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 .
Response to Amendment
The amendment filed on 04/13/2026 (hereinafter “amendment”) has been accepted and entered. Claims 1-15 are pending.
Claim Rejections - 35 USC § 112(b)
The 35 U.S.C. 112(b) rejections of claim(s) 2, 4, 10 and 15 are withdrawn as a result of the amendment.
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) 1-6, 8-10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. US 2021/002515 A1 in view of McGeorge et al. US 2001/0048891 A1, herein after referred to as Jain and McGeorge respectively.
Regarding claim 1 Jain discloses a packaging (Figs. 1-6A) for a sterilizable object (400 article), comprising:
a bag (300 package), which bag comprises at least two opposing walls (307 first side and 309 second side), wherein each wall has a thickness of at least 10 microns and at most 60 microns (paragraph [0072]) and is made of an ultraviolet-C (UVC) transmissive thermoplastic polymer (paragraphs [0068] lines 1-2 and paragraph [0070]), the at least two walls defining a first compartment (302 interior space) for receiving the sterilizable object (Figs. 5); and
a UVC indicator (paragraph [0133]), for changing color after exposure to UVC radiation (paragraph [0133]).
Jain is silent to the UVC indicator comprising photochromic ink suitable for changing color after exposure to UVC radiation.
McGeorge teaches a container (8 apparatus) with a UVC indicator (18 indicator strip) comprising photochromic ink (19 photochromic material) suitable for changing color after exposure to UVC radiation (paragraph [0022] lines 1-4 and paragraph [0024] lines 1-3) and wherein a label (22 reference card) is included with the UVC indicator and where in the label is provided separate too the first compartment (paragraphs [0028-0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the UVC indicator with photochromic ink as taught by McGeorge as doing so is well known in the art and would yield predictable results as shown by McGeorge. Additionally, the indicator of McGeorge allows the user to readily asses the sterilization success without having to include adding potentially dangerous bacterial spores thusly making the container safer.
Regarding claim 2 Jain as modified discloses the packaging according to claim 1 and further discloses wherein each wall of the bag is made from a polypropylene (paragraph [0068] lines 1-4, polypropylene being a polyolefin).
Regarding claim 3 Jain as modified discloses the packaging according to claim 1 and further discloses wherein the UVC indicator (18) is a single-passage indicator, which single-passage indicator is suitable for changing color once upon exposure to UVC radiation (paragraph [0026] lines 1).
Regarding claim 4 Jain as modified discloses the packaging according to claim 1 and further discloses wherein the UVC indicator (18) is a multi-passage indicator, which multi-passage indicator is suitable for changing color after exposure to UVC radiation and returning to an original state after a certain period in the absence of UVC radiation (paragraph [0027]).
Regarding claim 5 Jain as modified discloses the packaging according to claim 1. Jain as modified discloses substantially all the limitations of the claim(s) except for the transparency of the UVC indicator. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the UVC indicator made from initially transparent material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 6 Jain as modified discloses the packaging according to claim 1. Jain as modified discloses substantially all the limitations of the claim(s) except for the thickness of the UVC indicator. It would have been an obvious matter of design choice to for the thickness of the UVC indicator to be between 1 and 10 microns, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art
Regarding claim 8 Jain as modified discloses the packaging according to claim 1. Jain as modified discloses substantially all the limitations of the claim(s) except for having a second compartment provided with a UVC indicator located inside the bag. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have an additional compartment, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Additionally this allows for multiple items to be sterilized at the same time.
Regarding claim 9 Jain as modified discloses the packaging according to claim 8 and further discloses wherein a label (22) is provided with the UVC indicator, wherein the label is provided in the second compartment (can be mounted in various places and separate to the indicator, paragraphs [0028-0029] Fig. 4).
Regarding claim 10 Jain as modified discloses the packaging according to claim 8 and further wherein the first compartment and the second compartment are separated from each other (separated by the closed at the top and bottom when package is duplicated Fig. 5).
Regarding claim 13 Jain as modified discloses the packaging according to claim 1 and further the UVC indicator shows the level of exposure to UVC radiation (paragraph [0022] McGeorge).
Regarding claim 14 Jain as modified discloses the packaging according to claim 1.
Jain as modified discloses substantially all the limitations of the claim(s) except for the makeup of the photochromatic ink. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the ink contain between 15% by weight and 35% by weight of a UVC-sensitive pigment, and at least 65% by weight of a solvent, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 15 Jain as modified discloses the packaging according to claim 1. Jain as modified discloses substantially all the limitations of the claim(s) except for having a second and third compartment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have three compartments, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Additionally, all the compartments are suitable for receiving items associated with the object to be sterilized.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jain in view of Ludvig US 2012/0205269A1, herein after referred to as Ludvig
Regarding claim 7 Jain as modified discloses the packaging according to claim 1. Jain as modified is silent to first compartment (4) is provided with at least one opening (Fig. 2).
Ludvig teaches a packaging (10 pouch) with two walls (14 sheet and 16 sheet) defining a first compartment (Figs. 1-2) and the first compartment provided with at least one opening (24 open pouch end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the opening as taught by Ludvig as doing so is well known in the art and would yield predictable results. Additionally, it will allow the user to easily load and unload objects into the packaging.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jain in view of Lewis US 4,194,622, herein after referred to as Lewis.
Regarding claim 11 Jain as modified discloses the packaging according to claim 1. Jain is silent to the bag includes an appendage separate from the first compartment, wherein the appendage is provided with the UVC indicator.
Lewis teaches a bag (Figs. 1-4) including an appendage (20 triangular shaped portions, Fig. 1) separate from the first compartment (separated by the 24) and is provided with a sterilization indicator.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the package of Jain to include the appendage and sterilization indicator thereon as taught by Lewis as it is well known in the art and would yield predictable results as shown in Lewis. Further is indicator being separate from the first pouch allows the user to have an unimpeded view of the contents within.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jain in view of Lewis as applied to claim 11 and in further view of Dayton US 2017/0157279, herein after referred to as Dayton.
Regarding claim 12 Jain as modified discloses the packaging according to claim 11. Jain as modified is silent to where the UVC indicator is provided on a sticker, which sticker is provided on the appendage of the bag.
Dayton teaches a photochromic indicator for decontamination (UVC indicator) that is provided on a sticker (paragraph [0022], lines 9-13) and can be placed adjacent to the object to be decontaminated.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UVC indicator to be a sticker and place it on the appendage of the bag as taught by Dayton as doing so is well known in the art and would yield predictable results as shown by Dayton. Additionally, a sticker on the appendage allows the indicator to be easily replaced after use and will not prevent the user from seeing the contents of the bag.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that Jain does not disclose “two opposing walls, are made of an ultraviolet-C (UVC) transmissive thermoplastic polymer. Examiner disagrees. As stated in the rejection above Jain discloses two opposing walls (307 and 309) that are made from a UVC transmissive thermoplastic polymer (paragraphs [0068] lines 1-2 and paragraph [0070]). Applicant argues that Jain fails to disclose any UVC indicator, photochromic ink or structure for visually indicating UVC exposure. Examiner partially agrees. Jain fails to disclose a photochromic ink type indicator, but Jain does disclose a biologic UVC indicator (paragraph [0133]). McGeorge is used to teach a photochromic type UVC indicator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lauren Kmet whose telephone number is (313)446-4834. The examiner can normally be reached M-F 9am-6pm.
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/L KMET/ Examiner, Art Unit 3735
/Anthony D Stashick/ Supervisory Patent Examiner, Art Unit 3735
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