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 .
Status of Claims
This office action is in response to Applicant' s Request for Continued Examination filed on 24 April 2026.
Claims 1 – 13, 15 – 16, 18 – 19, 21 – 26, and 29 are pending. Claims 14, 17, 20, and 27 – 28 are cancelled by Applicant.
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 April 2026 has been entered.
Drawings
The drawings were amended on 24 April 2026. These drawings are acceptable.
Claim Objections
Claim 1 is objected because of the following informalities:
Regarding claim 1, the term, “and”, in lines 15 and 17, should be removed.
Appropriate correction is required.
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.
Claims 1 – 13, 15 – 16, 18 – 19, 21 – 26, and 29 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, lines 19 – 20, the limitation, “the bottom face”, is indefinite because the limitation lacks antecedent basis. For the purpose of compact prosecution, the Examiner interprets the limitation, “the bottom face”, to mean “a bottom face”. Please note, since claims 2 – 13, 15 – 16, 18 – 19, 21, and 29 depend upon claim 1, claims 2 – 13, 15 – 16, 18 – 19, 21, and 29 are likewise rejected under 35 USC §112(b) for indefiniteness. Additionally, since independent claim 22 recites, “providing the package according to claim 1, claim 22 and claims 23 – 26 which depend upon claim 22 are also rejected under 35 USC §112(b) for indefiniteness.
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 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.
Claims 1 – 8, 10 – 13, 15 – 16, 18 – 19, 21 – 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Duddy (US 2012/0195792 A1), in view of Smith (US 8 418 872 B2), in further view of Rainin (US 4 676 377 A1).
Regarding claim 1, Duddy discloses a box-shaped package, comprising:
a base (second container portion 324, fig. 8), and
a cover (first container portion 322, fig. 8) configured to be placed on the base to close the package, wherein:
in a closed configuration of the package, an interface between the base and the cover is gas-tight ([0023] describes that when the first container portion/cover and second container portion/base are in a closed position, the resulting sterilization container has a fully impenetrable barrier between the interior atmosphere and the exterior atmosphere indicating that the interface between the first container portion/cover and second container portion/base in this closed position is gas-tight);
the base and cover comprise one or more gas-permeable zones (filter 340, fig. 8. Figure 8 shows a filter 340 on both the first container portion 322 and the second container portion 324) the which are capable of passing gases into and out from the package in the closed configuration;
wherein the package further comprises a first seal element ([0033] describes a latch 150 on the second container portion/base including or being integral with a gasket system or seal that creates a sterilization tight seal between the first and second container portions. The examiner deems this gasket system or seal as the claimed, “a first seal element”), and
wherein at least one zone of said one or more gas-permeable zones is located in a bottom face of the base and is recessed from the bottom face of the base (Figure 8 shows a first filter 340 recessed on an exterior, top face of the first container portion 322 and shows a second filter 340 protruding from an interior, bottom face of the second container 324 implying or obvious to one having ordinary skill in the art that this second filter 340 is also recessed on an exterior, bottom face of the second container portion 324 in the same way as the first filter 340 is recessed. This is further evident or made obvious in figure 3 showing the filter protruding from an interior, top face of the first container portion in the same way as the second filter 340 is protruding from an interior, bottom face of the second container 324 shown in figure 8).
Duddy does not disclose the material of the base and the cover outside the one or more gas-permeable zones.
However, Smith, in the same field of endeavor, teaches the material of a base (tray 40, fig. 1) and a cover (lid 30, fig. 1) outside the one or more gas-permeable zones (filter 34, fig. 1) comprises a plastic material (Col. 7, ll. 8 – 15 describes a tray 40 and a lid 30 made of a plastic polymer).
Smith is evidence that having the material of the base and the cover outside the one or more gas-permeable zones comprise plastic was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the box-shaped package of Duddy such that the material of the base and the cover outside the one or more gas-permeable zones comprises plastic, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the box-shaped package of Duddy as described above because plastic is resistant to many chemicals and can withstand high temperatures which is crucial for many sterilization processes. Additionally, while Duddy describes the base and the cover, Duddy is silent regarding the material of the base and the cover thus the one having ordinary skill in the art would have been motivated look to Smith for acceptable materials for the base and the cover to build the invention of Duddy.
Duddy discloses the first seal element as a gasket system or seal on the base ([0033]).
Duddy does not explicitly disclose that the first seal element is on a perimeter of an open top end of the base and the first seal element is fixed to and runs on the perimeter of the top end of the base along the entire length of the perimeter.
However, Smith, in the same field of endeavor, teaches a first seal element (tray lip 42, fig. 1) being on a perimeter of an open top end of a base (tray 40, fig. 1) (As shown in figure 1) and the first seal element is fixed to and runs on the perimeter of the open top end of the base along the entire length of the perimeter (As shown in figure 1).
Smith is evidence that having the first seal element on the perimeter of the open top end of the base and the first seal element being fixed to and running on the perimeter of the open top end of the base along the entire length of the perimeter was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the gasket system or seal of Duddy such that the gasket system or seal is on the perimeter of the open top end of the base and the gasket system or seal is fixed to and runs on the perimeter of the open top end of the base along the entire length of the perimeter, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the box-shaped package of Duddy as described above because while Duddy describes the gasket system or seal to create a sterilization tight seal between the base and the lid, Duddy is silent regarding the structure, the material, and the installation of the gasket system or seal and the one having ordinary skill in the art would have been motivated look to Smith for this structure and installation to build the invention of Duddy.
Duddy discloses the package further comprises a tray (tray 330, 331, fig. 1) which may be any type of medical instrument tray or holding structure ([0024]), wherein this tray is located in an interior of the base (As shown in figure 8) .
The modified Duddy does not explicitly disclose the package further comprises disposable tips for a liquid handling device, wherein the tips are supported by a plate-formed tip tray located in an interior of the base, and wherein the tips have been inserted into respective openings in the tip tray.
However, Rainin, in the same field of endeavor, teaches a box-shaped package (container 12, cover 30, fig. 1) comprising disposable tips (tips 28, fig. 1) for a liquid handling device, wherein the disposable tips are supported by a plate-formed tip tray (tray 22, fig. 1) located in an interior of a base (container 12, fig. 1), and wherein said tips have been inserted into respective openings (openings 118, fig. 2) in the tip tray.
Rainin is evidence that having the package further comprise the disposable tips for the liquid handling device, wherein these disposable tips are supported by the plate-formed tip tray located in the interior of the base, and wherein these disposable tips are inserted into respective openings in the tip tray was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success replacing the trays of Duddy and modifying the package of Duddy such the package comprises the disposable tips for the liquid handling device, these disposable tips are supported by the plate-formed tip tray located in the interior of the base, and these tips are inserted into the respective openings in the tip tray, as taught by Rainin. Additionally, the one having ordinary skill in the art would have been motivated to replace the trays of Duddy and to modify the package of Duddy as described above in order to provide a package that supports pipette tips as needed by a user and to have a tip tray that holds these pipette tips so that these pipette tips do not touch the inside bottom of the base or the inside top of the cover which may contaminate the pipette tips.
Regarding claim 2, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses said one or more gas-permeable zones (filter 340, fig. 8) are non-permeable to microbes ([0026] describes the filter prevent any substance or microorganism from gaining access to the interior of the sterilization container).
Regarding claim 3, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses said one or more gas-permeable zones (filter 340, fig. 8) are configured to prevent build-up of a pressure difference between an interior of the package and the surroundings of the package in the closed configuration ([0026] describes the filter is air permeable thus the air would be able to move between the interior of the sterilization container and the exterior atmosphere preventing a build-up of a pressure difference between the interior of the sterilization container and the surroundings of sterilization container in the closed configuration).
Regarding claim 4, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses said one or more gas-permeable zones (filter 340, fig. 8) are configured to reduce pressure differences between an interior of the package and the surroundings of the package in the closed configuration ([0026] describes the filter is air permeable thus the air would be able to move between the interior of the sterilization container and the exterior atmosphere preventing pressure differences between the interior of the sterilization container and the surroundings of sterilization container in the closed configuration).
Regarding claim 5, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy does not explicitly disclose said one or more gas-permeable zones comprise or consist of a film material which is permeable to gases.
However, Smith, in the same field of endeavor, teaches said one or more gas-permeable zones (filter 34, fig. 1) comprise or consist of a film material which is permeable to gases (The plain meaning of the term, "film", is "a thin sheet of any material" - Oxford English Dictionary. Col. 5, I. 64 - col. 6, I. 14 describes a filter 34 using a gas-permeable filter material such as a medical grade paper called AMCOR PLP reinforced coated paper wherein the examiner deems this medical grade paper as a film material).
Smith is evidence that having the one or more gas-permeable zones comprise or consist of the gas-permeable film material was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the filter of Duddy with the gas-permeable film material, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the filter of Duddy with the gas-permeable film material, as taught by Smith, because while Duddy describes a filter, Duddy is silent regarding the structure or the material of the filter and the one having ordinary skill in the art would have been motivated look to Smith for this structure and material to build the invention of Duddy.
Regarding claim 6, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses a material of said one or more gas-permeable zones (filter 340, fig. 8) is more permeable to gases than a material of other parts of the package ([0023] describes when the first container portion/cover and second container portion/base are in a closed position, the resulting sterilization container has a fully impenetrable barrier between the interior atmosphere and the exterior atmosphere wherein only the filter permits a transmission of a gas between the interior atmosphere and the exterior atmosphere. Thus, the filter is more permeable to gases since the material of the other parts of the sterilization container 20 are a fully impenetrable or impermeable to gases).
Regarding claim 7, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses the package permeates gases only through said one or more gas-permeable zones (filter 340, fig. 8) in the closed configuration ([0023] describes when the first container portion/cover and second container portion/base are in a closed position, the resulting sterilization container has a fully impenetrable barrier between the interior atmosphere and the exterior atmosphere wherein only the filter permits a transmission of a gas between the interior atmosphere and the exterior atmosphere).
Regarding claim 8, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy does not explicitly disclose a material of said one or more gas-permeable zones comprises one or more materials selected from the group consisting of a paper-based material and high-density spunbound polyethylene.
However, Smith, in the same field of endeavor, teaches said one or more gas-permeable zones (filter 34, fig. 1) comprises a paper-based material (Col. 5, I. 64 - col. 6, I. 14 describes a filter 34 using a gas-permeable filter material such as a medical grade paper called AMCOR PLP reinforced coated paper).
Smith is evidence that having the one or more gas-permeable zones comprise a paper-based material was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the filter of Duddy with the gas-permeable paper-based material, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the filter of Duddy with the gas-permeable paper-based material, as taught by Smith, because while Duddy describes a filter, Duddy is silent regarding the structure or the material of the filter and the one having ordinary skill in the art would have been motivated look to Smith for this structure and material to build the invention of Duddy.
Regarding claim 10, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy discloses in the closed configuration said one or more gas-permeable zones (Duddy – filter 340, fig. 8) are separate from the interface between the base and the cover ([0033] of Duddy describes a latch 150 on the second container portion having a gasket or seal that creates a sterilization tight seal between the first and second container portions wherein Smith teaches this gasket would be on the perimeter of the open top end of the second container portion 324. This differs from the location of the filters 340 which are positioned on the top face of the first container portion 322 and the bottom face of the second container portion 324 – as shown in figure 8).
Regarding claim 11, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses outside said one or more gas-permeable zones (filter 340, fig. 8) the base and the cover are not capable of passing gases into or out from the package ([0023] describes when the first container portion/cover and second container portion/base are in a closed position, the resulting sterilization container has a fully impenetrable barrier between the interior atmosphere and the exterior atmosphere wherein only the filter permits a transmission of a gas between the interior atmosphere and the exterior atmosphere).
Regarding claim 12, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy discloses the material of the base (Duddy – second container portion 324, fig. 8) and of the cover (Duddy – first container portion 322, fig. 8) comprises or consists of a thermoplastic material (Smith – Col. 7, ll. 8 – 9 describes the tray 40 and the lid 30 made of plastic polymer such as nylon wherein nylon is a type of thermoplastic).
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[AltContent: textbox (A)][AltContent: textbox (B)][AltContent: textbox (C)][AltContent: textbox (D)][AltContent: textbox (E)][AltContent: textbox (W)][AltContent: textbox (X)][AltContent: textbox (Y)][AltContent: textbox (Z)][AltContent: textbox (V)][AltContent: textbox (Duddy (US 2012/0195792 A1)
Annotated figure 8)]
Regarding claim 13, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy discloses the base (Duddy – second container portion 324, fig. 8) is box-shaped (Duddy – The plain meaning of the term, "box", is "a square or rectangular container with stiff sides" – Cambridge dictionary, thus the examiner interprets the limitation, "box-shaped", as square or rectangular. Figure 8 shows the second container portion 324 as square or rectangular) and comprises four lateral sidewalls (Duddy – walls A, B, C, D, annotated fig. 8) and a bottom face (Duddy – face E, annotated fig. 8), the base having the open top end in an opened configuration (Duddy – As shown in figure 8); wherein the cover (Duddy – first container portion 322, fig. 8) is box-shaped (Duddy – Figure 8 shows the first container portion 322 as square or rectangular) and comprises four lateral sidewalls (Duddy – walls V, W, X, Y, annotated fig. 8) and a top face (Duddy – face Z, annotated fig. 8), the cover having an open bottom end in the opened configuration (As shown in figure 8); wherein the openings (Rainin – openings 118, fig. 2) in the tip tray (Rainin – tray 22, fig. 2) are adapted for receiving and holding the disposable tips (Rainin – tips 28, fig. 2) for the liquid handling device; wherein, in the closed configuration of the package, said cover lies on the base, the open top end of the base and the open bottom end of the cover face each other (Duddy – As shown in figure 8), and the perimeter of the base and the perimeter of the cover engage with each other via said first seal element ([0033] of Duddy describes a latch 150 on the second container portion having a gasket or seal that creates a sterilization tight seal between the first and second container portions wherein Smith teaches this gasket would be on the perimeter of the open top end of the second container portion 324 in the same way as tray lip 42 in Smith. As shown figures 1 and 2 of Smith).
Regarding claim 15, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy discloses said first seal element is configured to hermetically seal the interface between the base and the cover in the closed configuration of the package ([0033] of Duddy describes a latch 150 on the second container portion having a gasket or seal that creates a sterilization tight seal between the first and second container portions wherein [0023] describes when the first container portion/cover and second container portion/base are in a closed position, the resulting sterilization container has a fully impenetrable barrier between the interior atmosphere and the exterior atmosphere (i.e., a hermetically sealed interface)).
Regarding claim 16, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy discloses said first seal element runs on and along the entire perimeter of the open top end of the base ([0033] of Duddy describes a latch 150 on the second container portion having a gasket or seal that creates a sterilization tight seal between the first and second container portions wherein Smith teaches this gasket would run on and along the entire perimeter of the open top end of the second container portion 324 in the same way as the tray lip 42 in Smith. Figures 1 and 2 of Smith shows the tray lip 42 running on and along the entire perimeter of the open top end of the tray 40).
Regarding claim 18, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy discloses the material of the first seal element (Smith – 42, fig. 1) comprises or consists of a thermoplastic elastomer material selected from the group consisting of thermoplastic polyolefin elastomers (Col. 3, II. 17 - 22 describes the rim of the tray made of material that is heat activated during steam sterilization to secure the lid to the tray wherein such materials include hot melt adhesives made from polyolefins wherein polyolefins are a family of thermoplastic elastomers).
Regarding claim 19, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy does not explicitly disclose the package being hermetically re-sealable such that said first seal element is configured to repeatedly hermetically seal the interface between the base and the cover upon repeated closures of the package.
However, Smith, in the same field of endeavor, teaches the package being hermetically re-sealable such that said first seal element (tray lip 42, fig. 1) is configured to repeatedly hermetically seal the interface (barrier 60, fig. 2) between the base (tray 40, fig. 1) and the cover (lid 30, fig. 1) upon repeated closures of the package (Col. 7, ll. 12 – 15 describes the tray 40 and the lid 30 being reusable).
Smith is evidence that having the package being hermetically re-sealable such that the first seal element is configured to repeatedly hermetically seal the interface between the base and the cover upon repeated closures of the package was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the package of Duddy with the package being hermetically re-sealable such that the first seal element is configured to repeatedly hermetically seal the interface between the base and the cover upon repeated closures of the package, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the package of Duddy as described above because reusing the package saves money by avoiding the need of repeatedly purchasing disposable alternatives.
Regarding claim 21, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy discloses outside said one or more gas-permeable zones (Duddy – filter 340, fig. 8), the material of the base and of the cover comprises a thermoplastic material (Smith – Col. 7, ll. 8 – 9 describes the tray 40 and the lid 30 made of plastic polymer such as nylon wherein nylon is a type of thermoplastic), and wherein the package further comprises the disposable tips (Rainin – tips 28, fig. 1) for the liquid handling device.
Duddy does not explicitly disclose said one or more gas-permeable zones comprises a paper-based material or high-density spunbound polyethylene.
However, Smith, in the same field of endeavor, teaches said one or more gas-permeable zones (filter 34, fig. 1) comprises a paper-based material (Col. 5, I. 64 - col. 6, I. 14 describes a filter 34 using a gas-permeable filter material such as a medical grade paper called AMCOR PLP reinforced coated paper).
Smith is evidence that having the one or more gas-permeable zones comprise a paper-based material was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the filter of Duddy with the gas-permeable paper-based material, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the filter of Duddy with the gas-permeable paper-based material, as taught by Smith, because while Duddy describes a filter, Duddy is silent regarding the structure or the material of the filter and the one having ordinary skill in the art would have been motivated look to Smith for this structure and material to build the invention of Duddy.
Regarding claim 22, Duddy, as modified by Smith, as further modified by Rainin, discloses the method, comprising:
providing the package according claim 1 (see claim 1), and
sterilizing said package in the closed configuration by a gas sterilization process (Duddy – [0021] describes the sterilization container 20 being sterilized in a variety of sterilization environments such an autoclave wherein an autoclave is a gas sterilization process using high-pressure saturated steam).
Regarding claim 23, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 22.
The modified Duddy disclose sterilizing is carried out by the gas sterilization process in which a bactericidal gas is used as a sterilizing gas (Duddy – [0021] describes the sterilization container 20 being sterilized in a variety of sterilization environments such an autoclave wherein an autoclave is a gas sterilization process using high-pressure saturated steam. Steam is a bactericidal gas that can rapidly kill bacteria and other microorganisms), and wherein said one or more gas-permeable zones (Duddy – filter 340, fig. 8) are permeable to said bactericidal gas (Duddy – [0027]).
Regarding claim 24, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 22.
Duddy does not explicitly disclose sterilizing is carried out by the gas sterilization process in which ethylene oxide is used as a sterilizing gas, and wherein said one or more gas-permeable zones are permeable to the ethylene oxide.
However, Smith, in the same field of endeavor, teaches sterilizing is carried out by the gas sterilization process in which a ethylene oxide is used as a sterilizing gas (Col. 12, II. 62 – 66 describes a gas sterilization process using ethylene oxide), and wherein said one or more gas-permeable zones (filter 34, fig. 1) are permeable to the ethylene oxide (Col. 5, II. 24 - 26 describes the permeable filter 34 providing a path for a sterilant - in this case, ethylene oxide).
Smith is evidence that sterilizing is carried out by the gas sterilization process in which ethylene oxide is used as a sterilizing gas, and wherein said one or more gas-permeable zones are permeable to the ethylene oxide was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of Duddy with sterilizing is carried out by the gas sterilization process in which ethylene oxide is used as a sterilizing gas, and wherein said one or more gas-permeable zones are permeable to the ethylene oxide, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the method of Duddy as described above because sterilizing with ethylene oxide is more ideal for heat- and moisture-sensitive materials and materials having complex device structures.
Regarding claim 25, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 22.
Duddy discloses said one or more gas-permeable zones (Duddy – filter 340, fig. 8) are non-permeable to microbes that a bactericidal gas is capable of exterminating during said gas sterilization process (Duddy – [0027]).
Regarding claim 26, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy does not explicitly disclose after said sterilizing step, and after opening the package, the package is hermetically re-sealable by closing the cover and bringing the package back to the closed configuration.
However, Smith, in the same field of endeavor, teaches after said sterilizing step, and after opening the package, the package is hermetically re-sealable by closing the cover and bringing the package back to the closed configuration (Col. 7, ll. 12 – 15 describes the tray 40 and the lid 30 being reusable implying the tray 40 and lid 30 being useable after a sterilizing step).
Smith is evidence that after said sterilizing step, and after opening the package, the package being hermetically re-sealable by closing the cover and bringing the package back to the closed configuration was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the method of Duddy with after said sterilizing step, and after opening the package, the package is hermetically re-sealable by closing the cover and bringing the package back to the closed configuration, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the method of Duddy as described above because reusing the package saves money by avoiding the need of repeatedly purchasing disposable alternatives.
Regarding claim 29, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
Duddy does not explicitly disclose the package is configured, after a sterilization step and then opening, to be hermetically re-sealable by closing the cover and bringing the package back to a closed configuration.
However, Smith, in the same field of endeavor, teaches the package is configured, after a sterilization step and then opening, to be hermetically re-sealable by closing the cover (lid 30, fig. 1) and bringing the package back to a closed configuration (Col. 7, ll. 12 – 15 describes the tray 40 and the lid 30 being reusable implying the tray 40 and lid 30 being useable after a sterilizing step).
Smith is evidence that after said sterilizing step, and after opening the package, the package being hermetically re-sealable by closing the cover and bringing the package back to the closed configuration was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention. Therefore, the one having ordinary skill in the art would have had a reasonable expectation of success modifying the package of Duddy with the package is configured, after a sterilization step and then opening, to be hermetically re-sealable by closing the cover and bringing the package back to a closed configuration, as taught by Smith. Moreover, it would have been obvious to the one having ordinary skill in the art to have modified the method of Duddy as described above because reusing the package saves money by avoiding the need of repeatedly purchasing disposable alternatives.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Duddy (US 2012/0195792 A1), in view of Smith (US 8 418 872 B2), in further view of Rainin (US 4 676 377 A1), in further view of Frieze (US 2005/0238530 A).
Regarding claim 9, Duddy, as modified by Smith, as further modified by Rainin, discloses the invention as recited in claim 1.
The modified Duddy does not explicitly disclose the one or more gas- permeable zones comprise high-density spun-bound polyethylene.
However, Frieze teaches a similar package having one or more gas-permeable zones (vents 114 having a filter 124 in a top face of the lid 24, fig. 5A) comprising high-density spun-bound polyethylene ([0080], II. 25 - 35 describes when steam or ethylene oxide is used as a sterilizing agent, paper or the Tyvek® brand of spun-bound polyethylene can be used).
Because the filter material of Duddy and the filter material of Frieze having the high-density spun-bound polyethylene both inhibit microorganisms from passing through the filter in a sterilization container system, the filter material of Duddy and the filter material of Frieze are functional equivalents.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the filter material of Duddy for the filter material of Frieze having the high-density spun-bound polyethylene to achieve the predictable result of inhibiting microorganisms from passing through the filter in a sterilization container system.
Response to Arguments
Applicant’s amendments, filed 24 April 2026, with respect to the rejection(s) of claim(s) 1 – 13, 15 – 16, 18 – 19, and 21 – 26 under 35 U.S.C. §112(b) have been fully considered and are persuasive. Therefore, the rejection(s) has been withdrawn.
Applicant’s arguments with respect to the rejection(s) of claims 1 – 13, 15 – 16, 18 – 19, and 21 – 26 under 35 U.S.C. §103 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 DAVID G SHUTTY whose telephone number is 571-272-3626. The examiner can normally be reached 7:30 am - 5:30 pm, Monday - Friday.
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/DAVID G SHUTTY/Examiner, Art Unit 3731
1 May 2026
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