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 .
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.
Priority
The present application was filed as a continuation of proper National Stage (371) entry of PCT Application No. PCT/JP2022/023441, filed 06/10/2022. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2021-15997, filed on 09/29/2021 in Japan.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed 06/26/2024, 02/05/2025 and 06/22/2026 are considered, initialed and are attached hereto.
Drawings
The drawings are objected to because:
Figures 9A and 10 are labeled at their legend as “[RELATED ART 1]” AND “[RELATED ART 2]”, the drawings are objected to because it is unclear if these figures are intended to be indicated as “Prior Art”, or for example, if these are drawings show generally what is available in the prior art (not specifically prior art).
If it is the case that these figures are “prior art”, then Figures 9A and 10 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 2-14 are objected to because of the following informalities:
The claims use the claim language “the immunochromatography kit according to claim…” and “the assay apparatus according to claim…”, it suggested that the claim language be amended in order to recite the claim language “the immunochromatography kit of claim…” and “the assay apparatus of claim…” in the interest of improving clarity of the record.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a loading unit in which the cartridge….is attachably and detachably loaded” in claim 10.
Based on the originally filed specification, the “loading unit” is described as an L-shaped tray, into which the cartridge is loaded, which provides the cartridge into the apparatus (see Figure 17, embodiment 102, and para [0097]).
“a detection unit that detects intensity of luminescence from the fluorescent substance in the assay region” in claim 10.
The originally filed specification at paras [0056] and [0105] describes the detection unit as a spectrophotometer
“a processor that is configured to determine whether the sample is positive or negative based on the intensity of the luminescence acquired from the detection unit” in claim 10; “configured to supply the luminescent substrate to the assay region by the luminescent supply mechanism after the sample and the labeled binding substance are supplied to the assay region” in claim 11; “configured to supply the washing solution to the assay region via the washing solution supply mechanism after supplying the sample and the labeled binding substance to the assay region and before supplying the luminescent substrate to the assay region” in claim 12; “configured to acquire the first luminescence intensity and the second luminescence intensity from the detection unit and carry out the determination using a value obtained by dividing the first luminescence intensity by the second luminescence intensity” in claim 13; and “configured to acquire a first luminescence intensity and the third luminescence intensity from the detection unit and carry out the determination using a value obtained by dividing the first luminescence intensity by the third luminescence intensity” in claim 14.
The specification describes the processor (para [0131]) as general-purpose processor executing software to function as various processing units; based on paras [0107], [0108], [0109], the claimed processor is interpreted as a special purpose computer, i.e., a computer programmed to perform the claimed functions.
The claims and specification appear to recite sufficient algorithm to determine if a sample is positive of negative (para [0062]-[0063], and claims 13 and 14).
Regarding the action of “supply the luminescent substrate to the assay region by the luminescent supply mechanism”, para [0112] describes a luminescent substrate supply mechanism controller (152) which operates the luminescent substrate supply mechanism (described at para [0104]) to control the second pressing operation (indicating the supply mechanism is a pressable structure); see also description of Figure 15 and also para [0078] referring to how this mechanism is actuated by a pressing action, acting on part 20. It is understood that the computer is programmed in order to cause 108 (the supply mechanism) to press 20 cartridge.
Regarding the action “configured to supply the washing solution to the assay region via the washing solution supply mechanism after supplying the sample and the labeled binding substance to the assay region and before supplying the luminescent substrate to the assay region”, see similarly the specification further describes performing this action via the washing solution supply mechanism (para [0021]), the mechanism described at para [0102] (an actuator), see further para [0103].
Regarding the function, “configured to acquire the first luminescence intensity and the second luminescence intensity from the detection unit and carry out the determination using a value obtained by dividing the first luminescence intensity by the second luminescence intensity”,; and “configured to acquire a first luminescence intensity and the third luminescence intensity from the detection unit and carry out the determination using a value obtained by dividing the first luminescence intensity by the third luminescence intensity”, it is understood from the originally filed specification that the processor is programmed to acquire the intensity, by obtaining the intensity for the detection unit, namely, the spectrophotometer, see para [0113], detection unit outputs spectrum to a “determination unit” (see for example Figure 18, the determination unit (154) referring to part of the programmed CPU) . Those of ordinary skill in the art would understand how to program a computer to receive output from the spectrophotometer.
“a luminescent substrate supply mechanism that supplies the luminescent substrate to the assay region” in claim 11.
“a washing solution supply mechanism that supplies the washing solution to the assay region”.
See as discussed above, the structure considered associated with “supply mechanism” is structure that is an actuator.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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 § 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 1-14 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 recites “the energy is transferred to the fluorescent substance in a state where the labeled binding substance is captured by the binding substance for capturing through the test substance”; however, “transferred… in a state” is indefinite claim language, as it raises question as to what “state” the claim is making reference to. It is not readily clear what is or is not encompassed by “in a state”. It is suggested Applicant omit this language.
Claim 6 recites that the label holding pad is disposed at a “supply position of the sample on the assay strip”, however, it is not clear what is or is not a “supply position”, for example there is no indication what position would be considered a “supply position”, and further supply of what component/reagent/sample, such that may further provide description of what position this is on a strip.
Claim 10 is indefinite because it is unclear from the recited language whether or not the claimed apparatus includes as part of its components, the kit of claim 1. For example, as written the claim is directed to apparatus having 3 structural components, the limitation “in which the cartridge in the immunochromatography kit according to claim 1 is attachably and detachably loaded” reads as intended use of the claimed loading part (i.e., limits the loading unit to unit capable of attachably and detachably loading the cartridge). In the interest of compact prosecution, the claim is addressed with the prior art as both including and not including the kit of claim 1 as part of its structure.
Claim 12 recites the claim language “the processor is configured to supply the washing solution….after supplying the sample to the labeled binding reagent”, this language is indefinite because it is open to two plausible, conflicting interpretations. For example, this could be interpreted as indicating the processor performs the action of supplying the wash solution and the sample (supplies both, one after the other), or it could be interpreted more like the language of claim 11, as indicating that the processor performs the action of supplying the wash solution after the sample is supplied (i.e., it’s not the processor that supplies the sample). It appears that the intent is the second interpretation (based on the other claims and the originally filed specification, e.g., para [0029] describes supplying sample through a dropping port, there is no description indicating that this action is performed by the processor), and as such it is suggested that the claim be amended accordingly.
Claim Rejections - 35 USC § 102
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) 10 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Polito et al., US PG Pub No. 2004/0018637A1.
Regarding claim 10, the claim recites the invention of claim 10 is directed to “an assay apparatus”, the apparatus comprising 3 structural components, namely the loading unit, the detection and the claimed processor configured to determine sample is positive or negative based on intensity. Regarding the loading unit, the claim recites “loading unit in which the cartridge in the immunochromatography kit according to claim 1 is attachably and detachable loaded”, the claim language does not specifically require the kit of claim 1 (is not a part of the apparatus structure), rather merely that the apparatus is capable of loading such a structure.
Polito et al. teach an assay apparatus comprising a loading unit in which a cartridge (such as that of the kit of claim 1) is attachably/detachably able to be loaded (see para [0018], describes inserting a cartridge, a cartridge containing a test strip, para [0032], referring to figure 1, loads into a cartridge receptacle, see also paras [0019],[0020], [0031], [0033], describes coupling cartridge and the reader apparatus), a detection unit that detects an intensity of luminescence form the fluorescent substance at the assay region of the test strip device (see para [0018], [0019], [0049], [0055], [0063]) sensor that detects signal, and a processor that is configured (programmed) to determine sample is positive or negative based on intensity acquired from the sensors (having a computer system, such as a processor and memory resources to analyze the assay (paras [0031] and [0055])).
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.
Claim(s) 1, 2, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkland et al., WO2020/210658A1 (IDS entered 02/05/2025) in view of Long et al., WO02/10754A2 and Zuk et al., US 4,208,479, and as evidenced by Mottram et al., The Pennsylvania Green Fluorophore: A Hybrid of Oregon Green and Tokyo Green for the Construction of Hydrophobic and pH-Insensitive Molecular Probes, Organic Letters, 8(4), (2006) (pages 581-584).
Kirkland et al. (see page 78, b. lateral flow components, para [0380]-[0383]) teach an immunochromatography product, the product of Kirkland having an immobilized binding substance for capturing that specifically binds to the test substance, labeled with a bioluminescence protein (para [0383], detection region, one target analyte binding agent immobilized to the detection region, includes first component of a bioluminescent complex), and a labeled binding substance that specifically binds to the test substance, labeled with a fluorescent substance that gets supplied to the assay region having immobilized binding substance (Kirkland para [0308] describes as target analyte binding agent, see page 79, comprising a fluorophore capable of being activated by energy transfer, e.g., by a bioluminescent polypeptide). See further Kirkland at para [0385], the product comprising a luminogenic substrate that is supplied to the assay (detection) region, causes bioluminescent energy transfer (BRET), such to cause luminescent protein to generate energy and transfer energy to the fluorescent substance upon capture of the analyte at the detection region (binding between the conjugate binding substance and the immobilized binding substance).
Kirkland et al. fails to recite their product comprising a cartridge that accommodates an assay strip.
Further, with respect to claim 1, which recites the language “kit” at the preamble, it is noted that the terminology “kit” is not found to further limit the scope of the claims in that it fails to claim or suggest any further structural components beyond those discussed in detail above. The language “kit” does not clearly invoke any additional ingredients or provide antecedent basis for terms appearing in the body of the claim (such as specific packaging or container elements, for example). See MPEP 2111.02.
Consequently, when the claims are given their broadest reasonable interpretation, the teachings of Kirkland et al. addresses the claim even though the reference does not describe their immunochromatography product using the word “kit” in describing their invention, as the reference teaches a product comprising all the necessary components of the instant claimed “kit”.
Nonetheless, see also in the interest of compact prosecution, this claim limitation is further addressed presently under 35 U.S.C. 103.
Long et al. teach an assay apparatus comprising a moulded cartridge containing a lateral flow test strip (see abstract and Figure 1-5) intended for quantitative measurement of an analyte contained in a sample (page 1, technical field), the invention involving delivery of reagents such as substrate (e.g., an enzyme substrate) and/or wash delivery, see end of page 1 to page 2, the advantage of the design of Long et al. is indicated to be the ability to include reagents to improve sensitivity without the need of delay or secondary steps (referring to the on device releasable reagents). Long et al. teach an assay cartridge as serving a functional ability, namely protective of the test strip (see page 2, third paragraph). Long et al.’s invention encompasses cartridge insertable into an optical system (e.g., capable of absorbance, florescence or chemiluminescence) (see page 7, last paragraph, to page 8). See page 2, first full paragraph, Long describe their invention as including a meter (reader) in which an assay cartridge is inserted.
Zuk et al. teach that in performing assays, it is convenient to combine the necessary reagents together in a kit (column 22, lines 20-68 in particular). Zuk et al. further teach that this may improve assay accuracy.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the immunochromatography product of Kirkland (the immunochromatographic test strip), with the cartridge system of Long et al. because Long teach a cartridge (holding the test strip) as providing protection of the assay strip and further because the cartridge of Long et al. allows the ability to incorporate a wash solution, which Long teach desirable for improving sensitivity. One having ordinary skill in the art would have had a reasonable expectation of success implementing modification to enclose in a cartridge as in Long because such cartridge is specifically for enclosing a test strip (the invention of Kirkland is a test strip).
Regarding the limitation “kit”, in light of Zuk et al., it would have been obvious to one of ordinary skill in the art to provide the immunochromatography product of Kirkland together in kit form for convenience and accuracy as taught by Zuk et al.
Regarding claim 2, see Kirkland et al. teach NanoLuc system, see e.g., para [0149] and [0176] (and as such, blue luminescent protein, see the instant originally filed specification at para [0158], this system with 460 nm wavelength), and further teach a green fluorescent dye or protein (see para [0286]), which see as evidenced by Mottram et al., has a quantum yield more than .7 (see Mottram at Table 1).
Regarding claim 6, Kirkland describe a conjugate pad (label holding pad) containing the labeled binding substance disposed at a supply position of the sample on the assay strip (see for example, para [0079] describing supplying sample to conjugation pad).
Regarding claim 7, Kirkland et al. does describe providing the luminogenic substrate as either dried on the device, or as a solution which is provided as a separate agent as part of an assay method or system (para [0382] or [0388]).
However, Kirkland fails to recite a luminescent substrate solution holding part that encompasses a luminescent substrate solution containing the luminescent substrate provided in the cartridge.
As discussed in detail above, Long et al. teach their cartridge inclusive of reagent stores for releasing solution reagent such as substrate to cause detectable signal (see cited above). See, for example, page 2, paragraph 3, Long describe the cartridge as containing reagent storage blisters which are to be released (release substrate necessary for signal production) during its use onto the lateral flow immunoassay test strip (see also end of page 4 describing figure 3 through page 5)
It would have been further obvious to one having ordinary skill in the art to have modified the kit as taught by Kirkland et al., Long et al. and Zuk et al., in order to provide the luminogenic substrate reagent of Kirkland in a reagent storage blister as in Long et al., one motivated to perform the modification as an obvious matter of a known technique applied to a known product, specifically because the prior art taught the base product (the assay having as described in Kirkland), the prior art also teaching the known technique for providing solution reagent to cause reaction and produce signal (Long et al.), one further motivated to make the modification since the cartridge of Long would not only provide protection, but in addition allow the system to be provided as a one step assay, having no need to provide solution reagent as a secondary or additional step (referring to Long cited above).
One having ordinary skill in the art would have had a reasonable expectation of success as the results would have predictable, namely accommodating release of the luminogenic substrate to induce signal (through the BRET system of Kirkland) during use of the strip for detection, one expect success considering the cartridge is made for housing a immunochromatographic lateral flow test strip (Kirkland’s product also is a test strip).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kirkland et al. in view of Long et al. and Zuk et al., as applied to claim 1 above, and further in view of Dale et al., NanoBRET: The Bright Future of Proximity-Based Assays, Frontiers in Bioengineering and Biotechnology, 7(Article 56), (2019), 13 pages.
Regarding claim 3, Kirkland et al. and the cited art fail to teach a green fluorescent protein having a peak at 530 nm or higher.
However see Dale et al. who teach for NanoBret (luciferase in BRET assays, page 2, col. 1, para 1), appropriate fluorescent dyes, see teaching NBD (4-nitro-7-aminobenzofurazan) as a fluorescent dye having excitation ~470 and emission ~530, teaching this dye as having beneficial due to its increased fluorescence in hydrophobic conditions (page 5, col. 2, second to last paragraph, see a finite list of suitable dyes listed).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirkland and the cited art in order to use with the Nanoluc system, a fluorescent dye such as NBD (having peak emission at 530 nm) as an obvious matter to try, namely selecting from a finite list of known suitable fluorescent dyes for nanoBret systems, one motivated to use NBD as a result of its strong fluorescence and its compatibility with the nanoLuc system (as used in Kirkland). One having ordinary skill in the art would have a reasonable expectation of success using a known dye known to be paired with the NanoLuc for BRET assay.
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkland et al. in view of Long et al. and Zuk et al., as applied to claim 1 above, and further in view of Okuyama et al., US PG Pub. 2019/0064160A1, Gold et al., US PG Pub No. 2014/0227796 and Reich, US PG Pub No. 2007/0092977A1.
Kirkland et al. teach a kit substantially as claimed (see as referenced above), however fails to teach the kit comprising a sample collection tool for collecting the sample (claim 4), and fail to teach instructions manual that describes the assay procedure for supplying sample and labeled binding substance to assay region then supplying the substrate (claim 5).
However, see for example, regarding immunochromatographic test strip assay kits, it is known in the art to include such items as part of the kit, see for example Okuyama et al. as an example, Okuyama et al. teach kits may include (in addition to test strip) other reagents necessary for detection, for example sample diluent, test tube, a swab for fecal sampling (Kirkland’s invention teaching samples including blood, serum, plasma, urine, stool, cerebral spinal fluid, interstitial fluid, etc. (para [0321]), as well as instruction manual (see para [0094]).
See also as another example, Gold et al., at para [0115], describing kits including lateral flow assay device, further including tools for sample collection (e.g., a swab) and instructions for use of the assay. Also, Reich at para [0085] and claims 9 and 23, immunochromatographic test strip kits including swabs, swab wetting solution, sample tubes, sample tube holder, instructions.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit as taught by Kirkland et al. and the cited prior art in order to include tools for sample collection and also instructions for performing the method intended for the product (instructions for its use) as taught in the prior art (referring to each of Okyama, Gold and Reich) as applying a known technique to a known product, specifically it was recognized in the art at the time to include with immunochromatographic test strip devices additional components such as tools to enable sample collection as well as instructions for performing the intended methods (referring to those references cited above), one further motivated for the reasons as discussed above as taught by Zuk (convenience and accuracy provided by supplying all the necessary components together in kit form). As such, one would further have a reasonable expectation of success considering this was typical for these types of products (as is evidenced by the cited art, Okuyama et al., Gold et al. and Reich).
Claim(s) 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkland et al. in view of Long et al. and Zuk et al., as applied to claim 1, and further in view of Nazareth et al., US PG Pub No. 2016/0169887A1.
Regarding claims 8 and 9, Kirkland et al. does also teach performing a wash step before detection (para [0339]).
See also Long et al. describe using either the substrate as a wash solution (cited previously), or introducing a wash reagent (page 4, first paragraph).
Although Long et al. describe only a single blister (storage) for reagent, see further Nazareth, which is similar to Long in that Nazareth also teaches an immunochromatographic test strip device similar to Kirkland et al. described previously above (see abstract and Figures 1-2, paras [0008]-[0009]), Nazareth also describing (see Figures 1A-C) the test strip enclosed in a housing/outer component, the house also including storage for on board reagent, for example Nazareth describing more than one store for such solution reagents (paras [0008] and [0009]). See Nazareth describe storing on board the cartridge, washing fluid (para [0110]).
It would have been prima facie obvious to have included, in addition to the stored substrate, stored wash fluid, one motivated to include wash fluid/solution because the prior art recognized wash as increasing sensitivity (Long et al.), further one would have a reasonable expectation of success including wash solution as this is technique taught by each Kirkland, Long and Nazareth for lateral flow immunoassay strip products (applying a known technique to a known type of device).
Further, it would have been prima facie obvious to have modified the cartridge (that of Long et al., as taught by the combination of Kirkland and Long) to include a second blister (store) for wash fluid as a known technique for supplying more than one reagent (as taught by each of Kirkland, Long and Nazareth) to a single immunoassay test strip in a single step as in Long (see for example, Long specifically suggest as wash either substrate or wash reagent, the modification allowing both provided at the same device to accommodate the single step intention as taught by Long). As such, because it was known that such cartridges could store more than one reagent (more than one reagent store was a technique known to those of skill in the art for this type of assay product) in a single cartridge/housing (see Nazareth), one having ordinary skill would have a reasonable expectation of success implementing this modification to he cartridge of Long.
The modification to incorporate a wash solution store (i.e., holding part as claimed) that includes wash solution on the cartridge, as set forth above, also addresses the limitations of claim 8.
Although Claim 10 is rejected previously above (referring to the rejection under 35 U.S.C. 102), the claim is also addressed presently in the interest of compact prosecution (see discussed above under 35 U.S.C. 112(b)).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kirkland et al. in view of Long et al. and Zuk et al., as applied to claim 1 above, and further in view of Wang et al., US PG pub No. 2007/0154964A1 and Polito et al., US PG Pub No.2004/001837.
Kirkland and the cited art teach a product/kit substantially as claimed
Long et al. describe a loading unit in which the cartridge is attachably and detachably loaded (see figure 1, 24, Long’s slot reads on the loading unit, see also page 7, and Figure 5), see as cited above, the system comprising a detection unit (for example, see cited above, Long teach including, for example fluorescence system for detecting luminescence from the fluorescence substance in the detection (assay) region). Long describe the meter as having electronic support and displaying the result (page 2, paragraph 3). The main embodiment of Long (the exemplified embodiment) details the meter described in terms of electrochemical detection (comprising electronics, facilitating electrode detection), and although Long describe the optical systems as being able to be, for example, for detection of signal from a fluorescent label, fails to teach the fluorescent label detector/system for detection as comprising a processor that determines the sample is positive or negative based on the intensity detected from the detection unit.
However, reader systems are well known in the immunochromatographic test strip art, see for example Wang et al., Wang teaching providing a strip-reader instrument having a reader slot for receiving an assay strip, and electronics or a processor to record and process the signal from the optical detector, convert the signal to an assayed level, displayed on a screen or window (see para [0072])
See also Polito et al. as an example, Polito teach a rapid assay reading that receives and then analyzes a lateral flow assay, the reader having a region to receive the cartridge having the test strip, and having a computer system, such as a processor and memory resources to analyze the assay (paras [0031] and [0055]).
It would have been further prima facie obvious to one having ordinary skill in the art that the detector/meter system of Long et al. (Kirkland modified to include the cartridge and reader of Long) include a processor that analyzes the sample to determine the results i.e., quantity, and as such positive/negative, based on the intensity observed from the detection unit (optical detector), as an obvious matter of applying a known technique to a known technology, particularly given that it was well known that such systems include a processor for analyzing the results of the assay, one motivated as this known technological technique allows the user/practitioner to read the output by converting the obtained signal into an assayed level (see for example, cited above Wang and Polito). One having ordinary skill in the art would have a reasonable expectation of success given that such systems have been known and available to those of ordinary skill in the art, as is supported by Wang and Polito, both published well before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Copending 19/077,239
Claims 1 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/077,239 in view of Zuk et al.
Copending ‘239 recites an immunochromatography kit comprising the same structures as recited at instant claim, see copending at claim similarly recites a cartridge that accommodates a strip (described as a case, see ‘239, claim 1), a strip in which sample spreads, having an assay region where test substance is captured, a binding substance that binds that is labeled with a bioluminescent protein (‘239 at claim 1), a labeled binding substance having a fluorescence substance label (‘239, at claim 11), a luminescent substrate that is supplied to the assay region, causing BRET as claimed (see ‘239, claim 1).
‘239 fails to use the word “kit to describe the product.
However, with respect to claim 1, which recites the language “kit” at the preamble, it is noted that the terminology “kit” is not found to further limit the scope of the claims in that it fails to claim or suggest any further structural components beyond those discussed in detail above. The language “kit” does not clearly invoke any additional ingredients or provide antecedent basis for terms appearing in the body of the claim (such as specific packaging or container elements, for example). See MPEP 2111.02.
Consequently, when the claims are given their broadest reasonable interpretation, the teachings of Kirkland et al. addresses the claim even though the reference does not describe their immunochromatography product using the word “kit” in describing their invention, as the reference teaches a product comprising all the necessary components of the instant claimed “kit”.
Nonetheless, see also in the interest of compact prosecution, this claim limitation is further addressed presently under 35 U.S.C. 103.
Zuk et al. teach that in performing assays, it is convenient to combine the necessary reagents together in a kit (column 22, lines 20-68 in particular). Zuk et al. further teach that this may improve assay accuracy.
Regarding the limitation “kit”, in light of Zuk et al., it would have been obvious to one of ordinary skill in the art to provide the immunochromatography product of Kirkland together in kit form for convenience and accuracy as taught by Zuk et al.
Regarding claim 7, see ‘239, claim 1 (luminescent substrate holding part described as part of the case/cartridge).
Regarding claims 8 and 9, see ‘239 at claim 10 (washing solution holding part, and washing solution as claimed).
Regarding claims 2 and 3, ‘239 is silent as to the bioluminescent protein and the fluorescent substance, and as such fails to teach bioluminescent that causes blue luminescence, and fluorescence substance that is dye or protein that emits green fluorescence having quantum yield of 0.7 or more (claim 2), further fluorescent substance with peak wavelength at 530 nm (claim 3).
See however, Dale et al., who teach the use of luciferase coupled with a fluorescent dye for Bret (luciferase in BRET assays, page 2, col. 1, para 1 referred to as nanoBRET), the reference teaching a blue emitting luciferase (nanoluc, see end of page 2 through page 3) and appropriate fluorescent dyes, see teaching NBD (4-nitro-7-aminobenzofurazan) as a fluorescent dye having excitation ~470 and emission ~530, teaching this dye as having beneficial due to its increased fluorescence in hydrophobic conditions (page 5, col. 2, second to last paragraph, see a finite list of suitable dyes listed).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘239 and the cited art in order to use with the Nanoluc system and a fluorescent dye such as NBD (having peak emission at 530 nm, i.e., a blue emitting bioluminescent protein and a green fluorescent protein) as an obvious matter of a known BRET pair applied for its intended purpose, namely selecting from a finite list of known suitable fluorescent dye including pairs recognized in the prior art specifically for Bret systems, one motivated to use NBD as a result of its strong fluorescence and its compatibility with the nanoLuc system (as used in Kirkland). One having ordinary skill in the art would have a reasonable expectation of success using a known dye known to be paired with the NanoLuc for BRET assay, particularly because ‘239 does not recite any particular pair.
Claims 4 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. ‘239 in view of Zuk eta l., as applied to claim 1 above, and further in view of Okuyama et al., Gold et al. and Reich.
‘239 teach a kit substantially as claimed, however fails to teach the kit comprising a sample collection tool for collecting the sample (claim 4), and fail to teach instructions manual that describes the assay procedure for supplying sample and labeled binding substance to assay region then supplying the substrate (claim 5).
However, see for example, regarding immunochromatographic test strip assay kits, it is known in the art to include such items as part of the kit, see for example Okuyama et al. as an example, Okuyama et al. teach kits may include (in addition to test strip) other reagents necessary for detection, for example sample diluent, test tube, a swab for fecal sampling (Kirkland’s invention teaching samples including blood, serum, plasma, urine, stool, cerebral spinal fluid, interstitial fluid, etc. (para [0321]), as well as instruction manual (see para [0094]).
See also as another example, Gold et al., at para [0115], describing kits including lateral flow assay device, further including tools for sample collection (e.g., a swab) and instructions for use of the assay. Also, Reich at para [0085] and claims 9 and 23, immunochromatographic test strip kits including swabs, swab wetting solution, sample tubes, sample tube holder, instructions.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit as taught by ‘239 and the cited art in order to include tools for sample collection and also instructions for performing the method intended for the product (instructions for its use) as taught in the prior art (referring to each of Okyama, Gold and Reich) as applying a known technique to a known product, specifically it was recognized in the art at the time to include with immunochromatographic test strip devices additional components such as tools to enable sample collection as well as instructions for performing the intended methods (referring to those references cited above), one further motivated for the reasons as discussed above as taught by Zuk (convenience and accuracy provided by supplying all the necessary components together in kit form). As such, one would further have a reasonable expectation of success considering this was typical for these types of products (as is evidenced by the cited art, Okuyama et al., Gold et al. and Reich).
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. ‘239 in view of Zuk eta l., as applied to claim 1 above, and further in view of Kirkland et al.
Regarding claim 6, copending ‘239 similarly recites labeled binding substance disposed upstream (at a position, see ‘239 at claim 3).
However, fails to describe the structure holding the labeling substance as a “pad”.
See however, Kirkland et al., described in detail previously above (see above under 35 U.S.C. 103), Kirkland describe a similar test strip device, the conjugate described similarly as the copending ‘239 (upstream), Kirkland teach providing the labeled substance as a “conjugate pad) (see paras [0069], [01110], [0327]).
It would have been prima facie obvious to one having ordinary skill in the art to have provided the labeled binding substance at a structure that is a conjugate pad, as in Kirkland et al., as an obvious matter of applying a known technique to a known product, one motivated to provide as a pad because the prior art teaches providing mobilizable labeled conjugate at a pad in the flow path so that conjugate interacts with analyte and is captured at the assay region. One having ordinary skill int eh art would have a reasonable expectation of success using a known structure for its art recognized purpose.
This is a provisional nonstatutory double patenting rejection.
Copending 19/077,989
Claims 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/077,989.
Copending ‘989 similarly recites an immunochromatography assay apparatus, comprising a loading part as claimed (copending ‘989 claim 1), a detection unit ( ‘989, claim 1 recites light detection part), and a processor (copending ‘989, claim 7). As such, ‘989 anticipates claim 10.
Correspondence
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/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677
Prosecution Insights