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 .
Claim Interpretation
Regarding limitations recited in claims 1-6 and 22-27, which are directed to a manner of operating disclosed reactor, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim. See Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969) that states “Expressions relating the apparatus to contents thereof and to an intended operation are of no significance in determining patentability of the apparatus claim.”
Regarding the method limitations recited in claim(s) 1-6 and 22-27 the examiner notes that even though a product-by-process is defined by the process steps by which the product is made, determination of patentability is based on the product itself. In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). As the court stated in Thorpe, 777 F.2d at 697, 227 USPQ at 966 (The patentability of a product does not depend on its method of production. In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969). If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 2, 22-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seiko Epson Corp. (JP 2002/168348 A, cited in IDS filed 06/05/2020), in view of Peterson (USP 3,095,619) and Hammar et al. (US 2005/0250909 A1).
Regarding claims 1, 22-23, and 25, Seiko Epson Corp. discloses a sealing assembly for a sterilization packaging system, the sealing assembly (Fig. 1) comprising:
a gasket having an outer edge, an inner edge, and an upper surface and a lower surface each extending from the outer edge to the inner edge (see: O-ring 10 with cylindrical cross-section),
wherein the gasket consists of an outer layer and an inner core, the outer layer surrounding the inner core on the outer edge, inner edge, upper surface, and lower surface (see: internal signal member 102 enveloped by the O-ring surface 101),
wherein the outer layer includes a first material compounded with a first colored pigment, and the inner core includes a second material compounded with a second colored pigment ([0014], see: internal signal member has a color that can be visually compared with thew O-ring surface),
wherein the first material surrounds the second material on the outer edge, inner edge, upper surface, and lower surface (see: internal signal member 102 enveloped by the O-ring surface 101),
wherein a sufficient level of contrast exists between the outer layer and the inner core to detect a breach of the outer layer ([0014], see: identifiable internal signal member that is exposed as the O-ring surface deteriorates).
Seiko Epson Corp. does not explicitly disclose the first material comprises a foam selected from at least one of foamed polyurethane, foamed silicones, foamed polyvinyl chloride (PVC), foamed elastomers, foamed polyvinylidene chloride (PVDC), polyvinylidene chloride (PVDF).
Peterson teaches an analogous seal (Fig. 24) comprising an insert material (88) made out of a puffable material/compressed foamed epoxy resin, wherein the puffable material/compressed foamed epoxy resin is selected from a group including polyurethane (Claim 2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to select the gasket material taught by Peterson for the outer layer of the O-ring disclosed by Seiko Epson Corp., 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. In re Leshin, 125 USPQ 416. In this particular instance, once having ordinary skill in the art would have been motivated to do so in order to provide for increased compressibility, thereby providing for improved seal conformation (Peterson: C10/L55-65).
Seiko Epson Corp. does not explicitly disclose the second material comprises a titanium dioxide filler.
Hammar teaches an analogous gasket material comprising PTFE, a thermoplastic polymer, and a titanium dioxide filler which provides increased creep resistance ([0027]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to select the gasket material taught by Hammar for the inner core of the O-ring disclosed by Seiko Epson Corp., 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. In re Leshin, 125 USPQ 416. In this particular instance, once having ordinary skill in the art would have been motivated to do so in order to provide for the increased creep resistance, resulting in a more durable O-ring.
Regarding the limitations directed towards the sealing assembly being “configured to be disposed between a base and a lid of a sterilization packing system to provide a seal between a base and a lid of a sterilization packing system to provide a seal between the base and the lid during a steam sterilization proves, further wherein the gasket is configured to maintain sterility of the contents of the sterilization packing system post-sterilization by the steam sterilization process and allow for visual identification of the breach of the outer layer”, the instantly recited layered gasket arrangement comprising the disclosed gasket materials has been interpreted as providing the claimed functions. As the prior art device comprises the same gasket materials and structural arrangement as instantly claimed, it is the position of the Examiner that the prior art discloses said limitations. Additionally Seiko Epson Corp. explicitly discloses the analogous seal is intended for use in “plasma etching apparatus” and is intended to maintain a seal between members despite being exposed to “plasma gas” ([0003]). Therefore it is the position of the Examiner that the prior art device is fully capable of performing the instantly recited functions of maintaining sterility during a steam sterilization process.
Regarding claim 2, Seiko Epson Corp. further discloses a breach of the outer layer exposes the second colored pigment of the inner core to facilitate detection of the breach ([0014], see: identifiable internal signal member that is exposed as the O-ring surface deteriorates).
Regarding claim 25, modified Seiko Epson Corp. does not explicitly disclose the outer layer having a thickness of 0.03 inches to 1.5 inches. As the gasket volume and durability is a variable that can be modified, among others, by adjusting said thickness of the outer layer, with said gasket volume and durability increasing as the outer layer thickness is increased, the precise outer layer thickness would have been considered a result effective variable by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed coating thickness cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the thickness of the outer layer in the apparatus of modified Seiko Epson Corp. to obtain the desired gasket volume and durability (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim(s) 3-6, 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seiko Epson Corp. (JP 2002/168348 A, cited in IDS filed 06/05/2020), in view of Peterson (USP 3,095,619) and Hammar et al. (US 2005/0250909 A1), as applied to claim 1 above, in further view of Hafner et al. (USP 5,579,944, cited in IDS filed 06/05/2020).
Regarding claim 3, Seiko Epson Corp. does not explicitly disclose the outer layer is darker than the inner core, wherein the outer layer and the inner core exhibit a AE* color difference greater than about 2.5 as determined according to the Commission Internationale de l'Eclairage (CIE) 1976 standard.
Hafner teaches an analogous multi-layer gasket (Fig. 2, Fig. 3) comprising a blue colored outer layer (24) and a red colored inner layer (22) for indicating defects (C7/L6-18). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to select contrasting colors for the O-ring layers in the device disclosed by Seiko Epson Corp., as taught by Hafner, in order to reduce any false positives and false negative indications of gasket failures.
Regarding claims 4 and 5, Seiko Epson Corp. does not explicitly disclose the inner core exhibits a saturation level of greater than about 25% and a value level of greater than about 25%.
As the material costs and quantity of colorant are variables that can be modified, among others, by adjusting said saturation and value levels of the inner core, with said material costs and quantity of colorant both increasing as the saturation and value levels are increased, the precise saturation and value levels of the inner core would have been considered a result effective variable by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed saturation and value levels of the inner core cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the saturation and value levels of the inner core in the apparatus of Seiko Epson Corp. to obtain the desired material costs and quantity of colorant (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 6, modified Seiko Epson Corp. further discloses the second material comprises non-foamed polyurethane, silicone, polyvulcanate, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinylidene fluoride (PVDF), or polytetrafluorethylene (PTFE) (Hammar: [0027], see: PTFE).
Modified Seiko Epson Corp. does not explicitly disclose the second material is less compressible and more rigid than the first material.
Hafner teaches an analogous multi-layer gasket (Fig. 2, Fig. 3) comprising a rigid plastic middle layer (20). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to select materials having different compressibility and rigidity for the O-ring disclosed by Seiko Epson Corp., as taught by Hafner, in order to prevent deformation of the O-ring which could interfere with sealing (Hafner: C5/L3-15).
Regarding claim 24, Seiko Epson Corp. discloses a sealing assembly for a sterilization packaging system (Fig. 1), the sealing assembly comprising:
a gasket having an outer edge, an inner edge, and an upper surface and a lower surface each extending from the outer edge to the inner edge (see: O-ring 10 with cylindrical cross-section),
wherein the gasket consists of an outer layer and an inner core, the outer layer surrounding the inner core on the outer edge, inner edge, upper surface, and lower surface (see: internal signal member 102 enveloped by the O-ring surface 101),
wherein the outer layer includes a first material compounded with a first colored pigment, and the inner core includes a second material compounded with a second colored pigment ([0014], see: internal signal member has a color that can be visually compared with the O-ring surface),
wherein the first material comprises a first durometer and the second material comprises a second, different durometer, the first durometer being lower durometer than the second durometer (Fig. 4, see: O-ring surface 401 deforms greater than the colored member 402 when a load is applied),
wherein a sufficient level of contrast exists between the outer layer and the inner core to detect a breach of the outer layer ([0014], see: identifiable internal signal member that is exposed as the O-ring surface deteriorates).
Seiko Epson Corp. does not explicitly disclose first material and the second material comprise the same polymer.
Peterson teaches an analogous seal (Fig. 19) comprising two layered materials (48 and 58) made out of a puffable material/compressed foamed epoxy resin, wherein the puffable material/compressed foamed epoxy resin is selected from a group including polyurethane (Claim 2).
Halfner teaches an analogous multi-layer gasket comprising a high density polyethylene middle layer and a low density polyethylene inner and outer layers (Fig. 2, Fig. 3, ABSTRACT).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to select a plurality of the same polymer material having a plurality of different densities for the O-ring disclosed by Seiko Epson Corp., 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. In re Leshin, 125 USPQ 416. In this particular instance, once having ordinary skill in the art would have been motivated to do so in order to provide for increased compressibility, thereby providing for improved seal conformation (Peterson: C10/L55-65) and advantageous sealing and adhesion characteristics of soft plastics with the support provided by more rigid plastics to form a gasket superior to those of the prior art (Halfner: C9/L43-49).
Seiko Epson Corp. does not explicitly disclose the second material comprises a filler.
Hammar teaches an analogous gasket material comprising PTFE, a thermoplastic polymer, and a titanium dioxide filler which provides increased creep resistance ([0027]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to select the gasket material taught by Hammar for the inner core of the O-ring disclosed by Seiko Epson Corp., 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. In re Leshin, 125 USPQ 416. In this particular instance, once having ordinary skill in the art would have been motivated to do so in order to provide for the increased creep resistance, resulting in a more durable O-ring.
Regarding the limitations directed towards the sealing assembly being “configured to be disposed between a base and a lid of a sterilization packing system to provide a seal between a base and a lid of a sterilization packing system to provide a seal between the base and the lid during a steam sterilization proves, further wherein the gasket is configured to maintain sterility of the contents of the sterilization packing system post-sterilization by the steam sterilization process and allow for visual identification of the breach of the outer layer”, the instantly recited layered gasket arrangement comprising the disclosed gasket materials has been interpreted as providing the claimed functions. As the prior art device comprises the same gasket materials and structural arrangement as instantly claimed, it is the position of the Examiner that the prior art discloses said limitations. Additionally Seiko Epson Corp. explicitly discloses the analogous seal is intended for use in “plasma etching apparatus” and is intended to maintain a seal between members despite being exposed to “plasma gas” ([0003]). Therefore it is the position of the Examiner that the prior art device is fully capable of performing the instantly recited functions of maintaining sterility during a steam sterilization process.
Regarding claim 26, modified Seiko Epson Corp. does not explicitly disclose the outer layer having a thickness of 0.03 inches to 1.5 inches. As the gasket volume and durability is a variable that can be modified, among others, by adjusting said thickness of the outer layer, with said gasket volume and durability increasing as the outer layer thickness is increased, the precise outer layer thickness would have been considered a result effective variable by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed coating thickness cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the thickness of the outer layer in the apparatus of modified Seiko Epson Corp. to obtain the desired gasket volume and durability (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
As claim 27 is a product-by-process claim, patentability of said claim is based on the recited product and does not depend on its method of production. Since the product in claim 27 is the same as product disclosed by modified Seiko Epson Corp., as set forth above, the claim is unpatentable even though the modified Seiko Epson Corp. product was made by a different process. In re Marosi, 710 F2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
The Examiner respectfully disagrees with the Applicant’s assertion that the prior art device disclosed by modified Seiko Epson Corp. would not be capable of maintaining the sterility of the contents of a sterilization packing system post-sterilization by a steam sterilization process. Since the instantly claimed materials are arranged in the same instantly claimed manner in the device disclosed by modified Seiko Epson Corp., it is the position of the Examiner that the prior art device would have the same material properties as the instantly claimed device (durometers, resistance to temperature, resistance to humidity, etc.), and therefore would similarly have the same material properties which enable the instantly claimed device to function in a steam sterilization process. Additionally, Seiko Epson Corp. explicitly discloses the analogous seal is intended for use in “plasma etching apparatus” and is intended to maintain a seal between members despite being exposed to “plasma gas” ([0003]). Therefore it is the position of the Examiner that the prior art device is fully capable of performing the instantly recited functions of maintaining sterility during a steam sterilization process.
In response to applicant's argument that Seiko and Peterson are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Seiko Epson Corp. (JP 2002/168348 A, cited in IDS filed 06/05/2020) is directed toward an analogous O-ring having different colored layers to detect deterioration; Peterson (USP 3,095,619) is directed towards an analogous seal having a plurality of materials with different compressibility; Hammar et al. (US 2005/0250909 A1) is directed towards an analogous multilayer gasket material; and Hafner et al. (USP 5,579,944, cited in IDS filed 06/05/2020) is directed toward an analogous multilayer gasket.
For the above reasons, the previous ground of rejection have been maintained and updated to address the claim amendments filed 02/18/2026
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 5712721254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797
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