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 .
DETAILED ACTION
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 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.
Response to Restriction/Election
Applicant’s election without traverse of the followings species in response to restriction/election requirement is acknowledged:
“Horseradish peroxidase” in relation to peroxidase enzyme species;
“Percarbonate salt” in relation to peroxide oxidizer species;
“Sodium 3-(phenothiazine-10-yl)propane-1-sulfonate” in relation to N-alkylphenothiazine species; and
“4-morpholinopyridine” in relation to co-enhancer species.
Applicant stated that claims 1-18 read on the elected species.
Examiner searched prior arts with the scope of the elected species and found arts that renders the claimed method and kit obvious with the scope of the elected species and therefore, the non-elected subject matter of claims 1-18 (i.e. all other non-elected species) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention. See MPEP 803.02. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1-18 are examined on merits in this office action.
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 7 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.
Claim 7 lacks antecedent basis for the recitation ‘wherein the concentration of the peroxide”. Claim 1 from which claim 7 depends recites “peroxide oxidizer” and thus in order to clearly refer the compound and to avoid any confusion, “peroxide oxidizer” should be recited in claim 7.
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 of this title, 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 1-18 are rejected under 35 U.S.C. 103 as obvious over Nishinaka et al (Biochemical and Biophysical research communication 1993) in view of Chen et al (Food & Agricultural Immunology 2017), Leopoldo et al (EP2405016A1) and Leopoldo (EP1962095).
In regards to claims 1-5, Nishinaka teaches a chemiluminescence method for measuring superoxide ion (Abstract). Nishinaka teaches that luminol and MCLA (2-methyl-6-[p-methoxyphenyl]-3,7-dihydroimodazp[1,2-al]pyrazin-3-one) are the most commonly used chemiluminescence probes for monitoring O2- (page 557) but a luminol derivative L-012 (8-amino-5-chloro-7-phenylpyrido[3,4-d]pyridazine-1,4(2H,3H)dione; Fig. 1) provides sensitive chemiluminescence detection of O2- (page 555, result and discussion). Nishinaka teaches utilizing stimulatory agent c5a, fMLP, PAF and PML in the chemiluminescence reaction, but however, does not disclose utilizing peroxidase enzyme, an enhancer, a co-enhancer as described in instant claims.
Chen in a review for enhancers for chemiluminescence enzyme immunoassay, discloses utilization of enhancers in chemiluminescence (CL) immunoassays (Abstract). Chen teaches that CL immunoassay causes luminescence materials catalyzed by horseradish peroxidase (HRP) and alkaline phosphatase (ALP) using oxidants to actively luminesce during a transition from the excited state to the ground state. Chen teaches that some oxidants or compounds are required to enhance the intensity of luminescence materials to improve instrumental testing results and increase its sensitivity (page 316, 3rd paragraph). Chen teaches luminol with enhancer and teaches that common enhancer includes phenolic and its derivatives, N-phenoxazine derivatives, D-luciferin, metallic ion and other enhancers (page 316, 5th paragraph). Chen teaches that in the mechanism of co-enhancer based on the mechanism of HRP–luminol based CL reaction, the secondary enhancer accelerates peroxidase-catalyzed primary enhancer by hydrogen peroxide to produce cation radical for increasing CL intensity. Chen teaches that N-alkylated phenothiazine could be used as an enhancer in luminol–oxidant–HRP system and N-alkylated phenothiazine is a highly advantageous enhancer and increases light output (up to 10-fold) observed in their presence can be translated into a corresponding improvement in sensitivity of chemiluminescent assays. Chen teaches that the CL intensity was improved with the addition of the co-enhancer SPTZ and MORP. (page 319). Chen teaches co-enhancer of the luminol–H2O2–HRP CL system and teaches enhanced chemiluminescence reaction (ECR) by horseradish peroxidase (HRP-C) in the presence of the enhancers 3- (10′-phenothiazinyl)-propane-1-sulfonate (SPTZ) and 4-morpholinopyridine (MORP) (page 320, section 2.1.2).
Each of the Leopoldo references (EP2405016A1 & EP1962095) teaches increasing chemiluminescent reaction of luminol with peroxidase, oxidant and catalysts (Abstract). Leopoldo (EP2405016A1) teaches chemiluminescence enhancement of luminol with a peroxidase enzyme, an oxidant, a primary enhancer, a secondary enhancer, wherein the peroxidase enzyme is horseradish peroxidase (claim 3), the oxidant is sodium perborate or hydrogen peroxide (claim 5), the primary enhancer is sodium 3-(phenothiazine-10yl)propane-1-sulfonate (claim 6) and the secondary enhancer can be 1-methylimidazole (claim 2). Leopoldo (EP1962095A1) teaches chemiluminescence enhancement of luminol with a peroxidase enzyme, an oxidant, and an electron mediator and a hypernucleophilic acylation catalyst (HNAC) (claim 1), wherein the peroxidase enzyme is horseradish peroxidase (claim 6), the oxidant is sodium perborate or hydrogen peroxide (claim 7), the HNAC can be 4-morpholinotyridine (MORP) the electron mediator can be sodium 3-(phenothiazine-10yl)propane-1-sulfonate (claim 10) and the secondary enhancer can be 1-methylimidazole (claim 2). Leopoldo (EP ‘095) teaches pH range between 8.9 and 9.4 and 8-10 (paragraph [0017] of ‘095 and claim 10) and the references of Leopoldo (EP ‘016) teaches pH range between 8.3 and 9.3 (paragraph [0020] of ‘016 and claim 7).
Therefore, from the description in mind of the Chen and Leopoldo references that utilization of HRP with an oxidant and various enhancers provides enhance chemiluminescence from luminol, it would be obvious to one of ordinary skilled in the art before the effective filing date of claimed invention to easily envisage providing the luminol derivative L-012 of Nishinaka with HRP, oxidant and the enhancers with the expectation of further enhancing chemiluminescence of the luminol derivative L-012 with a reasonable expectation of success. Since Nishinaka teaches luminol derivative L-012 (8-amino-5-chloro-7-phenylpyrido[3,4-d]pyridazine-1,4(2H,3H)dione provides better luminescence compared to luminol and since the references of Chen and Leopoldo (EP ‘016 & ‘095) teaches improvement of chemiluminescence from luminol with a peroxidase enzyme, an oxidant, a primary enhancer, and a secondary enhancer, one of ordinary skilled in the art would obviously consider similarly incorporating the enhancing components with the luminol derivative L-012 with the expectation of providing enhanced fluorescence. The references of Leopoldo (EP ‘095) teaches pH range between 8.9 and 9.4 and 8-10 (paragraph [0017] of ‘095 and claim 10) and the references of Leopoldo (EP ‘016) teaches pH range between 8.3 and 9.3 (paragraph [0020] of ‘016 and claim 7) and thus one of ordinary skilled in the art would obviously consider optimizing a pH range with various pH and or optimal ranges with the derivative of luminol L-012 for optimization.
In regards to concentration of enhancer of claim 5, Both the references of Leopoldo (EP ‘095 &’016) teaches enhancer 3-(phenothiazine-10yl)propane-1-sulfonic acid between 0.1 and 10mM (paragraph [0020] of ‘095 and paragraph [0028] or ‘016) and thus one of ordinary skilled in the art would obviously consider various concentrations of primary enhance with the derivative of luminol L-012 for optimization.
In regards to concentration of enhancer of claim 6, the references of Leopoldo (EP ‘095) teaches co-enhancer between 0.1 and 10mM (paragraph [0016] of ‘095) and the references of Leopoldo (EP ‘016) teaches co-enhancer between 0.1 and 50mM (paragraph [0019] or ‘016) and thus one of ordinary skilled in the art would obviously consider various concentrations of secondary enhancer (co-enhancer) with the derivative of luminol L-012 for optimizationIn regards to concentration of luminol of claim 8, both the references of Leopoldo teach luminol between 0.1mM to 50mM (paragraph [0026] of EP ‘016 and paragraph [[0018] or EP ‘095) and thus one of ordinary skilled in the art would obviously consider various concentration of the derivative of luminol L-012 for optimization.
In regards to claim 7 of peroxide concentration, the references of Leopoldo (EP ‘095) teaches peroxide between 0.5 and 10mM (paragraph [0018] of ‘095) and the references of Leopoldo (EP ‘016) teaches peroxide between 0.5 and 50mM (paragraph [0027] or ‘016) and thus one of ordinary skilled in the art would obviously consider various concentrations of peroxide sources with the derivative of luminol L-012 for optimization.
In regards to concentration of luminol of claim 8, both the references of Leopoldo teach luminol between 0.1mM to 50mM (paragraph [0026] of EP ‘016 and paragraph [[0018] or EP ‘095) and thus one of ordinary skilled in the art would obviously consider various concentration of the derivative of luminol L-012 for optimization.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 9 & 10, the references of Leopoldo (EP ‘095) teaches pH range between 8.9 and 9.4 and 8-10 (paragraph [0017] of ‘095 and claim 10) and the references of Leopoldo (EP ‘016) teaches pH range between 8.3 and 9.3 (paragraph [0020] of ‘016 and claim 7) and the pH and concentration ranges of the enhancer, co-enhancer, peroxide oxidizer and luminol derivative, as described above, Leopoldo teaches various pH, and concentrations of oxidant, enhancer and co-enhancer, ordinary skilled in the art would obviously consider various pH and or optimal ranges with the derivative of luminol L-012 for optimization with a reasonable expectation of success. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 11, Leopoldo teaches using Tris Buffer (pages 7-8 of EP ’016 and pages 6-7 pf EP ‘095).
In regards to claim 12, the reference of Leopoldo (Claim 11 of EP ’016 & ‘095) teaches utilizing the composition for detection of analyte in a sample and thus utilization of the composition with the luminol derivative for detection of analyte would be obvious to one of ordinary skilled in the art.
In regards to kit claims 13-18, the reference of Leopoldo (claims 10-17 of EP ‘016) discloses compiling the components for luminescence detection in a kit for convenience wherein the components includes luminol, an oxidant, a primary enhancer and a secondary enhancer (claims 10-17) and thus compiling in a kit, the various enhancer components (i.e. luminol derivatives, the peroxidase, the oxidant, the primary enhancer and the secondary enhancer) as shown obvious with luminol derivative, would be consider obvious to one of ordinary skilled in the art.
Claims 1-18 are rejected under 35 U.S.C. 103 as obvious over Ichibangase et al (Luminescence 2013) in view of Chen et al (Food & Agricultural Immunology 2017), Leopoldo et al (EP2405016A1) and Leopoldo (EP1962095).
In regards to claims 1-5, Ichibangase teaches luminol derivative L-012 for measuring HRP and H2O2 (Title). Ichibangase teaches L-012 as an enhanced replacement for luminol in CL methods (Abstract). Ichibangase teaches testing various enhancers such as 4-iodophenol, biphenylboronic acid, p-iodophenol, p-hydroxyphenylthiazole and N-azole, to improve sensitivity for luminescence detection but however, does not disclose utilizing the enhancer and the co-enhancer as described in the instant claims.
Chen in a review for enhancers for chemiluminescence enzyme immunoassay, discloses utilization of enhancers in chemiluminescence (CL) immunoassays (Abstract). Chen teaches that CL immunoassay causes luminescence materials catalyzed by horseradish peroxidase (HRP) and alkaline phosphatase (ALP) using oxidants to actively luminesce during a transition from the excited state to the ground state. Chen teaches that some oxidants or compounds are required to enhance the intensity of luminescence materials to improve instrumental testing results and increase its sensitivity (page 316, 3rd paragraph). Chen teaches luminol with enhancer and teaches that common enhancer includes phenolic and its derivatives, N-phenoxazine derivatives, D-luciferin, metallic ion and other enhancers (page 316, 5th paragraph). Chen teaches that in the mechanism of co-enhancer based on the mechanism of HRP–luminol based CL reaction, the secondary enhancer accelerates peroxidase-catalyzed primary enhancer by hydrogen peroxide to produce cation radical for increasing CL intensity. Chen teaches that N-alkylated phenothiazine could be used as an enhancer in luminol–oxidant–HRP system and N-alkylated phenothiazine is a highly advantageous enhancer and increases light output (up to 10-fold) observed in their presence can be translated into a corresponding improvement in sensitivity of chemiluminescent assays. Chen teaches that the CL intensity was improved with the addition of the co-enhancer SPTZ and MORP. (page 319). Chen teaches co-enhancer of the luminol–H2O2–HRP CL system and teaches enhanced chemiluminescence reaction (ECR) by horseradish peroxidase (HRP-C) in the presence of the enhancers 3- (10′-phenothiazinyl)-propane-1-sulfonate (SPTZ) and 4-morpholinopyridine (MORP) (page 320, section 2.1.2).
Each of the Leopoldo references (EP2405016A1 & EP1962095) teaches increasing chemiluminescent reaction of luminol with peroxidase, oxidant and catalysts (Abstract). Leopoldo (EP2405016A1) teaches chemiluminescence enhancement of luminol with a peroxidase enzyme, an oxidant, a primary enhancer, a secondary enhancer, wherein the peroxidase enzyme is horseradish peroxidase (claim 3), the oxidant is sodium perborate or hydrogen peroxide (claim 5), the primary enhancer is sodium 3-(phenothiazine-10yl)propane-1-sulfonate (claim 6) and the secondary enhancer can be 1-methylimidazole (claim 2). Leopoldo (EP1962095A1) teaches chemiluminescence enhancement of luminol with a peroxidase enzyme, an oxidant, and an electron mediator and a hypernucleophilic acylation catalyst (HNAC) (claim 1), wherein the peroxidase enzyme is horseradish peroxidase (claim 6), the oxidant is sodium perborate or hydrogen peroxide (claim 7), the HNAC can be 4-morpholinotyridine (MORP) the electron mediator can be sodium 3-(phenothiazine-10yl)propane-1-sulfonate (claim 10) and the secondary enhancer can be 1-methylimidazole (claim 2). Leopoldo (EP ‘095) teaches pH range between 8.9 and 9.4 and 8-10 (paragraph [0017] of ‘095 and claim 10) and the references of Leopoldo (EP ‘016) teaches pH range between 8.3 and 9.3 (paragraph [0020] of ‘016 and claim 7).
Therefore, from the description in mind of the Chen and Leopoldo references that utilization of HRP with an oxidant and various enhancers provides enhance chemiluminescence from luminol, it would be obvious to one of ordinary skilled in the art before the effective filing date of claimed invention to easily envisage providing the luminol derivative L-012 of Ichibangase with HRP, oxidant and the enhancers with the expectation of further enhancing chemiluminescence detection with the luminol derivative L-012 with a reasonable expectation of success. Since Ichibangase teaches luminol derivative L-012 (8-amino-5-chloro-7-phenylpyrido[3,4-d]pyridazine-1,4(2H,3H)dione provides better luminescence compared to luminol and since the references of Chen and Leopoldo (EP ‘016 & ‘095) teaches improvement of chemiluminescence from luminol with a peroxidase enzyme, an oxidant, a primary enhancer, and a secondary enhancer, one of ordinary skilled in the art would obviously consider similarly incorporating the enhancing components with the luminol derivative L-012 with the expectation of providing enhanced fluorescence. The references of Leopoldo (EP ‘095) teaches pH range between 8.9 and 9.4 and 8-10 (paragraph [0017] of ‘095 and claim 10) and the references of Leopoldo (EP ‘016) teaches pH range between 8.3 and 9.3 (paragraph [0020] of ‘016 and claim 7) and thus one of ordinary skilled in the art would obviously consider optimizing a pH range with various pH and or optimal ranges with the derivative of luminol L-012 for optimization.
In regards to concentration of enhancer of claim 5, Both the references of Leopoldo (EP ‘095 &’016) teaches enhancer 3-(phenothiazine-10yl)propane-1-sulfonic acid between 0.1 and 10mM (paragraph [0020] of ‘095 and paragraph [0028] or ‘016) and thus one of ordinary skilled in the art would obviously consider various concentrations of primary enhance with the derivative of luminol L-012 for optimization.
In regards to concentration of enhancer of claim 6, the references of Leopoldo (EP ‘095) teaches co-enhancer between 0.1 and 10mM (paragraph [0016] of ‘095) and the references of Leopoldo (EP ‘016) teaches co-enhancer between 0.1 and 50mM (paragraph [0019] or ‘016) and thus one of ordinary skilled in the art would obviously consider various concentrations of secondary enhancer (co-enhancer) with the derivative of luminol L-012 for optimization. In regards to concentration of luminol of claim 8, both the references of Leopoldo teach luminol between 0.1mM to 50mM (paragraph [0026] of EP ‘016 and paragraph [[0018] or EP ‘095) and thus one of ordinary skilled in the art would obviously consider various concentration of the derivative of luminol L-012 for optimization.
In regards to claim 7 of peroxide concentration, the references of Leopoldo (EP ‘095) teaches peroxide between 0.5 and 10mM (paragraph [0018] of ‘095) and the references of Leopoldo (EP ‘016) teaches peroxide between 0.5 and 50mM (paragraph [0027] or ‘016) and thus one of ordinary skilled in the art would obviously consider various concentrations of peroxide sources with the derivative of luminol L-012 for optimization.
In regards to concentration of luminol of claim 8, both the references of Leopoldo teach luminol between 0.1mM to 50mM (paragraph [0026] of EP ‘016 and paragraph [[0018] or EP ‘095) and thus one of ordinary skilled in the art would obviously consider various concentration of the derivative of luminol L-012 for optimization.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 9 & 10, the references of Leopoldo (EP ‘095) teaches pH range between 8.9 and 9.4 and 8-10 (paragraph [0017] of ‘095 and claim 10) and the references of Leopoldo (EP ‘016) teaches pH range between 8.3 and 9.3 (paragraph [0020] of ‘016 and claim 7) and the pH and concentration ranges of the enhancer, co-enhancer, peroxide oxidizer and luminol derivative, as described above, Leopoldo teaches various pH, and concentrations of oxidant, enhancer and co-enhancer, ordinary skilled in the art would obviously consider various pH and or optimal ranges with the derivative of luminol L-012 for optimization with a reasonable expectation of success. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 11, Leopoldo teaches using Tris Buffer (pages 7-8 of EP ’016 and pages 6-7 pf EP ‘095).
In regards to claim 12, the reference of Leopoldo (Claim 11 of EP ’016 & ‘095) teaches utilizing the composition for detection of analyte in a sample and thus utilization of the composition with the luminol derivative for detection of analyte would be obvious to one of ordinary skilled in the art.
In regards to kit claims 13-18, the reference of Leopoldo (claims 10-17 of EP ‘016) discloses compiling the components for luminescence detection in a kit for convenience wherein the components includes luminol, an oxidant, a primary enhancer and a secondary enhancer (claims 10-17) and thus compiling in a kit, the various enhancer components (i.e. luminol derivatives, the peroxidase, the oxidant, the primary enhancer and the secondary enhancer) as shown obvious with luminol derivative, would be consider obvious to one of ordinary skilled in the art.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of US Patent No.11761964. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims are encompassed or would be obvious from the disclosure of claims 1-8 of US patent ‘964. The claims 1-8 of the US patent ‘964 discloses various peroxidase enzymes, enhancers, coenhancers and oxidant for chemoluminescence detection using various chemiluminescent compound including 8-amino-5-chloro-7-phenylpyrido[3,4-d]pyridazine- 1,4(2H,3H)-dione. The claims are directed to enhanced light emission utilizing substrate, enzymes, enhancer and coenhancer and utilization of the composition for chemiluminescence detection and providing the composition in a kit for convenience would be obvious to one of ordinary skilled in the art.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of US Patent No.11573183. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims are encompassed or would be obvious from the disclosure of claims 1-16 of US patent ‘183. The claims 1-16 of the US patent ‘183 discloses kit composition for performing chemiluminescence assays and discloses methods utilizing the kit components wherein the kit composition comprises peroxidase enzymes, enhancers, co-enhancers and oxidant for chemiluminescence detection. The kit composition comprises various compounds for chemiluminescent assays including 8-amino-5-chloro-7-phenylpyrido[3,4-d]pyridazine- 1,4(2H,3H)-dione as substrate. The claims are directed kit composition determining analyte chemiluminescent assays utilizing substrate, enzymes, enhancer and co-enhancer and the disclosure broadly encompasses or provides obviousness for the composition and kit composition of instant application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zielonka et al (Free Radical Biology and Medicine 2013), discloses L-012 (8-amino-5-chloro-7-phenylpyrido[3,4-d]pyridazine-1,4(2H,3H)dione, a luminol based molecule that has been reported to produce much stronger chemiluminescence (CL) than other CL probes, but does not disclose the enhancers and co-enhancer as claimed in the instant claim for enhancement of chemiluminescence.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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