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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/08/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claim 2 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Moreover, the specification does not provide any guidance as to the scope of the term “about” with reasonable certainty.
Claim 1 recites the limitation "the entire inner perimeter" in line 22. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the entire inner surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, and 3-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0217107 A1-Pederson et al (hereinafter “Pederson”).
Regarding claim 1, Pederson discloses a biological sterilization indicator (a biological sterilization indicator 100, para. [0047], lines 6, Fig. 1) comprising: a housing (housing 102, para. [0050], line 2, Fig. 2); a container containing a liquid (container 120, para. [0052], lines 2-3, Fig. 2) and being dimensioned to be positioned in the housing (container 120 is dimensioned to be received within the biological sterilization indicator 100, para. [0052], lines 4-5, Fig. 1), at least a portion of the container being frangible (a portion of the container 120 is frangible, para. [0052], line 12), the container having a first state in which the container is intact and the liquid is not in fluid communication with an interior of the housing and a second state in which the container is fractured and the liquid is in fluid communication with the interior of the housing (container 120 can have a first state in which it is intact and the liquid 122 is contained therein, and a second state in which at least a portion of the container 120 is fractured. In the second state of the container 120, the liquid 122 can be in fluid communication with the reservoir 103 of the biological sterilization indicator 100, e.g., when the container 120 is positioned in the biological sterilization indicator 100, para. [0052], lines 15-21);
“ a first compartment (first chamber 109, of housing 102, para. [0057], lines 3-4, Fig. 2) in the housing in which the container is positioned when the container is in the first state;”
“ a second compartment (second chamber 111, para. 0057], line7, Fig. 2 in housing 102) in the housing in which the container and the liquid are not positioned when the container is in the first state, the second compartment containing a source of biological activity (second chamber 111 can be referred to as a “spore growth chamber or a “detection chamber, and can include a volume to be interrogated for spore viability, para. [0057], lines 8-11) that is not in fluid communication with the liquid when the container is in the first state and that is in fluid communication with the liquid when the container is in the second state (the first chamber 109 and the second chamber 111 can be positioned in fluid communication with each other, para. [0057], lines 12-13);”
“a substrate disposed in the housing between the first compartment and the second compartment, the substrate further positioned such that the substrate is not in direct contact with the source of biological activity (substrate 119 can be positioned between the upper portion 116 and the lower portion 114 of the biological sterilization indicator 100, para. [0078], lines 6-7, Fig. 2, where substrate 119 is shown disposed between the first compartment 109 and the second compartment 111);”
“wherein the substrate comprises a hydrophobic nonporous film (substrate 119 materials can include nonwoven polypropylene, para. [0081], line 5) having an aperture (aperture 121, para. [0079], line 9, Fig. 2);”
“wherein the substrate and the aperture are dimensioned to control fluid flow between the first compartment and the second compartment (apertures 121, which can be configured to control (i.e., facilitate and/or limit, depending on number, size, shape, and/or location) fluid movement between the first chamber 109 and the second chamber 111, para. [0079], lines 9-12, Fig. 2);”
“and wherein the substrate extends around substantially the entire inner perimeter of the housing between the first compartment and the second compartment (substrate 119 can be dimensioned to be positioned adjacent the wall 118, Fig. 2, para. [0078], lines 3-4, where wall 118 encompasses the entire inner perimeter of housing 102, Fig. 2; that is, substrate 119 is shaped to extend the housing between the first compartment 109 and the second compartment 111, Fig. 2).”
Regarding claim 3, Pederson discloses wherein the substrate is attached to a substrate support (insert 130, para. [0053], line 3, attached to substrate 119, shown in Figs. 2 and 3), wherein the substrate or the substrate support extends around substantially the entire inner surface (Figs. 2 and 3 show insert 103 extends around an entire inner surface of housing 102).
Regarding claim 4, Pederson discloses a breaker located in the housing (the insert 130, or a portion thereof, can sometimes be referred to as a “carrier (e.g., the carrier 132) and/or a “breaker”, para. [0113], lines 20-21, Fig. 2) and configured for holding the container (the carrier 132) can be configured to hold the container 120, para. [0111], lines 10-11, Fig. 2), when the container is intact, and for fracturing the container (insert 130 can sometimes function to hold the container 120 intact before activation, and can function to break the container 120 during activation, para. [0113], lines 17-19).
Regarding claim 5, Pederson discloses wherein the second compartment includes a volume to be interrogated to determine the lethality of a sterilization process (second chamber 111 is disposed in the lower portion of biological indicator 100, shown in Fig. 1; the lower portion 114 can be referred to as the “detection portion” or “detection region” of the housing 102, because at least a portion of the lower portion 114 can be interrogated for signs of spore growth, para. [0056], lines 11-15), and wherein the substrate is positioned outside of the volume to be interrogated (substrate 119 is shown oriented outside of the lower portion 114 and second chamber 111, as shown in Fig. 2).
Regarding claim 6, Pederson discloses wherein the substrate at least partially defines the first compartment and the second compartment (substrate 119 can be positioned between the upper portion 116 and the lower portion 114 of the biological sterilization indicator 100, para. [0078], lines 5-7, Fig. 2, where the first compartment 109 is positioned in the upper portion 116, Fig. 2, and second compartment 111 id positioned in the lower portion 114, shown in Fig. 2).
Regarding claim 7, Pederson discloses wherein the substrate is positioned to limit diffusion of a detectable product from the second compartment to the first compartment when the container is in the second state (substrate 119 can be positioned to minimize diffusion of an assay signal out of the second chamber 111, para. [0079], lines 1-3; moreover, minimizing diffusion of the spores 115 and/or signals from the second chamber 111 to the upper portion 116 of the housing 102 after activation—second state, para. [0140], lines 11-13).
Regarding claim 8, Pederson discloses wherein the substrate is positioned to control a sterilant delivery rate to the source of biological activity when the container is in the first state (biological sterilization indicator 100 can include a first fluid path 160 that can be positioned to fluidly couple the first chamber 109 and the second chamber 111, and which can allow sterilant (e.g., during sterilization, when the container 120 is in a first, unfractured state, para. [0084], lines 1-5).
Regarding claim 9, Pederson discloses a first fluid path positioned to fluidly couple the first compartment and the second compartment, the first fluid path positioned to allow a sterilant to move from the first compartment into the second compartment when the container is in the first state (biological sterilization indicator 100 can include a first fluid path 160 that can be positioned to fluidly couple the first chamber 109—first compartment and the second chamber 111—second compartment, and which can allow sterilant (e.g., during sterilization, when the container 120 is in a first, unfractured state, para. [0084], lines 1-5), and to allow the liquid to move from the first compartment into the second compartment when the container is in the second state (and/or the liquid 122 (e.g., after sterilization and during activation, when the container 120 is in a second, fractured, state, para. [0084], lines 5-7);
“and a second fluid path positioned to fluidly couple the second compartment and another compartment of the biological sterilization indicator (a second fluid path 162 positioned to fluidly couple the second chamber 111 with another chamber or portion of the biological sterilization indicator 100, such that as the first chamber 109, para. [0085], lines 1-9), the second fluid path positioned to allow displaced gas to move from the second compartment as the sterilant or the liquid moves from the first compartment to the second compartment (he second fluid path 162 can be further positioned to allow gas that was previously present in the second chamber 111 to be displaced and to exit the second chamber 111, for example, when the sterilant and/or the liquid 122 is moved into the second chamber 111, para. [0085], lines 5-9).”
Regarding claim 10, Pederson discloses wherein the source of biological activity (spores 115, para. [0093], lines 5-9, Fig. 2) is housed in a source carrier (spore carrier 135, para. [0093], line 2, Fig. 2, where spores 115 are housed in spore carrier 135, Fig. 2), and wherein the substrate is not in direct contact with at least one of the source of biological activity and the source carrier (substrate 119 is not in direct contact with at least a source of biological activity—spores 115 and the source carrier—spore carrier 135, shown in Fig. 3).
Regarding claim 11, Pederson discloses wherein the substrate is not in direct contact with the container when the container is in the first state (substrate 119 is not in direct contact with container 120 when in the first state, as shown in Fig. 3).
Regarding claim 12, Pederson discloses a wall positioned to separate the first compartment and the second compartment (lower portion 114—lower portion includes the second chamber 111 and an upper portion 116—upper portion includes the first chamber 109, which can be at least partially separated by an inner wall 118, para. [0056], lines 2-4, Fig. 2), wherein the substrate is positioned adjacent the wall (substrate 119 is positioned next to wall 118, shown in Fig. 2).
Regarding claim 13, Pederson discloses wherein the breaker is located in the first compartment of the housing (breaker/carrier 132 is disposed on insert 130, is positioned in first chamber 109, Fig. 4).
Regarding claim 14, Pederson discloses a wall positioned to separate the first compartment and the second compartment (lower portion 114—lower portion includes the second chamber 111 and an upper portion 116—upper portion includes the first chamber 109, which can be at least partially separated by an inner wall 118, para. [0056], lines 2-4, Fig. 2), wherein the substrate is positioned between the breaker and the wall (substrate 119 is shown positioned between the breaker 132, which is disposed on insert 130 and the wall 118).
Regarding claim 15, Pederson discloses wherein the breaker (breaker/carrier 132, Fig. 3) is positioned to hold the container (breaker 132 holds container 120, shown in Fig. 3) intact when the container is in the first state in a substantially consistent location in the housing (breaker 132 holds container 120 in a consistent region of housing 102, shown in Fig. 3).
Regarding claim 16, Pederson discloses wherein the breaker is positioned to hold the container (breaker 132 holds container 120, shown in Fig. 3) intact when the container is in the first state (first state shown in Fig. 3) in a position that maintains a substantially constant sterilant path (the insert 130 can be adapted to hold the container 120 intact in a position in the housing 102 that maintains at least a minimal spacing (e.g., a minimal cross sectional area of space) between the container 120 and the housing 102 and/or between the container 120 and any other components or structures in the housing 102 (e.g., at least a portion of the insert 130, such as the carrier 132, etc.), for example, to maintain a Substantially constant sterilant path 164 in the biological sterilization indicator 100, para. [0109], lines 1-9, where insert 130 includes carrier 132, shown in Fig. 2).
Regarding claim 17, Pederson discloses wherein the breaker (breaker/carrier 132 included in insert 130, para. [0092], lines 6-7) is adapted to allow the container to move in the housing between a first position in which the container is in the first state and a second position in which the container is in the second state (insert 130 can be further adapted to allow the container 120 to move at least somewhat in the housing 102, para. [0092], lines 12-13; that is, the insert 130, which includes carrier/breaker 132, allows the container 120 to move in the housing 102, from a first position—first state/intact container 120, shown in Fig. 3; to a second position—second state or broken container 120, shown in Fig. 4).
Regarding claim 18, Pederson discloses wherein the substrate (substrate 119, shown in Fig. 3) is positioned between the container (container 120, shown in Fig. 3) and the source of biological activity (spore carrier 135 which includes spores 115, Fig. 3) when the container is in the first state (also shown below in annotated Fig. 3).
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Regarding claim 19, Pederson discloses wherein the substrate is positioned in the liquid when the container is in the second state (moving the liquid 122 through or past the substrate 119 and into the second chamber 111 when desired, para. [0087], lines 9-10; additionally, Fig. 4, the second state, shows substrate 119 positioned in liquid 122 of container 120; that is, when container 120 is broken is substrate 119 is in contact with the liquid 122).
Regarding claim 20, Pederson discloses wherein the wall and the substrate are oriented at a non-zero and non-right angle with respect to a longitudinal direction of the biological sterilization indicator (the wall 118 can be angled or slanted, for example, oriented at a non-zero and non-right angle with respect to a longitudinal direction DL, of the housing 102, para. [0065], lines 1-4; Figs. 2-4 show wall 118 and substrate 119 positioned at an angle or a slanted position).
Therefore, the reference of Pederson meet the limitations of claims 1, and 3-16.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0217107 A1-Pederson et al (hereinafter “Pederson”) as applied to claim 1 above, and further in view of US 2020/0056219 A1-Young et al (hereinafter “Young”).
Regarding claim 2, Pederson discloses the invention discussed above in claim 1. Further, Pederson discloses an aperture of the substrate, also discussed above. However, Pederson does not explicitly disclose wherein the aperture has an area at least about 1.2 mm2.
For claim 2, Young teaches devices for microbial detection of microorganisms are provided including a body member including a substrate having a first major surface and a second major surface (abstract). Young teaches an aperture 20 defines a peripheral boundary of a sample receiving zone; the aperture 20 can be any shape (para. [0051], lines 8-9) and Young teaches the area of the sample-receiving zone (and aperture 20) the area of the sample-receiving zone is about 10 cm2 (para. [0051], lines 8-12-17), which reads on the instant clam limitation of wherein the aperture has an area at least about 1.2 mm2.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the aperture of the substrate of Pederson and further include an aperture having an area at least about 1.2 mm2 as taught by Young, because Young teaches the area of the sample-receiving zone (and aperture 20) may be selected based on, for example, the volume of sample (e.g., aqueous liquid) to be deposited in the zone (para. [0051], lines 12-15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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