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 with traverse of Group II, claims 11 and 14-16 in the reply filed on 6/23/2026 is acknowledged. The traversal is on the ground(s) that the technical feature shared by Groups I and II make a contribution over the prior art. In particular, Applicant has argued that the prior art cited in the Office Action dated 4/28/2026 does not disclose or teach a process challenge device configured so that a biological indicator can be activated and analyzed without disconnecting or detaching the biological indicator from the process challenge device, an activation support member disposed in the cavity and movable into contact with the biological indicator, a first portion of the biological indicator is disposed in the casing, or a second observable portion is disposed outside the casing (pgs. 8-9 in Remarks filed 6/23/2026). This is not found persuasive because:
Unity of Invention is determined only by common matter of the independent claims and the features of note are not shared between Groups I and II (MPEP § 1850).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/23/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 3/4/2024 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "202" and "102" have both been used to designate the second portion of biological indicator 200 (see Figs. 3 and 4B in the drawings filed 11/28/2023). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Examiner notes that structure for claim limitation “means for opening the frangible container” in claim 16 can be found in U.S. Patent No. 9,322,046, which is incorporated by reference in its entirety (carrier 132; col. 28, lines 15-17).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zwarun et al. (US Patent 4,828,797, hereinafter referred to as Zwarun) (presented in IDS dated 3/4/2024) in view of Chandrapati et al. (US Patent 9,322,046 B2, hereinafter referred to as Chandrapati) (presented in IDS dated 3/4/2024).
Regarding claim 11, Zwarun discloses a process challenge device for verifying efficacy of a sterilization process (abstract, “biological test pack adapted for use in testing the efficacy of an ethylene oxide sterilization process”), the process challenge device comprising:
a casing formed of a sterilant vapor-impervious material (abstract, plastic syringe; Fig. 5, plastic syringe 22 – see annotated figure below), the casing forming a cavity with at least one opening that places the cavity in vapor communication with an ambient environment in which the process challenge device is disposed (Fig. 5, cavity shown with at least one opening); and
a self-contained biological indicator operatively connected to the casing (Fig. 5 shows a biological indicator 20).
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an activation support member disposed in the cavity of the casing, wherein the activation support member has a first end moveably disposed in the cavity of the casing, wherein the activation support member has a second end disposed outside the casing, and wherein the first end can be moved into contact with the self-contained biological indicator (see annotated Fig. 5 below).
Zwarun is silent to the details of the self-contained biological indicator. Particularly:
a housing comprising at least one wall, the housing having an open end and an interior space;
a plurality of viable test microorganisms or an active enzyme, the plurality of viable test microorganisms or the active enzyme being disposed in the interior space of the housing;
a sterilant pathway extending from ambient through the housing to the plurality of viable test microorganisms or the active enzyme;
a detection reagent for detecting the plurality of viable test microorganisms or the active enzyme, the detection reagent being disposed in the interior space;
wherein the detection reagent is convertible by the plurality of viable test microorganisms or the active enzyme from a first state to a second state that is distinguishable from the first state;
a fluid pathway extending through the housing to the interior space;
an aqueous liquid disposed in an openable container, the aqueous liquid being in selective communication with the plurality of viable test microorganisms or the active enzyme;
wherein the first portion of the self-contained biological indicator comprises the open end of the housing of the self-contained biological indicator, and;
wherein the second portion of the self-contained biological indicator comprises a part of the at least one wall through which the aqueous liquid and the detection reagent can be observed.
However, Chandrapati discloses a biological sterilization indicator (abstract), i.e., a self-contained biological indicator, suitable for use with process challenge devices (col. 8, lines 37-39). Chandrapati teaches that the biological sterilization indicator is activated by moving a cap relative to a body (col. 6, lines 18-23; Figs. 4 and 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the self-contained biological indicator disclosed by Zwarun for that of Chandrapati because one of ordinary skill in the art would readily recognize that the activation support member of Zwarun would provide means of activating the biological indicator of Chandrapati.
Furthermore, the incorporation of Chandrapati’s biological sterilization indicator meets limitations (a)-(g) above because Applicant admits in [0064]-[0068], particularly in [0064], of the specification filed 11/28/2023 that Chandrapati’s biological sterilization indicator meets the limitations with regards to the claimed self-contained biological indicator (MPEP § 2129).
The prior art combination does not expressly disclose the position of the first portion and second portion of the self-contained biological indicator relative to the casing.
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However, Chandrapati discloses that the second portion includes a detection window (Fig. 1, detection window 167 – see annotated figure below) and tapered walls (Fig. 1, tapered wall 123, 152, 170) to allow the biological sterilization indicator to be coupled to a reader or detection device and minimize user error (col. 37 lines 6-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position a second portion of Chandrapati’s self-contained biological indicator such that it is disposed outside the casing to provide a reader device access to the detection window and to minimize user error. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position a first portion of Chandrapati’s self-contained biological indicator to allow the prior art activation support member to activate the self-contained biological indicator, as discussed above.
The limitation “that places the cavity in vapor communication with an ambient environment in which the process challenge device is disposed” is directed toward the intended manner of operating the claimed at least one opening and does not differentiate the claimed at least one opening from the prior art at least one opening because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art at least one opening would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 14, the prior art combination teaches the process challenge device of claim 11.
Zwarun of the prior art combination discloses the casing comprising at least an elongated lumen structure, wherein the at least one opening is disposed in the elongated lumen structure, as shown above.
Regarding claim 15, the prior art combination teaches the process challenge device of claim 11.
Chandrapati of the prior art combination discloses wherein the self-contained biological indicator further comprises a cap, wherein the cap is slidably attached to the housing so that, when the cap is moved from a first position to a second position, it closes the open end of the housing, as set forth above.
Regarding claim 16, the prior art combination teaches the process challenge device of claim 15.
Chandrapati of the prior art combination discloses means for opening the openable container (note: this claim element invokes 35 U.S.C. 112(f)), wherein the openable container is a frangible container, wherein when the cap is moved from the first position to the second position, the means for opening the openable container causes the frangible container to open, as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Smith et al. (US Patent 8,840,837 B2) drawn to a biological sterilization indicator and method of using same.
Brown et al. (US Patent 4,732,850) drawn to a frangible container and rupturing device.
Sullivan et al. (US Patent 10,513,678 B2) drawn to a self-contained biological indicator.
Pederson et al. (US 2013/0210069 A1) drawn to a biological sterilization indicator system.
Landgrebe et al. (WO 2020128959 A1) drawn to an activator system for a biological indicator.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.C./Examiner, Art Unit 1799
/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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