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 1-11 are pending and have been examined.
Priority
This application, Serial No. 18/713,773 (PGPub: US2025/0035630) was filed 06/27/2024. This application is a 371 of PCT/JP2022/044078 filed 11/30/2022. This application claims foreign priority to Japan 2021-194361 filed 11/30/2021.
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 Statements filed 05/28/2024 and 11/03/2025 have been considered by the Examiner.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 recites “an immunological partner capable of a pancreatic elastase…” and there appears to be some words missing after “capable of”.
Appropriate correction is required.
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 5 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 5 recites “the reaction solution” and there is no antecedent basis for this limitation as no reaction solution has been recited in any of the claims from which claim 5 depends.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brower et al. (Blood Vol. 61, No. 5, pages 842-849, IDS).
Regarding claim 8, Brower teaches throughout the publication a reagent for immunological measurement, comprising a solid phase carrier on which an immunological partner capable of a pancreatic elastase 1-α1-antitrypsin complex is immobilized, and al-antitrypsin (page 843, first column, ELISA).
Regarding claim 9, Brower teaches the reagent wherein an amount of α1-antitrypsin contained in a reaction solution to be subjected to a reaction step is 100 ng (page 843, second column, Detection of α1-Antitrypsin, 0.5 to 1600 ng/ml).
Regarding claim 10, Brower teaches an extraction solution (page 843, second column, Detection of α1-Antitrypsin). While Brower does not explicitly state that the solution is for pretreatment used in a pretreatment step of a fecal sample subjected to a reagent for measurement of pancreatic elastase 1 or pancreatic elastase 1-α1-antitrypsin complex, this limitation is drawn to intended use of the extraction solution and therefore the solution must only be capable of performing this intended use. As currently recited, the only active component of claim 10 is an extraction solution and therefore the teachings of Brower read on the broadly claimed extraction solution since it is considered capable of performing the same functions as claimed.
Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sawai et al. (US2004/0091940, IDS).
Regarding claim 8, Sawai teaches throughout the publication a reagent for immunological measurement, comprising a solid phase carrier on which an immunological partner capable of a pancreatic elastase 1-α1-antitrypsin complex is immobilized, and al-antitrypsin (paragraph 0023).
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Groen et al. (US 2020/0209252, Pub Date: 07/02/2020, hereinafter “Groen”).
Regarding claim 10, Groen teaches throughout the publication an extraction solution for processing a fecal sample (paragraph 0009). While Groen does not explicitly state that the solution is for pretreatment used in a pretreatment step of a fecal sample subjected to a reagent for measurement of pancreatic elastase 1 or pancreatic elastase 1-α1-antitrypsin complex, this limitation is drawn to intended use of the extraction solution and therefore the solution must only be capable of performing the recited intended use. As currently recited, the only active component of claim 10 is an extraction solution and therefore the teachings of Groen read on the broadly claimed extraction solution since it is considered capable of performing the same functions as claimed.
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) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Brower et al. (Blood Vol. 61, No. 5, pages 842-849, IDS), as applied to claim 8 above.
Regarding claim 11, Brower teaches an extraction solution containing α1-Antitrypsin (page 843, second column, Detection of α1-Antitrypsin). While Brower does not teach that the solution contains 41-975mg of α1-Antitrypsin, 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 11 are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the solutions disclosed by the prior art by normal optimization procedures known in the extraction art.
Allowable Subject Matter
Claims 1-4 and 6-7 are allowed.
While it is well-known in the art to test blood samples for elastase 1 utilizing complexes of elastase 1 and α1-Antitrypsin (see for example, Brower et al. and Sawai et al. above), the prior art fails to teach measuring pancreatic elastase 1 in fecal sample by adding α1-Antitrypsin to a fecal sample to form a complex of the α1-Antitrypsin-pancreatic elastase 1 for the analysis required by claim 1.
Similarly, Groen et al. (cited above) teaches the measurement of pancreatic elastase in stool samples (paragraphs 0038-0044), however these methods utilize ELISA comprising a dried stool sample reacted with anti-elastase antibodies. Therefore, the reference fails to teach the addition of α1-Antitrypsin to the fecal sample to react pancreatic elastase 1 with α1-Antitrypsin to form a complex that can then be incubated with a solution containing a carrier on which an immunological partner capable of recognizing the complex is immobilized to analyze a change caused by the reaction.
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
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