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 .
Applicant’s filing of claims 1-20 on 1/23/24 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/28/24, 8/5/25 and 5/14/26 were acknowledged. 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.
Claims 1-11, 16, 19 and 20 are 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.
Claim 1 is rejected because it is unclear how the claimed properties or functions, “a material having a permeability to oxygen of less than 50 cc/m.sup.2/24 hours, and the second barrier comprises a material having a permeability to oxygen of 50 cc/m.sup.2/24 hours or more” structurally further defines the claimed apparatus. What particular material(s) performs the claimed properties or functions?
Claim 1 is rejected because it is unclear how the “oxygen scavenger is separated from the liquid analytic reagent by the second barrier?
Claim 1 recites the limitation "the liquid analytic reagent". There is insufficient antecedent basis for this limitation in the claim.
The term “generally” in claim 2 is a relative term which renders the claim indefinite. The term “generally” 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. For example, the specification does not appear to provide examples that can be used to measure the meaning of the term, “generally impermeable to liquids”.
Claims 3-6 recites the limitation "the second material" or “the first material”. There is insufficient antecedent basis for one of the rejected limitations in the claim. The Office recommends amending claim 1 to recite “a first material” and “a second material”.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 is rejected because it is unclear how the claimed properties or functions, “the liquid analytical reagent is an oxygen sensitive analytical reagent,” structurally further defines the claimed apparatus.
Claim 11 is rejected because it is unclear how the claimed properties or functions, “the liquid analytical reagent is a pool or spa reagent,” structurally further defines the claimed apparatus.
Claim 16 is rejected because the claim language, “the liquid analytical reagent is placed into the second section prior to incorporation of the second section into the container,” is unclear. How can the reagent be placed into the second section if there is initially no second section?
The term “amount sufficient” in claims 19 and 20 is a relative term which renders the claim indefinite. The term “amount sufficient” 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. For example, the specification does not appear to provide examples that can be used to measure the meaning of the term, “amount sufficient”.
Claim Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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 1-9 and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hama et al. (“Hama,” WO 2005/004902), cited in IDS).
As to claim 1, Hama discloses a heat stable liquid analytical reagent apparatus comprising: a first barrier (15 outer packaging material in e.g., fig. 1) forming all or a portion of an exterior of the apparatus, and a second barrier (2 plastic container in e.g., fig. 1) forming all or part of a second section within the apparatus; wherein the first barrier comprises a material having a permeability to oxygen of less than 50 cc/m.sup.2/24 hours, and the second barrier comprises a material having a permeability to oxygen of 50 cc/m.sup.2/24 hours or more (the plastic container 2 is made of plastic having at least a layer containing an ethylene-butyl alcohol copolymer, and is characterized by having gas barrier properties; and plastic container is made of, for example, a resin material include polyolefin such as polyethylene and polypropylene, polychlorinated vinyl, and ethylene monoacetate biel copolymer; see MPEP 2112.01(II)), and wherein a liquid analytical reagent (3 rHSA preparation in e.g., fig. 1) is contained within the second section and an oxygen scavenger (see e.g., “As a result, it was possible to suppress the change in appearance and the increase in ammonia content and polymer content by wrapping it in a gas-paria outer wrapping material together with the oxygen scavenger”) is separated from the liquid analytic reagent by the second barrier.
As to claims 2-4, Hama discloses the first barrier, the second barrier, or both the first barrier and the second barrier are generally impermeable to liquids; the second material is formed from a synthetic polymer; and the second material is a polyethylene. See e.g., claim 6 of Hama.
As to claims 5-6, Hama discloses the first material is formed from a metallized or ceramically coated film or a polyethylene and polyamide copolymer; the first material is a ceramically coated or metallized polyester. See e.g., “the outer packaging material 15 is composed of a single layer, it may be prepared only with an ethylene-vinyl alcohol copolymer, or may be made of polyethylene, polypropylene, polyvinyl chloride, cross-linked ethylene-vinyl acetate copolymer, or poly (ethylene-vinyl alcohol). It may be prepared from a mixture of at least one (preferably two or more) selected from vinylidene chloride, polybutene, polyester, and ethylene copolymer, and an ethylene-butyl alcohol copolymer.”
As to claims 7-9, Hama discloses the first barrier is in the form of a e.g., bag; second barrier is in the form of a bottle in fig. 1; the second barrier is in the form of a e.g., bottle; and the second barrier is partially or wholly surrounded by the first barrier in e.g., fig. 1.
As to claim 12, Hama teaches a method of prolonging functionality of a liquid analytical reagent comprising: placing an oxygen scavenger into a first section of a container formed from a first material (See e.g., “the outer packaging material 15 is composed of a single layer, it may be prepared only with an ethylene-vinyl alcohol copolymer, or may be made of polyethylene, polypropylene, polyvinyl chloride, cross-linked ethylene-vinyl acetate copolymer, or poly (ethylene-vinyl alcohol). It may be prepared from a mixture of at least one (preferably two or more) selected from vinylidene chloride, polybutene, polyester, and ethylene copolymer, and an ethylene-butyl alcohol copolymer.”); and placing the liquid analytical reagent (3 rHSA preparation in e.g., fig. 1) into a second section of the container; wherein a second material (2 plastic container in e.g., fig. 1) separates the first section from the second section, the first material has a permeability to oxygen of less than 50 cc/m.sup.2/24 hours, and the second material has a permeability to oxygen of 50 cc/m.sup.2/24 hours or more. See MPEP 2112.01(II).
As to claims 13, Hama teaches the container is not purged with an inert gas. See e.g., “The conditions for producing the container” section.
As to claims 14-15, Hama teaches the second section is in the shape of a bottle and forms an enclosed structure in e.g., fig. 1.
As to claims 16-20, see e.g., “The conditions for producing the container” section, and 112 rejections above.
Claim Rejections - 35 USC § 103
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.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hama in view of Harp (US 5362650, cited in IDS).
See Hama above.
As to claims 10-11, Hama does not specifically disclose the analytical reagent is an oxygen sensitive analytical reagent, or is a pool or spa reagent. Harp discloses improved method for determination of ultra-low amounts (e.g., detection down to 2 micrograms per liter) of chlorine in water. The method involves the use of the N,N-diethyl-p-phenylenediamine (DPD) indicator. See MPEP 2112.01(II), and e.g., col. 1, line 65 et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include a oxygen sensitive analytical reagent such as N,N diethyl-1,4 phenylenediamine sulfate (DPD) because DPD is known to be a reliable indicator for chlorine in water, especially in the ultralow range chlorine test (col. 2, line 3 et seq. of Harp).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
8/8/2026
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