8 - 4:30.
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/CYNTHIA L SCHALLER/Primary Examiner, Art Unit 1746