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
Status of Claims
Claims 16-30 are pending and have been examined.
Priority
This application, Serial No. 18/271,493 (PGPub: US2024/0060976) was filed 07/10/2023. This application is a 371 of PCT/JP2022/001905 filed 01/20/2022. This application claims priority to foreign application Japan 2021-007775 filed 01/21/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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 Statements
The Information Disclosure Statement filed 07/10/2023, 11/21/2024, 04/01/2025 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 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 19 is indefinite because it recites “said allergen-immobilization regions” and claim 16 has only mentioned a single region so it is unclear if the two or more and 100 or less allergens are all immobilized in one region or separately in a plurality of regions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 16-19 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Harwanegg et al. (US 2019/0079083, Pub Date: 03/14/2019, hereinafter “Harwanegg”) in view of Popescu et al. (World J Methodol 2018 Nov 29; 8(3), pages 17-36, IDS).
Regarding claim 16, Harwanegg teaches throughout the publication an allergen-immobilized carrier for detecting an allergen-specific antibody, wherein said carrier comprises an allergen-immobilization region on which said allergen is immobilized (paragraph 0028, coupling of detection antigen such as an allergen to the solid phase to which the antibodies can bind). However, Harwanegg does not specifically teach that the allergen is immobilized at a density of 120 ng/cm2 or more and 500 ng/cm2 or less.
Popescu teaches throughout the publication allergy diagnosis for the in vitro assessment of a patient immunoglobulin E sensitization (abstract). More specifically, Popescu teaches that IgE antibodies from the patient sample bind to immobilized multiple allergen components spotted on the solid phase, wherein 100pg of allergen are immobilized on a single spot of the chip, spot size being 200 micrometers, which is equivalent to an immobilization density of 318.36 ng/cm2 (calculated by: spot diameter is equivalent to 0.02 cm and spot radius is therefore 0.01 cm. The area is calculated by πr2, which in this case is π(.01)2 and thus an area of 0.0003141 cm2. Given that the concentration of the allergen is 100 pg per spot, which is 0.1 ng, the concentration can be obtained by dividing 0.1 ng by the area of 0.0003141 cm2, which results in 318.36 ng/cm2).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the immobilized detection antigens of Harwanegg to be immobilized at a density of 318.36 ng/cm2 as taught by Popescu because Harwanegg is generic regarding immobilization density while stating it’s importance as a variable in determining optimal support size (paragraph 0172) and one skilled in the art would be motivated to choose the optimum immobilization density based on the desired antigen capture capabilities and overall support dimensions.
Regarding claim 17, while Harwanegg in view of Popescu teach an immobilization density of 318.36 ng/cm2 , the references do not specifically teach that the allergen is immobilized at a density of 180 ng/cm2 or more and 300 ng/cm2 or less. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 17 are for any particular purpose or solve any stated problem, and the prior art teaches that immobilization density is an important variable to consider during device construction. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the immunoassay art.
Regarding claim 18, Harwanegg teaches the carrier wherein said carrier comprises a protrusion provided thereon, and said protrusion is said allergen-immobilization region (paragraph 0031, antigen-coated beads fixed on the solid carrier).
Regarding claim 19, Harwanegg teaches the carrier wherein two or more and 100 or less types of allergens are immobilized on said allergen-immobilization regions (paragraphs 0116-0118)
Regarding claim 21, Harwanegg teaches the carrier wherein said carrier comprises a reaction vessel including said protrusion provided thereon (paragraphs 0090 and 0170-0175).
Regarding claim 22, Harwanegg teaches the carrier wherein at least one of said allergen(s) is egg white (see Table 3), milk, peanut or mite (paragraph 0128).
Regarding claims 23-26, Harwanegg teaches the carrier wherein said carrier is made of a resin containing an aliphatic structure, a resin containing an ester, an acrylic resin or a polyacrylate or a polymethacrylate (paragraph 0173).
Regarding claim 27, Harwanegg in view of Popescu teaches a method of detecting an allergen-specific antibody (paragraph 0051), the method comprising the steps of: bringing a sample into contact with the allergen-immobilized carrier of claim 16 (See above), to form a complex of said allergen, and of an IgE antibody specific to said allergen contained in said sample; and detecting the thus formed complex of said allergen and said allergen-specific IgE antibody (Harwanegg, see paragraphs 0051-0064).
Regarding claim 28, although Harwanegg does not explicitly teach that the sample is a sample from which at least one type of antibody selected from the group consisting of IgG antibody, IgM antibody, IgA antibody and IgD antibody is removed, the reference teaches that the performance of the test shall not be influenced significantly by the biological sample even if the sample is not in perfect condition, which happens frequently during routine blood drawing. Typical problems can be lipemic, hemolytic or icteric sample fluids, samples with high protein content or even high antibody content (IgG, IgE, others) (paragraph 0206) and therefore it would be obvious to one skilled in the art to remove unwanted protein/antibodies from the sample since the reference also describes the need for further enrichment of the allergenic fraction and removal of non-allergenic materials (paragraph 0014).
Regarding claim 29, Harwanegg teaches throughout the publication a method of producing a carrier, wherein said carrier comprises a protrusion provided thereon, and one or more and 100 or less types of allergens are immobilized on said protrusion(s) said method comprising the steps of: immobilizing said allergen(s) on said protrusion(s) provided on said carrier; and quantifying the thus immobilized allergen(s) (see paragraphs 0321-0338, antigens coupled to beads and then beads were dispensed on solid phase. Coupling efficiency was also characterized using concentration measurement). However, Harwanegg does not specifically teach that the allergen is immobilized at a density of 120 ng/cm2 or more and 500 ng/cm2.
Popescu teaches throughout the publication allergy diagnosis for the in vitro assessment of a patient immunoglobulin E sensitization (abstract). More specifically, Popescu teaches that IgE antibodies from the patient sample bind to immobilized multiple allergen components spotted on the solid phase, wherein 100 pg allergen are immobilized on a single spot of the chip, spot size being 200 micrometers, which is equivalent to an immobilization density of 318.36 ng/cm2 (calculated by: spot diameter is equivalent to 0.02 cm and spot radius is therefore 0.01 cm. The area is calculated by πr2, which in this case is π(.01)2 and thus an area of 0.0003141 cm2. Given that the concentration of the allergen is 100 pg per spot, which is 0.1 ng, the concentration can be obtained by dividing 0.1 ng by the area of 0.0003141 cm2, which results in 318.36 ng/cm2).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the immobilized detection antigens of Harwanegg to be immobilized at a density of 318.36 ng/cm2 as taught by Popescu because Harwanegg is generic regarding immobilization density while stating it’s importance as a variable in determining optimal support size (paragraph 0172) and one skilled in the art would be motivated to choose the optimum immobilization density based on the desired antigen capture capabilities and overall support dimensions. Additionally, it would be obvious that the density quantification would be encompassed with the coupling efficiency measurements of Harwanegg in order to ensure the appropriate amount of detection antigen has been immobilized for antibody binding.
Regarding claim 30, while Harwanegg in view of Popescu teach an immobilization density of 318.36 ng/cm2 , the references do not specifically teach that the allergen is immobilized at a density of 180 ng/cm2 or more and 300 ng/cm2 or less. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 30 are for any particular purpose or solve any stated problem, and the prior art teaches that immobilization density is an important variable to consider during device construction. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the immunoassay art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Harwanegg et al. (US 2019/0079083, Pub Date: 03/14/2019, hereinafter “Harwanegg”) in view of Popescu et al. (World J Methodol 2018 Nov 29; 8(3), pages 17-36, IDS), as applied to claim 16 above (hereinafter “Modified Harwanegg”), and further in view of Ellinger et al. (EP 3505934, Pub Date: 07/03/2019, hereinafter “Ellinger”).
Regarding claim 20, Modified Harwanegg teaches the carrier as described above but fails to teach that the allergen(s) is/are immobilized via a polymer comprising a unit represented by formula (Ia) or (Ib).
Ellinger teaches throughout the publication a sensor body for binding an analyte (paragraph 0006), such as a spot immobilized on a surface of a substrate (paragraph 0013). More specifically, Ellinger teaches that the capture agents for the analyte are immobilized via porous polymer scaffolds such as the polymer of Formula Ia (paragraph 0006, poly(allylamine)-co-poly(allylurea)).
It would have been prima facie obvious to one skilled in the art at the time the invention was filed to modify the immobilized antigens of Modified Harwanegg to be immobilized via a polymer of Formula Ia as taught by Ellinger because Modified Harwanegg is generic regarding the types of functionalized supports that can be used for the solid support (Harwanegg, paragraph 0173) and one skilled in the art would have been motivated to choose to appropriate support and functionalization for immobilization of the desired capture agents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677