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 .
Claims 2-4, 6-7, 9, 11-19, 21, 23 and 25-98 have been canceled.
Claims 1, 5, 8, 10, 20, 22 and 24 are pending and under examination.
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.
Claims 1, 5, 8, 10, 20, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12216127. Although the claims at issue are not identical, they are not patentably distinct from each other because US 127’ patent reciting a kit for use of detecting depression, nevertheless the 127’ patent using the SAME food preparation, including orange, cucumber, corn, wheat, honey, rye, strawberry, tea, soybean, grapefruit, cane sugar, cow’s milk. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Therefore the kit of 127’ patent can also be used for diagnosis of irritable bowel syndrome as the current application.
Claim are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5-16, 20-40, 46-60, 74, 78-85 of copending Application No. 19191417 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 417’ application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Even though co-pending 417’ application directs to a different diagnosis, nevertheless use of the SAME product assay (ELISA) would have resulted in the same functionality. Co-pending application 417’ in the Table 1 and Table 2 have used the same food preparation as the same as the current application including: Blueberry, cabbage, cane sugar, chicken, corn, cow milk, crab, egg, grapefruit, halibut, lemon, oat, onion. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods. Note, the method claims in the co-pending 417’ also recite using the SAME food preparation for diagnosis, therefore the methods claims would have also rendered the current claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25, 26, 30-33, 46-53, 74-100 of co-pending Application No. 19193883. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 883’ application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Even though co-pending 417’ application directs to a different diagnosis, nevertheless use of the SAME product assay (ELISA) would have resulted in the same functionality.
Co-pending application 883’ in the Table 1 and Table 2 have used the same food preparation as the same as the current application including: orange, oat, rye, cow milk, cucumber, walnut, wheat, cane sugar, yeast, egg, corn, cabbage, lemon, onion. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods. Note, the method claims in the co-pending 883’ also recite using the SAME food preparation for diagnosis, therefore the methods claims would have also rendered the current claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25 of US 10788498. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) the same as the 498’ patent. In 498’ patent, claims 8, 12, 18 recite the same food preparation as the same as the current application including: tea, oat, cabbage, cow milk, onion, honey, rye, corn, yeast, wheat, soybean, egg, pineapple, cucumber, orange, halibut, walnut, grapefruit. Claim 14 and 19 also direct to FDR multiplicity adjustable p-value based on at least one gender/age. Claim 25 also directs to use of a kit for performing method of analysis in claim 24, 18 and 17.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13, 21-31, 46-52, 93-99 of copending Application No. 19/193886. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 886’ application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Even though co-pending 417’ application directs to a different diagnosis, nevertheless use of the SAME product assay (ELISA) would have resulted in the same functionality.
Co-pending application 886’ in the Table 1 and Table 2 have used the same food preparation as the same as the current application including: cucumber, tea, grapefruit, rye, oat, cabbage, cane sugar, orange, honey, wheat, onion, cow milk, lemon, barley. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods. Note, the method claims in the co-pending 886’ also recite using the SAME food preparation for diagnosis, therefore the methods claims would have also rendered the current claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 of US 10309970. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) the same as the 970’ patent. In 970’ patent, the same food preparation having the capability for triggering irritable bowel syndrome as the current application including: tea, oat, cabbage, cow milk, onion, honey, rye, corn, yeast, wheat, soybean, egg, pineapple, cucumber, orange, halibut, walnut, grapefruit (examples and table 2) where these food preparations have an IBS raw p-value of <0.07 or an IBS false discovery rate (FDR) multiplicity adjusted p-value of <0.01.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 11-13, 20-31, 40-51, 77-78, 91-99 of copending Application No. 19208078. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 078’ application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Even though co-pending 078’ application directs to a different diagnosis, nevertheless use of the SAME product assay (ELISA) would have resulted in the same functionality. Co-pending application 078’ in the Table 1 and Table 2 have used the same food preparation as the same as the current application including: cucumber, orange, egg, cabbage, grapefruit, wheat, cow milk, rye, yeast, oat, honey, onion, lemon, corn, strawberry. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods. Note, the method claims in the co-pending 078’ also recite using the SAME food preparation for diagnosis, therefore the methods claims would have also rendered the current claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25, 26, 30-33, 46-53, 74-100 of copending Application No. 19211870. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 870’ application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Even though co-pending 870’ application directs to a different diagnosis, nevertheless use of the SAME product assay (ELISA) would have resulted in the same functionality. Co-pending application 870’ in the Table 1 and Table 2 have used the same food preparation as the same as the current application including: barley, cabbage, corn, cucumber, grapefruit, honey, lemon, oat, orange, rye, tea, walnut, soybean. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods. Note, the method claims in the co-pending 870’ also recite using the SAME food preparation for diagnosis, therefore the methods claims would have also rendered the current claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 100-111 of copending Application No. 19211875 in view of Cousin (US200701222840). Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are obvious by the co-pending 875’ application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Co-pending application 875’ in the Table 1 and Table 2 have used the same food preparation as the same as the current application including: cane sugar, barley, rye, orange, oat, walnut, lemon, grapefruit, corn, cabbage, strawberry, honey. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods.. It is noted that the co-pending 875’ directs to a method but using the same food for ELISA analysis but no explicit use of a kit for conducting ELISA. Nevertheless placing all the ingredient and reagents in a kit for an assay is well-known and commonly practiced in the field. Such as Cousin also teaches placing food preparation for detecting allergy on ELISA plate for analysis. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put all the food preparations on microplate in a kit for analysis as taught by Cousin (see claim Examples 1-3) for convenience and one artisan in the field would have reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 134-148 of copending Application No 19218292 in view of Cousin. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 292 application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Co-pending application 292’ in claim 142, 144-146 have used the same food preparation as the same as the current application including: cane sugar, barley, rye, orange, oat, walnut, lemon, grapefruit, corn, strawberry, cabbage, soybean, honey. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality including identifying IBS triggering foods. It is noted that the co-pending 292’ directs to a method using the same food for ELISA analysis but no explicit use of a kit for conducting ELISA. Nevertheless placing all the ingredient and reagents in a kit for an assay is well-known and commonly practiced in the field. Such as Cousin also teaches placing food preparation for detecting allergy on ELISA plate for analysis. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put all the food preparations on microplate in a kit for analysis as taught by Cousin (see claim Examples 1-3) for convenience and one artisan in the field would have reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 109-115 of copending Application No 19008110 in view of Cousin. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 292 application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Co-pending application 110’ claims 109, 112-113 have used the same food preparation as the same as the current application including: orange, cucumber, corn , wheat, honey, oat, rye, strawberry, tea, soybean, grapefruit, cow milk. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality. It is noted that the co-pending 110’ directs to a method using the same food for ELISA analysis but no explicit use of a kit for conducting ELISA. Nevertheless placing all the ingredient and reagents in a kit for an assay is well-known and commonly practiced in the field. Such as Cousin also teaches placing food preparation for detecting allergy on ELISA plate for analysis. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put all the food preparations on microplate in a kit for analysis as taught by Cousin (see claim Examples 1-3) for convenience and one artisan in the field would have reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 8, 10, 20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14-28 of copending Application No 19037016 in view of Cousin. Although the claims at issue are not identical, they are not patentably distinct from each other because the current kit claim directs using a plurality of food preparations in identifying irritable bowel syndrome in a patients (e.g. ELISA) are anticipatory or obvious by the co-pending 016 application based on the SAME food preparations. PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Co-pending application 016’ claims 22, 24-263 have used the same food preparation as the same as the current application including: orange, cucumber, corn , wheat, honey, oat, rye, strawberry, tea, soybean, grapefruit, cow milk, cane sugar. As to the intended use, such as FDR multiplicity adjustable p-value based on at least one gender/age, using SAME food preparation for analysis would have the SAME functionality. It is noted that the co-pending 016’ directs to a method using the same food for ELISA analysis but no explicit use of a kit for conducting ELISA. Nevertheless placing all the ingredient and reagents in a kit for an assay is well-known and commonly practiced in the field. Such as Cousin also teaches placing food preparation for detecting allergy on ELISA plate for analysis. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put all the food preparations on microplate in a kit for analysis as taught by Cousin (see claim Examples 1-3) for convenience and one artisan in the field would have reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 10 is objected to because of the following informalities: please provide full name of FDR. Appropriate correction is required.
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) 1, 5, 8, 10, 20, 22 and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vojdani (US 20160320403).
The current application directs to a kit for use of identifying food that triggers symptoms associated with irritable bowel syndrome (IBS) in a subject. The kit comprises a plurality of food preparation coupled to a solid carrier wherein there are at least 10 distinct food preparations are used for the assay. In brief, the kit claim can be considered a kit having ELISA plates coupled with at least 10 distinct recited food preparations thereon.
With the above features in view, Vojdani teaches using immunoassay in a kit, e.g. ELISA which contains individual addressable solid well supports therein, to test food allergens. The food preparations are immobilized on the surface of the microwells and labeled serum anti-IgG is employed to detect food allergic IgG in patients (See Abstracts, 0017-19; section 0128l; claim 11 and 21).
It is noted that at least 13 SAME food preparations were used by Vojdani, including
Cucumber, orange, tea, cabbage, grapefruit, wheat, honey, onion, lemon, walnut, corn, pineapple, strawberry. Note, Vojdani also teaches testing the food preparations in different combinations (See section 0048-49)(emphasis added). PRODUCT, MPEP §2112 states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Since Vojdani uses the SAME food preparations, this kit inherently can also perform the SAME function in identifying IBS triggering food in the test subject.
As to claim 10, the feature of the FDR adjusted p-value adjusted based on either age or gender is an inherent characteristic since the SAME food preparations are used for the kit.
As to claim 20, 22 and 24, Vojdani teaches preparing food extracts and coupling the extracts to the ELISA plate for analysis.
Claim(s) 1, 5, 8, 10, 20, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Suga (US 20120058497).
Suga teaches using an immunoassay kit, e.g. ELISA which has individual addressable solid well support therein, to test food allergens. The food preparations are immobilized on the surface of the well and labeled serum anti-IgG is employed to detect food allergic IgG in patients (See Abstracts, section 0016-17; 0092).
It is noted at least 15 SAM food preparations disclosed in Suga read on the current invention, including grapefruit, cabbage, onion, oat, yeast, cane sugar, rye, walnut, orange, lemon, strawberry, shrimp, pineapple, chicken, buck wheat, corn, rice (See Examples and claims 1-15). Note, the same Markush selection format is recited in claim 1 for a plurality of food. Since Suga uses the SAME food preparations, this kit inherently can also perform the SAME function in identifying IBS triggering food in the test subject.
As to claim 10, the feature of the FDR adjusted p-value adjusted based on either age or gender is an inherent characteristic since the SAME food preparations are used for the kit.
As to claim 20, 22 and 24, Suga teaches preparing food extracts and coupling the extracts to the ELISA plate for analysis.
Claim(s) 1, 5, 8, 10, 20, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cousins (US 20070122840).
Cousins teaches using an immunoassay kit, e.g. ELISA which has individual addressable solid well support therein, to test food allergens. The food preparations are immobilized on the surface of the well and labeled serum anti-IgG is employed to detect food allergic IgG in patients (See Abstracts, section 0016-17; 0092).
It is noted at least 12 SAM food preparations disclosed in Suga read on the current invention, including soybean, walnut, orange, strawberry, cabbage, cow milk, chicken, barley, corn, rye, wheat, yeast, egg (See Examples and claims 1-15). Note, the same Markush selection format is recited in claim 1 for a plurality of food. Since Cousins uses the SAME food preparations, this kit inherently can also perform the SAME function in identifying IBS triggering food in the test subject.
As to claim 10, the feature of the FDR adjusted p-value adjusted based on either age or gender is an inherent characteristic since the SAME food preparations are used for the kit.
As to claim 20, 22 and 24, Cousins teaches preparing food extracts and coupling the extracts to the ELISA plate for analysis.
Claim(s) 1, 5, 8, 10, 20, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Power (US 7601509).
Power teaches using an immunoassay kit, e.g. ELISA which has individual addressable solid well support therein, to test food allergens (see example 1).
It is noted at least 12 SAM food preparations disclosed in Power read on the current invention, including soybean, walnut, egg, rye, wheat, orange, corn, cow milk, yeast, cane sugar, shrimp, chicken (See Table 3). Since Power uses the SAME food preparations, this kit inherently can also perform the SAME function in identifying IBS triggering food in the test subject.
As to claim 10, the feature of the FDR adjusted p-value adjusted based on either age or gender is an inherent characteristic since the SAME food preparations are used for the kit.
As to claim 20, 22 and 24, using ELISA kit for identifying food allergens, this implies that the food preparation are coupled to the ELISA plate (see example 1).
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/ Primary Examiner, Art Unit 1678