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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-9, in the reply filed on 08/21/2026 is acknowledged.
Claims 10-13, 15-16, and 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/21/2026.
Claim Interpretation
Regarding the method limitations recited in claim(s) 1-9 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.).
Specification
The disclosure is objected to because of the following informalities: Para [0034] appears to contain typographical errors, see: “organge” and “thymolblue”.
Appropriate correction is required.
Claim Objections
Claim 2 objected to because of the following informalities: Line 2 appears to contain a typographical error, see: “organge” and “thymolblue”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kane et el. (US 2010/0178203 A1, cited in IDS filed 06/26/2025).
Regarding claim 1, Kane discloses a sterilization indicator for detecting the presence of nitric oxide (Fig. 3), comprising:
a chromophore-containing compound capable of undergoing a color change in the presence of nitric oxide ([0076], see: plurality of indicator compositions, including thymol blue);
a support layer comprising the chromophore-containing compound (Fig. 3, see: substrate with indicator composition), and
a top coating or diffusion layer (Fig. 3, see: porous portion) coupled to the support layer, wherein an amount of the chromophore-containing compound and an identity or thickness of the top coating or diffusion layer is selected to tune sensitivity and timing of response of the sterilization indicator to the nitric oxide (These limitations are directed towards the specific properties of the recited chromophore-containing compound and the recited top coating or diffusion layer, it is noted that the prior art discloses analogous elements comprised of the same materials as instantly claimed, therefore, it is the position of the Examiner that the prior art elements will inherently display the recited properties. See MPEP 2112).
Regarding claim 2, Kane further discloses the chromophore-containing compound comprises 2,2'-azinobis(3-ethylbenzothiazoline-6-sulfonic acid), methyl organge (MeORG), thymolblue (ThBlu), or combinations thereof ([0076], see: plurality of indicator compositions, including thymol blue).
Regarding claim 3, Kane further discloses the support layer comprises a cellulose-containing material ([0071], see: plurality of cellulose materials appropriate for the substrate).
Regarding claim 4, Kane further discloses the top coating or diffusion layer is formed from a polymeric material comprising polyvinyl chloride, polyester, a cellulose-containing material, polypropylene, or combinations thereof ([0081], see: plurality of materials appropriate for porous portion, including PVC, polyester, and plurality of cellulose materials).
Regarding limitations recited in claim 5 which are directed towards the specific properties of the recited top coating or diffusion layer, it is noted that the prior art discloses analogous elements comprised of the same materials as instantly claimed, therefore, it is the position of the Examiner that the prior art elements will inherently display the recited properties. See MPEP 2112.
Regarding claim 6, Kane further discloses the support layer comprises a first portion and a second portion adjacent the first portion, and wherein the first portion comprises the top coating or diffusion layer and the second portion is substantially free of the top coating or diffusion layer (Fig. 3, see: bottom surface of the substrate with indicator composition is in contact with the porous portion while the top surface is not in contact with the porous portion).
Regarding claim 7, Kane further discloses the support layer has a first surface and a second surface opposite the first surface (Fig. 1B, see: top and bottom surface of substrate with indicator composition), and wherein the top coating or diffusion layer is overlying at least a portion of the first surface (Fig. 3, see: bottom surface of the substrate with indicator composition is in contact with the porous portion).
Regarding claim Kane, Hu further discloses a backing layer overlying the first surface (Fig. 3, see: hydrophobic barrier).
Regarding claim 9, Hu further discloses an adhesive layer overlying the second surface ([0074], see: adhesive to bond the substrate to the hydrophilic barrier layer).
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hu et al. (US 2020/0340981 A1, cited in IDS filed 08/28/2024).
Regarding claim 1, Hu discloses a sterilization indicator for detecting the presence of nitric oxide (Fig. 1B), comprising:
a chromophore-containing compound capable of undergoing a color change in the presence of nitric oxide ([0017] see: plurality of indicator materials, including thymol blue and methyl orange; [0028], see: plurality of indicator materials, including 2,2′-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid));
a support layer comprising the chromophore-containing compound (Fig. 1B, see: membrane layer 102 and indicator layer 103; [0036], see: indicator layer is integral with the membrane layer), and
a top coating (Fig. 1B, see: transparent layer 104) or diffusion layer (Fig. 1B, see: base layer 201) coupled to the support layer, wherein an amount of the chromophore-containing compound and an identity or thickness of the top coating or diffusion layer is selected to tune sensitivity and timing of response of the sterilization indicator to the nitric oxide (These limitations are directed towards the specific properties of the recited chromophore-containing compound and the recited top coating or diffusion layer, it is noted that the prior art discloses analogous elements comprised of the same materials as instantly claimed, therefore, it is the position of the Examiner that the prior art elements will inherently display the recited properties. See MPEP 2112).
Regarding claim 2, Hu further discloses the chromophore-containing compound comprises 2,2'-azinobis(3-ethylbenzothiazoline-6-sulfonic acid), methyl organge (MeORG), thymolblue (ThBlu), or combinations thereof ([0017] see: plurality of indicator materials, including thymol blue and methyl orange; [0028], see: plurality of indicator materials, including 2,2′-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid)).
Regarding claim 3, Hu further discloses the support layer comprises a cellulose-containing material ([0034], see: plurality of cellulose materials appropriate for the membrane layer).
Regarding claim 4, Hu further discloses the top coating or diffusion layer is formed from a polymeric material comprising polyvinyl chloride, polyester, a cellulose-containing material, polypropylene, or combinations thereof ([0035], see: plurality of materials appropriate for the transparent layer, including PVC, cellulose acetate, and polypropylene; [0040], see: plurality of materials appropriate for the base layer, including PVC and hydrophobic polyesters).
Regarding limitations recited in claim 5 which are directed towards the specific properties of the recited top coating or diffusion layer, it is noted that the prior art discloses analogous elements comprised of the same materials as instantly claimed, therefore, it is the position of the Examiner that the prior art elements will inherently display the recited properties. See MPEP 2112.
Regarding claim 6, Hu further discloses the support layer comprises a first portion and a second portion adjacent the first portion, and wherein the first portion comprises the top coating or diffusion layer and the second portion is substantially free of the top coating or diffusion layer (Fig. 1B, see: top surface of the combined membrane layer 102 and indicator layer 103 is directly contacted by the transparent layer 104, while the bottom surface is not directly contacted by the transparent layer 104; alternatively see the bottom surface of the combined membrane layer 102 and indicator layer 103 is directly contacted by the base layer 201, while the top surface is not directly contacted by the base layer 201).
Regarding claim 7, Hu further discloses the support layer has a first surface and a second surface opposite the first surface (Fig. 1B, see: top and bottom surface of the combined membrane layer 102 and indicator layer 103), and wherein the top coating or diffusion layer is overlying at least a portion of the first surface (Fig. 1B, see: transparent layer 104 covers the top surface, while the base layer 201 covers the bottom surface).
Regarding claim 8, Hu further discloses a backing layer overlying the first surface (Fig. 1B, see: transparent layer 104 or base layer 201, since one of the top coating and diffusion layer are optional limitations, either remaining element is interpreted as being analogous to the recited backing layer).
Regarding claim 9, Hu further discloses an adhesive layer overlying the second surface ([0037], see: plurality of adhesives appropriate for attaching the transparent layer to the indicator layer and membrane layer).
Conclusion
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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/ROBERT J EOM/Primary Examiner, Art Unit 1797
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