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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/22/2025 has been entered.
Response to Amendment/Arguments
The Amendment filed 8/22/2025 has been entered. Claims 1-16 remain pending on the application. Claims 7-16 are withdrawn, pursuant to Applicant’s election of claims 1-6 in the reply filed 4/19/2024.
Applicant argues:
The Office's basis for rejecting claim 1 relies on the phrase "polypropylene resin construction" in the "Autoclave Bags and Liners" product sales web page. As an initial matter, Applicant respectfully submits that the "Autoclave Bags and Liners" sales page does not provide enough information to indicate whether, in fact, the polypropylene resin construction constitutes one nonwoven textile or additional components. The phrase "polypropylene resin construction" is vague and generic. Furthermore, polypropylene resin can be made into either a film or a nonwoven textile (see Dixit paragraphs [18] and [19]) and the cited art, alone or in combination, gives no guidance as to which is preferred.
Examiner submits that one of ordinary skill in the art looking to replicate the bag would only know to construct the bag out of polypropylene, and thus "polypropylene resin construction" would be interpreted to only teach polypropylene as a material. Anything other than polypropylene would be outside the scope of what the prior art teaches. Moreover, within Applicant’s own claim, the single nonwoven textile can comprise one or more layers of different materials that may be used in combination, which means that “one nonwoven textile” may still include at least two materials in combination. That is, even if the polypropylene resin construction did include other components, it could be interpreted as one nonwoven textile by the same standard as that of the instant claim. In addition, "Autoclave Bags and Liners" teaches the need for high heat resistance, which motivates the modification by "MSDS" to specifically use spunbond polypropylene, which is a nonwoven textile. In fact, par. 18 of Dixit specifically mentions that spunbonded polypropylene is a nonwoven textile but does not list spunbonded polypropylene as a film material (par. 18: In the first embodiment, the porous nonwoven fabric layer provides the laminate with air/gas permeability, tear resistance and shrink resistance in heat. The preferred nonwovens would be spunbonded polyester (PET), polypropylene (PP)).
In fact, the ordinarily-skilled artisan, reading the combined teachings of the "Autoclave Bags and Liners" sales page and Dixit, would expect to have the most success including additional materials in the bags. Dixit, for example, teaches that paper exhibits superior printability compared to cloth, film, or nonwoven fabrics (see paragraph [10]. The "Autoclave Bags and Liners" sales page indicates that the bags feature English and Spanish language printed text as well as a printed Universal Biohazard Symbol. Since the "Autoclave Bags and Liners" page does not offer enough information to exclude other materials, the ordinarily-skilled artisan following the teachings of these references combined would be motivated to include the laminated paper portion of Dixit in order to improve printability of the text on the bags (assuming paper is not already present in the "Autoclave Bags and Liners" and simply not mentioned in the product description). It is also noted that the ink printed on the "Autoclave Bags and Liners" constitutes an additional component beyond the claimed one nonwoven textile.
Furthermore, the "Autoclave Bags and Liners" page indicates that the autoclave bags described therein have "an integrated heat/steam indicator (minimizing the amount of tagging/marking required)." It is understood in the art that heat/steam indicators cannot be made from one nonwoven textile without further indicator components Various indicator components exist, but such indicators are made with chemical indicator ink that changes colors upon sufficient exposure to heat or steam. Applicant respectfully refers the Examiner to the "Quality assurance" section of the non-patent literature document "Autoclave" submitted with this response for a description of commonly-used indicators.
Meanwhile, "MSDS" is relied upon for properties of polypropylene spunbond nonwoven fabric and does not remedy the deficiencies present in the combined teachings of "Autoclave Bags and Liners" document and Dixit.
In sum, the "Autoclave Bags and Liners" non-patent literature document necessarily includes components (printing ink, integrated heat/steam indicator) not presently allowed for in claim 1 as amended and claims dependent therefrom. Furthermore, the combination of cited references suggests better results will be achieved by incorporating a laminated paper for printability, and does not offer teachings as to whether films or nonwoven textiles are preferred. For at least these reasons, Applicant respectfully requests the rejection be withdrawn.
On page 5 of “Autoclave Bags and Liners”, an integrated heat/steam indicator, English/Spanish language printed text, and a printed Universal Biohazard Symbol are listed as “Add-ons”, which are interpreted as optional. Therefore, the NPL teaches both a bag consisting solely of the polypropylene resin construction, and a bag consisting of the polypropylene construction plus the add-ons.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over “Autoclave Bags and Liners” (NPL 2019) in view of Dixit (WO 03068505 A1) and “Material Safety Data Sheet (MSDS)” (NPL 2018, hereinafter referred to as “MSDS”).
Regarding claim 1, “Autoclave Bags and Liners” teaches A system for sterilizing waste, comprising a receptacle configured to receive and contain the waste during sterilization (pg. 2: Some of the autoclave applications where high temperature bags and liners are used are: medical waste),
wherein the receptacle is bag consisting of one nonwoven textile, wherein the nonwoven textile consists of one or more layers of polypropylene (PP) (pg. 2: polypropylene resin construction), polyamide (PA), polyethylene terephthalate (PET), silicone, polyvinylidene fluoride (PVDF), such as polytetrafluoroethylene (PTFE), polyaramid, polyimide, polyetherimide, or a combination thereof,
and wherein the bag optionally comprises a closure (since this limitation is optional, the prior art does not need to read on it)
but does not teach
and wherein the nonwoven textile is water permeable.
Dixit teaches a nonwoven fabric for containing an item for sterilization in an autoclave (abstract: A novel approach is offered to produce a sterilizable medical package by laminating either a nonwoven fabric… autoclave). Dixit teaches wherein a spunbond polypropylene material can be used for the nonwoven fabric to provide gas permeability (par. 18: In the first embodiment, the porous nonwoven fabric layer provides the laminate with air/gas permeability, tear resistance and shrink resistance in heat. The preferred nonwovens would be spunbonded polyester (PET), polypropylene (PP)… The type of spunbonding; par. 4: More particularly, the present invention relates to an improved sterilizable laminate that is flexible, non-rigid, air/gas-permeable, steam permeable), which is advantageous because it allows sterilant gases such as steam to enter and exit the fabric without breaking the fabric seal (par. 6: During heat sterilization, the packaging must be permeable to both air and steam so that gas inside the package can diffuse. However, the package must also resist the entry of bacteria and pathogens during and after the sterilization process, keeping the package and its contents sterile until opening. Without sufficient air permeability, sterilization may cause the seal to open due to the build up of pressure inside the package).
“Autoclave Bags and Liners” teaches a polypropylene resin construction but does not teach what kind of resin construction. Dixit provides a specific kind to fulfill this need.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify “Autoclave Bags and Liners” to be composed of porous, steam-permeable, spunbonded polypropylene, as taught by Dixit, in order to provide a suitable type of polypropylene resin construction that allows entry and discharge of the steam sterilant without breaking the seal of the sterilization wrap if the wrap is sealed.
In light of this modification, “Autoclave Bags and Liners” modified by Dixit teaches and heat resistant at a temperature of up to about 320 F in view of “MSDS”/
“MSDS” provides the material properties polypropylene spunbound nonwoven fabric, wherein this material has a melting point of 165 C (pg. 2; NOTE: this is equivalent to 329 F). Thus, the spunbonded polypropylene of Dixit would be temperature resistant up to 320 F.
Regarding claim 2, “Autoclave Bags and Liners” modified by Dixit teaches the system of claim 1, as set forth above, and teaches wherein the one or more layers of the nonwoven textile are selected from carded, air laid, wet laid, spunbond (see Dixit modification in claim 1 rejection), melt- blown, spunlaid, flashspun, staple nonwoven, spunbond + meltblown + spunbond (SMS), or combinations thereof
Regarding claim 3, “Autoclave Bags and Liners” modified by Dixit teaches the system of claim 2, as set forth above, and teaches wherein at least one layer of the one or more layers of the nonwoven textile consists of polypropylene (pg. 2: polypropylene resin construction).
Regarding claim 4, “Autoclave Bags and Liners” modified by Dixit teaches the system of claim 1, as set forth above, and teaches wherein the closure is selected from a flap, a drawstring, and a tie (NOTE: since the closure was optional to begin with, the prior art does not need to read on a specific type of closure).
Regarding claim 5, “Autoclave Bags and Liners” modified by Dixit teaches the system of claim 1, as set forth above, and teaches wherein the system further comprises an autoclave (pg. 2: Some of the autoclave applications where high temperature bags and liners are used are) and an autoclave bin (pg. 2: Autoclaving guidelines… selecting the right bin liner), and the receptacle is a liner for the autoclave bin (Title: Autoclave Bags and Liners).
Regarding claim 6, “Autoclave Bags and Liners” modified by Dixit teaches the system of claim 5, as set forth above, and teaches wherein the receptacle does not adhere to the autoclave bin after autoclaving (NOTE: since the prior art has the same materials and structure as that of the instant invention, it would also be capable of the same function of not adhering to the autoclave bin after autoclaving, and moreover, whether or not it adheres is also dependent upon the sterilization cycle conditions, so that this is a recitation of intended use).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A. Robinson can be reached on (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796