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
This is an office action in response to Applicant's arguments and remarks filed on 02/03/2026. Claims 1-4, 7-8, 12, 15-18, and 21-28 are pending in the application. Claims 1-4 and 7-8 have been withdrawn and claims 12, 15-18, and 21-28 are being examined herein.
Status of Objections and Rejections
The rejection of claim 29 is obviated by Applicant's cancellation.
All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 12, 15, 17-18, 21-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20130280134) in view of Chen (US 20100270304).
Regarding claim 12, Hoffman discloses a sterilization container (Fig. 1, container 1) comprising:
a rigid body (Fig. 2, rigid body = lower bottom component 20, para 0026) comprises a lower surface, an upper rim, and a plurality of side walls that extend between the lower surface and the upper rim (component 20 has plurality of side walls and upper rim, Fig. 2),
wherein the upper rim defines an opening to an interior space of the body (component 20 defines an opening to an interior space of the body, Fig. 2);
a rigid or semi-rigid lid that covers the opening of the body (Fig. 1, upper lid compartment 10, para 0026);
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wherein the rigid or semi-rigid lid comprises a valve bore (Fig. 3, valve 42, para 0028), and a recessed portion (see annotation below) that surrounds the valve bore
a flexible gasket arranged between the body and the lid (Fig. 3, gasket 30 positioned between lid rim 18 and upper periphery of body 20, para 0028).
Examiner notes that under broadest reasonable interpretation, one of ordinary skill in the art would assert the body (Fig. 2, 20) and lid (Fig. 2, 10) as disclosed by Hoffman to meet the limitation of a “rigid body” and “rigid lid” with a rigid body/lid being understood to include any body/lid formed from a firm, non-flexible material that enables a body/lid to have its own shape. It is also noted that Hoffman discloses an objective of the invention is to provide terminal sterilization containers that are durable and can be stacked for storage and transport (para 0018-0019), thus implying that the body/lid must be firm enough to withstand multiple containers being stacked on top of it and survive transport operations.
Hoffman fails to teaches a valve body arranged in the valve bore that is in fluid communication with the interior space of the body, the valve body comprising a first enlarged end on a first side of the valve bore and a second enlarged end on a second side of the valve bore opposite the first side and within the interior space of the body, the first enlarged end and the second enlarged end being larger than the valve bore, wherein the valve body is moveable between an open position and a closed position in which the valve body closes the valve bore and isolates the interior space of the body, wherein the valve body in the closed position is configured to maintain a negative pressure differential between the interior space of the rigid body and an external space exterior to the rigid body, and wherein the recessed portion of the lid is configured to fully accommodate the valve body when the valve body is in the open position.
One having ordinary skill in the art would be concerned with further regulating the partial vacuum within the container, motivating one to turn towards Chen. Chen teaches a sealed container (Fig. 1, 10) comprising a valve body arranged in a valve bore that is in fluid communication with the interior space of the container (Fig. 4, valve body 160 positioned in a valve bore), the valve body comprising a first enlarged end on a first side of the valve bore and a second enlarged end on a second side of the valve bore opposite the first side and within the interior space of the body the first enlarged end and the second enlarged end being larger than the valve bore (Fig. 7, 160 has enlarged end 162 on the outside and enlarged end 163 on the interior space of container wherein 163 is large than the valve bore), wherein the valve body is moveable between an open position and a closed position in which the valve body closes the valve bore and isolates the interior space of the body [0034-0036], wherein the valve body in the closed position is configured to maintain a negative pressure differential between the interior space of the rigid body and an external space exterior to the rigid body [0036], and wherein the recessed portion of the lid is configured to fully accommodate the valve body when the valve body is in the open position (Fig. 7, recess 101 accommodates valve body when open).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the container as taught by Hoffman with the recess and valve body as taught by Chen since Chen teaches the valve body to allow for the creation of a vacuum within the container and preserve the interior contents [0036] and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A).
Further, the Examiner notes the preamble of claim 12 recites language that is merely a statement of purpose that does not provide any distinct definition of the claimed invention’s limitations. Specifically, claim 12 recites “a sterilization container” but does not provide further structure of the “sterilization container” that would make it structurally different from the generic container as disclosed by Kim. Therefore, the preamble is not considered a limitation and is not being given patentable weight. See MPEP 2111.02(II).
Regarding claim 15, Modified Hoffman discloses the container according to claim 12, wherein the lid comprises one or more clips (Hoffman, Fig. 3, lid 10 includes horizontal pins 12A and 12B which cooperate with latching mechanism 24 on body 20, para 0027-28) that releasably engage the upper rim or sidewall of the body.
Regarding claim 17, Modified Hoffman discloses the container according to claim 12, wherein the valve body comprises a substantially planar top surface (Chen, valve body 160 has a substantially planar top surface 161)
Regarding claim 18, Modified Hoffman discloses the container according to claim 12, wherein the lid comprises one or more clips (Hoffman, Fig. 3, lid 10 includes horizontal pins 12A and 12B which cooperate with latching mechanism 24 on body 20, para 0027-28) that releasably engage the upper rim or sidewall of the body.
Regarding claim 21, Modified Hoffman discloses the container according to claim 12, wherein the first enlarged end and the second enlarged end of the valve body are connected by a valve stem, the valve stem disposed through the valve bore (Chen, Fig. 6, top end 162 and second end 163 are connected by a valve stem disposed through a valve bore).
Regarding claim 22, Modified Hoffman discloses the container body according to claim 21, wherein the valve body comprises at least one passageway along the valve stem, the at least one passageway configured to allow gases to pass through the valve bore in the open position of the valve body (Chen, Fig. 7, air vent 103 is positioned alongside valve stem and allows for the passage of air when the valve body is in the open position [0036]).
Regarding claim 23, Modified Hoffman discloses the container body according to claim 22, wherein the at least one passageway of the valve body further extends along the second enlarged end disposed within the interior space of the body (Chen, air vent 103 extends into recess 101 alongside second enlarged end 163).
Regarding claim 24, Modified Hoffman discloses the container body according to claim 12, wherein the first enlarged end of the valve body comprises a sealing surface configured to seal the valve bore in the closed position of the valve body (Chen, Fig. 6, first enlarged end has sealing surfaces 161 to seal the valve bore [0034-0035])
Regarding claim 25, Modified Hoffman discloses the container body according to claim 12, wherein the valve body is a single monolithic part (Chen, Fig. 7, valve body 160 is single monolithic part).
Regarding claim 27, Modified Hoffman teaches the sterilization container according to claim 12 (Hoffman, Fig. 1, 1) configured to be placed into an autoclave, wherein the container is exposed to high temperature steam (Hoffman, [0005-0007]). Modified Hoffman teaches wherein the valve bore is configured to open and close at predetermined temperatures, ([Hoffman, [0014]) understood to allow the steam (a sterilant) to enter the interior of container.
Claim(s) 16 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20130280134) in view of Chen (US 20100270304), further in view of Kim (WO 2020262760).
Regarding claim 16, Modified Hoffman discloses a flexible gasket arranged between the body and the lid (Hoffman, Fig. 3, gasket 30 positioned between lid rim 18 and upper periphery of body 20, [0028]) but fails to teach wherein the gasket is integrally formed with the lid.
Kim discloses a container (Fig. 3, 10) wherein the gasket is integrally formed with the lid (Fig. 3, sealing portion 210 integral with lid 200).
Generally, a mere integration of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.01(V)(B). Therefore, it would have been obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the lid as disclosed by Modified Hoffman to be integral with gasket also disclosed by Kim to eliminate an interface between the gasket and the lid and further reduce an area of contamination as well as increase the sealing properties of the sterilization container and this involves the integration of parts which has been found to be obvious (see MPEP 2144.01(V)(B)).
Regarding claim 26, Modified Hoffman discloses the container body according to claim 25 including a valve body (Chen, Fig. 7, valve body 160) but does not teach wherein the valve body is made of silicone.
Kim teaches a container (Fig. 5, 10) comprising a valve body (Fig. 4, 300 = valve body) arranged in a valve bore (Fig. 2, 260 = valve bore) that is in fluid communication with the interior space of the body, wherein the valve body 300 is formed in lid 200 which may be formed from silicone to be rolled (page 5, para 2, valve body also understood to be made of silicone if incorporated into silicone lid).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the material of the valve body as taught by Modified Hoffman to be made of silicone as taught by Kim since silicone was recognized to be a suitable material for the sealing of a container prior to the effective filing date of the invention. See MPEP 2144.07.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20130280134) in view of Chen (US 20100270304), as applied to claim 27 above, and further in view of Spencer (US 20200147253).
Regarding claim 28, Modified Hoffman teaches a sterilization container (Hoffman, Fig. 1, 1) configured to have a sterilant disposed inside the interior of the container, wherein the sterilant is steam (Hoffman, [0005-0007], [0014]). Modified Hoffman does not teach wherein the sterilant disposed inside the container comprises vaporized hydrogen peroxide.
Vaporized hydrogen peroxide is well known in the art as a suitable sterilant as exemplified by Spencer [0004], who teaches a sterilization container (Fig. 1, 100) configured to selectively allow the entry of vaporized hydrogen peroxide into the interior of said container [0028] through permeable vents 118 [0038].
Spencer and Modified Hoffman are considered analogous to the claimed invention since both are drawn to sterilization containers. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sterilization container as taught by Modified Hoffman to include the permeable vents as taught by Spencer since Spencer teaches the vents to allow for the selective transfer of chemical sterilization agents into the interior of a sterilization container to sterilize the contents [0038] wherein the agent may be vaporized hydrogen peroxide [0004, 0028] and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A).
Response to Arguments
In the arguments presented on page 1-3 of the amendment, filed 02/03/2026, the Applicant argues that one having ordinary skill in the art would not have been motivated to combine the check valve 300 as taught by Kim with the device of Hoffman since the check valve operates to vent pressure from inside the container, not maintain a partial vacuum within the container with respect to the rejection(s) of claim(s) 12 (the scope of which was previously presented in claim 29, now cancelled) under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the art Chen (US 20100270304). See rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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