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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-15 in the reply filed on 12/15/25 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/15/25.
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 1-2 and 7 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 “essentially impermeable” throughout the claim which renders the claim indefinite because it is not clear whether the layer is impermeable or not. It is respectfully suggested that applicant change “essentially” to - - substantially - -.
Claim 2 recites “the first layer (b2)” in line 3 which renders the claim indefinite since it is unclear whether the claim includes (b1), which is referenced later in the claim, or not. For purposes of examination, the claim has been interpreted to include (b1).
Claim 7 recites “heat shrink properties” which renders the claim indefinite since the term “properties” is not defined.
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, 5 and 15 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Dworak (US 2011/0139650).
Dworak discloses A multi-layer sealing film for gas or vapor decontaminable
packaging of a container having an opening to be sealed with the multi-layer sealing film
before gas or vapor decontamination, the multi-layer sealing film comprising, in a
sequence from an outside towards an inside of the container: (a) a layer of a selectively permeable non-woven that is essentially impermeable
to microorganisms; and (b1) a first layer of film having one or more predefined cut-out regions within an area of the multi-layer sealing film that is to cover the opening, or
(b2) a first layer of film that is essentially impermeable to a gas or vapor of the
gas or vapor decontamination, the first layer of film having a first needling,
perforation and/or cut pattern within the area of the multi-layer sealing film
that is to cover the opening, wherein the layer of a selectively permeable non-woven (a) and the first layer of film (b1) or (b2) are bonded by a sealing seam configured and arranged at least partially subject to and non-overlapping with a sealing seam area for
sealing the opening (paragraphs [0002], [0020 – 0026], [0039], [0042 – 0046]).
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) 2-4, 6, 9-10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dworak (US 2011/0139650) in view EP 3782809 (cited by applicant).
Claim 9, in its entirety, recites method limitations in a product claim and has been given little to no patentable weight since the method by which a product is made is not germane to the patentability of a product in a product claim (MPEP 2113).
Dworak does not disclose further comprising, in sequence from the-an outside towards the-an inside of the container after the first layer (b2): (c) an adhesive layer that is activated by an energy transmission and that (i) covers an entire surface of at least one of the layer of a selectively permeable non-woven (a) and the first layer of film (b1) or (b2) or (ii) is arranged in a pattern over the entire surface; and (d) a second layer of film that is essentially impermeable to the gas or vapor of the gas or vapor decontamination, the second layer of film having a second needling, perforation and/or cut pattern that is incongruent with the first needling, perforation and/or pattern, wherein the energy transmission is at least one energy transmission selected from the group
consisting of: heat, UV irradiation, IR irradiation, induction, and microwave irradiation, wherein the adhesive layer (c) is a hot melt heat sealable adhesive system containing additives that are responsive to the energy transmission, wherein the selectively permeable non-woven is made of high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET), wherein the first layer of film (b1) or (b2) and/or the second layer of film (d) is made of a film comprising two or more layers, wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer comprising polyethylene, polypropylene, polyamide 6, polyethylene terephthalate, or blends and/or copolymers thereof.
EP 3782809 discloses further comprising, in sequence from the-an outside towards the-an inside of the container after the first layer (b2): (c) an adhesive layer that is activated by an energy transmission and that (i) covers an entire surface of at least one of the layer of a selectively permeable non-woven (a) and the first layer of film (b1) or (b2) or (ii) is arranged in a pattern over the entire surface; and (d) a second layer of film that is essentially impermeable to the gas or vapor of the gas or vapor decontamination, the second layer of film having a second needling, perforation and/or cut pattern that is incongruent with the first needling, perforation and/or pattern, wherein the energy transmission is at least one energy transmission selected from the group
consisting of: heat, UV irradiation, IR irradiation, induction, and microwave irradiation, wherein the adhesive layer (c) is a hot melt heat sealable adhesive system containing additives that are responsive to the energy transmission, wherein the selectively permeable non-woven is made of high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET), wherein the first layer of film (b1) or (b2) and/or the second layer of film (d) is made of a film comprising two or more layers, wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer comprising polyethylene, polypropylene, polyamide 6, polyethylene terephthalate, or blends and/or copolymers thereof in decontaminable packaging for the purpose of providing a non-destructive integrity check and avoiding hydrogen peroxide contamination (paragraphs [0001], [0007 – 0020], [0024 – [0029], [0035], [0037]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided further comprising, in sequence from the-an outside towards the-an inside of the container after the first layer (b2): (c) an adhesive layer that is activated by an energy transmission and that (i) covers an entire surface of at least one of the layer of a selectively permeable non-woven (a) and the first layer of film (b1) or (b2) or (ii) is arranged in a pattern over the entire surface; and (d) a second layer of film that is essentially impermeable to the gas or vapor of the gas or vapor decontamination, the second layer of film having a second needling, perforation and/or cut pattern that is incongruent with the first needling, perforation and/or pattern, wherein the energy transmission is at least one energy transmission selected from the group
consisting of: heat, UV irradiation, IR irradiation, induction, and microwave irradiation, wherein the adhesive layer (c) is a hot melt heat sealable adhesive system containing additives that are responsive to the energy transmission, wherein the selectively permeable non-woven is made of high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET), wherein the first layer of film (b1) or (b2) and/or the second layer of film (d) is made of a film comprising two or more layers, wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer comprising polyethylene, polypropylene, polyamide 6, polyethylene terephthalate, or blends and/or copolymers thereof in Dworak in order to provide a non-destructive integrity check and avoiding hydrogen peroxide contamination as taught or suggested by EP 3782809.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dworak (US 2011/0139650) in view EP 3782809 (cited by applicant), as applied to claims 2-4, 6, 9-10 and 14 above, and further in view of JP2020-131436 (English machine translation provided herein).
Modified Dworak does not disclose wherein the first layer of film (b1) or (b2) and/or the second layer of film (d) have monoaxial or biaxial heat shrink properties, wherein the monoaxial or biaxial heat shrink in one or both directions is 20%-55%.
JP2020-131436 discloses wherein the first layer of film (b1) or (b2) and/or the second layer of film (d) have monoaxial or biaxial heat shrink properties, wherein the monoaxial or biaxial heat shrink in one or both directions is 20%-55% (paragraphs [0002], [0023], [0090], [0096]) in medical packaging in order to provide improved transparency and inter layer adhesion.
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the first layer of film (b1) or (b2) and/or the second layer of film (d) have monoaxial or biaxial heat shrink properties, wherein the monoaxial or biaxial heat shrink in one or both directions is 20%-55% in modified Dworak in order to provide improved transparency and inter layer adhesion as taught or suggested by JP2020-131436.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dworak (US 2011/0139650) in view EP 3782809 (cited by applicant), as applied to claims 2-4, 6, 9-10 and 14 above, and further in view of Trent et al. (US 2004/0224134).
Modified Dworak does not disclose wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer comprising polyolefin plastomer, isotactic polybutylene-1, and/or an ethylene propylene copolymer, wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer consisting of polyolefin plastomer, isotactic polybutylene-1, or an ethylene propylene copolymer.
Trent discloses wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer comprising polyolefin plastomer, isotactic polybutylene-1, and/or an ethylene propylene copolymer, wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer consisting of polyolefin plastomer, isotactic polybutylene-1, or an ethylene propylene copolymer in a sterilizable object for the purpose of providing slip resistance (paragraph [0109]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer comprising polyolefin plastomer, isotactic polybutylene-1, and/or an ethylene propylene copolymer, wherein the first layer of film (b1) or (b2) or the second layer of film (d) is a layer consisting of polyolefin plastomer, isotactic polybutylene-1, or an ethylene propylene copolymer in modified Dworak in order to provide slip resistance as taught or suggested by Trent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
January 22, 2026